Event ID: 863540
Event Started: 11/19/2007 8:19:28 AM ET
Please stand by for real-time relay captioning.

this is my introductory good morning. That was the attention getter. Now the official warm good morning. That was the real good morning.

Thank everyone for being here. I have a cold, but I'm okay, not infectious. It's a genomic thing with allergies. Where is the new cure, I am tired of this stuff that doesn't work crap.

Oh. First day. All right. Well, we do want to welcome everyone to the 14th meeting of the Secretary's Advisory Committee on Genetics, Health, and Society. The public was made aware through notices in the federal registry, as well as announces on the website and listserv. I welcome members of the public in attendance and the many viewers tuning in throughout the webcast. This is widely viewed on the webcast, so be on your best behavior.

We encourage those in attendance to comment, sign up at the desk. Extended period for public comment is tomorrow afternoon. On the draft report on oversight, released for public comment two weeks ago.

Secretary love Lovett made five new appointments. I will introduce them [ indiscernible ] providing diagnostic testing and genetic counseling services, MBA from Harvard business school. She's been serve as ad hoc member of the task force on gene patents and licensing practices the past year. We appreciate that work very much. Thank you very much.

Also welcome our good friend Paul Billings, a consult@lab Corp, works on special projects. He was lab Corp's vice-president, professor of anthropology at U C Berkeley, go golden bears. Member of the joint national NIH DNA advisory committee. Degrees from Harvard, and clinical training at University of Washington wash.

Paul Miller, we must say, where are you, welcome back?

I never left.

Paul is now the Henley M Jackson professor of law, director of disability studies at University of Washington wash. Commissioner of the EE C previously, serve as ex officio on this committee. White House liaison, and we recognize your service on our oversight task force. Two areas of expertise you bring to us, our legal eagle, you are also our consumer representative as well. We very much appreciate your involvement.

Paul wises. The Richard -- professor at Stanford, work focused on children's health, help outcome disparity by race, social status and the impact of technology on disparities in health outcomes. He received medical degree from Cornell, masters from children's hospital medical center in Boston.

The secretary appointed Rochelle dray fuss, long commitment at national academy, she's the Pauline new man professor of law, two national science committees, intellectual property issues, and the past chair of the American association of law schools, intellectual property committee. Before earning law degree she earned a masters in chemistry. I understand you are serving today as ad hoc members of the committee, pending completion of the wonderful appointment process. In that capacity you are not yet voting members of the committee. None None the less, we encourage you to comment. And we hope you have the courage to say I don't understand where you are in the discussion, please explain, because I haven't been here the 13 years everybody else has. That's a good thing. I hate it when I come to a committee new, or newly, or something. Everybody knows everything and I don't know diddley squat, so I urge you to ask as many questions as you want. Participate in everything but the vote. We will be happy. Welcome to the new members.

While the appointment is occasion to celebrate, often accompanied by departers. Tomorrow we will say good-bye to three retirees. Cindy Barry, and [ indiscernible ] Hunt Willard. Oh, there you are, she is here. Coming tomorrow. Sad about that, but we will be sad tomorrow. Not today.

I will welcome a new exfishio pb, Dr. E AE sop -- [ indiscernible ] I hope I got that right. I have never gotten it right. First time in history. Medical officer, clinical consultant with the office of population affairs, issues relating to family planning and adolescent family life. We appreciate Dr. [ indiscernible ]'s contributions, look forward to working with Dr. Aesop. Barry is a good valued colleague of mine, a chief medical officer at -- taking a much more direct involvement in our work on behalf of CMS. His presence today, know he can't stay the whole day, but Barry is making a conscious decision by his presence to really really emphasize how important this work is to CMS. I really appreciate your being here today.

I recognize ex officio's contribution, Dr. Robinson -- the director for the office of civil rights, responsible for overseeing program operations, policy development, received the secretary's highest award, distinguished service. Honored for commanding leadership in the work of civil rights. I congratulate you from the committee for your dedication to the citizens of this country. You dedicated your career to upholding civil rights employ after doing that, she's not here yet. That's fine, because it's in the record, and we will remind here we did this.

She's terrific, and great.

I will update you on the secretary's personalized healthcare initiative. In September a report, opportunities, pathways and resources. You may recall the secretary was kind enough to send each of us a copy. Identifies -- as well as the work that lies ahead to bring it to reality. We commend them for the work. Summary of an expert panel meeting in March. Assistant secretary office for planning and evaluation. Payers, representatives from industry and government, advocates. Five issues need to be addressed to represent personalized healthcare. Clinical -- validity, and utility. Value and cost effective fens, the need to build -- impact on health disparities and education of providers and patients. A copy of that workshop summary is in your table folder, and you can of course, download it from the HHS website.

There have been activities within the personalized healthcare group related to the second's personalized healthcare initiative. We are staying abreast through the participation of Andrea. There you are. Steve, as well, and Mark Williams. Thank you very much for your effort in this initiative. I have been tuning in by telephone, conference calls, and the work is very important, and key to what we are trying to do. At the beginning of each meeting I have established a tradition, will continue to take a moment to review our strategic plan, the status of our progress in fulfilling each of our study priorities. This gives an overview of what we accomplished to date and helps us stay focused.

New members of the committee, this was a plan that we as a collective team developed several years ago. It will be, before very long, time to revisit this again. This is not one of those government committees that just wanders around aimlessly and bumps into walls. We actually have a plan, have a set of priorities. We actually are implementing them and keep track of what we do. Hopefully we will continue in that vein. We may bump into a wall here and there, but we usually know what walls we are bumping into. The vision statement, how we reached them, in 2004, and continues to guide the group. The misuse of genetic information and discrimination has been our highest priority issue. We have written a number of letters to the secretary to enact laws to prohibit discrimination. Provided a legal analysis regarding the inadequacy of public law, documents showing public fairs about genetic discrimination. Interesting and compelling DVD of testimony received in the fall from the public in 2004. We also strongly supported the genetic information non-discrimination act of 2007, HR 253, commonly referred to as GINA, protects from discrimination based on genetic information. Supported on both sides of the political system. President -- will sign the bill in presented to him. Tom coul burn placed a hold on the bill in July, debate in the Senate. Supporters working hard to move the bill forward. Louise slaughter of New York set up a petition to ask senator Coul burn to drop the hold.

We developed a resolution about the importance of health education and training of professionals, how they could be advanced, genetics information and training for health professionals. Six speakers will report on the progressing of genetics education and training activities. These presentations will be followed by a one-hour discussion of critical needs in education and training and the best approaches to meet the needs. Four A decisional panellests will -- you will be deciding what if anything we need to do going forward on this topic. Whether we will continue to keep it as a priority or move it forward or let it go, say the world is safe, we may all return to our homes. That will be your task.

In 2006 we transmitted a report and recommendation to the secretary on coverage and reimbursement of genetic test and services, highlighting how problems in the system affect, and nine steps to overcome the barriers. These recommendations cover a range of topics, including evidence based -- Medicare coverage of preventive services, the procedural terminology codes, billing by non-physician genetic counseling provider and genetic education of health providers. And July CMS sent feedback on the recommendations. A shawl group of members led by -- has been reviewing. A copy was shared with you in October. We will take two CMS exfishio, Barry, in December. Our report. I will report back to you on the outcome of that discussion. Barry, you actually were at the meeting when presented to the head of CMS. It was a t was a terrific discussion. This is one of our successes, I am pleased about, led to enhanced collaboration between the FDA, CMS, and FTC, consumer alert issued to warn about using at-home genetic tests that have not been evaluated and be wary of claims. In it July we heard from CDC about their work with the potential to -- genetic testing. As part of the personalized care -- to coordinate activities and -- the office of secretary is leading this effort, will keep you updated on the progress. Greg is actually here. Would you wave? We have enjoyed such good close access to the secretary's office on a day by day basis, Greg is the person behind the curtain to make that happen. We are greatly dedicated to Greg for it. Concerning large population studies, the committee's report, cohort study of genes, environment and disease completed and transmitted to secretary Lovett. In August the secretary sent a letter acknowledging receipt of the report and the timeliness of our recommendations. You can find this letter in tab 6 of the briefing book and posted on the website. I point out an article about the LPS report published in the July issue of science and medicine, the development of report, letter to clarify the skoals goals and scope of the report. We have given them a what-for.

For more than two years we have been developing a reported on opportunities and challenges on genomic research, products, incorporation into public health practice. In March the draft report was released, comments carefully considered and in the fall a revised draft prepared. Most of our work today will focus on the recommendations is and the draft. Our goal is to come to closure on the recommendations and approve the report for submission to the secretary. No fooling around. We are going to close this out and make a report.

In June 2006 we decided to -- licensing practices on patient access it genetic technologies. The task force hosted a round table to discuss international perspectives on gene patenting and licensing strategies. Since then the task force has been working with Bob Cook began. We will continue to meet monthly to develop -- report and final product expected in 2009. Sprve issues related to the adequaciy of -- an extraordinary 33-member Task Force Chaired by Andrea. In response to the secretary's charge. It takes a village.

Now, for those now new members, the number one issue for us is genetic discrimination, always been. Number one historic issue of which is committee is successor of preexisting committee, was the issue of genetic testing. This is really in our -- don't get mad -- in our DNA. So, through dedicated effort, exceptional leadership the report was released for public comment on October 25, public deadline for comments on -- we will review, have presentations together, academic and public perspectives, brief on the analysis of genetic testing, learn about the conclusions of the summit meeting, topic in -- providing opportunity for interested stakeholders to share their perspective. I want to make sure this is absolutely clear: There is a considerable time period for people to comment. The public comment period does not end until December 21. I am say IT several times. We are having much opportunity for public input. At the end of this, I am trying to be as transparent as I can to every stakeholder in had this process. It is an open process, transparent process. If you are a member of the consumer, if you are general public, if it you are industry, if you are health professional, whatever your particular stakeholder view is, this is open process with lots of time to get your comments in.

I have reasons for being as emphatic as I am. To not be participated in the public comment, all the ideas gotten, so Andrea can duly deliberate over the best ideas. We have been pretty clear about that. In Mar much we added gene based applications. This effort combines two proposals, on the economic impact on genomic consideration and gene based applications. Steve Tor itch will be leading, including some of the same questions, issues involved in evaluating outcomes. I want to be clear the evaluation of outcomes based gene based applications, identified, hanging out there. Quite frankly, as you can tell from the long introduction, we have a lot on the plate, want to get this other stuff done, then will move on to that. The cross-cutting issues of access, public awareness and genetic exceptionalism, we have continued to integrate into the committee's other work you have heard.

With that, I hope you all get a sense, and for the new folk, I hope you don't get intimidated by the amount of work, but we are a very active, very committee. When all said and done, evaluated by committees, I want us to be not only the most prolific, but the most focused and intense. We are out front on all those scores.

Any questions from anyone before we get down to -- I will take a moment. We put a lot in front of you, let's take a minute and ask for questions.

That will give me a chance to drink my coffee, perfect.

Now for the serious highlight of the meeting, the ethics rules review by Sarah kier.

Good morning everyone, thank you Reid. You all have been A pointed as special government employees to the committee. Although in a special categorying you are subject to the rules of conduct that apply to regular government employees, outlined in a document called -- received when you were appointed to the committee. I will highlight two of the rules, as I usually do. First, conflick the of interest. Before every meeting you provide us with information about your personal, professional and financial interests. Information used to determine whether you have real, potential or apparent conflicts of interest -- while we waive conflicts of interest for general matters, we believe your ability to be objective will not effect your interest, we rely on you to be attentive to the possibility that an issue will arise that could effect or apeer to effect an interest in a specific way. We provided each of you with a list of your financial interests is and relationships that could become an issueif this happens, we ask you to recuse yourself from the discussion and leave the room.

Government employees are also prohibited from lobbying, and may not lobby as individuals or as a committee. If you lobby in your professional capacity or as a private citizen it's important for you to keep that activity separate from the activities associated with this committee. Keep in mind we are advisory to the committee of secretary of health and human services, we don't advise the Congress. I thank you for being very conscientious about these rules.

Reed V. Tuckson: The idea, also important, reminder to everybody, the idea of we are advisory to the Secretary. As you start to think about what we can do, you think about the multiple roles of the secretary of health. Those multiple roles are clearly, in terms of responsibility for the CEO of all those agencies, but also of course the Secretary [ indiscernible ] our recommendations are within that framework. We can't go tell the Congress what to do even though we thinking we know. Be careful there. I want to be shore as a committee we are attentive to each other of the hats we wear. The reason you are on this committee is because of your expertise, because of the places from which you arise. It is a very considerate process to get people from industry here, from academia, the genetic counseling community, from government, the payers. People from many different places. It is -- everyone knows who you are, they are following this discussion. So you are free to let people know what you think. Let them know where you are, where you are coming from. Conflicts of interest will be attempted to, monitoring, all kind of people monitoring those sort of things. At the end of the day you are who you are, you bring the expertise to bear, you shouldn't be shy about that. I want to make sure you are comfortable because of who you are.

One of the main goals of this meeting is to finish the important work we are doing on pharmacogenomics . We need to come to closure, be satisfied on the final content. The discussion in tab three in the briefing book, we will go through those. Before I turn to our leader, Kevin FitzGerald, I want to express the committee's appreciation, and Emily, chairing the task force during her appointment. You were instrumental in conceptualizing the approach and getting it off the ground. I thank the members of the task force, Kevin will name you. I thank -- for providing additional resources for the report's depment and the excellent services of Clint good man of the lo in group, and Susan goodwin of our staff for excellent work as staff lead on the project. Anybody who worked with Suzanne knows she's a tough tough task master, and intimidates all of us. We are grateful for you and your high standards, hard work and commitment to excellence.

We will go at this an orderly way, we will bring this thinking in on time. Kevin?

Kevin FitzGerald: Following up on what Sarah was telling us, I have to make an announcement that I have a significant personal interest in getting this done today. So I have a bit of conflict here. If this doesn't get finished today my personal well-being will probably be at stake. During the break if you want to see the psychological scars I have received sitting here between Reid and Suzanne, I will make those manifest.

Right now I would like to give you history, overview of the report, where we have been, what's gone on, to bring us to this day. As you can see on the first slide, indeed as we reiterate what Reid said, we are all about the finalization of this report.

The we of course is significantly dependent on the task force. Now, it's not exactly a village, more like an extended family. As extended family we were very open and frank with one another, that's how we got to where we are. As you can see, it's a great group, we had Jim Evans, Andrea, JULIA, Steve from the committee itself, and of course everything was begun by Emily. I too would like to thank her. She got the ball rolling, I just let it run me over and hang on. I would like to thank very much the input we have from our HHS representatives, Ger bin, Steve, Liz, Allen, Greg and Rochelle. Without their imput this report would be no where. We really did rely on their expertise and insight. At the end of today I will do a few more acknowledgments of people who were instrumental in getting us to where we are today.

How did we get here? Well, we began with some informational sessions which gave us the direction and the goal for the report. The first thing we had to do subsequent to that was a compilation of all the activities that were already ongoing. This is not something we initiated out of thin air, as the report from the secretary indicates, this has been building for some time and is really taking on a great deal of momentum.

To get a good sense of that momentum we did a review of the literature to see the different perspectives that are out there, particularly to try and pick up the concerns that different experts from different perspectives have about how to move ahead with the idea of pharmacogenomics. This led to revision says of a draft report, we came up with a certain number of recommendations, then sent that draft report out to be reviewed by some experts that had been identified as people who could give us a more comp comprehensive sense of where our report was sit waited at that time in the thinking about pharmacogenomics. In response we did a if you few more revision and sent out for public comment. I would like to give you now a sense of that public comment process.

The public comment period was from March 23 to June 3, ample time to get ahold of the report and give us responses. To facilitate that process there was a directed targeting of some people, as you can see. After the announcement it was put on the website and the listserv, totally 936 different addresses. There was a dear colleague mailing to A decisional 283 addresses, and finally, some specific requests to organization membership, that was about 31 different organizations. We really did attempt to get a broad and deep response from people because of the significance we feel of this report.

We tried to break down for you a sense of the terrain of the responses. Now, one thing I would like to point out, it says at the bottom the total is 57, that's not 57 individuals. That's 57 different compilation responses we received. If you look at the public responses, many came from multiple individuals or from entire institutions or organizations, as you can see, obviously representing the thought of multiple people within one response. As you break down those public comments you can see in our little pie chart four were from government, 10 came from companies, 18 from organizations, and the largest group from groups of individuals or individuals themselves. On the right, gives you some of the idea of the specifics of those subgroups. From the government, NIH, O CR, veterans administration, E EE lie lily, host of acronyms. This is wash Barb Washington D.C., you don't exist if you don't have an acronym. The individuals came from academia, healthcare providers, researchers, et cetera.

What was in the comment? It really ran the gamut, covered broad spectrum of concerns and suggestions, and some were fairly focused, looking at the text itself and offering corrections to inaccurate statements, data, or data we needed to update. Update of various activities that were ongoing about which we were not aware, and general ideas on how we might improve the report overall. Then there were also comments on the recommendations, that area that most people look at when they look at one of these reports. As far as modifications to existing recommendations, thoughts about which recommendations we should prioritize over others, and finally whole areas that we had not considered, so new recommendations that we thought about adding to the report. That was the sense of the overview of these public comments. Now, to give you some more specifics, just so you get a feel for some of the content itself. One of the comments that we heard more than once was that the report was somewhat overly optimistic about the long-term potential of pharmacogenomics. It doesn't do good to put something out that isn't -- we took that seriously. We wanted to in fact make sure that the report, as it goes out, is the best we can do to give people a sense of the terrain and the possibilities.

It was suggested that we needed greater discussion of the international efforts that are ongoing. Obviously we are advising the Secretary of the Department of Health and human services of the United States, however, when one looks to see what decisions one might make on a policy level, one wants to know what's going on elsewhere to get compare and contrast. That was beefed up, we looked more [ indiscernible ] at some of the collaborations that were going on internationally and in a public/private venue. This raises the question of whether our conceptualization, our definition of pharmacogenomics is adequate. I thinking it's a moving target. I certainly do not want to chaim what we will put out in the report will remain true for all time, we hope it provides a platform for the Secretary to move ahead.

I mentioned several times the desire for SACGHS to -- oversight of genetic tests. We are responding to that disiefer in desire in an entirely different report. There were more focused suggestions, call for federal government to call for collection of DNA samples to facilitate the report research. This is addressed in the report.

Need criteria to design what farm pharmacogenomics -- obviously another important aspect. More emphasis on the need more clinical effectiveness, payer reimbursement, approach to reimbursement for genomics products. Interestingly, a disagreement in the comments, whether pharmacogenomics will necessitate genetic counseling. Something we attempted to wrestle with, not necessarily saying it will come out one way or another, we can't predict how things will go in the future, but certainly an issue that needs to be continually revisited.

We received, as you saw from the timeline before, the full set of comments in June of 2007. Each of the task force members was assigned eight comments to review, so that we would get two people on each comment, and then hopefully get a little bit of variety of opinion from our own task force members, and then staff, IE Susan, reviewed all 57 public comments, and after the therapy she seems to be doing okay.

In our review of all the public comments, we tried to answer a series of direct questions. First of all, looking at the comments that one had to address, which should be in the next draft of the report. In In other words, should something be changed in response to a particular comment. Of the coms addressed, which would require the entire task force to discuss, or which could just be addressed directly by staff. Primarily, the updates were something that could be directly addressed by the staff, putting in new information. That was one of the examples for how we would take something, and not necessarily bring it to the entire task force. Of those that warranted discussion by the task force, how then did the task force think we should go ahead with those comments. How did we do this? Logistically? We had conference calls, long conference calls, two long conference calls, both TWO, and TOO. One was October 16, one September 10. If any of you have done these three-hour calls, after a while you are concerned about having to have the phone surgically removed from your ear. But in any case, a lot of was done. We reviewed the discussion compiled by staff, comments organized as you see, and primarily primarily focused by the task force and we discussed the items, flagged the ones that we had to discuss as a whole, ask then and then just made decisions about how or whether to incorporate the comments into the report.

I will mention this too, at the end, Reid already mentioned it. As with many of these things, there are people behind the scenes, without which nothing like this would get done. Again, the Lowen group has been fantastic, professional, also responded well to intense psychological pressure. Very handy thing to note for the future. So, in collaboration with them, the report was revised, recommendations were revised and then we went forward with that and the revised report is in the briefing books under tab three.

As we have heard several times, we wanted to reiterate that today's goal is to finalize the recommendations. We need to get even the wordsmithing done so we know what will move forward from here. This is what the committee needs to vote on. Now, if anyone again has specific editorial suggestions to the report itself, we would be very happy to hear those, receive those. Those we don't necessarily need to address today, those can be incorporated in a continual editing process that will go on after this meeting. I would recommend if you have anything specific in the report itself, body of the report, that you somehow indicate what that change would be, and please give that to Suzanne so we can compile those and look to see how they can be incorporated into the report. Our focus today is on the recommendation, we need to get the wording down for all of them so we can go forward with those.

Why do we need to do that today? Because after this we pull together everything so that in December the committee members can see the final report. What exactly is going to go to the Secretary. Then that report will be copy edited, made camera ready, and printed. Finally in February we target that time to send the report to the Secretary, so the secretary's office has a month to look over the report, respond, then release to the public, hopefully within a month. That is where we hope to be able to go in the immediate future. So now my understanding is everybody is to get a break before we get into the report or no? Keep going, get started? This is the way it is. Every time I suggested a break Reid would say no, go, go. It's just --

All right. Forward we go.

The organization of the report. As you noticed, mentioned before, the report is in tab 3 of your books. I believe, due to a specific recommendation from Andrea in one of our earlier meetings, the report, we all agreed, was organized into three overarching themes. These were areas where we thought important aspects of pharmacogenomics could be broken out into subgroups and addressed in a way that would allow us to keep contained within that subgroup our comments, and yet at the same time make them into an integrated whole, which the whole report is supposed to be. Research and development, the gatekeepers and implementation of pharmacogenomics, to improve out comes in clinical and public health practice.

It would be impossible for me to overstate that third piece, and the focus there, to improve outcomes in clinical and public health practice. This is something again and again to come which we returned. This is where we hope, think the good of pharmacogenomics can go.

There are 15 recommendations, but any of you that remember your college exams, one question, eight subparts. We have 15 recommendations and only 37 subparts. Not so bad.

This is the first significant section of the report, research and development. This broke down into further areas, basic research, translational research overall; raising the questions, how does one then build an infrastructure that will enable and facilitate this research. Finally the ethical, social and legal issues that come up in research and development. One thing you will notice going through the report, the L C issues are raised in each of the three sections. We could have had an L C session, thought it was better this way, thought it was better to address issues as they came along looking at the other subsections.

Looking at the second section, we talk about the gatekeepers, those who we identified and others helped us identify as the individuals critical to moving pharmacogenomics into the public sphere, of getting it to those improved clinical and public health out comes. The four groups identified: Industry, FDA, CMS, other party payers and clinical guideline developers, professionals in particular. If you notice one thing here. Before I said we well eight recommendations, here we only have one. That doesn't mean that this subsection somehow is of less importance. As I mentioned, these are the gatekeepers, the bottleneck. You are only talking about the bottleneck you need one recommendation; how to make it work better.

Finally we get to the third section, the section that focuses on where we hope pharmacogenomics can ultimately go, the implementation to improve outcomes in public heeling public health practice. This will address self, public health, guidance, economic implications of pharmacogenomics, ethical, legal and social issues in clinical implementation of fampl copharmacogenomics, and pharmacogenomics activities.

One of the difficulties in any of these reports is being able to draw clear lines of distinction. It's virtually impossible. However, I think what one can do is try to identify [ indiscernible ] from which one looks out then at the broader picture. Technology, economic implication, coordination of activities within HHS are going to be relevant to all kinds of different issues we address. Large population studies, oversight of genetic testing. What we tried to do here is to situate some of the broader issues within the context or focus of pharmacogenomics. The fact that, and we intentionally took this into consideration, parts of this report will in fact hopefully overlap well, or accord that coordinate with earlier studies and subsequent reports, like the oversight of genetic testing. We tried to in that way formulate this report so it is part of a continuum of the work of SACGHS. You will see in this section we have recommendations 10 through 15 with 16 subparts.

I hope that gives you a sense of how the report was structured and how we think, in any case, the report can best address the issue of pharmacogenomics. What are we going to do today? We are going to stop now and listen to Reid.

Reed V. Tuckson: Given we are getting ready to get into the discussion, report. We will take a break for a second, that way we won't interrupt the discussion, just plow right through it. This is the challenge, we [ indiscernible ] breaks. I don't. We start exactly when we say we are going to start. We do what we say we are going to do. You know that. By the way, Robin, we have read into the records all manner of incredible things about you. I want to say to you that we are very proud of the honor you received, highest award [ indiscernible ] ethic and great on this committee, we think you are wonderful. A round of applause for Robin.

Applause.

Now she will beat me up at the break. We will start at 20 of, that gives you 15 minutes, five, 15 -- 20 of, starting with the discussion. If you are late, oh my God, the woe that will befall you.

[BREAK until 9:40:00 a.m. eastern time. ]

we will now get to the discussion of the recommendations of the report. If you will all will take your seats, and we will now begin with going through the report itself, take it away Kevin.

Kevin FitzGerald: Let me begin by trying to focus our responses to the recommendations as we go through the report. For each section of the report we're going to review the key issues that we thought important to make clear, then we're going to look at the current language of draft recommendations. So the emphasize here is on current. Nothing is written in stone, however, if you wish to change the language you have to write the changes in blood. I want you to know it's going to cost you. No, we certainly are open, encourage all improvement to the language of the recommendations. Then we will work -- Suzanne is going to do this real-time. As we're making the recommendations you will see them up on the screen, and you will always have what's in your book to do compare/contrast as we move along. The idea is that we will get these recommendations to where we want them to be, then at the end, when we have done all the recommendations, and subparts, that's when we will vote on them as a group. Why don't we vote on them? Because we may do something later on, in a subgent recommendation that makes us re-think the wording we used previously. I want you to know that all remains flexible. If you believe to go back, revisit something, something pertinent, subsequently we can do that. At the end, the idea is to take them as a package, say this is what we want to put forward as recommendations. If we have time sub subsequent to that we can look at other recommendations. The key today is to get the recommendations well-structured and claved.

Recognize clarified.

As looking at recommendations, things we want to keep in mind. We are as advisory body to the secretary. The recommendations we want to make to the Secretary, these recommendations the best way to address the opportunities and challenges that we raise in the report? And of course, if you are not satisfied with the wording of the recommendations what wording do you suggest?

Subparts, clinical, translational, infrastructure, and again, we are in Washington D.C., so everything is acronyms, but sometimes it's good know what the acronyms stand for. Elsey is the short way of saying ESLI. The acronym for ethical, social and legal issues. It's not the name of my cow. Easily, easily L C, I'LL issues in legal and social ethics, however you put the acronym together, those are the issues to be addressed.

In the report what we identified is that more basic research is required. That needs to identify biochemical pathways, markers in drug response, to refine and improve sensitivity of high throughput methods for gene expression and drug response and look at gene -- in variability. As you see here in the basic research the focus is a great deal on what the response is going to be to particular drug therapy. Or drug intervention. One example of a group looking at this kind of thing is the genetic association information network. On page 24 of the report there's a small explanation of that, I don't want to go into that now. You can follow along in the report as we go through it.

Moving from basic to translational, team one translational research to validate basic research findings and apply to development of pharmacogenomics products. We are all familiar with the intent of that research. This has to be an important part of the entire pharmacogenomics project. Another example there is the pharmacogenomics research network. You can find that on page 25 of the report.

Moving from translational to clinical, one aspect discussed, also saw a great deal in the literature, the hope, at any rate, that pharmacogenomics can enable smaller, more efficient crinical trials. How? By using the test results to screen out subjects more likely to experience adverse drug reactions and conversely, identifying subjects more likely to respond well to a drug. The whole idea again is to use the basic science information and data that is gathered to bring it to clinical trials. A greater focus on avoiding harm and gaining the benefit.

Obviously in order to do that you have to have tests, how will people respond to the drugs? What incentives are there to develop these tests? One would be projected market utilization, return on investment, as mentioned obviously if you can avoid adverse events and improve benefits from any kind of drug therapy, that presumably would have a better return to your investment. This would lead to positive clinical impact because you would have the contribution, bringing in DNA sequence as a way of improving on overall healthcare, come includes non-genetic aspects. As mentioned already, hopefully reducing the prevalence of adverse drug reactions.


Licensing practice is something that needs to be addressed, very much a driver in the A A arena.

So if there is going to be a development of the pharmacogenomics test, how does one look to see this development working along side current drug development. Will there be a code development of pharmacogenomics drug and diagnostics?

It's not the resistance is a bad thing, it's a good thing, helps us focus on the issues, formulate good responses.

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Some of the areas that --[please hang up phone line so that new captioner can dial in ]


[AUDIO LINE RINGING BUSY FOR CAPTIONER. PLEASE HANG UP LINE SO THAT NEW CONNECTION CAN BE ESTABLISHED FOR AUDIO]

So let me add, although I am not sure it tinges the recommendation, it may not necessarily be a very small piece of the population for which is the case. It could be one for which there is a dramatic negative effect on a small piece of the population where it is critical that does come out in that the report itself you talk about this, but it is important to link this to the comment on market segmentation is the idea that it could lead to a smaller market segmentation is one piece, but it could also lead to the creation of a market that otherwise did not exist. The two-part close, but directly comparable.

Thank you. The focus at least we were looking up today is on resistance. Obviously that would be an incentive. Thank you. It is worth the effort of getting you up the microphone. So he packed as we address these issues one of the questions that came up was, let's see how we can, perhaps, delineate these incentives or these resistances. This is one way in which we put to do it. So as you mentioned that testing does have the potential to improve the safety and efficacy of drugs on the market even in a Broadway. So what are the incentives for pursuing edification of these new indications? Well, obviously if one skill as a drug of the patent, that would create a greater financial incentive. Obviously less if it was off patent. Again, if that adverse reactions are severe than one has greater incentive to address rather thought mild. And if of course there are alternative treatments available care is less incentive because one can't just use an equally effective treatment. So we just wanted to clarify the spectrum on that issue. Looking at the small target populations and where pharmacogenomics might get a far from, it raises the issue of what if it is a very small target population? "we already have special provisions for orphan drugs and humanitarian use devices, and these could propel or could encourage the development of pharmacogenomics Christ Darden and test all populations. The difference is in this distinction we have the threshold for help these devices or drugs might be categorized so for an orphan drug, for something to be an orphan drug the target population must be an intuitive thousand people. Over something to categorize as an orphan diagnostic, aren't standing is and has to be under 4,000. One question is, if we are talking about the co development of diagnostics and drugs, is that different to have is that a to make a difference? So in other words the orphan drugs could be favored in its development over the companion diagnostic. Is that Greg to be a problem? This too was raised in the report. Moving from basic to a transitional, these were some of the issues that were raised in our investigation of pharmacogenomics. Obviously the adoption of technologies will hinge upon evidence in critical and public health practice which is as we mentioned at the beginning, the cold. Is this going to get us better clinical utility? , also and involved and this will be the idea of cost effectiveness. At what point does the cost of a particular to could begin to affect how it might actually be disseminated into the public in spite of the fact that it might have a significant clinical utility. One of the major issues we discovered which will run throughout the report, there just isn't sufficient evidence. In part, that is because we are early on and the pharmacogenomics process. In part it is also that there haven't necessarily been a lot of incentive to gather that evidence. That does not mean that some groups are to looking at it come up really one of the things that we found was copper hit we did not find sufficient incentive to produce this evidence which, of course, is absolutely necessary if we are trying to understand what that clinical utility is to be. Looking at the Research and Development infrastructure pharmacogenomics research and development could benefit from sharing and linking of research and clinical data bases, repositories, and records. When looking at live report that was cut output by the Secretary of personalized medicine you find the right treatment for the right person at the right time. Great. Nobody can argue with that. How does one get there? One of the things that had become clear is in order to do that you must have an inordinate amount of information and the ability to compare and contrast different datasets across different areas and an infrastructure. How can these be better linked so that that sharing of information can occur? There are significant challenges to this. There are IP concerns. There are variations and data format. Electronic health records are still in early stages of development, and there are different funding streams for all of these things. For the stakeholders, the adminstrative protocol and for organizational cultures -- different funding streams as well as different [ indiscernible ] different administer [ indiscernible ] and organizational cultures. They all lead to be addressed for us to get this sort of information sharing that we think is going to be absolutely necessary for moving ahead with the benefits of pharmacogenomics. As I mentioned, even the these challenges are very real there are areas and groups that are beginning to look at these challenges, and we have this list at the bottom here. They're is a daughter longer list in the report of projects that are already attempting to address these challenges. To the ESLI issues, all ethical, legal, and social, and the research and development of pharmacogenomics, here are some of the issues. Obviously many of these will be familiar to you, but it is important to bring these to the fore. Certainly privacy and confidentiality concerns are associated. If the only way that this does word is that researchers and clinicians have a great deal of access to personalize information, how well those persons be protected from any misuse of that information? And there will be trade-offs. The war has kept -- to access call the more risk. So how do we balance protection curses Abela sensitivity? This is one of the big issues that must be addressed. Another is that currently there are discrepancies between human subjects Research regulations, especially for coated specimens. One example is the comment rule versus that FDA regulation. If you what more specific secant look on pages of 51 and 52. That was another issue we flagged as something that the secretary could certainly help to have addressed. Another area that has come up, and this is not just in the pharmacogenomics arena, but one that must be addressed, is the concern that concepts like race and ethnicity might be involved in the development of pharmacogenomics in a way that is not beneficial. Instead it leads to greater health care disparity or even their confusion of exactly what the biological categories are being addressed versus some more socioeconomic categories that are often used in society. These issues also must be flags. Finally looking as we try to from a variety of different perspectives from the perspective of the industry, there are liability risks associated with questionable marketing cames -- claims were incorrect or misinterpreted test results. How will these areas of the to some confusion and potential conflicts be addressed in a way that everybody can move forward with the benefits of pharmacogenomics? Okay. So with that overview we get at the draft recommendations. This is a draft recommendation one on page 25 of your report. El at this point I need to let you know that the wording you will see on these slides does not always match the wording that is in the report before you. So some changes have already been undertaken. We are here to finalize. Would you see on the screen may vary from what is in your report. This recommendation is on pace 45. If you notice under number one on the slide you will not find two propositions that are in your report. Basically a search on the biochemical pathways as assistive but drop would double as an antidote pathways. In the report it says on the gene and gene creations. And on the function of the genes tested the safety and effectiveness. That is sub part one to a draft recommendation one. Take a look at it. Any comments, questions, suggestions? Our people happy with this? This is our first recommendation. NIH should put more research into, research on the bottom of the path is associated with drug metabolism and strike action, jeans and Jean variations involved in these pathways and the functions of the scenes with the to the safety and effectiveness of directory read.

By the way, can we is still caught Kevin, what is on the board is the newest?

Yes.

That is what we are working from?

We are right to work on what is on the screen and any wordsmith thing will be immediately placed on the screen. And in the end we will have all we have on the screen. For its point of clarification 43 When we say more resources do we mean a higher level than currently where do we simply been continue to put resources? And if it is a higher level can you tell me what that is?

Compared to what? Compared to.

But I to know whether it is compared to or something you continue to put resources and.

To be particularly precise I will just pull up what is in the report. First of all, the board that is there, if I believe this is accurate, it does indicate more in that sense of increased. I cannot give you the exact level of what is their right now, and I am --

Because NIH couldn't tell you.

Correct.

Suzanne knows, but she is not telling. So the idea here was to say that this the tip be an additional effort. That answers your question.

Yes, Paul?

The recommendation is asking for NIH to dedicate more resources. Is there a problem with asking Congress to sort of appropriate more resources as opposed to NIH basically taking from its limits upon the loss sort of moving the chairs around as if it were some day?

We can't recommend to Congress, right? If you what sets itself officially --

No got I guess that is sort of just -- I just want to fight that, that basically the reports is saying preference this immediate need and pressure on NIH over other immediate needs NIH we really the issue, I think, goes back to cars in terms of appropriating money. And given where we are and given the limitations on the advisory committee, that is just the way it has to be, is that correct?

I think what you are getting at is that be what the committee or the recommendation to the other call for the request for additional funding word you want us to specify whether we are asking for NIH to adjust it's current priorities.

My preference would be that it comes out of additional funding and it is hard for me to -- or it is hard personally for me or the committee to state pharmacogenomics deserves a higher price a priority than cancer research or never. That is an implicit issued within the recommendations.

Are you saying that NIH should have more resources available? How are we advocate the have more resources to put into?

That would be my preference. I don't know if NIH has a problem with more resources.

We can do it that way.

Okay. So NIH should be given more resources to put into.

What about the initial resources? Would that be --

You know, we recommended the secretaries seek more resources. The way to fudge it wold be to say the budget would be more resources be made available without exactly saying how.

Or maybe the way to identify the issue would be NIH is in need of additional resources, and those resources should -- additional resources to put into.

To increase its efforts and that areas of -- something like that.

It be appropriate to say something on the order of that NIH should develop funding initiatives? That is the process. You actually develop an initiative with defined goals.

I guess it is my understanding that NIH prepares a budget request each year to give to congress and so that is their opportunity to ask for what they need. So I think that is where we were trying to get to. They should define how much more resources they need and ask for those.

Yes, I guess this has not come up before. Our recommendation going to the agency's, we would all like to have extra. I am not sure that we need to massage as this one to death, but obviously what needs to happen is the integration of of economics into all of these activities from basic to a transitional, there could be a global statement at the beginning of the report rather than personal out each one of these recommendations because they all require additional resources.

And this one, it is that now it is pretty obvious that there is this time of very constrained resources. Even during the middle of the and desirable some estimates dissipated and the this did not so I think that it should be an area of importance with whatever budget you have. Even when new funds have been made available in large amounts, not everybody saw that need.

Would people be comfortable with NIH should receive and and put more resources into? That covers both.

I guess that would work.

Thank you. Bahrain?

Why do we have to say that? Everything will have to say the same date.

Roll-call why don't we just go through the rest of.

Okay.

We will put this down temporarily until the -- all right. Member to -- first of all, is a really happy with one?

The segment you have lifted out safety and effectiveness which is that the FDA said the Tory language. And it is and a victory of course. I would suggest that frees up to add to about reasonable and necessary is that term. Medical as a succeed in its present quite a bit. And what of the weakest we have had over the years is that the basic research.

At six and effectiveness but it is the look at medical necessity and gather evidence as much as it might to make the payments structure be able to respond. So I put suggest that this ought to include some mention of medical necessity are reasonable necessity. We will talk later on when we get to [ indiscernible ].

Elite?

At think we were trying to differentiate that basic research, understanding the underlying science from the kind of things you are talking about would come later in our recommendations as we get more into that a transitional aspects of it. At that point absolutely we want to look at those things, but if you don't understand the basic biology then it is hard to move to the next step. What we try to do is break this down into several subsets. The first you have to do is basic and then a transitional and clinical. At the end you obviously want to have all of those measures plus the health economics understood.

I understand the logic. I have a just suggesting that I can't tell you how many times we have many folks including around this table coming in and are asking for information that if it had been talk about way back and that basic science face could smooth the road. That is all.

So let me just get the sense of this. If at some point in one of these basic research recommendations put in that would it -- would you what it in every one?

No. I am did try to sensitize the committee.

The next one might have a slot work it would fit nicely.

Okay.

Just one question on number one of one. When it talks about drug treatments, but her aunt you to are correct diagnosis of as well. Does this one need to or can it brought an adjust to say safety factors effectiveness of treatments and diagnoses are with this just yet to be [ speaker unclear - audio low ]?

We would put in effectiveness of drug treatments and diagnostics.

Or diagnostics.

Anybody have any problem with that? It is just more inclusive. So then diagnostic is good. All right. Any others on this is to on a parade. Let's move on to the second one. If your hand is up and I miss you, just throw something blunt and heavy. None hypothesis based approaches to the understanding -- putting more resources into an on hypothesis based approaches to the destiny of the rest should between genetic variation in individual's response to drugs. Response to drugs. Yes? Please? How.

Could meet a little background. Give me a little about why this was included.

Recommendation one assisted with this approach. We also wanted to include the effect that we don't always know. So we wanted to open the possibility for non hypothesis this. So saying the drug is working to this particular genomic way and the only standard that, but to look at more whole genome approaches to things.

Good. Anybody else on this? We will keep that the way it is and will want to the next draft recommendation which is on pace 26. And this recommendation you will notice again a slight -- let me just make sure I have this right. Okay. So in this recommendation what you have in your text differs from what is on the screen, and I will point out where. As a loss of the of the line Pelletier cruise further research will be needed to translate this into clinically useful PGX test ends is not in your book, but it is on the screen. Test AND technologies to assess their critical validity and utility. This is where I thought maybe we could add something along. Be those that it is as should facilitate the development of currently useful pharmacogenomics Technologies by investing more resources into all components of transitional research including the transmission of a basic research findings into clinical trial. And that, I believe, right. It is not in that text. The as is missing as well as the translation of clinical research findings into critical and public health practice and policy. One of the emphases of this transitional research should be to foster -- and I believe that is also not end the text of the report, to foster the development of more rapid cost-effective to attack and technologies. Rather than just say to be the development, we have put into foster the development. Barry, does this get at more what you were --

It does somebody.

Could we make it stronger?

I and just wondering since he used the language here of critical and public health practices and policies it might Intel coverage, but you might want to put covered and they're also.

We could put into critical and public health practice and policy. Is everybody comfortable with that? Great.

I am going to exercise this one or time. The recommendation recommends gene mapping technologies when, in fact, phenotype and is probably in many cases closer to the clinical reality of changing practice. So what was the background for the final sentence for the?

Well, again. This is not a situation where this is being emphasized to the exclusion of the other. And so here the idea was -- up here are the slide it says can foster the development of more rapid than a stepping technologies. Phenotype and technologies would be incredibly broad and $0.1. That could involve all sorts of biochemical -- Jim? ARS this must have gone by me in one of the conference calls. I am -- that does kind of stick out. I am not sure why agree necessarily need to or should emphasize very specifically more rapid to detect and technologies. I think the first sentence really sums up what we want to get to. I'm not sure we should be that specific.

One way to address this but just be too in the last sentence strike and the typing and substitute diagnostic.

All right. That is what a way to go. This was a recommendation made specifically by one of our members who is not here at the so we can either get rid of the sentence were put in diagnostics. Diagnostics better? Yes?

You could just go back to the beginning of the paragraph where you say PGX technologies. Genotype would be more or less DNA and RNA. It is will make more specific.

Again, I think when one thinks about as a single research it is extraordinarily important at that level that think about a very broad range of things that include clinical validity and clinical utility. This it's far beyond diagnostics. I think diagnostics or even Technologies is too narrow. We should just walk out of licenses. There is much work category utility then technology.

What Jim is recommending is we got out that last sentence but the.

I just I will just counter that. If you only develop the collation -- that is what we were trying to achieve.

By singling out one aspect of technology one that loses the important general recommendation which is to encourage a neglected facets which is translation of research. I think that a specific recommendation that focuses on technologies and diagnostics runs the considerable risk of really putting it back. You need a surgeon at tapping but farms which is as traditional research. Eddie this will come to about 14 read of that last sentence.

Let me just do it this far. We have -- the two trusts it to be getting rid of that sentence and the other is about changing the last sentence. So looking at that, is there anyone here who is engaging read of the last sentence? Okay. We could all live with that and we have one person who does not want to live with tinging it even if it is changed. So for right now why don't we get rid of that last sentence. If we come back and say we need to be more specific, we can do that. It just did it for now. That solves that issue. Great. Next -- by the way, our tactics and will be calling around. He should do whatever he needs to do. Pay no attention to this person running around.

Okay.

This particular recommendation is the same in both the report and on the screen. Again on clinical research where study results will be used to test its safety and efficacy to report a pre-market review EDS application and sponsors and researchers should be encouraged to study with the FDA. This would help to insure that these have adequate critical study design and quality controls in place should to the research with their be submitted for regulatory review. I think this is the idea, you can pick out some of what he was talking about. Get down the road and see if we can't get these closely together.

I suggest you put in FDA and CMS. We are talking about parallel review. That gets people in earlier.

FDA and see CMS All right. Good. Any other suggestions? Great. All right. They are trying to move on. 3B. Okay. Again this is different than what is in your text. We have as appropriate at the beginning of this rendition. So as appropriate that NIH should consider making their standards a component of the scientific race of grants and contracts submissions. Everyone is comfortable with that? Fantastic. NIH should encourage grantees to end this participate in FDA if voluntary this submission Perkins to insure consistency in standards that may affect drug prescribing. Yes?

I had a question on this. I'm sure there was debate about the board increased purses require given that NIH does have the ability to supply funds it would be, as I understand it, within their purview to be able to require submission as part of the RFA. So tell me why it was to the why the word encourage was chosen as opposed to require.

You are absolutely right. That was discussed. My sense was that to leave it voluntary and not make it mandatory was something that was thought to be preferable.

I would just note that it does not change the program from being voluntary. But for people who want to do research using NIH funding there is nothing to say that the NIH couldn't require it.

That's true.

Whom exactly should be required? Every NIH grantee, I don't think so. As appropriate, I suspect.

So is that what you are saying, it should be of every NIH?

I guess I would need clarification or recall properly there are lots of DHHS groups that have nothing to do with this area. What would not require it to of those currencies.

So would you be comfortable if we said NIH required great cheese and contractors as appropriate?

I think you could put the as appropriate it.

That is the direction that I would favor unless there is compelling reasons from the task force discussion.

I would keep it as encourage because there are at the research done in a special groups that would not be able to do there research if it was required of them to participate in the FDA voluntary economic data collection.

Okay.

I this it is very important thing. If you make it optional few people would do it. But if you make it mandatory that it may affect some types of research. It is a difficult one.

And this is basically per our discussion was.

And that is where the as appropriate might work.

Okay. Let's get Paul and some others. Joe? Okay. Well, I would use both. You would encourage, but it should be as appropriate because he still have to designate who would be responsible for monitoring whether or not that occurred or not. And so as appropriate would go to the appropriate agency program, some program within the NIH and Abbas to me working with that. Because you wouldn't just leave that open. The same arguments being made for a mandatory should also be considered as to who then would be responsible for even moderate weather does that workers to carry it out actually carried it out.

Okay. Great. Paul?

Just as a matter of were expecting or sort of maybe just a style issue, and I am a those sort of -- I am uncomfortable with a throwing in the phrase as appropriate on both this -- because I am not quite sure what that means. And at the is a pretty when she what she termed. And to the extent that I want to limit this, this hour of the previous -- and I broke my tongue on the previous, then we should state exactly what we mean because as appropriate is so ambiguous it tends to confuse rather than clarify. That is my opinion.

I have marked and Steve.

Just to respond to the Soviet and Paul. From a Soviet perspective there could be an exception process for research that is considered -- where this would be a barrier to during research. And Paul's point, what we are really talking art is some language that would encourage -- and I don't know who this would be, to basically develop policy around what is meant -- who would be exempt from submission and under what circumstances that the exemption would be reviewed.

That is fair, if I could respond. It may be that you place some language in that text of the report explaining that rather than putting it in the -- or recommendation that that might be an appropriate -- as appropriate as anything for that phrase.

Mike, it was as we go further in this field are having a randomized trauma and I am assuming that the CDC would also grant grantees or contractors. So is it liable to think they'd hopefully fund research to be in this recommendation?

Mike? Go ahead.

Just to clarify, to Paul's point. It might be wise to include the statement, when it indicated is decorated in a study funded by a NIH then you can say required or encouraged. It is up to you guys.

Okay. That gives us our best the city.

Is this clinical research relevance to the research that is meeting for the pharmacogenomics application to be put as a test or as a tool? There's all kinds of research and we have reached the point where we are at this interface in translation between after gene discovery for pathways or whatever. And now you're trying to develop an application that could then be submitted to the FDA. So one could be a dishonest to appoint to say that that funded research that is designed to evaluate or develop applications to be used for practice of pharmacogenomics purchase the courage map would be for that kind of pressures to add to raise more with the FDA process is whether it is funded by NIH or wherever. I know we will be funding some, but most of it will come from NIH. It is probably a small fraction of Connecticut plants? Has reached a point in that pathway that is more selected. So there could be some words to thing that does a lot.

That is what we'd are supposed to do. smith away.

When sentiment data is [ indiscernible ] that is ridiculous because that involves hundreds and thousands of studies that will never read the light of day in terms of applications. So when a farmer could genetic data to a mistress for the purpose of developing a pharmacogenomics application are test for use in practice, that is when the trigger happens. I am stumbling over by onward because -- AB of this can help me.

That is not entirely right. They are actually posit to look at the use of the economic data earlier in the life and up the point about a diagnostic device is poised to enter the market as a companion products. When a diagnostic device is poised to the market the voluntary data submission process is that art process. You need to start thinking about CDRH protocol review process. So if you are asking me to play around with the language it is going to need to be parsed a little more cleverly and this. There is this stage when you are playing around with data in the context of the drug. The person did this submission hits the spot. And when you have a companion diagnostic that looks like it is on the way and you need to start thinking about a pre I T ER protocol review the need to be careful what we wish for. They don't actually have the resources to the in the pot out generous funding in this area is to start looking at dozens and thousands. Some kind of a disclaimer. Some kind of buffer. For one thing the data submission is an exploratory process. Could the doctor as. But he does not lead to keep reinventing the wheel. You don't need to submit back because that road has been established. I personally prefer a lulling some kind of flexibility. I thought it would have been a really nice to have a new diagnostic product that NIH was finding that they required that they at least read FDA regulatory documents so they understand the research has certain obligations about quality control and following protocol and doing things that may have a heightened [ indiscernible ].

So for the voluntary this submission program, do you have wording that would fit that program for this recommendation? The mic is not on.

It would be, should participate. And the submission prepared during the exploratory phase of drug development.

And Review Program is offering tax parts per -- note, it would be after voluntary to make data submission. The pre I T E process, when a dynastic is thought to be essential and the critical use of the truck.

It is thought to be essential.

That is the mark difference voluntary data submission and the pre IDE. You're not sure about the need for a drug or you may suddenly get the you need a drug -- you need a diagnostic when you know that you will need both the enter the marketplace as bright -- bride and groom. Then we are the winning all.

We are still some things here. When the pharmacogenomics data is generated for the purpose of -- that can be had. Hong okay. We have to clean desk. That would be down here, maybe.

So do we want to go back to HH as should encourage or require?

Let's try require grantees as appropriate to participate in the FT a voluntary state as well as the review process. So court comes after the pre IDE review process?

In situations were diagnostic is thought to be set so the truck used or clinical drug use.

Okay.

Scott, sorry. You have the like. Okay. We have of earth on trainee here.

This is the language of requiring participation in a voluntary activity is kind of -- is really not. As I pointed out before anybody can submit said that voluntary program, but what I'm saying is if you get money from the program they need you have to. That is completely consistent surgically and any other way that you want to look at it. But it you are giving money at somebody they can require you to do something that might otherwise be voluntary.

I have a point and a question. There are two Pauls here. I would be like to refered to as Paul the lesser. That is Paul the wiser. First of all, I am a little confused. Segmentation can occur very early on either in the pre critical phrase or and contemplation of the critical phase of that segmentation in this compilation of the collection of data may have nothing to do at the end with any labeling recommendation. So I've got little confused that this language as to how that is dealt with. I don't have a recommendation how to improve it. Maybe Steve just said in my year of minutes ago you put or in the pre IDE review process because that would then cover people contemplating a clinical trials but then not actually deciding that they want to submit with the segmentation data.

Okay. This is what we have currently. We should require grantees and contractors as appropriate to participate in the voluntary to know this is a mission program which major of the Pete. Renamed. During the exploratory phase of drug development or the pre IPE review process in situations where diagnostics are thought to be essential to critical IDEs. What a way to a wordsmith is it a little bit more would be to remove as the proper it says we are already saying what their conditions are at the end. Microphone please.

So notwithstanding the comments which are typically correct would be meeting requirement and voluntary. I don't think there is any problem getting rid of all Terri. It is still the program. If everyone feels it should be a requirement that they are required to participate in the that the number to Ted suppression program. So while you are right technically there would be a lot of confusion.

I have an a and then Steve.

I don't think we can change.

We can always use the acronym and to open have a clue what it is.

I think it would be very ought to take voluntary out.

I want to come back to the point that Paul Miller or whatever Paul was referring to. I just want to a reference with and that recommendation that the secretary will convene the relevant HHS agency to produce -- and I don't know whether these would be rules or regs our policies to address the specific circumstances under which this requirement would be active.

You want that in the recommendation? Assistive be expanded, but I think we are making a recommendation to the secretary. So it must be there.

That.

So convene the appropriate agency to address implementation. Parts and that got just reminds you that everyone, we are voting on these because there is recommendation 158 which is to say that an interdepartmental working group should be established to review all regulations. So it is sort of a grab bag trying to get at what you just said for all recommendations.

What you could then do is basically say that this recommendation will be addressed per recommendation 15 a.

Something like that.

Let's give send a moment here, get this together.

Change the or talk and work because there might be circumstances where both processes are appropriate.

A day.

And then and rather than or.

Okay. No, we did not take up voluntary. We will just use the acronym. HHS should require grantees and contractors to participate in FDA's VGES program during [ indiscernible ] phase of drug development or situations where pharmacogenomics diagnostics are about to be essential for clinical drug use. Implementation will be addressed in recommendation 15 a. All right.

Since you said the implications of all recommendations are "to be addressed it seems a bit redundant to have that. I mean apologies to you. Everything would have to be implemented in an orderly process. So just testing of this one out sends out a little odd.

Would it be adequate to have times when looking ahead to? We may have other recommendations we want to make sure that we make. We just want to emphasize. Don't need it? No? All right. All those who think we don't need this pick up your glasses and throw them out art. Nope, nope. Are you okay with that? Presumably this will. All right. How are we with the thing which right now? It should require grantees and contractors to participate in the voluntary economic data submission program. You know, if we just can't bring the public took greater clarity and the use of the English language, what good are we? Terri the exploratory phase of a truck development and/or they pre review process in situations where production alike diagnostics are taught that the -- it is changing again. They are thought to be essential technical drug use. What did you just change? It is grantees. Again. Wait a minute. It is you're right.

Test of a small part. In situations applies to both that too. So what if you began that recommendation with that phrase? Would that make it easier to follow?

Said the suggestion is to move that to the fraud because it applies to the pre and [ indiscernible ] bucket. Of that to the front. Thank you. All right.

Paul. During that discussion of this recommendation was there some consideration of what is part on and the drug industry and that non grantee population and how there might be some harmonization of what is part on and that non grantee and grantee world?

That was part of our discussion, why it was encouraged rather than required. Power at are accused suggesting --

I don't think it serves the purpose of this committee to set up two parallels. It does not serve the public interest either. Nergal I recognize that there are barriers, some important ones, but that does not mean that we can recommend better harmonization or sharing of data or ways of that.

We have that in their recommendations. At the it is brother on when we talk about the information. Go ahead.

It is just a matter of making sure that as we get each of these recommendations that we understand what our committee can do. We can only recommend to the secretary. The secretary has no ability outside of moneys that they control that they paid tribute to private entities to really compel them to do anything. And so and the text of the report there is a lot of verbiage as to why it is important that there be communication and consistency and that we have that as it that way. Beyond encouraging voluntary participation there is not what else that can be done in that context.

With a second.

I think that idea was that by taking the format that has already been vested with the side that note asking the federally funded researchers to use that same format, the idea was that those things would be more credible across was privately funded researchers as well as the public rather than having the public set up on a whole separate database structure and everything. So there was but the to the madness of choosing the FDA and voluntary data submission.

Certainly and the text of that it should be clear so that when the votes rate is they can get the idea of what we are getting at.

Do me a favor. Take a look at the text. Just to point out to you, we are trying to address this also so we have in situations where are cut to pound diagnostics of thought to be essential to critical Truckee's its rates as should require its grantees and contractors to participate in FDA voluntary genetic data submission program during the exploratory phase of a truck development and word the pre I T E review process. Going once, going twice, sold.

Paul the crater has something to say.

What do you mean by, are thought to be? Why not just diagnostics are essential?

You want diagnostics -- considered is the same thing. Diagnostics are essential.

I think you are still and the hypothesis States.

Not always. There is our problem. It may be essential. I know where Paul is current from. That can be used. We need to be adequately explicit about what we mean. The key to avoid the result words.

With a minute. We already have in situations where. So where pharmacogenomics diagnostics are essential, it is the situations that count. That needs to designated. That is part. Is that okay?

You may have resolved it with doing that, but I agreed with getting rid of are thought to be. I think the question is, at what point did you know they are essential?

That will have to be determined. That is recommendation 15-8.

And there.

A so now we have in situations where pharmacogenomics diagnostics are essential technical charts used. All right. I look around. Do it once, twice, three times, sold. Remember, we can come back and visit these if it thinks come on.

[ indiscernible ]

Until we vote and is truly kukri the final. Unless we don't get to a vote. This is just in here, this is for your information. This will not be in that recommendation. We just wanted to fly recommendations that came in from college. We should enable the investigation of markers associated with dirt response by encouraging sponsors of federally funded drug trials to request appropriate biological samples from Research participants.

The be it is implied but it seems to stop a little short. To request samples and get the relevant submissions --

They would have to be done with informed consent.

And be done with them as opposed to just getting the sample. Maybe that but is it is implied that and the text, but it seems to me it was missing the second half which is we are not just getting samples were samples but samples to be used.

By our markers associated response.

You could say to facilitate pharmacogenomics research.

I think the first part says we should enable the research of Bear markers associated with dark response. Is that not clear? We could rotate things around and put that in that and if you want to do it that way.

You can disabling things in the broadest way and request samples from research participants. I think is -- people get more concerned about requesting samples. I think it is important to connected with what we are -- for its part to be done.

Okay. So HSS should encourage sponsors to request -- in order to.

May be the other way. In the HHS should encourage sponsors across to request the samples -- I lost myself. I would add, get the appropriate permissions --

Informed consent.

That would be relevant.

Exactly.

I am just we are getting wrapped up on regularity. Comparing it, it is so broad you're facility all kinds of technologies. And in this recommendation we are to talk about access to some specimens in one situation on it. This is the larger issue. Their boss be a by a bank and other kinds of infrastructure issues here. This is just one part of this process we are focusing on. I'm not sure why we choose to focus on this part.

In part in response to public comment. And we thought this was reasonable in that response because when you talk about that need for the bill makes "plus some of that was already addressed in the report. So the question is, is this too granular? But this was in response to the public, at which we thought was our way of further specifying some of the things that had begun to be addressed in part population studies.

So what -- go ahead.

Can you look at recommendation five b. Does this get closer at what your talking about? It is 5-B, 5-c.

It could come and there also. Because as you are indeed you talked about the legacy which is really getting into specimens and using it.

And that would make it more profitable because this would just as a recommendation we are getting samples, but not enough connection. So this raises anxiety as opposed to reducing.

The reason this is in here is because in the public, but somebody said specifically it needs to be recommended. I had like and then again.

So if you are court to include this recommendation it is critical that we fall to the statement that right now there are no standards for either obtaining storage organization of any biological specimen that -- there are no national standards. And so if you are going to include this recommendation I would highly recommend that additional language be placed in that document to support the development of standardization for handling such specimens. Now, if your car to pull this out and put it in five be of just jump ahead. Maybe you should add to the laundry list of people that everyone should work with.

Okay.

But some are and this document it is a little anemic in this regard. You really need to emphasize the need for technology and sampling standards.

Let me make sure I got it right.

I was just trying to reiterate. When you were trying to point out why this was suggested -- I think there is some doubt rationale and having it, maybe with the modifications that Michael suggested. The point being that critical drug trials don't necessarily collect pertinent data, and really the entire promise of pharmacogenomics rests art collecting certain samples, namely DNA. That way they are available for study when we began to get a response data, a center. So I think it is a reasonable recommendation. I take something to that effect of what was just suggested about incorporating that into a I usable more comprehensive type structure.

Okay.

I definitely agree that we have to provide some additional context. The question on three or five or maybe both is, this is the clinical research section and five is in establishing the evidence. My assumption -- I am looking at the public the idea is we wanted to mention it in technical research session. It's sort of feels like it is missing. I encourage and I will try to spend a little tired -- I can't do this in real time, but we be to add some additional specificity on this. By Paul suggested what this means, how the samples would be used or are at least consistent with an appropriate guidelines on this type of work.

To enable the investigation of a player markers associated with stroke response within the development of national guidelines or something along those lines, just think about that. We have a few more cards to go to.

I just wanted to ask in terms of the standards and guidelines you are talking about technical issues rather than ethical and legal issues. I am sure you are aware that the guidelines -- yes, those are obviously focused on samples, but argues suggesting and other is suggesting that that is what is needed for this field, the way in which the samples are collected and stored. They're must be standardization along technical lines. So we take what in the CIA has done an oncology and focus on what is needed in this field.

Well even in NCI is involved in putting more money in is because there are no real standards yet for how to handle and collect and fix and stored tissue samples. So och --

So if we take a look at what is on this screen that sits at CS -- Suzanne did put up to enable by a marker assistive response HHS should encourage federalese sponsored to require research for participants HHS should have guidance on how these are collected, stored, and shared.

Fort previous reporting did we ever recommend development of these standards?

I don't have that on my computer. I would have to take that up. I am trying to remember.

There is certainly a call for the consideration of the ethical issues. It was focused more on societal implications and not so much the technical, as I recall. But Yvette has that report backwards and forwards.

We will check with her on that.

Just looking at the list of firms. The one that seems to be missing is used.

With your question of this development dinettes and standards on how samples should be collected, stored, used to likes the job. That was one of the recommendations.

In the body of this we can obviously clip of that. We will make a mark word that is a great idea. We wanted to add to rate these reports. I have Michael still on this. We have to move.

It is not just how the samples are collected and stores. It is held the clinical data associated with this, that we know if it is the same got to a condition or disease or some type. So the princess of critical data is a major impediment and not a technical issue.

We have here how these samples and they're associated critical data -- okay.

One quick one. I was hoping that maybe you could change request to obtain? It requesting is requesting.

Should -- or, you can encourage sponsors.

Requesting responses.

You encourage them to obtain because that does not require them to obtain. You could require the responses to requests. Right. But you cannot do both. We can encourage them to read quest or recant require them to obtain. And there is always work who is --

I will use the required work. I suggest that the recommendation especially reflect the recommendation from the population study report because a lot of times people don't read the whole report. If you bury it in the text it will be seen. That is consistent with what we have done in other reports we're recommendations preference that. So wherever that is and there I just say you should insert it there and the recommendation and not just a tax.

Are you what the words from the other reports put in here?

Not the words, but the specific records.

We are still all this would.

This is a the a bit of a choir.

When you collect the samples it is very important that the genetic data goes to the FDA or to regulatory agency who will have access. The patient has the right to withdraw the consent. But what this sense I don't know they can't take That away. I don't think it is even possible. It evokes the design of the study. I would add a word here saying that future studies should be designed in a way that would permit the submission of data with the FDA if appropriate. If the study wasn't designed for that you can't even have a sample and not do it.

That position if we are developing guidance and standards on how these should be collected, wouldn't that be part of those guidelines and standards? Obviously it would involve the informed consent but also which ones are appropriate.

Ahead. I think it does a little bit more than that. It is held the -- the intent of the study.

But if we -- it should also involve which should be collected, right? Okay. Maybe on how -- we need words here. Who had comments before?

Some costs because it to response and sometimes start prescribing which is, I think what meant to be the same.

Up there?

Not in this recommendation, but come bearing -- comparing recommendations. If folks think those are interchangeable I am fine with that.

Which term is preferred?

I'd like a drug prescribing which is broader than draw response. That is how we did it on the last one. So I suggest we be consistent

Do you know which produce recommendation?

3-seat.

The development?

Maybe it got out of there.

Well we agree driving is the term we can stick with? Note. That was a mistake. Okay.

I don't think we need to parse it. The concept is a reasonable one that we need to be consistent with our use of rather than try and fix that here which may be well impossible, to target the task force to say, you must look at drugs and use the same language consistently unless there are specific reasons in a recommendation to make it different.

This -- we don't have a chance for their on from here. It's --

It is called lunch, Kevin.

Obviously there is no preferred term.

Why don't we need it as is, and maybe as we look at the recommendations over the last --

I just want to agree with her because prescribing takes into account of response as well as 80 art. Whereas if you just say response then you sort of let the other side of the whole thing out.

Okay. Steve?

I disagree. Prescribing gets you into the hall utilization, and this is about clinical research and finding out what relates to the response. I would keep it the way that it was.

All right. Let's put it this way we started with response. Let's use that as a default. Are you okay with response? Do you need prescribing? This is critical translation.

Probably leave it as response now. I would like to as we get back to it but to see if it needs to be consistent.

Either we can leave it at response our response / 80 art.

Okay.

If you think it covers that, it is fine. I was trying to get the concept that it wasn't just initial response.

Everybody is good? One more time through this. To enable the investigation of Bias' markers associated with the response HHS should encourage sponsors of a federally funded clinical drug trials to obtain appropriate chemical biological thralls. HHS should develop guidance and standards on how these samples and they're associated data should be collected, stored, shared, and he used. We could put in parentheses here or a footnote whatever recommendation from the large population study report. Okay? Okay? Okay. Great. Next. It

[ speaker unclear - audio low ]

What? This is why the NFL has that new problem with that rule. Okay.

We want critical data. What does that mean? This is drug use. Do you want other data? IBM when you are trying to make records and you are the key at outcomes, there is other data related to team environment and action.

What did you have in mind with clinical data?

Okay. There we go.

I just want to add to that step that the initial recommendation was phrased to focus on the biological sample. Not, depending upon the context of how it is right to be used it could be purely political or have more of a team environment. So that I'd be up to the committee has how broad you want to make it.

How about if we have associated patients day? Is that better?

Not all participants are patients. They could be healthy individuals.

Participant to eject Iraq that keeps it great, but there is some clinical data. There is also a cartel that.

Okay. We have art and Paul.

This is and the context of developing guidance and standards. The point being brought up is something that be addressed in developing guidance and Sanders. We don't need to parse it out anymore. And my comment is, there are too should in the second birth. Maybe you should turn the second one into on will.

So in developing the guidance and standards, would that be part of what sort of data will be involved? Okay. Other data will be collected and stored and used. Okay. Try it again. To enable the investigation of by a work associated with response to the top should encourage sponsors to obtain appropriate biological samples from research participants. HHS should develop guidance and standards on how these samples and other participants did will be collected, stored, shared and used and also see recommendation was never from the earlier parts population study. I am calling to get -- house samples and -- you have to push your buttons.

I think this will help with the earlier discussion. How these samples and that debt associated with them will be collected. Then you have all of that debt associated.

[ speaker unclear - audio low ]

But the samples, for all participants, don't they? We are not talking about anything but simple participants treated participants samples.

Wait a minute. This is starting up again. I agree. I think participant data is socially but importantly different from just accompanying --

All right. That could be concentration of the sample.

I hear people leaning toward participant. Is everybody -- during was? Note. All right. So what was your comment?

How about participants sample?

None out. The samples, the Czech of tissue, the syrup, that he and a. What we are getting at --

I would bet on this in our party. I don't I will throw [ indiscernible ] in front of you. Okay. I think we are good. No? Y? I have to ask. Next. Page 35. Here we go HHS should -- by the way, nobody these until we are done. If we are here until three and the order to buy isn't that how it works you back

HHS should ensure sufficient resources are available to build on an employment agencies' efforts to develop guidance on the code development of pharmacogenomics drugs and diagnostics. FDA guidance should clarify the review process work of developed pharmacogenomics products word that chart is subject to FDA review but the average rate developed companion diagnostic test may not be. It also should promote cooperation between drug and tight plastic manufacturers. Steve? Where? Down there.

Well, again could somebody clarify why diagnostic manufacturers are specifically noted and why not the laboratory and industry which is the major provider of these tests?

[ indiscernible ].

At the what we are asking for was guns on both aspects. That is where there are just available for service laboratories as well as tests that would be put in a box.

But we want cooperation amongst all entities in the provision of these, but we? In the last sentence it's as promote, but in fact report collaboration across the whole spectrum of providers and this field.

That way we get back into combat does FTA have purview? This recommendation was a third to specifically to develop guidance.

Can I make a suggestion? I am the stand that is a bigger issue. But I you wonder if we just want to say diagnostic companies? That way that will encompass both manufacturers come on about service companies. It is broader and the FTA has some draft guidance now with some a as our that oversees things at the laboratory service companies to.

We have run as well.

I want to go back to the point that when [ indiscernible ]. That is the use of the board resources. This recommendation is calling for us to ensure sufficient resources are available. Recommendation one ask for NIH to put more resources and. We see recommendation 58 HHS should provide resources. Why in this recommendation there is a need to emphasize resources. I agree that we should just have an omnibus recommendation at the end, perhaps expanding when we get to a recommendation 15 p to talk glibly about looking at needed resources to carry out their recommendations.

So in changing this one how would you --

I would just --

[OVERLAPPING SPEAKERS]

Okay. And then refer to a 15-be.

I am just wondering if this recommendation covers when a truck company develops its own diagnostic. Is this language includes a of that?

That was trying to get back to a your point.

No, but was a different point. I actually think the way it is written now by diagnostic developer's does include that because it would not matter what kind of company.

Update. All right. So we have diagnostic developer's. Good.

So should we say diagnostics or development of drugs and be to extract the six?

Drugs and --

Code development, you are talking about a specific target a specific diagnostic. It does not need any additional explanation.

Mark, what are you saying? Should we go back to the way it was art just say drugs and diagnostics?

Note, I think the key Texas, the that is part.

I agree.

Doesn't that limits you because then by definition it has to be cut developed with that drug? There will be other diagnostic tax --

Those are addressed and other recommendations. This is specific to cut development. Let's read what we have no. Wait a minute. Emily?

Somehow we got to the diagnostic developer's -- part of this guidance has to take into account for the battle sentence its seats to take into account both processes where the diagnostic is developed by a manufacturer and bird the diagnostic is a separate for developed test. Somehow when we changed the last sentence we lost the whole manufacturing part of the industry.

So what would you recommend?

How about and instead of but? I am just trying to see where the right place to put this is

And the note leopard for developed --

Yes. So the little sentence is just one case where the drug is subject to refute, but the diagnostic might not be. We need the contents of that for when the drug and that diagnostic are subject to review.

Could it be brought her and just say the guidance should clarify the review process? Do we need to clarify it?

Wait.

Take the laboratory out.

Wait a minute. One more time.

Take the part about the laboratory developed companion out.

Stop the sentence after review and get rid --

Some of these issues will be further down.

Exactly.

So to the that part.

You don't need the including? And so get rid of including.

Start at parks. Okay. Try it again. We are into brevity if we can do it. All right. Let's see what we have. FT Asia develop and implement guidance on the coat development. The guidance should clarify the review process for code developed pharmacogenomics products. It also should promote collaboration between drug and diagnostic. First to weigh in?

What do we mean by broad collaboration?

Beat them about the head and shoulders

The text talks about some ideas where they could work together where they have meetings together and the voluntary separation data. In my mind that is one of those examples.

Her cat. So we have examples. That is good enough? Okay. Anybody else? It is living. This looks good for the moment. FDA Office of combination products should coordinate their review of Farquhar genetic tests and drugs among the various FTA centers / offices to minimize delays and approvals of car developed pharmacogenomics products and to insure timely access to such products. Great. So far, yes? All right. Excellent. Everyone is happy.

Once used as a private parts is needed to do that job you can to be the third line. It seems redundant to have that third fund.

Okay. Shorter is always better. The Office of commission price should coordinate the review of our good to know it's just

To minimize delays and the approval and to ensure timely access. Yes? Yes. Excellent. The key.

I think by taking out among the various centers offices the sentence may be too broad. So I suggest the qualifier should coordinate that have be a preview. And we are addressing all the FDA, is that correct?

Yes.

Does that bring into account the fact that some tests are produced by that at the a that wouldn't test become review? Because I was going to have a slightly different comment, but that may broaden it enough to get to that because some of the tests are not under the FTA.

But we are talking just the FDA review, read?

All, I think with the addition it helps clarify that.

Okay. Going once? Going twice? Salt. Grade. This is on page 39 in your book. And there is a distinction between the way we have it on the screen and the way it is in your book. We will have to discuss that because they're up could be a significant difference treated HHS said the gates all stakeholders in provided incentives and the development of pharmacogenomics products especially for smaller -- of the screen it says markets and in your pocket says patient populations. Arquette was our the tradition. Why markets? Hi think people wanted it to be proper that a patient population?

So we need to go beyond orphan drug possession and create a new think based on market instead of number of patients?

I am trying to recall -- I think it was -- we certainly can't do patient populations. If people want patient populations we can do that. Is that okay?

I have a question on that.

There are very large patient populations that represent small markets. And that should be captured in some way. What do I mean? The development of drugs that would be extremely useful for useful people, but considered small markets. And incentives should be developed in accord with those considerations as well.

I think that may have been one of the points behind the market thing. Yes?

This may be a question, but it gets to what Paul was getting too. And the summary there was to doesn't possess or below for trucks. Where does the 4,000 come from? Is there a visit to the humanitarian crisis exception? That brings in another of -- a number of other regulations that you can -- that have to get through approval. They cannot profit off of it. It seems to set up a very different standard. It is also subject to a steep. It seems to have a whole other hurdle of unnecessary regulations, approvals and profit restrictions that the orphan Drug piece does not permit that was have a statement, but for the a question.

I think the point we were trying to break was to point that out those two numbers are out of sync with one another. If you have this system it is an orphan on the trucks' side. And I think we provided the committee with some insight that really this is that all the diagnostic mechanism that is available in a "world and status. There is an equivalent. Correct me if I'm wrong.

No, that's right.

I'd think the comment is a very important want to read it was the driving force. Why not include both an say for smaller patient populations.

I think this gets to it and that way. The patient population is a market. But to be get to a recommendation that goes to analyze point about the differential here? This is one that may not be effective.

There is no recommendation that is specific for that, but we discussed that and whether or not there need to be. And the thought was a way that would be working that was what we should recommend to the Secretary and not necessarily for something on that specific issue of the understanding is that issue would be addressed as part of the process of following up on these recommendations that left it open to how it might be resolved

I understand how. I wonder if it should be -- I guess I'm recommending it should be more explicit because I don't think you did it.

And the question that relates to the explicit this is whether it is under the secretaries per view. Is it able to be done under a rule making or is this something that would require of the assistive change? If it is the lesser we can't make an explicit recommendation. If it is the former, the weekend.

I think you could recommend to the Secretary that he seek a assistive change if it did require a stop the story changed. Does it?

I don't actually know.

Okay. Why?

Just sort of it's just a question. If I were looking at this recommendation, if it were published in a list of recommendations, I think the way your point to present this is your right to have a separate sheet with the list of recommendations along with part of an executive summary.

This would be part of the this is not a specialist.

Is there enough information in here that somebody would know what you are talking about with this recommendation?

I would agree with Michael I think in and of itself this is a piece of that, but to serve the or to -- I don't think it gets too, as in late described it, that differential and that need so we look at the be at a minimum the small patient market issue around diagnostics. I don't think the uneducated -- most people --

Again, there is always this tension between how much should go in that recommendation as far as a story materials and how much goes into text. There is obviously more in-depth report on this because we already saw that. So I guess the question is, says it is a recommendation to the Secretary then as you say, if the public is seeking more information about what is explicitly involved in this they cancer and they look at the larger report. Even in the assistive summary there is material. Even if you want to work to get this to make -- how would you give it to ` extra Santos would you want to put in to back Suzanne is doing it right now. If you have something -- maybe what we could do is --

I have a suggestion. I think the issue that we have heard is -- it would be aware as. Given the inconsistency between the numbers of patients for orphan drugs versus the numbers of patients that would qualify for orphaned devices and that inconsistencies between those two sets of rules, it is recommended -- that would at least give it some context.

I don't know. I think that having the parts to recommendations brief and to the point makes a sense. And an MTV hundred you can say those kinds of things and put it in context. I tend to think that brevity is probably -- I think party should be something we speak and there is expired for inflation. Even and the executive summary they don't have to dig through it.

Okay. He likes that too. Whit.

I think you have to be careful. It is very much because of the cost of these things that needs to needing different kinds of economic incentives to bid I think that is in here. Schroeder is better.

All right. Is this short enough? Let's take a look.

With a minute. HHS should engage all stakeholders in the to the buying and providing incentives to the development of pharmacogenomics products specific incentives should be identified for a smaller patient populations in the world markets to address inconsistencies between prevalence, thresholds' for orphan drugs and devices. We're worried back we definitely want markets.

We are back to a HHS should engage all stakeholders and identifying and providing incentives to encourage the development of products especially for smaller patient populations and work markets and make sure that that is explicated clearly and the materials. Yes?

I may have a simpler art. The fundamental problem for me is for orphan drugs the system works as an incentive. For orphaned devices are test the system currently works. I think it is a disincentive with more restrictions than incentives. So I wonder if be in as simple way to do it. I appreciate that comment, but we have content and a lot more of the other recommendations. I don't think we are having too much. At 81 multistate the development of these products and diagnostics, if you think about products as drugs or drugs and stuff agnostics --

Rather than products.

Because some people will consider price being drugs, not everyone I've wanted to highlight diagnostics because the process today works as a disincentive.

Okay.

There are two concerns here. One is the technical conversation about the different types of pharmacogenomics development and there is a great sensitivity that is generated the conversation around this recommendation. Very large populations that are small part markets. In other words, a large populations of people who can't pay. If it would require credit the six -- it has to be balanced by a strong statement that also elevates this issue of small patient populations and markets. If they are right to put an extra bag which to clarify that it might require moving into a 4-The that explicitly elevates or addresses the sensitivity around small patient populations and small markets.

Look at what we have now. Is that sufficient to sufficient emphasis?

Work language was born to be placed to clarify the issues that you are racing. My concern is that it is completely lost.

Let's look at what we have now. HHS should ingates all stakeholders in providing descant incentives for the development of drugs and diagnostics especially for smaller patient populations as or markets. Does that get to where we want to go? Yes? Yes? Yes? Excellent. Very good. Next. All right. We are supposed to break at noon. If we can get one or two were done, page 43 is right you will find a draft recommendation 458. They should provide resources and the analytic validity, critical validity and utility and cost effectiveness. Progress would require high quality Data Resources. Improved methodologies and design, conduct an analysis of a series of studies and empirical research arm of the evidence and standards necessary for making decisions for various purposes. For example covered a lot performance that tricks and different political context. This is getting at establishing an evidence base.

Again, this is a bad crowd question. The this report is surprisingly to avoid on the current use of testing. There isn't a table that shows the frequency of use or P450 testing or anything. We are advocating for the established brands. I am curious about why that occurs.

Was flat because the data is out there.

Well got the people who provided that tests are keeping data, is that what you are trying to tell me?

There are a number of different issues. If any outside agency that wants to review that can't because of the coating deficiencies. You can't collect the information or tell based on generic goes with it this was a task or an and the year as a or b RCA. So the third party payers cannot develop data as, as these tests are being done. Manufacturers are variable in terms of their willingness to put their data out for public review in terms of numbers, results, except for. So there are no sources of data and the available to the chair that can give any sort of an estimate about utilization.

Can I just -- so does that mean that the committee or somebody asked the providers of tasks and the sector to voluntarily provide that data and they've refused?

No, we did not do that.

This is actually an issue that is addressed and the oversight report because we talk about what or of the transitional process and the critical decision support.

It is worth while making sure that we cross our friends said.

That will come out what's letter.

Steve, actually we can't. My understanding for what I have implanted in my brain is, we cannot anticipate because nothing has been voted on yet for that report. But that report could certainly respect to this one which will --

You can do that. But we did not attempt to do that because our idea was to look at what the current trend is. And that is currently that that information

I am aware of the whiteboard or unevenness of the public data. But that doesn't mean that there aren't ways of voluntarily providing some of the predators of this data. Because some of these tests upbeat and the public domain for of all time.

Was there something you wanted to then address?

It is a striking deficiency of this report that there is no compilation or at least comment about the compilation of data in this area.

So can we make sure we go back into that narrative of the report and reference the fact that there is stuff going on and the keyboard and this recommendation is the word progress and be deal with it that way.

I had Jim. Barbara?

I wondered if we could remove some of the methodology and just make it say something like using acceptable methodologies are using explanations to explain them. Aren't those standard methods for critical validity and cost effectiveness?

Well, we had a discussion on that and some people thought it was important but we can still have that discussion. Steve?

I will be the way. The methods are developed and they aren't accepted and the use of service or other things. Whether you want to include them is another question, but there is a general problem. This isn't unique. How do you incorporate them in and accepted manner is still a subject of considerable debate

Empirical research on the evidence and standards necessary for making decisions for various purposes whether it is coverage, a clinical guidelines, performance the tricks from your point of view is research that supplies the evidence? I mean you know what the evidence and standards are.

I am wondering, is the operative thing here research arm -- are you suggesting we do more research on what evidence and research are necessary or research that answer is the basis, the evidence basis of making these decisions? Because the people making critical coverage decisions and bad decisions pretty much know what those are. They don't need more research. They need answers. "swell is primarily for coverage purposes. I would agree with you. I was quick to suggest that in fact and the parentheses we put critical guidelines and performance of tricks, something that will set well with the Secretary committee he usually talks about this. It goes beyond those categories and gets into improving quality and improving efficiency

So to add value health care after performance, tricks.

Okay. Credit -- did I miss somebody over here?

Just to respond, the issue relating to your specific question is that the key issue in the first sentence is a that by evidence that. We don't necessarily know what those are. Some of them 80 relating to equality of evidence and some be related to critical data. So I think it captures the point that she made.

There were two living variables and the equation and I wanted to block when and. The evidence gap necessary to answer the paradigm of decision making as it exists and the real world today. We want to figure out what the Perot type of decision making research is and figure out what the caps are at the same time. Basically let live it along. You know what it takes to answer these questions. We know how the people think of it every day. Now let's provide the data and information.

So did you want to recommend a change in wording?

Its research that supplies the evidence

It has been my experience that the evidenciary requirements differ from all walks different agencies, private, public so unless your car to offer some harmonization of what the evidence Santos are and have some bite across the public and private sector, I don't know quite decently how you are part to resolve that.

I would advocate giving it the way it is. I don't think it is a no brainer as to what evidence really is important and what should drop Shantay acceptance. So I think he might want to play in. He would want to run out of the throne. And I would advocate giving it the way it is.

Can be said of? That we sit research only evidence and standards necessary to back that is fund. If you want to keep it there, I don't want to prolong it. I'll withdraw the suggestion

That is a marvelous template by the chair to the does forward into the afternoon. Yes.

I'll -- if you're talking about an "analytical validity or talking about standards. I want to bring up the point that there are only a handful of actual physical standards for diagnostic tests available. And if part of your evidence cap is the reliability of the essay then you really should put some additional language in here regarding the actual physical standards in standardizing the technology and platforms.

So would you recommend?

I have to think about it.

You have to have answers.

Hold on. Go ahead?

We will deal with that in that next report.

Right.

But we can -- can we say in this report that and other reports is under way? That is going to attempt to address it or something like that? We will make sure that is in the text. That question is being addressed more complete in a later report. I don't think we can say exactly what we are cord to say.

A quick edit for consistency. Should we take action to provide resources? It should read instead HHS should as a to buy and address of its caps?

HHS should identify HHS should identify evidence gaps and the critical let's see come critical utility and cost effectiveness of pharmacogenomics. Progress will require high progress Data Resources, approved methodologies and the desire to my conduct an analysis and empirical research on that evidence and standards necessary for making decisions for various purposes. Coverage color critical guidelines, performance records to what I you driven health-care and different critical cantrips. Okay. We have been told we are done. Let's do a quick process check. If we sort of think about this we now have to talk when we come back at 12:45 p.m. We have to go through all the rest. We are about okay. Of a little nervous, but will push through. What do you think?

This is maybe just a point of order some other work that we have done in other groups, we sort of set a time, on progress related to certain activities given how you break it up. And I realize that there may be that need for process on some of these things, but I think that if we set a time limit that will accelerate our thinking and sort of really make this come to a decision or quicker. If the plan is to try to pin and get through a are several conditions before the end of the day, I would recommend that we said summit set up time and it was the amount of dialogue that we have either buy recommendation or by -- by block a recommendation or some perimeter of Thai.

Thank you for that. We are quick to do their quanta calculus and to our last so that we don't have any recommendations. That is great. One way or another broken through it. Those of you who are appointed to enter to cut there at the fabulous in its growth need to inform if you already haven't had the. You tell her that you are going to -- their will be no food. And then there is the food court. And it is not our fault. You did nothing. You walk like a pretty else walks of the weight to the food court about 18 miles down the street. And the same building on this floor and you just walking. But it takes about 10p. The thing is somehow you have to get your food and get back here part of 45. So he should go right now. Leave anything you want here. [Session on lunch untill 12:45]Please stand by for real-time relay captioning.

busy signal on audio line.

Just perfect. Everyone came back exactly on time, knew when we were going to start.

It's coming to my attention from mean people like Mark, that apparently I once again, instead of recalling gur ven eat, I called him gur ven at. Everybody snickering at it. For the people who don't know, I mangle everyone's name regularly, that's my responsibility. Of all the people I mangle, it's gur ven it, man dale a.

I will find somebody else to -- we have the Paul wise and Paul the less esh.

Take it away, Red.


Okay, we are on. 5 B. So gearing up again, after lunch, get the synapses firing. Tab three, and it reads, HHS should initiate and facilitate collaborations between public, for example that long list of acronyms, and private entities. For example, private health insurance plans, healthcare facilities with electronic medical records, research genetic databases and repositories to advance generation and sharing of knowledge on the Ann lytic validity, and cost effectiveness of genomics.

Can you add NE SS to the list?

It's up there. We try to -- okay, I love this, this is good. No, wait wait oh.

Back to what I was saying on the prior one, the first sentence of 5 A, very research focused but the term value, cost effectiveness is in there, but if you insert value into the first sentence of 5 A and also 5 B. Quality and cost.

We have, not underclinical utility?

No.

Not really.

We need value, put the word --

I would add it because cost effectiveness is way too narrow. We are looking for a bigger picture here.

Analytic validity, and value?

Just the word value? Everything comfortable with that?

And value.

In the same phrase, present in 5 A, may want to change that to be consistent.

Great. Okay, excellent. All right. We have made a couple of changes. HHS should indicate, facilitate collaborations, including -- including the whole list to advance the generation in sharing of knowledge on the analytic validity, clinical utility, cost effectiveness and value of pharmacogenomics. Fantastic, next.

5 C, same page in the report. HHS should encourage and facilitate studies on the clinical utility -- we will see about value -- dissemination of stud I findings, including negative findings where appropriate through publications, meetings and information clearinghouse.

Mark?

Do we need "where appropriate?"

The question here was, since obviously you are going to get lots of negative findings, right, some come may or may not be relevant, would relevant be better? Doesn't do more specificity than appropriate. The just say including negative findings.

Right. Reflects, there's a reasonable amount of literature saying this is a major issue. Saying negative findings is sufficient.

Not too draconian for anyone? All right. Anything else on this Great. HHS should encourage, and facilitate studies on the clinal -- dissemination of study findings, including negative findings, through publications, findings --

Great.

Now, NIH should provide mechanism that's promote interactions between basic, translational and outcomes researchers for the identification of end point and -- the goal of these would be to maximize the value and utility of basic and translational research data for down stream assessments of -- and clinical utility of pharmacogenomics tests. What's in the report has another sentence. We are recommending deleting that sentence and stopping here.

Yes?

Should it read NIH or HHS?

Good, thank you. Anyone else? This is good, we should have lunch more often. Going once, twice, three times, fantastic, sold. Next.

Six A, is on page 47 of your report. Again this, is slightly different on the slide than in your text. HHS should encourage private sector entities, including academic institutions, here's where the difference is -- voluntarily to share -- doing a little word submitting ahead of time, proprietary data to advance the development and codevelopment of pharmacogenomics products. Manufacturers should be encouraged to make their data publicly available to allow others to do research and publish such studies. Decided not to split the inif I havative and make English professors across the nation unhappy with us.

Voluntarily may be in the wrong place, sounds like you are voluntarily encouraging, might want to put it after --

To share voluntarily?

Or -- data voluntarily.

To share proprietary data voluntarily. Okay.

Is that -- to share proprietary data voluntarily. Okay, anything else now that we finally decided where we are going to volunteer. Trust me, we had long discussions about this. The final is SS H should encourage -- voluntarily. To advance the development of, codevelopment of pharmacogenomics products, publicly available to allow others to conduct research and publish such -- this will make Red very happy.

Six B. I am getting 10-dollars every time I say that, from gur -- to develop solutions to overcome the obstacles. For example, legal and data confidentiality assurances, intellectual property protections. Okay, ruminations, suggestions? Yes?

Have we been working on this extensively over the last year or two in terms of Medicare data, claims data in particular. I suggest you put in parenthesis funding. You focused on legal issues, but who will pay to collect data -- share it.

Funding of the data collection.

Yes.

Funding data collection rather than just funding.

Specifically data collection, okay. Mark?

A question, does intellectual property and Barry can comment on this maybe, the intellectual property productions, within the purview of SS H or another government agency to deal with that?

That can be within HHS. Other agencies might need to be pulled in, definitely could be HHS.

I am not sure, but is confidentiality and privacy the same thing?

No.

At least not from ethic -- I don't know about legally.

Do you want to also add something in here about privacy assurances in addition to confidentiality assurances or is that something different.

That's different, but I am willing to be corrected.

The company as opposed to privacy for the individual.

Any other --

Issues here, put into the parenthesis section?

The good news is with an EEG you can E sernlly -- this is not E exclusive ear restrictive list, other things can be added if the HHS feels necessary.

We try to deal with the HIT issues later, but we can put that in here too.

Good idea [ indiscernible ]. I think it's a good idea given the secretary's focus on HIT around personalized medicine. Great to add as example.

Okay. We could do funding of databases and health information technology -- thank you Suzanne.

All right. So we have HHS should work with the private sector to identify obstacles to data sharing and work on solutions to overcome -- including legal and data confidentiality -- and health information technology. Good, got it. Everybody happy, great. Next.

Six C, found on page 48 of your report. We are into the data sharing and new database interoperability. Research, regulatory, medical record and claims databases need to be interoperable to facilitate research on genomic technologies and build the necessary evidence base. Interoperability of these databases will facilitate molecular pathogenesis of disease. Validation of pharmacogenomics technologies, assessment of health outcomes associated with the use of pharmacogenomics technologies, and the cost effectiveness and economic impact of using these technologies. HHS and other relevant departments, for example -- and Department of Defense should work to improve data sharing and interoperability among databases. Specifically, HHS should work with existing organizations to create uniform genomic data standards, explore ways to harmonize methodologies and develop infrastructure to enable data exchange.

Yes?

A couple of points this. First, I think the first sentence is over stated. I think it's interoperability is nice to facilitate those things, but I don't think you need interoperable records in order to conduct research.

The need is to facilitate.

They need to be interoperable, it's note really a need, it's --

All right.

And second point, I thinking there's technically difference between data sharing and interoperability. In the second paragraph it talks about data sharing and interoperability, perhaps that should also be in the first. Something like data sharing -- suggesting combining the if I ever the two sentences, data sharing and interoperability of various databases, EG, then put the list on the first sentence, will facilitate. facilitate.

The text lists a number of barriers to interoperability, but you are basically logistical, practical barriers, I think it's important to note there may also be some philosophical barriers to interoperability. In other words, you might read this to suggest that ideally every database should be interoperability with every other database, and I don't think that is accurate. There may be, for example, differences in the way the data is collected, the purpose, the mission of the organizations that -- we are combining databases would not be appropriate.

This is a perfect time to, once again, remind everybody, including if you could do this, anybody who has any recommendations for the text itself, please get those recommendations very specific where you want it in the text, what you want in the text, to Suzanne, that can be done today or shortly after the meeting. Whatever you have, please, get them to Suzanne and we will incorporate those.

Gur Gurvanit. The first paragraph starts out and the second is narrowly, database standards, a reason to exclude the others?

If I remember correctly, the idea was that yes, while we did want the more generic to be in the recommendation, there was discussion where people wanted to make sure that specifically that narrow area of creating uniform genomic standards, exploring ways to harmonize was mentioned. Where we thought just generic -- wouldn't be sufficient. If I remember correctly how that came about.

You say the second paragraph is specifically focused on -- just on genomic data -- I see.

Not how you started out.

This is one we started with generic, broad, decided, people in the task force thought it was important to make that specifically mentioned. All I can tell you.

He just wondered how it got there.

The second issue, some people are distinguishing data sharing from information sharing. Because data sharing implies access to the data that is present in the database which may or may not be feasible -- intellectual property issues, privacy issues, and business model issues. Some folks have suggested that it may be feasible to share information present in databases, without sharing the data per say. I don't know if you want to make the distinction here or not.

That's a good question; my recollection of our discussion of this particular was on the data, not information. Obviously if there's information already a process of filtering, interpretation, ongoing, doesn't give person access to that, the data itself rather than how the data is processed. We can discuss that. But if I remember correctly that was the point.

An issue, not to be agnostic on the point, but this recommendation is drafted differently from the others. That all of the others sort of are really much more directive, start off HHS should, NIH should. This has an introductory paragraph which really isn't a recommendation for action, but rather a broad statement. Then the recommendation comes differently. So my question is, assuming this is done purposefully, does that make sense just in terms of creating the recommendations, or is that better served being put in the text because it really stands out as different in terms of format from the rest of the recommendations. If you look at the other recommendations they are all HHS should, this that is the other. This is open paragraph of statement.

Again, back to the Tennessee tension we already felterrer, about maybe the need to put justification into recommendations. This is for the committee to decide, granted. I am agnostic about being there, just want to point out it's very different from other recommendations.

The idea is this was useful here. In any case, mark?

I offer the suggestion that if you flip the two paragraphs it would fit the format of the others.

I am taken by Paul's comment as to whether we need the now second paragraph. I think it's otherwise in the executive summary, in the same way the others have the assumptions.

If we want to whittle this down we certainly can.

I would note several of the other recommendations contain a small amount of text to keep it in context. I don't see a reason not on do that.

Scott?

There are a few locations where the Department of Defense is named specifically this, is one of them. In this context it seems to imply that we are going to recommend that the Department of Defense work with the prief sector, is that a recommendation for the Department of Department of Defense specifically?

The way this is worded it suggests it is a recommendation to the Department of Defense. I wanted to clarify that.

This is recommendation to the secretary. The idea, maybe you are right, we could word better. To collaborate with --

The language suggestion would be to remove the and, and just put work with other -- we cannot make specific recommendations.

Not recommending to Department of Defense or --

If you are making that change this, has a role in interoperability and data standards, you can add --

Part of the EG list. Right. Yes.

Discern disrn.

I [ indiscernible ] discern, I don't know we will find out.

What we have at the moment. We have reversed the paragraphs, HHS should work with other relevant departments, for example D VA, Department of Defense, to share interoperability among databases. Specifically HHS should work with existing organizations to create uniform data standards, explore ways to harmonize data, develop infrastructure to enable data exchange. Second paragraph: Data sharing and interoperate obligate, research regulatory medical record and claims databases will facilitate study of the molecular pathogenesis of disease, the -- validation of pharmacogenomics technologies, assessment of health outcomes associated with the use of pharmacogenomics technologies and the impact of using these technologies. Where we are at the moment. People are good with that? Other questions, comments? General malaise? Good. Excellent. Next.

On page 49 of your report. Draft recommendation 6 D. FDA should identify, initiate and facilitate research opportunities and public/private partnerships to encourage the development and codevelopment of pharmacogenomics products, through the critical path initiative.

Yes?

This sounds like FDA is paying for the research? Does FDA -- it is?

Should identify, initiate and facilitate --

The deal for the critical path is very largely being generated out of leveraged activity, so collaborative activity. Funding has been modest up until now, it's been a deliberate effort to make sure the funding is always matched in some way. I think the funding may become more generous whenever we -- corner of NIH. I am certain it would be to continue to look for partnerships with industry or other government into it entities.

Just wanted to be sure -- [ indiscernible ]

Anyone?

Yes, Michael?

The NIH, their biomarker consortium, is that mentioned anywhere? It could fit here, it's a public/private partnership, along the same lines as critical path.

Now, there's an appendix in the report so everyone knows, of all the various efforts going on in the government. Is that A?

In the text about the biomarkers consortium, also in appendix. This is example of one activity -- we can do that, want to add others, or not mention specifically.

If anybody notices in the report an effort or program is missing, please let Suzanne know, we are happy to add things to the list. We want to be as comprehensive as possible.

Mark. The thing that looks different, identified just one. In many other recommendations we identified more than one. It may appropriately or not give pride of place. If it we want -- might be good to mention a couple.

We will do critical path initiative, or Biomarkers Consortium. All right. Fine. Fine, fine.

So, we haven't made too many changes, looks great.

On to the next. 7. Page 51 of your report. This is into the realm of personal information protection. As data access and sharing expand, it will be important to strike the right balance between protecting the privacy and confidentiality of personal data and fostering access to data for pharmacogenomics research. Stronger data security measures may be needed as more pharmacogenomics researchers access patient data.

It will be person to the strike the right balance, well, HHS should strike the right balance.

Should work to strike -- or guide or whatever. Paul?

I have a problem with this particular recommendation, because it's important now, and it's important in the future; it was important in the past as well. What is exactly new about this? What are we calling for that isn't already in place or --

I think the reason behind it was just what you said, it's important. So the thought was to leave it out by its absence might suggest it's not as important as it is. It's not to say this is the definitive recommendation or this changes anything from the past, reduces from the future, but to say it's of such importance it needs to be in here. Part of the idea. It is such an important issue.

Mark: To address that, to expand a bit on the recommendation, I think the issue that is resurfaced that makes it different, the idea of information technology, whether or not that previous recommendations have in fact been specific enough to capture that. What I would reference is the work being done through the American Health Information Community, AHEC, a DHS initiative that has a specific work group on privacy. I think this would be a perfect opportunity to make a specific recommendation to say we recommend the Secretary raise this specific issue with the privacy work group of AHEC to develop guidance, as part of that initiative.

Okay, Joseph?

Yeah, I don't have anything to add to the last comment, but I thought the recommendation should start off with a much stronger statement. This last sentence, I recommend it be in the starting sentence. I would change the word may to will. Thenal whatever comes after that the committee can decide. I would just move that around.

Done. Then I have mar a, Barry and --

Same comment.

Okay. That's good.

In addition, Mark, to the privacy work group there's the one Greg Downing, Personalized Medicine work group. There's --

A different work group under AHEC, but the personalized health work group agreed to work with the privacy -- on these issues. It would be captured within that discussion.

That works fine. What some of us within NIH is trying to do is cut down on the number of work groups.

Right. Thank you.

In response to this discussion I want to point out draft recommendation 12 A, specifically does reference AHEC. That may be the place to get some greater specificity, although it's fairly specific.

Underscore the privacy and security, that recommendation.

That's a different orientation, looking at decision support, a different aspect of that. So if this is really -- we have several recommendations here, around six and seven relating to the database. I don't know that we necessarily need to combine them, though if everybody feels strongly about that, IT would be fine.

Paul: As a matter of drafting, I would strike -- not quite sure what that means. HHS, rather than should strike the right balance, whatever that means; HHS should balance the protection and privacy and confidentiality with blah, blah, blah, rather than strike the right balance.

Okay, still working. Okay,

Let's read what we have now. Stronger data security measures will be needed as more pharmacogenomics -- access patient data. As data access and sharing expand HHS should balance the privacy and confidentiality of patient data with access to pharmacogenomics data for research.

This is about -- personal data with access to --

AHEC's confidentiality and privacy and security work group should be tasked with addressing this issue. Yes?

Joseph: So it seems a bit -- starting with HHS should balance, I am not quite sure, but seemed to me something should -- should have --

HHS should strike a balance -- I am agreeing with that part. Saying before that should be the way you get there. First statement is stronger. I am not great at wordsmithing. If the first statement is there, pretty strong statement. Then something about recommending how they really should do it. Seems to me that's what's missing. You have that as third sentence, how it should be done. Somehow or another it should become earlier, as a way to get to this, to accomplish this, something to that effect U such that -- seems to be a miss there.

You wouldn't see what we said at the end, that the AHEC work group should be tasked with addressing this issue, with creating that balance, delineating the balance, something like that?

Yeah, I agree with the part, the balance between the two should occur. Seems HHS -- seems to be a bridge missed. A set of bridging words between the last part of that, moving to the tasking part. All I am saying. I A apologize, I am not good with wordsmithing. This is the sort of -- open to suggestions from people better at words than I am.

JULIA? Julio -- not only a matter of balance, the way it states there, it's like either you have privacy and confidentiality or you do research. It's a balance between the two. I think that it should be more than that, should be like to ensure that research can be conducted, perfecting privacy and confidential it. I know sometimes there's a conflick the between the two. I think research should be done with --

We have run into this issue before. Even how you phrased that, you say research should be done with -- some people read that as "the research should be done," and along the way protect privacy and confidential it. Others see privacy and research should be protected and then research can be done. We are trying to figure out how to say it in a neutral way. That's been a struggle all the way. If anybody has a better way of saying it, Ellen? Please.

Perhaps related to that is -- seems to me there is an inadequate distinction between security and privacy and confidentiality. Is this about data security? Then we could get out, rid of privacy and confidentiality and talk about balancing security. You want to maintain privacy and confidentiality, data security to provide access, you have to -- going to be a give-and-take there.

I understand. The idea is why do you need data security, apart from privacy and confidentiality --

You always need data security, even if you are not keeping something confidential.

The emphasize is more on privacy and confidentiality than data security?

I assumed it was the opposite.

When you have -- the issue about research, may be security bridge, privacy, but in the context of conducting research you may have information that makes the person identifiable. That's the big issue. Not so much --

You can break into a database, big issue, not discussing that.

Bigger than just that.

Absolutely. Is that not coming -- we're still working. Any other -- look to see what we have?

I actually like Paul's balance, because that does remain not open to the interpretation that we're doing one, the other as an afterthought. I think in truth it is a balance. There are issues that need to be balanced, absolute privacy would preclude research, and absolute openness would preclude privacy, thus it's a balance. I like the way Paul put it.

We have now, almost will have soon, two balances on how to balance the need to balance.

Okay, let's try this. See what people think.

Stronger data security measures will be needed as more pharmacogenomics researchers as patient data. AHEC privacy and security work group should develop guidance on how to bells balance the privacy and -- against research.

Sorry to go back to this, but I want to again just pause and thinking whether AHEC's privacy/confidentiality work group is the best vehicle to look at this. I raise it for a couple of reasons. One, there are plans that AHEC will be phased out next fall, will be a successor organization that will be stepping in for AHEC. I don't know if there's continuation of that work group. The work group, Mark knows this better than I, I would like you to address it, but it certainly has its hands full right now without looking into the context of electronic health records, looking at all the privacy and security aspects. Is this the right group to give this very important issue the kind of expedited attention that it needs?

To move this along, you are right, AHEC's future is questionable, we don't know what will happen with it. If we say that -- through mechanisms such as AHEC -- then you signal where you are headed, trying to decrease redundancy Barry is worried about.

We have Steve --

Let's bring this to closure.

I think part of the problem is this focuses on how to balance, rather than access assessing what the right balance should be, recognize trade-offs, figure out where it needs to be. The focus is mostly on mechanisms.

Martin?

I thinking that the way this is worded might sound like we are not giving -- a 50/50 thing. I think that's not the right balance, if you will. I think we should say something like, take the word balance out, do something like on how to protect the privacy and confidentiality of personal data --

While ensuring --

Doesn't mean that you are going to have hundred 100% success, but what you are trying to do.

While enabling access --

Okay --

I still thinking it sounds like we are not giving appropriate consideration to the privacy thing.

If we say -- appropriate, what is appropriate, right, just another word for, right.

There are two issues. This is not the only group that is sowsing assessing thsh of personal privacy, for fark coJen pharmacogenomics research. The ability to do research. What we are really talking about here is there's an inform attics component linked to doing pharmacogenomics research. I see it as at the print time, the consensus of the group is we don't have tho ease specific issues addressed for these types of pharmacogenomics -- news to hear that AHEC may be going Aing way. That's the way of things. But to address the issue of yes, they have a lot on their plate, but it's within the Secretary's purview to tell them what to do, when to do it.

What would you recommend, you happy with this?

I am happy with it as currently constructed.

Okay. All right. Let me go through it one more time, stronger data security measures will be needed as more pharmacogenomics researcher access patient data. Access to mechanisms such as AHEC's privacy security work group should work on how to balance the privacy and confidentiality of personal data without -- access to pharmacogenomics research. I am looking. All right, we're good. Thank you very much.

Thanks for all the good input. Now on 8 A, page 56 of your report.

This is population stratification in drug response, some of the questions there. Because genomic factors may be more meaningful predictors of drug response than race and ethnicity categories, FDA should develop guidance that encourages the collection and analysis of other biological factors and may better explain differences in drug response. Specific recommendation to address a relatively specific problem. Everybody comfortable this? The wording?

Joseph?

Allen?

You first --

Better than what? In the last sentence.

That may better explain -- better than what we have now.

Better than --

Better explain differences than using race and ethnicity --

I

If you feel that's clear in context --

Not quite the same, but similar pathway of thinking is that ethnicity, biological categories, not appropriate to say, to categorize them in that way. They are more sociological categories, say using biological -- you need to, really do need to have a little more explanation at the end as to what you are going to do.

You are not going to help with the wordsmithing because you don't do --

Because I am not a biologist, not my area. The difference is you can talk about other differences, but differences that --

How about if we do this, encourage collection of genetic and other biological data -- that may explain differences in drug response.

Key word here, may be overly simplistic, explain individual differences in drug response. It's drug response in the individual you are concerned about, not in the cultural class. Social classification.

I would agree with that, what I am -- even though these categories are there, they are actually grouped, sociological, if the outcomes are more individualistic you need to say they are.

There will probably be inclusion of data such as biological an sees tree --

I have Mar a, Paul,

I was going to put it into sociological -- thought that would be useful to categorize in -- use race and ethnicity --

More meaningful than --

The if I ever the

first sentence.

Not very good proxies.

Not exclusive proxies in the sense that for the individual, the population genetic factors as well as socio economic, others, at the individual and group level may be co-explanatory. I think you are looking for things that are better, things that are more comprehensive descriptors, aren't you?

Recommendations?

Both.

Recommendations to words?

Take a look at what's up there.

I wouldn't say more meaningful predictors, I thinking they are predictors, for instance.

Any concrete suggestions?

First, example of this where race and ethnicity and age only explain 25% of the variables, but when you put in genomic factors you then explain 75% of the variables, is that the idea?

My interpretation as I read this was that we know that some drugs are coming to market using race and ethnicity as the defining -- vital, really the example of this, that we say, try trying to say genomically that doesn't make sense, within a self-identified group of African Americans there's a dramatic difference based on genomic factors. I think it addresses a current issue, which is that these things are being used as proxies for development of drugs for sub groups, recognizes that's a reality, but saying we need to move beyond that.

Paul?

I actually disagree. I agree with what Mark just said. I think that in the end socio economic class and the biological -- will have to do with who takes the drug and how they respond.

The question is, is this socio economic data relevant that's captured by categories such as race and ethnicity. That's one of the question. Gur van it?

Question here, qualify -- logical predictor, I don't have argument, predictor to treatment, then there are non-biological -- completely. If you say biological to the predictor there's a better way of --

One of the concerns here is that categories such as race and ethnicity, which everyone acknowledges are socio economic categories. Not even perhaps the best socio economic categories to use. Right? Go ahead.

I was going to say I don't think them as socio economic categories, but I thought we had -- I wouldn't put economic in. Socio logical -- that's important, nothing to do with economics. Socio logical. I make two suggestions. At beginning in the first sentence, maybe it changed now. Sorry. It changed. Someone the . shouldn't be socio economic. But also, the issue, dose based on race, ethnicity, age, weight. Now can be dosed on those and genomic factors.

There aren't any --

Oh yes, there are major differences in response to -- by race, and it turns out -- explain most of that. I think if we go back to the original eight A in our -- that artfully dodges the contentious issue of defining race. Is there a biological -- don't need to get into that. We would be foolish to tackle it. I think eight A says -- may be more useful predictors, therefore encourage analysis of genetic and other biological factors, that done the say that race is some biological issue that better explains differences. I didn't design it, I can say this, is an artfully worded recommendation that --

Are you saying we had all this discussion for nothing in

Look up on the screen, see, people, if what is up there captures things more adequately than what we had, or what we had is closer.

FDA should develop guidance that encourages collection and analysis of genetic and other biologic predictors -- socio logical categories --

No --

I have Michael, I have Martin, and Jim --

Michael?

Isn't the problem when you try to use race and ethnicity as a biological marker? That's the problem. Right?

Yes.

Well, when you --

Wait --

I have to keep --

If you just explain that that's -- you run into problems when you use race and ethnicity as biological marker.

What are you suggesting?

Martin?

I thought the one we had up a minute ago, the par parenthesis, and put race and ethnicity --

Okay, Martin, help us out. What are we doing?

The formulation we had before we flipped back. At the end of that put parenthesis, after factors, e.g., race, ethnicity, gender.

But again, you are jumping right into the controversy.

Can we wait, I want to get the suggestion right. Before we comment on it.

Do you have it?

Gender is not a socio logic --

Well, sex --

Wait wait wait.

I can give you --

Whoo.

I can give you the words --

Women -- let's see what people think about this. Still not comfortable. Michael?

I was thinking that, drug responses, when attempting to use socio logical factors as biological markers.

Drug responses than when using socio logical factors as biological markers.

Or biologic -- should develop guidance --

May be better predictors of individual differences in drug response -- than when using socio logical factors -- new recommendation up there. Now I will take comment and questions and -- Joe?

Biological markers, use the word as proxy, instead.

Take out biological markers. Use proxies.

No, biological markers, put in proxies.

Next comment, anybody? Yes?

I will make one more stab at this. I am already bleeding profusely.

Last sentence, as it stands, defines, for example, gender as a sociological conduct, as many would argue, race is, therefore, I don't think that's accurate. You can say something liking "in drug responses," broad proxies. How about just using broad proxies. Then we can avoid this fruitless debate which inflames everyone, how to define these things.

There you go, leave that.

When you attempt to define --

Okay, wait a minute.

everybody take a look at what we have, door number three. FDA should -- still changing --

Okay, here we go. FDA should develop guidance that encourages the collection and analysis of genetic and other biological factor and may be better predictors of individual differences in drug response than broad proxies.

E.g., race ethnicity and gender.

Is the words category better than proxies? To me sounds a little inappropriate there, doesn't sound like -- not necessarily proxies, they are different ways of categorizing.

We have category suggestion, gur van it is on that too.

I agree with that. The pharm co-- I would not fwrea with this recommendation, looking at it, would not agree, race A has a better response, may be a better pretickettor than genomic -- it's not quite true here. Biological response, not a better predictor of drug response. Drug response has many factors. That's a small part. Unless you make it clear it's a biological predictor, not predictor per say.

One problem with race and ethnicity, they are usual self-assigned.

Doesn't matter. From an effectiveness move point of view, you cannot afford the drug, genomics not good enough, doesn't matter. If you look purely biological phenomena, that's a different issue.

Okay, we are developing guidance, suggestion about the recommendation, how do you want to change that?

When you put biological in there.

Good. Joe?

I concur with that, because that's really what the original, my original thought.

You and gur van it have nit have to --

Steve in

Better than proxies, I would probably talk about socio demographics.

No -- not a category.

Categories.

Okay, we will try this. Just, I will point out -- it does may be, doesn't say is.

Okay.

Martin is back on. Real fine tune, maybe at the end, rather an e.g., categories like -- a lot of other things could be categories besides race, gender, lots of categories, I want to make is sound like those type of things.

We will try another time here.

FDA should develop guidance that encourages the check and analysis of genetic and other biological factors that may be better biological predictors of individual differences in drug response than broad categories such as race, ethnicity and gender.

All right. Are we happy with that? Oh! That's wonderful. Because now I am going to go to the next one, 8 B, turn this over to Reid. I am going to go get a drink.

Is it the bar open?

A drink of water.

When drugs are shown to be effective in certain racial ethnic -- encourage manufacturers to conduct additional post market studies to identify biological, social and behavior models that underlie the individual drug response. The floor is open.

Reid?

Following on to the last discussion, I think you should say genetic.

In the end, instead of the whole list -- just genetic biologic markers.

Other things too, just conduct additional post-market studies to identify genetic biological, social, add that to the list. That's -- what we are saying in the one before, this might be a better predictor.

Difference between genetic and biological?

Yes. Genetic, biological, social, behavior and --

I object to that difference. I think biologic is broader. Genetic is biological, to --

I am not going to get into the last debate, maybe somebody can help -- there aren't many other --

Let's get this one nailed. Are we saying -- adding genetic or not?

No.

Not.

I would just -- two points. I completely pray with Allen. We did specifically -- language consistency perspective between the two recommendations -- the second spoint this spoint this a pharmacogenomics report, should probably be specifically stated. Genetic and other biological. Thank you.

Exactly what my remark was. Maybe somebody can explain where social behavior and environmental come in on this one where they hadn't previously come in at all. To make it consistent, I like genetic and other biological that may under lie the differential drugging response.

This is a fundamental difference of opinion here as to whether or not you say we would get beyond the biological to include behavioral and environmental.

This case, this talks about effectiveness. Not simply the biological response, gets back to what Gurvenit said, effectiveness takes into effect lots of -- things very germane, other than just biological phenomena. I con tour I concur with that.

I appreciate you raising that, begin to see the key word to focus on is effectiveness and many different determine nants of effectiveness other than -- want to open it to include those, post-marketing stuff, which ff, which is terrific.

I suggest --

Good.

I agree with what you just said about the difference in response, effectiveness. Should we change the very last word to differential effectiveness?

Yes. The response is too narrow. Difference of drugging --

Effect, because --

Deals with my discomp fort, broad eps.

Drug effects. Good. Anyone else?

Does response include safety and effectiveness? Talking about safety here as well.

Effects both positive and negative. Thank you.

Let's make sure everybody agrees with this. 8 B, when drugs are shown to be more effective in certain racial or ethnic populations, conduct additional post market studies to identify other genetic and socio behavioral, environmental markers to irnd underlie the different effects.

I suggest we might just, although we did it for discussion, but doing the EG vital, that singles them out --

I also have never really been -- we are going to take out vie don't don.

You wanted it there Reid.

How do you undelete?

All right. Is this it? Did we catch it all?

Good? Set. Process check.

We're moving toward the break. When?

No breaks. There are no breaks until we get to a better calculation of whether we will make it.

Gatekeepers, brief overview, entities that enable, halt, redirect the course of pharmacogenetic technologies, patient technologies, identified, I will not go through all this, roles of each. You are all familiar. Let's go to recommendation number 9, slide 58 --

Can I make a comment on that?

The gatekeeper section, we have role of industry, FDA, CMS. We have is the role of the laboratories performing the testing, regulators through cli a, might be control of CMS, has role as coverage, reimbursement, that needs to be moved to earlier in the section or actually highlighted, because I think it's a very important gatekeeper.

Which slide are you on? 56?

Either, 53, gatekeepers, industry, FDA, CMS and -- CMA should maybe have two bullets, different roles.

You want to change the text of report.

Write up that suggestion, give it to Suzanne. Won't change the recommendation 9 yet, right?

Good.

Slide 56, I will give you the language, role of CMS, other third-party payers, reimburser may not be perceived to be adequate.

Give that to Suzanne, we will take care of it. We are going right to the recommendation as you would order us. Recommendation 9, page 74 of the report.

This is on reimbursement. In clinical situations where a pharmacogenomics test has been shown to test safety or effectiveness of clinical management, IE, clinical utility compared to alternative strategies, and provides value comparable to or an improvement over other coverage services, public and private health plans should provide coverage and reimbursement for the test and the most clinically appropriate drug as indicated by pharmacogenomics test results.

Mark, then Paul, then Joseph.

This has major scope issues. We are recommending to the secretary, the secretary only has purview over, in terms of reimbursement over CMS related payers. That would be Medicare, to some degree Medicaid. Any reference to private health plans in this is really -- we can all feel that way, but it really doesn't -- is not within the scope of what we can recommend to the secretary. The second point, missed, critically important, is the idea that what we really should be recommending to the secretary is that clarification be other not coming from CMS as to whether or not pharmacogenomics testing will be considered to be preventsive and therefore not covered by CMS because of the legislation that basically excludes that without modification. Or, as has been rumor to the effect that it will be considered in the context of the disease, in which case it would be covered. That's the critical issue I think this recommendation needs to address, that the Secretary clarify with CMS how these will be treated.

A point of clarification, Suzanne?

Two points of clarification. First, that recommendation is in the coverage, reimbursement report, and in the text we reference that recommendation. I know at one point during development of these recommendations we had a specific one saying exactly what you said, reiterating what the coverage report says. After discussion amongst the task force it was decided that it would not be included in this set of recommendations. I am not recalling --

To ask for clarification about how the pharmacogenomics tests will be --

Yes.

If it's in the coverage and reimbursement report we should --

No, not specifically pharmacogenomics, but the recommendation in this report asked for clarification on the screening policy of CMA replies to --

My personal opinion, it absolute Lee has to be in here.

Joe and Barry --

In this particular one I would prefer to take out the clause comparable to or improvement over other coverage services. This would allow for this to have to do with comparison to other coverage services or de novo improvements, as long as we deliver value, what do we care if it's covered before or not.

Second, I would like to see the word adequate reimbursement or some other modifier of reimbursement put in, sense we all know coverage or reimbursement can be inadequate. Finally --

Wait. Where would you put?

Before reimbursement. Finally, to what Mark just said, it is true that we can only recommend that policies that could implement, be implemented, but we could hope or wish that as some payers do, follow PMS protocol.

That was our intent.

You might even say that. My list here. Mar Mara?

Joseph.

It's okay, I was a actually agreeing with Paul the lesser, the second comment, was part of mine. I just agree with that.

Mara? Then Barry.

I also agree with what Paul said, but I am struggling with the beginning piece, about in clinical situations. By definition if already in a clinical situation there will be coverage or not already. I didn't know if we needed, I don't think we need that phrase at the beginning.

Start with where.

Right. Number two is does it need to meet above, when it says enhance safety effectiveness of clinical management or to show effectiveness of clinical management? I didn't know the intention there, above a standard of what existed now?

Right, in order to change reimbursement policy. Why change reimbursement policy if nothing's better?

I will come back to that.

I have to agree with where Mark was headed. As written here it's possibly a meaningless recommendation. We are governed by statute in terms of how we cover things. Safety and effectiveness is the way used used to be covered by -- anything FDA approved safe and effective is covered, that's not the case anymore. Reasonable and necessary, struggling, trying to define that. Getting comparative effect, little known, cost effectiveness, slowly working its way in. Talking about how we make a coverage decision, the way I am reading this, almost instructing us, we don't use value. That's not anywhere in the -- in terms of coverage decisions of policy. It would far better to recommend to the Secretary, already starting to do this, why I am here today, struggling with the issue, if the law says prevenz prevention is never covered, or is, we look back to physical findings, possibly family history, other entities, a whole way of approaching this that could be extra statutory, could be requiring statutory approach. That's what probably, when you read the preamble, everything that leads up to this recommendation, people are struggling with how do we change the Medicare program in particular to even allow us to make a coverage decision, nothing to do with value.

Do you have a recommendation for how we can re-word this? Or --

Along the lines of what Mark was saying.

Take a look at what we have. Where we are at the moment.

When a pharmacogenomics test has been shown to enhas safety or effectiveness of clinical management, i E, clinical -- strategies, and provides value, CMS and other federal health insurance programs should provide coverage and adequate reimbursement for the test in the most clinically appropriate drug as indicated by pharmacogenomics test results. Is that closer? Further?

I will do Mark, Maya.

This gets to the point Barry was making, you are basically telling Medicare how to make its coverage decisions, language not within, consistent with the CMS decisions on how they make the decisions. I default back to recommendation that states the Secretary explore with CMS the issue of whether pharmacogenomics tests will be included based on screening or prevention language, or whether there are non-statutory solution ings that would allow consideration of coverage using the usual mechanisms under which CMS operates. I think that's what we can actually tell the secretary that can actually be accomplished by the HHS group.

Reid, then Maya.

Reid: I will struggle with the word adequate. I don't want to put -- once you put those kind of words in this kind of thing you open enormous contractual issues, debate, fighting and so forth. I think you reimburse it, adequacy is perceived by who ever it's perceived by.

Where was the adequacy part, you want adequate struck?

Right.

All right. I have Mara, Jim.

I am closer to where Mark was. Before I wordsmith, I wanted the need. I want to take it up a level. Was the idea here the fact that if there are tests for which pharmacogenomics are relevant, useful, not using the perfect words here, we want them covered? What I am struggling with. Not a comparable piece that says -- head lines reimbursement for pharmacogenomics products. Talking about tests, if I ever the question is there's an assumption if there's a pharmacogenomics drug it will be reimbursed, not a terrible assumption. I wanted to get it up a level to not get to quite so much detail, but rather say the group is in favor of test that's are pharmacogenomics, related to tests gone through, related to drugs gone through the process outlined in the other recommendation, that HHS should find a way to cover these because by definition if we have done all this, showed the basic research, showed the translational research, then the test isn't covered, there will be no incentive to create these tests beyond that basic research.

Reid has a question.

Question, let's take it outside of this for a minute. Say all the manufacturers of gnu nuclear imaging machines, every nuclear imaging machine, wonderful thing, CMS has to cover every nuclear imaging machine out there, say there's a test for a new drug, beyond the realm. Formulary today, open the door to everything on the table now?

Well, I look at it as it may be different options for the same thing, the same way that many different drugs are approved for the same condition if there are multiple tests, in the way this is going with pharmacogenomics, my suspicious is there won't be multiple tests initially. A test for X condition is covered, may be three tests, but the patient only goes to it once. The mark the may be the lowest priced one. Nuclear imaging machines, they use one, that test, the machine is covered to get the answer to decide who best or how best to use that particular drug.

Before we go on further --

Saying there might be multiple tests, patient only needs one.

I think I can clarify this. Up here clarify it, not --

I think --

We're a little over half way through.

The specific language we are dealing with is really, without name integrity ing it as such, issue of formulary. At the present time pharmacy benefit managers, health plans use formularys to control costs. If you have comping data a certain individual will benefit from a certain drug, our formulary is really appropriate. Getting back to what CMS can do, under Medicare part D, to some degree Medicare part C, if there was compelling evidence that there were differences within the category, CMS could say to its contractors, we are not going to allow you to apply a formulary to this class of medications. You need to consider medical necessity, based on pharmacogenomics information that will lead to best dosing. So the issue is that we're kind of talking around the issue. Clinically appropriate drug is really referring to the idea there is a best drug that could be identified for an individual, getting away from using formularythat's all I will say.

The moderator is moving us forward. I want to make sure this does not get red as just because you can come up with a trif being pharmacogenomics test, match it to a drug, therefore CMS is obligated to cover that test and that drug when they may not have been willing to cover that drug in the first darn place --

I have Jim, Barry, Kira --

I think Barry's points are well taken, it would be silly of this committee to make recommendations that can't be recommended or aren't under the purview. Is there utility to suggesting a category, categorization for pharmacogenomics tests that would short-circuit some of this, make them covered or coverable more easily, whether they meet criteria in improving efficacy, effectiveness. That's my question for you Barry.

Barry: I am not sure I ned I understand the question.

Question about how to categorize pharmacogenomics tests that would allow more action or leeway on the part of HHS.

I was going to suggest a slightly different thing, and I am not paying attention to this language at all. Recommend to the Secretary he ask CMS to produce a gietdance document on current status of genetic testing as it relates to pharmacogenomics. Including surveying the private sector to see what coverage was -- in that setting, and to make recommendations to him as to what options were available. Something of that nature.

Maybe say with the intent of being able to cover improved tests, or improved use of drugs.

Make sure we are not impinging on your territory.

Take a look. Responding to this, down here? The highlighted part. CMS should clarify how the Medicare screening exclusion policy applies to pharmacogenomics tests -- no.

Try again.

This committee recommends to the Secretary that he request CMS produce a guidance document detailing current coverage and coverage issues pertaining to pharmacogenomics in the Medicare program, including surveying private sector for what is currently covered extant there -- forget the extant --

Keep watching the lower paragraph --

Detailing current coverage -- pertaining to pharmacogenomics coverage, as opposed to tests --

Detailing current Medicare coverage of pharmacogenomics drug and did I aging gnostics?

No.

just pharmacogenomics, period.

Next?

In doing so, someone should survey the commercial sector policies and should identify issues for -- future coverage issues. We can word that better, but --

Now, that I am presuming all you are suggesting in this. That whole top part can get tossed.

Can I ask what commercial sector policies, private health plans, and the purpose of that survey?

To see what the current compel policies are, so we can compare that to coninstructions under Medicare, get them in alignment. We will fined they are different, grossly different or not remains to be seen.

That's actually being done in the area of cyber genetics and molecular did diagnostics.

There's interesting private sector work looking at the total cost of treatment with the addition of pharmacogenomic tests, reducing the full cost of treatment.

Okay, what we have here, currently, everybody take a look so we can move on with this. CMS should develop -- secretary of HHS -- how did that begin? Secretary of HHS should -- okay, CMS should develop guidance document detailing current Medicare coverage of pharmacogenomics, in doing so C CMS should survey private healthcare coverage, and identify issue -- identify inconsistent elseys --

Do we mean inconsistencies, or to understand current coverage?

Current coverage and also, base said on this committee's report how do we get to other issues raised and if we can't --

Now everything has to be in terms of words going into that recommendation. I want to be sure it's -- plans, policys to identify inconsistencies in --

Not sure where that word is coming from.

To get rid of --

Gross differences between public and --

To identify --

To identify differences in between Medicare --

I think the differences is not the primary issue. The real key issue is what can we cover or not right now. If we can't cover anything in terms of tests, we can cover medications.

Let's focus on you putting words on the screen so we can all agree to the words. In doing so CMS should survey private health plan policies to identify differences in -- okay so far? To identify differences in Medicare and private health plan coverage and future coverage issues --

Sure. I am okay with that. I would put Medicare coverage and reimbursement, because -- well, coverage, reimbursement and oversight --

Can't do oversight. Don't go there.

Okay.

So everybody -- this is what we have right now, not yet, now we do.

CMS should develop a guidance document detailing current Medicare coverage and reimbursement for pharmacogenomics. In doing so, CMS should survey private health plans to identify differences between Medicare and private health plan coverage. No --

As well as future coverage issues.

Okay, happy so far?

Paul, the not often heard from, yet.

The original recommendation in the book, the first slide, was fairly generic, it wasn't about Medicare pir say, all children thrown out of the recommendation. That's fine, if we want to be explicit about that. But there's still plenty of other issues originally part of the content for recommendation that are irrelevant to children and Medicaid. So, if we move to what's up there now, which might be have been helpful, someplace else, the other programs need to be included to reflect fairly what was originally the content, in the content of recommendation 9.

Any reason to not have Medicare and Medicaid coverage?

That was going to be my suggestion, if the Medicare types are happy with that.

We have less to say about Medicaid policies --

Vu something to say.

We could comment on that, yes.

I am getting that we have Medicare, Medicaid, and S-chip.

All right. Next, Steve?

I want to -- perfectly fine with this recommendation. I am concerned there were a number of things that came up in the report that related to utility, value, to coverage of decision-making. I ned we are trying to push CMS for sure, actually got feedback from the private sector as well. They look to Medicare for guidance, CMS, leadership on these issues. That we somehow pull this together. There's also the influence HHS has over the federal employee health benefits program and others. The concern was by waiting for a report, which is great, it's going to be years until all of this really happens, and we wanted to provide some guidance to the agencies that they should do this on the basis of incremental effectiveness and value. That was part of the intent to do that.

Now, we may decide we don't want to go there and this will suffice, I want everybody to be clear that's why that recommendation was crafted the way it was.

My response is basic allege, the CMS decisions have to be made on statutory terms they are given, which is necessity and reasonableness. So we can put that language in there, but it means nothing. We know there's overlaps between what we mean by utility, effectiveness, what you mean by reasonableness and necessity. If we are going to reflect that here we need to reflect the language that CMS can act on within it's purview.

Ellen?

I suggest, you may want to survey public health plans, as well as private, other public --

Public and private health plans.

Okay.

Any other comments? Gurvenit?

Focusing on that point itself, if we focus only on differences between the plans, the thing we need to get to help inform future decisions.

Identify similarity and differences?

The way current coverage, policy or issues, to help inform future CMS coverage. Leave it at that. Different criteria, whatever it may be.

You would like, in doing so CMS should survey current coverage -- survey private and public health plans to identify issues --

To help inform future coverage issues.

Decisions.

Okay.

Now we have --

CMS should develop a guidance document -- e imbursement of pharmacogenomics. In doing so, CMS should survey public and private health plans to help inform future coverage decisions. Now we are really --

This sentence needs to clarify what CMS is surveying these health plans about.

Coverage decisions, how they make their own coverage. I am guessing.

About how --

Survey public and private health plan decision-making.

Whatever.

All right.

I like decision-making, end with coverage and reimbursement, comparable to the first sentence.

Should survey public and private health plans about their decision-making, right? About their -- decision-making. Processes, policies? Policies maybe? Policies probably. Process -- to help inform future coverage decisions. Martin?

small point. In doing so ties as well to the first sentence. Should say CMS should also -- instead of --

CMS should develop a guidance document detailing current Medicare/medicate and S-chip coverage and e imbursement of pharmacogenomics. Should also survey private and public health plans about the decision-making processes to help inform CMS's future pharmacogenomics decisions and reimbursement decisions. Just there, or anyone else's decisions?

Its future -- okay. Also should survey public and private heeling the plans about decision making proagzs to inform it's reimbursement decisions. All right. How are we doing now? Most everybody has been beaten into a complete stupor.

Kevin: As a point of interest to folks, I can, in some cases with the Medicare program ask for public comment on guidance documents. This might include the capability of seeking public comment. I don't know that we want to put that --

Okay, fine. No.

This is getting scrapped and that's where we are going so far.

I have a concern that by only talking about surveying people's decision-making processes we are not going to get information on their actual coverage and reimbursement decisions, do we want that as well?

That was the intention.

We want what?

Decision-making processes and c overage/reimbursement decisions.


One has to go longer than all the rest, hopefully this is it. Recommendation 9, going once, twice, and it is finally put to rest.

Okay.

Before you go to 10 can I say something? It's not about 9. Nine is fine.

LAUGHING.

The only place you talk about reimbursement, some of the other reimbursement issues, in coverage report, seems like we have to put some recommendation in there about some of the things we mentioned in there about genetic expertise --

We will, it's referenced certainly, in the report. The earlier report, on coverage.

I think that in our reports that have been after the coverage reimbursement report, we actually reference the report in the recommendation.

You are saying we should do what we did before, a footnote?

Not for recommendation 9, a separate recommendation. This is the only area where you talk about reimbursement. Later you talk about education, other stuff. But it doesn't talk about how do you pay for some of those things to help with understanding and education. If you are only talking about reimbursement in this one section --

You are not talking about recommendation 9, you want --

We can say specifically, covering the report, issues are still current, secretary should go back and really look at that.

Do we want to make a recommendation to that extent.

That report is still current, valid.

Everybody -- 9 B right here, come on, you start Thanksgiving Day.

ed this.

The issues raised in the reimbursement report impact this report is and the committee recommends these issues be -- therefore the secretary should -- right, right, secretary should revisit, review and apply -- implement those -- the recommendations from that report.

To move forward the recommendations --

The secretary --

Can I ask what the major 10ents of s of the other tenets of the other report were?

You have to read --

Make it quick.

Kevin, you might want to borrow from the report.

Identify the coverage and reimbursement of genetic -- okay, there it is. Thank you Andrea. Recommendation 9 B. Adding to the list of recommendations.

As the issues identified in the SACGHS coverage and reimbursement report are still current, SACGHS urges HHS to act on the report's recommendations.

There it is, okay? Gets right to what you want. Excellent. Everybody is okay? Good. Wonderful.

Now, here we go. This is the implementation section. I am, again, not going through all these details. These are the issues we will try and address. Education and guidance; IT, economic implications, ESLI, and coordination of HHS activities. Let's go right to 10 A, slide 65, and that is on page 90 of your report.

The recommendation is that HHS should assist state and other federal'ss and private sector organizations in the development, cataloging and dissemination of case studies and practice models relating to the use of pharmacogenomics technologies. Comments, questions, confusions?

Complete agreement? That we like.

Everybody is good with this. Good! Next.

10 B. This is use of pharmacogenomics technology and clinical practice and public health practice. HHS should assist professional organizations in their efforts to help their memberships achieve established competencies on the appropriate use of pharmacogenomics technologies. HHS also should encourage and facilitate collaborations between the organizations and the federal government around these activities.

Are there established competencies on pharmacogenomics activities?

Are there established -- maybe say should cease assist in -- question is do we have any now. If there are any they are few and far between.

I don't think there are any.

Establish some.

I see what you are saying.

For example, [ indiscernible ]

That's about as close as you get.

So we have one.

We can encourage to have more.

Take out establish, you got it.

Good.

Established.

Any other comments, questions, decisions?

Let's accept this as it is now. Once, twice, no?

Change memberships to members.

To help their members. Okay.

That's -- those are the kind of suggestions we like, brief.

Everybody, is happy? We are happy. Moving along. 10 C.

Page 91.

Pharmacogenomics technologies and clinical practice and public health. As evidence of clin cam Val IDity, utility for pharmacogenomics technologies HHS should support the conduct of periodic reviews to summarize the evidence based. The systematic reviews and technology assessments should being disseminated to professional organizations to foo facilitate the development of --

I would remove professional organizations, lots of groups will -- may be ARC, others will do that --

Should be disseminated to facilitate.

Yes.

Good. Mara?

Are these reviews of the drugs? Post-market, after the drug has been launched?

HHS should support the conduct of systematic -- technology assessment -- this is post-market? Yes. Or it could be --

If there's a good evidence base before bringing to market, no reason -- I don't think it defines. We are really talking about transparency ever data, putting on the public domain so people can use it.

I am trying to understand for a drug how this is different from what exists now, or just that it's transparently available.

The transparnzy was something we were attempting to achieve. I can't tell you now -- but Gurvenit will do that.

I'll try. The intent here was focusing on the technology assessments, systematic reviews, which are contingent on public information. Also the fact that there aren't that many around. There's relevant information, the synthesis -- what you are trying to encourage here.

So when you say technology you mean -- [ indiscernible ] or a particular drug category, trying to figure out who is the person, what would they be doing this on?

Folks like the -- [ indiscernible ] collaboration, who will evaluate all different domains, utility, anything of any drug, diagnostic device, anything relevant to clinical practice.

So those kind of organizations would be the people you are talking about here that would have to do that. We are recommending to do that.

This is already in place for other things, just saying it should be applied to pharmacogenomics as well.

Okay.

Anyone else? Paul?

Words Smithing thing, may not have any meaning, but I noticed that as we go through the tens, 10 A, B, C, and D, we're using the word assist, support and facilitate. Do they mean the same thing, asking HHS to do the same thing in each context or mean different things, and if show should you use the same words?

Assist, got it. Facilitate -- one may have fiscal resource implications, maybe they all do. Not sure.

Trying to see if I pick up differences, I don't think so. Support, facilitate, assist the development --

I don't think there's anything in the text of the document that would support we have specific intent with any of those --

May be a distinction --

Right.

We didn't want to be boring. . At recommendation 10 I think it's a little late. We never said we achieve what we want, brevity is not achieved.

10 C, where we are now, as evidence of clinical validity, utility for pharmacogenomics technology should support the conduct of systematic reviews, technology assessments to summarize the evidence based. These systematic reviews should be disseminated to facilitate the -- guidelines. People happy with that? I don't see any great suffocate surf suffering.

10 D, ... by support suggest -- these consensus building efforts should include the development of standards that define the minimal level of guidance, the standards should take into account the clinical context, e.g., treatment, diagnosis, in which pharmacogenomics tests may be offered. Also include development. Guideline methods.

Okay? I think most of the committee is passed into unconsciousness, a good thing. What we have been working for. All right.

How are we? Looking good. Gur vn it.

This is fine, nothing to add to this.

Good, thank you.

But, I did want to bring back one point that Steve had mentioned earlier, which was the original intent of the recommendation 9 on reimbursement, where -- we can think about to add, utility of information, decisions -- that recommendation [ indiscernible ] considered.

In 9 B, since we dragged in the entire previous report, I think --

I don't know that had clinical utility and -- in there.

By reference to 10 C, the clinical utility is there, the forward end. Adjunctive recommendation.

A symptom in cere much search of a disease. Only idiots are not going to adopt that, or if there's a specific contract language that prevents them from doing anything genetic which exists. I don't know that we necessarily need to point that out. If the evidence is compelling this works, people will try and facilitate Tate that happening.

Okay, Sylvia?

Can we get rid of the last sentence by making the first sentence HHS should facilitate the standardized evidence based blah, blah, blah.

Should facilitate the standardized development of evidence-baized --

Clinical practice guidelines --

I am not sure it's necessary. There's already a standardized process -- not sure we are talking about a repository --

Get rid of that sentence.

Brevity is good. How about the brevity of moving along to the next one. Everyone good? Let's go. 10 D, 10 E.

You took that sentence out?

Again, another recommend gz that came directly from the public comments. To inform the development of pharmacogenomics tests and dosing guidelines, HHS should fund clinical trials that provide information on whether pharmacogenomics is clinically useful, and how to use the information in addition to other relevant factors, e.g., age and jendzer, other -- being taken.

Joe?

I wonder if part of this has not already been covered in previous recommendations.

There's a little overlap, but not as specific as what we have here, saying HHS should fund clinical trials to provide evidence.

Yes?

Gurvenit?

One issue, not sure -- this information from trials. It may be clinical studies, some trials, some not trials.

Clinical studies, okay.

To some extent we have discussed this in the more generic form, the evidence based, per say. Specific aspect, part of pharmacogenomics, one can argue about the other part, targeting the drug, what drug to take, we focused on those areas --

Dosing was specifically mentioned to be there, needed to be emphasized. That was the reason it's there.

Yes?

Question: Do we really need that last clause, if so, how to use this information, other relevant factors. What does that add, is that necessary?

After the and if so, right? You want to possibly end it right after pharmacogenomics is clinically useful?

Yes.

We are saying we don't need to emphasize -- [ indiscernible ]. Joe?

I concur. I think we already covered this part. I would concur.

Okay. Get rid of that.

Right now, take a look at what we have.

Okay, we have to inform the development of pharmacogenomics testing, HHS should fund clinical studies that provide evidence on whether pharmacogenomics information is clinically useful. Pushing the studies. Looking around, going once, twice, yes. On to 10 F.

Professional organizations are encouraged to submit clinical practice guidelines that they develop for pharmacogenomics testing, to national guideline clearinghouse to facilitate dissemination and encourage implementation and use. Actually, I suppose we could phrase differently. Say the Secretary should encourage professional organizations to submit. Sorry. I raise the issue with are we trying to be specific about professional society organizations, healthcare delivery systems develop guidelines. I would want it more generic.

General organizations and --

Should encourage organizations to submit.

Okay.

Instead of professional organizations.

Good. Okay.

Great. Up there we have now: The Secretary should encourage organizations to submit clinical practice guidelines they develop for pharmacogenomics testing -- to encourage implementation and use. Everybody seems happy.

On to 10 G, page 94 of the report. Clinical practice and public heeling the practice.

FDA and drug manufacture everies should focus more attention on ensure all relevant pharmacogenomics -- information should be included about the test analytical validity, clinical validity, dosing, adverse events or drug selection for clinicians, or drug selection when making treatment decisions based on pharmacogenomics -- information to be included in the label.

This is our labeling recommendation.

People seem to be happy with that. Good. Nope nope, Paul?

Was there a discussion about different parts of the label? That is, there's real estate in -- on the FDA labels, dism and the question is if the group thought about what part of the label we are talking about here.

We did not -- thought it best to leave to FDA to decide that. Not that we would make a specific recommendation to that content. Yes?

Mara: Question, if a test is laboratory developed test and not -- the FDA does not review it, how is that thought about in the midst of putting on the label. Get it from CLEA, how would laboratory tests fit into this recommendation?

I think it depends on what the test is. Obviously if it goes through codevelopment process you can have labels pointing at labels. If it doesn't go through the codevelopment process, usually -- discerp discern [ indiscernible ], the label says list of factors, genetic factors you should consider -- didn't go into the specifics of exactly which should be tested for. Depends on the evidence base, commercial availability of specific test, how much information you can put in the drug label. That's why I wanted to leave a laundry list of things that could go in.

Okay. Ellen, then Steve.

Shouldn't or be and/or?

Okay. Steve?

Recommendations for manufacturers, should say FDA should work with manufacturers, then get rid of the next sentence to ensure -- next phrase, to ensure PGX information appears in label.

Should work with manufacturers, not drug manufacturers.

Take a look.

Okay. Paul?

I was going to make the same point.

On the same wave length. Here we go.

FDA should work with manufacturers to ensure that all relevant pharmacogenomics information is included on drug labels in a timely manner. Any pharmacogenomics test mentioned, information should be included about the clinical Val ID it, utility, dosing, adverse event, for clinicians to use when -- FDA should provide guidance on the standards of evidence that must be met for pharmacogenomics information to be included in the label.

All right. Paul?

Can I ask a point of clarification? Subsubmitee's view, impact of current labeling is effective one? The impact of current label --

Trying to put this in a politic way.

Polite way. Maybe that's the right --

Nobody believes anybody reads the labels.

Yes?

To be fair. FDA, improve the label, but beyond that it's critical for what can be said about a drug. Although I agree, docs don't sit and read the label. It's critical to what the companies can promote and educate about.

Okay. Once, twice --

It's 3:00 --

You have the potential for a quick break. You can have a choice. You can wander over, grab your coffee, as the discussion continues. Probably the best thing to do. You are always invited to use the facilities, whenever you so desire. I think we should press on through. Know there's stuff there, you go get it quietly, don't trip over your neighbor.

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Okay. We are good to go. On set 12. All right. This is on page 105. In fact this might be all of under five. A lot of adjectives in here. This is health information technology. The office -- I thought he would like that. The office of the national coordinator for affirmation technology through the eight cities of the American health affirmation committee and in consultation should take steps to ensure a the inclusion of pharmacogenomics test results and patient records. Along with a decision support Systems and tools to enhance the corporate test used an interpretation. Decision support Systems and tools should include information about the availability of the pharmacogenomics tests, patient test results and relevant information for making different and opposing decisions. As the infrastructure develops HHS should account for that needs of a physical -- basic and clinical testing is indeed as to ensure that often information is available to accelerate the integration of the pharmacogenomics breakthroughs into clinical practice. HHS should support efforts to establish standards for the development of electronic critical decision support Systems and tools. Pharmacogenomics tests and the clinical practice guidelines should be developed in a manner that allows for their integration into subsystems and tools. Comprehensive, but we thought substantively useful. Yes?

I am not sure that this really captures what the groups are actually charged to do. BTA and TNT may in fact be developing some to implement their are basically developing a platform that will enable these to actually work within the electronic help record environment. They aren't really dealing with the concept at all. It is just basically making sure that the clinical decision support engines can access the relevant data that generate the algorithms that would arise from clinical use. As I read that first paragraph it really sounds like you are calling on those groups to work to develop content, and that is not their role.

I thought if I remember correctly it was obviously you need both structure and content. One without the other is a pretty useless. So I think we are looking for both. If you have zero way of refining that were twice --

But I am not sure content -- for example, in here we are taking steps to ensure the clinically validated peaky as. Are you had seen -- acting into -- said the idea is to have to develop the infrastructure and cutting to put this information in electronic format. I am not sure we are really capturing what we want with this language.

Okay. Yes, basically all of recommendations and relates to a developing that evidence and putting that evidence out in guidelines so that people can actually use it. This recommendation, says it is around help information technology, has to ensure that that developments in Haiti will be able to support a conclusion of things like genetic information which currently we don't have standards or ability to include in the vast majority of information systems. So that release to be the intent of this regulation in my mind.

I have read and Ellen.

It is too much. I don't think it is redundant. To me, the inclusion of DVA to take steps to advance the inclusion of this is test results into patient records along with a decision support Systems and tools to enhance the corporate that use an interpretation. I don't think you need the rest of that paragraph. It is just redundant.

Said a decision, takeout.

All of that goes.

Than the second paragraph, once you set it up front this doesn't add any more to it.

He would take up that paragraph.

Take it out, too.

Then this last part about establishing the development -- well, that is built into what they are doing. So I would take that out. They are already trying to, through the process, developed electronic decision support systems. So clinical practice guidelines should be developed in a manner which is a whole other -- that is another recommendation. I don't think you need that. I only come up with the first two sentences.

Ellen?

I am confused as to what this is asking. You know, if you do a get the test, all of our records are electronic. It will be included in the electronic record today. So if the issue is developing uniform cinnamic Data Standards [ indiscernible ] where we are asked to create uniform to number distance. I'm not sure what it is that they are being asked to do. I don't know if they include clinically validated data into patients' records.

Before I answer that I have Scott, Tim, Mark.

I agree with the previous point. We should at least clarify the process and structure first. But also I think what is lacking here is the content. Not only do we need some credit for or exactly the support of the Clyde, but also planning for it. This is a support system prompt the past, for example, that we created for a potential drug interactions treated our track record of how well they are used is not all that great. So apart from creating the content what would be the best way to make sure it actually gets used. That would allow some studies to be done by other agencies may be beyond just a [ indiscernible ]. What would you add to their recommendation?

So what is lacking right now is, there is no mention of any funding of pilots studies to actually look at the issues of how to integrate test into clinical practice, what are the best means of the implementing decision making. Kurtz said going back to the balance point. You said there is already that information in the Department of Veterans. Is that correct?

Well, that is my point.

This is the attraction [ indiscernible ]. Well, this is a means or writing and we don't know exactly what the decision is in terms of writing. So there are tools available. How well they have been used in practice and how well they farm current utilization, we don't really know a whole lot about that.

And who would buy those studies?

Any of the agencies in HHS should be able to do it.

I just want a big sure we are capturing what you are recommending up here.

I have the Office of National credit for health technology and in consultation with DVA a DOD which we will get back to should take steps pilot studies.

That is the structure report talking about which mark had mentioned. I am talking about the content. Let's take these far cousin of the tests and use it in the seat POV or wherever archaism we have and find out how it has been used in practice and if it has actually helped or quiver is using it in their decision making. If not --

Can you say that in six words?

Out for now.

Let's see if we can get it up there. I had Tim, I believe. Did I miss somebody? No.

Mine is very brief. I'd like what was done in getting that. I think that the reason there were put in there is examples of sophisticated electronic medical record, especially with regard to decision support systems. Because obviously these things will get into the medical record, but because of the gap that exists and petitioner knowledge the decision support systems become very important.

I think the consultation part was paid. You already do a lot.

Two points. One is that having something in the electronic record -- and I haven't seen the system, but my guess is they are presented as images and not cutting debt. An image won't work with a this is the support. So does coded data elements are still part of the structure of comments that are necessary to be able to run this is a support engines. So not all is the cord for the purposes -- I am basically arguing to say that we need to keep the structural elements represented in this recommendation. I certainly don't disagree, but I wonder as we look at the fact that this was a problem across on Madison and I always feel a bit embarrassed that we focus in on a pharmacogenomics test as opposed to try to get people on their heart medication. Specifically recommending brought cities around pharmacogenomics CP of the type of systems is the direction that we really want the aid it has to go or read their are bigger fish to fry. I still struggle with the idea of where the best place is to relate learn how these things work, whether it is talk at our site that must be developed at each individual level. If it really comes down to each individual of all then it is released as a matter of being able to pull information to be able to run the engine that you want to.

Again, Lynn we started this recommendation we attempted to extract both structure and content which get cut down and now we are trying to the structure and content again. Is there a way that we can look at this and work it so that we can get some of that in this single recommendation? This is what we have so far. Opposite that national health of Russian technology in consultation with DVA and DOD should study how quickly validated pharmacogenomics test results are being incorporated in patient health records. HHS should also take steps to make sure the necessary infrastructure is in place to support the inclusion of pharmacogenomics and health system to port systems and tools. Is that enough?

I think it would be clearer -- the problem I am having is the inclusion of the pharmacokinetics'. That's unclear to me what that means. This is Southern blacks support the use of decision support Systems and tools relating to former Ku genetics. I don't the it is the data.

Well, it is to some degree. Maybe the word to use their is the support that the right representation of pharmacogenomics data because how you -- the data has to be in the system to do any of the other things, but it must be in the proper way and at least in the ITT World retard representing Data, structured data elements are river. That is the concept by think it's critically important and the second car of. We have to have the infrastructure to put that data and they're in a format that can be used.

I am personally not familiar, but I think the last three maybe could use the infrastructure to support.

Okay.

But the board representation, I am unclear about that.

Settle HHS should take steps to ensure that necessary if the structure is in place says supports pharmacogenomics data in electronic health records and decision support Systems and tools. So in electronic and other records for reduced and -- for use in decision support Systems and tools. That got a family back on board. All right.

Can I it's just ask for clarification of the meaning of that term consultation?

Up in the first paragraph?

Right.

It means that -- no. We were thinking again of getting that different groups. The secretary is within HHS. Set this is to go outside of HHS and consult with both you and the Veterans administration on how you do it.

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This is HHS saying, why don't we get together with the other groups that are ahead. Sure. Fine. Constructive dialogue.

Is this something the committee will support? Is there any other clinical support position we can have? I'm sure we can learn the same support from other areas and apply that. They're is a whole lot during on%. The second thing as we get more funding for activities we might have more liable to do this. I want to get a sense if we want to go in that direction she records but you're running up and we will let you know.

With what we have up right now -- go ahead.

One more comment. I just want to make sure the committee is not misled. I think we have a very sophisticated electronic record system. I don't believe they have any decision support relating to the pharmacogenomics. We are right to consult to learn how that is done. That what is to make sure report clear on that.

We'd just want to learn from what is out there rather than being inside the.

Would you prefer the high as the cause get whipped down to the second paragraph? Would that be a better place?

How are you doing?

Proper I was trying to decide if I wanted to speak. These are test pilot studies that developed clinical decision support systems of our good genetic technologies. And what I am struggling with right now is facilitate or approve a decision making at the point of care. I would appreciate somebody helping me with that language.

Okay. This is what we have so far.

Let me take a shot at this.

HHS should fund pilot studies that examine the practice -- the impact on practice of decision support systems for from economic technologies.

Impact on the practice of critical decision support systems -- the impact on practice of critical decision support systems for pharmacogenomics Technologies at the point of care tout maximize that best practice -- yes, to maximize evidence based Best practices. Because what I need I hear being said is, we know what to do and we know that there is critical decision support. What we have not been able how to do is figure out how to use critical decision support to make the best practices go forward and the example of that drug interaction is alert fatigued. Every time you order a truck you get an alert and you tend to ignore them all. Does that capture -- and I think I can support that. I just want to recognize the fact that we started with three paragraphs and right the way down debt three sentences and are back to the two paragraphs.

Eye and test others a bit concerned. We were trying to get to some consensus. We spent an awful lot of the government's money today and we have to be careful about how much stuff we are saying they must spend money on. With you add up the tab on this deal is impossible. So if there's something we could not recommend that to be a part of something else that is ongoing, but keep a cap of this. We are of control.

We are still working on this. Don't worry. We all sends you the bill.

Let's take a look as we go through. Here is what we have. The national coordinator for health of Russian technology through the activities of the community should study how clinically valid as it pharmacogenomics test results are being incorporated into a patient's health records. HHS in consultation with DVA and DOD should take that steps to make sure the necessary infrastructure is in place to support that representation of data in electronic health records for use in decision support Systems and tools. HHS should fund pilot studies that examined the impact of critical decision support systems for farmers to not technologies at the point of care tab maximize evidence based Basque practices.

We somehow went from electronic of records to a patient of records. Those are two very different things. We we may want to include both, but I take the focus areas and a strikeout records.

I was probably just moving at words around. Take a look because it has changed substantively. Is that everybody now completely lost focus and the desire? All right. That is are we are.

Nobody went with me.

No, we are sending you the belt. There is no money. So it again becomes a redundant recommendation. And in fact we are the key for ways to bring in the private sector. This particular Secretary is a very equal to the year to get things out. And in doing so part of that requires other funding streams. So perhaps you can work the last paragraph that HHS should restore establishing policies, but not bring up the funding issue.

Should export.

What this you too? Of back to what you had. Should export. Pilot studies.

Should export development of studies.

Okay.

They examined the impact. All right.

I agree that we don't have [ indiscernible ]. But we are funding pilot projects on support. That was recently announced. So it wasn't pharmacogenomics, but at least there is something going on and they fund it.

That is what I am saying. Be a little more practical about saying can't use the money to do this.

All right. Any other words the thing recommendations for this recommendation? We seem to be somewhat in agreement at least in a nebulous way. So, we art moving on. Still on Health Information Technology and tell systems become like universal feature of the system it identifies other ways for Telmex more readily available to help provide this as they are developed yes?

A few wording changes. We want to take into account what was just recommended. If you can replace other ways with you just systematic pathways which is a term. Systematic pathways. Courts should add that by systematic pathways?

Right. Instead of the past, he's urging.

To make emerging. Clinical practices. Okay.

We have a question about this recommendation. I just did not understand it. Is this saying that this should make available general information or individual critical information?

I am going to look now at our new version here. So we have New Political practices for pharmacogenomics your urgent medical practices. And they can't automatically be made universal because the Health ordered system isn't universal.

I'm just not sure their places in between an individual's electronic held a record and NIH making available best clinical practices.

The intent was that until you have the electronic of record and then the I tried this is a support tools that draw from that record you need both of those, there needs to be some alternative way to get positions about what the current best practices. And I think maybe we need to word spread that, but --

Seventy everybody is awake. Wonderful. I have a Tim, Steve, marquetry it.

I feel in a way that it is holding redundant.

Well.

We already discussed getting things out to professional societies. I don't think we need --

They're is a move afoot obviously to get rid of 12 p. How many people here would be deeply disturbed and we did if we do that? Okay. We are getting rid of a recommendation rather than adding one. Is a pretty good with the degree of that? Looks good. Once, twice, yes. Gone. That's right. Okay. Economic implications of pharmacogenomics. Bank my pardon? To issue a the address let's our boat spent HHS should gather data to assess the economic value of assistance relative to other health-related investments. This should encompass the cost effectiveness technologies and take into account their short and long-term impact on specific sectors in society as a whole. Yes, Sylvia? You want 12 be back?

No. I mean within the my optimistic nature it is difficult for me to say that this sounds. Pollyannas. You are asking them said to analysis that the money is -- the federal government is going to analyze that the money is well spent for this house related initiative purses all the other millions of house related initiatives that we have? I mean, to me, that sounds to Pollyannas.

Okay. Steve?

I'd like Pollyanna. I mean it is true, but this is a fundamental problem of allocation of resources. Somebody needs to pull it together. This is clearly not the only bank. We talked about doing this earlier on in terms of generating information and somebody needs to pull it together and make it available. It really doesn't say that there needs to be in a leveraged investment here beyond pulled together the information that is available.

I get greedy and and Barbara.

By a car to come back to being that mean courage at the party. There are too many recommendations with too much money. This is just can absolutely unnecessary in the scheme of everything. If we can get rid of something, let's get rid of it. The this is too far.

Barbara and then Alan.

I am not sure about that, but if we decide to keep it became up with language rather on onslaughts two or three on 6:00 this morning when we were encouraging HHS to encourage research in this area. So it is directed to many federal agencies and there was one early on that we use some language -- and maybe that would be more of a directive. Do want to redistribute the funds are something. Do you read that? So if that is what people are asking we should use consistent language.

I think that was more focused on basic research.

Isn't that what you're asking?

Fifty-eight / 42. Is that the when you were talking about?

I read this as being there needed to be more research on the economic issues.

Right.

Is this the one you are thinking of? We are talking what cost effectiveness and the value of peaky have.

Yes, I thought we started off the sentence with to do but it adds something to bite NIH Research in funding. I didn't write them down. Maybe just never mind.

We have another move afoot here to get rid of a recommendation.

All the light generally agree that we need to be careful with these recommendations I want to advocate for keeping this one and. I think that this is an area where there is the potential to develop infinite numbers of tests at infinite costs. This is a huge issue. You know, this could actually take money away from other health expenditures and a big way. So just advocating for cost effectiveness analysis along with all the other research is important.

So somebody disagrees yet again.

I have a dairy and Joe and Scott.

I think I support getting rid of this but also I have been looking at the economic value. If there is a business case to be made it is often made by the people who will benefit from it. And in that absence of that it is often because there isn't a business case. So I think this would be something that I would think folks who are counting pharmacogenomics as being in a cost-effective positive thing will likely have that information and be able to make it available. The second thing just as an aside to warn people, when we recommend to the Secretary that you do something, he can of course delegate that to any number of entities including this committee.

We have been there.

I guess on that last note is what I was going to look at. I think that eliminating this is not unreasonable, but I would say that the intent of it can be encompassed with some of the recommendations made earlier about other cities. It seems to me that the list of other studies, cost effectiveness would be given that choice to either accept or not. You out on the delegate but except or not accept for my understanding of recommendations. So this is more of a compromise thing here. It just sort of event and it's the whole one. This just keeps the fact that you need some kind of study done but add it to the list of studies from ready your recommendations.

Okay. You have to pick which ones you want to put that in.

All right. Then you are happy with what was said earlier? I just want to be short. I have Scott now.

I just want to concur that I take it is great to be pulled into some of the other recommendations bill the way I read the assistive cost savings is the fundamental tenets. If it is not addressed in transit fleet there will be plenty of critics and members of the Loyal Opposition that will address it for the secretary.

Steve?

I only point out that this was basically to look in a broader context rather than the specific studies of cost effectiveness with technologies that are not in any particular context.

I guess it is under 5B which is where it sits now. I understand what was just said. I think that there is still the option to expand it beyond just that even though we had a specific recommendation. Because by there very nature themselves they can either be specific or broad to cover areas that are relevant to the assistive itself. So I would still agree to eliminate it, but highlight that it is encompassed in the earlier recommendation.

Again, there does seem to be it as a clarification required here. When you look at 5P it is under that general rubric of establishing an evidence based for pharmacogenomics technology. It is not exactly necessarily the same as this, and is also and the first section of the report which is the basic research traditional conical section. We could say that this is part of that basic research for Farquhar to nematology. I don't think most people would ever it is it that way or conceptualize it that way, but if we do that and of course we would have to clarify in the budget report that is indeed what we are doing. I'm not sure people would naturally fit with that. So I would say, that is an option we can take. It seems right now we have the option of keeping this recommendation and reworking it however group wish, getting rid of the recommendation and getting rid of the recommendation and then in an earlier recommendation listening to this. Then in the report.

But getting what exactly we mean by having that in one of the earlier recommendations.

This is just another piece of the evidence.

But I think when people talk what the evidence you were talking about before is what the biological rather than economic, but we can make that clear. All of these are possibilities. What I need is that sense of where people wish to go. Are we going to report this? Let's just do it this way. People who are generally in favor of still trying to hang on to this recommendation and report it in some way, just indicate by standing up or raising your hand. Does anyone want to try to fight this out? Okay. So the rest, -- how many people would like to move this idea to an earlier recommendation and explicate it clearly in that tax that it was done and this is part of the evidence of establishing technologies? We have one, too, three, four, five, six, seven, eight to 19 contents. That is a much larger group. The third is just drop it. What did you too? Slip him a 20? It looks like we are moving toward a compromise. We agree to drop this were it is and mentioned the need to do this in an earlier way. So we will probably have to come back to 05 the. That looks like the best place to put it.

All right. Eveready quickly looking at 58 which is slide 42, of we talk about HHS should provide resources to identify and address evidence gaps in the utility and cost effectiveness and value.

We could then have to extricate and probably the executive summary what we mean by value and that it would include a okay? All right. People are happy with that. Okay. Done. A13 is gone. 5A will include that. We have that down. Okay. A13 is gone. Fifty-eight is an indication of value. All right. Thank you. Fourteen. That is on page 113 of your report this is ethical, legal, social occasions, research. NIH in collaboration should continue to encourage and fund research on these social applications of pharmacogenomics. This should include studies of whether integration of the pharmacogenomics is a clinical and public health practice exacerbates health and health care disparities, let's access to or decreases the quality of health care, increases the medical liability or results in jetted discrimination this is building on what is already there.

Does this not say the same day as the economic value? Because it is part of the value equation.

This struck me as a little peculiar. In the text is talking about disparities that exist and are widening in our society. And the recommendation is for NIH to study it. Is there no stronger commitments that we could make in this document to the reduction or the anticipation of disparities writing without more directed policy and action on the policies part?

Sets it is trying to get to both questions at the same time the significance and importance of these issues we consider to be -- one could in a broadcast appears opposition of value "in ethics and legal issues and all that sort of thing. But due to exactly what Paul was just mentioning the significance of these issues, this was seen as important as sort of hide. Now, in that highlighting, what can we get as? In the thing cooking at the literature and discussions of this sort of thing as you may well know there are U.S. back-and-forth as to whether pharmacogenomics actually will reduce health care disparities or exacerbate them and that is something that is still ongoing. So the idea was that perhaps study is not enough. They're is a sense of a continual review of what is called on to make sure that it isn't in fact create greater health care disparities. So I'm not sure we capture that in here. Paul, go ahead.

Can you say sit fund research to pick avoid adverse social the ethical and legal implications to include or including the desecration of health care disparities, and it's of access and genetic discrimination?

I think the idea was to avoid. Go ahead.

I like that.

This is still about research. It is going to come on line five for 10 years more likely. Is there nothing in that document that is going to say that the Secretary should help develop policies or facilitate access to how advances in pharmacogenomics? We already know differentials and access are profound. We also know that will in fact effects to utilizes these advances. As opposed to do research, which is fine, it is this the only place where disparity reduction is going to be addressed?

As part as the specific rendition, yes. We could put in if you would like to suggest some language, but will hear from Mark.

I think one of the recommendations we talked about is the idea that we have federally funded health care provision Medicare, Medicaid. It we are essentially giving direction to say, we think there may be some problems in terms of how we can actually find this which will have an impact on being able to actually provide services. And that can be studied in April to the short turnaround time to direct policies relating to coverage and reimbursement that would impact disparity. So at least indirectly this impacts where you are talking about.

Did you have that language that you wanted --

I have actually changed it. Should continue to encourage and fund research to avoid adverse --

And we could actually had and the secretary should develop policies in this and based on the likelihood of that outcome or something like that.

Said let's go back up here. Encourage and fund research to avoid adverse ethical legal and social implications huff pharmacogenomics?

Yes.

Okay. Then this research should include cities that are -- and mentee and.

Right. Okay. And then HHS should develop policies.

Kevin, at the beginning it should be caught the secretary should directed agencies to develop policies and support activities that would discourage health disparity surrounding key [ speaker unclear - audio low ]. Something like that. HHS should direct its agencies.

The secretary should direct the teeth of it sees. I don't know how that works, to develop policies and support activities.

Okay. Go ahead.

Well, she is still working.

Okay. Here we go. We were just chatting. Maybe what they need to narrow down here is that the resources that need to be -- we all the that there is tons of health care this series. So in some sense, will this be different than the other disparities out there? I did need to say, are there specific issues related to pharmacogenomics that would -- that is what every need to study. The things that pharmacogenomics would specifically increased at over and above all the others that.

We also want to be more proactive in addressing the use of pharmacogenomics to reduce disparity currently.

I have some language that would accomplish that. HHS activities should supports integration of PG access to critical and public health practices that increase -- that reduced health -- wait a second. That reduced health and health care disparities, increase access to and quality of health care. Decree's medical liability, although I'm not sure whether we really need to include medical liability.

Okay.

And reduce or eliminate static.

St. John. It'll take as the second to get all this.

So rather than focusing on studies we focus on the impact.

Just let me know.

We have teeth collectivities should support HHS can you cut all of that out? P there we go. Tito until Jesus support integration of pharmacogenomics into the medical and public health practices in ways that reduce health and health care disparities, increase access -- increase access to -- what happened to health and to cut you get something done. Put something back.

Increase in quality of health care. Increased access to and quality of health care. And reduce genetic discrimination. Let's get this. Is that goes? A cat. I was as listening to it. If this rally changes anything can add anything new or is a restatement of what presumably is already being done to the extent that that isn't really directing HHS to do anything different. I wonder whether it is necessary or whether it can be folded and her brother and a fracture our political reasons why he what that recommendation. So I just put those thoughts on the table.

And just as we have the recommendation about privacy and confidentiality because it is such an important principle that underscores the basis of the committee's recommendations --

That is fair. That is fair and appropriate. I just wonder if we are quick to have a recommendation, whether there is -- and I don't know what it necessarily should be, but within their they should be something that really is it the vote meteor consort of me because of little further or says something of a little different. Other than just short of supporting issues. I mean, let's spend some money.

To me, that is actually eight justification. There are specifically designated funds. So we are targeting what Israel ordering priorities where the secretary could say, I would like a certain pot of these funds to be designated around the issues of pharmacogenomics specific so there may be of practical reason.

Sam and then all.

I'd just want to remind people. I think that Genesis or at least one of the starting points for this was again that he had that is out there that pharmacogenomics may be less problematic from a standpoint than any other aspects of us I would be in favor for going to keep the boat that we emphasize it studying that. Heat the Ocala is pharmacogenomics indeed less problematic than the other genetic to elegies? And something to the fact that is obviously of great importance to minimize problems I just want to remind you all that there is a specific pharmacogenomics Elsie question.

Paul?

This is a question which can be addressed in April ordered research statement. The thing it would be helpful and appropriate. They're is a broader context dislike there was the focus on race and ethnicity. You have this of technical innovation, and at some point is this committee going to recommend that the Secretary facilitate access of these new offenses to all people in need? Any other arrests, it is not a research question alone. There they stood the attention to this research question, but at some point the decision might have to be made within the committee is going to recommend that this is such an important area of technical innovation and health care that this committee it states clearly and sharply that teacher of need to facilitate access to these events is to all people in need.

Anyone else? So one follow-up question to that. And to everyone else I suppose. What we had initially which focused more on their research -- but we have now is the more active. Do you want to take what we have now and support it with further research? In other words, are we going to say, in order to do this whenever Research's to be done or do we want to just stick with what we have here? That is my question.

I'm still a rookie from the crowd here, but license for a pizza, if all or part of back to the original language for research except maybe to expand beyond NIH because there are other agencies doing research in these areas. In T-shirts and it or change it because that was still focus on research. But then to have a second sentence or even our second recommendation that release dates that HHS should develop policies that facilitates from a project of France intervention is of value to all people in need.

I would only support all the wise by saying that set should stick to come first.

The research can be supportive of that.

Okay.

I was thinking about this. They're is a bit of disconnect here. I understand that sentiment. We all want to do research. But I am not sure we always know what policies will reduce our excess rate disparities. Unintended consequences. So apart from research on the factors that can cause disparities what we are lacking is a research and intervention that have been shown to reduce disparities and acting on that. And I don't quite see that the bank being made.

That is what we are part to try to do right now, try to also put in, perhaps second, the fact that more research will be required in order to perhaps developed the sort of activities that you were saying should be there to support the integration. Of? So whatever research is necessary or useful in that regard people also have in this recommendation does that get the three polls?

What we wanted to is wordsmith the second paragraph to fit better with the first. This is what we had originally. I would like to fix that to fit better with the first paragraph we have now. So recommendations in that regard to black how about we start of the second paragraph with the this and because that would refer to what we have been the beginning.

I apologize, but that first paragraph also seems like we are still talking about practice guidelines. In other words, integrating pharmacogenomics into critical public health practices. We are really talking about broad access policies far more importantly. So it might be something like should support policies that afford access to and then that integration of. In other words, integration into -- of trying to follow as it is moving here, critical public health practice is not really what I was getting at. I think that is great. It is an important area. But should support policies that afford access to the farmer could genetic advances or advances of the value or just advances would be fine with me.

Art technologies okay?

Sure.

Right.

And just that in and of itself.

And then the other parts.

In ways that reduce health and health care disparities because we have that twice. Prepared to assist go right to equality.

Increase quality of health care. Is that what you had in mind? Paul? Paul? Paul? The pols are happy. The this and HHS should continue to encourage and fund research that supports the school?

Find.

Good. Research after that and support of the school. Then get rid of the rest of it.

Michael?

So that would mean actually funding the development of better, faster, cheaper technologies. Because that is really but the missing factor in getting it set everyone, have the technology to be have said that it can be accessible by everyone. That is part of it. Well, it is part of it. So to restate anywhere in here that HHS should fund the development of new technologies? Is that appropriate? That is part of the equation.

We had that in one of the earlier recommendations and we ended up taking out the specific reference. I think we that did more broad.

Right. In those earlier ones we had the value in which we are putting a large concept now. So if obviously it is better, cheaper, faster, it would be valuable and that is the way it would be pursued.

I'm not sure if you could make a broad statement that the cost is always the home heating factor.

That is not what I'm saying. I am saying that within a certain context if it costs $100 to conduct a test some people aren't going to have access to that.

The there the costs tend thousand dollars and some people aren't right to have access.

That is part of that discrimination. It is cost-effective medicine, basically we were trying to talk about that in a more general terms, I did.

Okay. This is where we are. HHS should support.

Prioritize those recommendations.

I see.

And how to implement them.

That is fine. Got that. That is even better than the estimate. I have Joe and Andrea know, to tell.

I guess mine would be, given what was just said -- and if I am wrong on this, I can be corrected. If this is a intergovernmental or enter the proposal isn't this something they're going to do anyway? Isn't that something that will happen anyway?

No, that was not our understanding of what happened.

It is just a point. If we understand that is going to happen anyway --

This is what we heard from our representatives of the various departments that at least some people there said they want this as a recommendation to make sure that it happened. I mean are representing that accurately, it to be the.

I don't think it cost any money.

So for your information, the key.

You mean entered the park mentor and trauma?

Not other departments?

Yes. It is government.

I am just trying to think of whether we have been this descriptive about actually forming a separate group the --

Line understanding is no. Has it happened before?

Let's see. Yes, sort of.

Okay.

I think this is to await the sort of --

This is in response to requests from members of different agencies that they wanted this. Now I guess we have the study which is also represented by their desire.

I am just thinking in keeping with REITs admonition about proliferation of work groups and money. Should this be the function of the exit the seals?

This may very well involve them. I would expect them to.

I think some wanted that to be the case.

You know, I think it is many the committee's recommendation that these are a complex set that require a lot of thinking and deliberation. I think it is the committees way of dodging that it is not just something that can't just be taken up by the secretary's office perhaps by itself. So I think that is part of what you were getting at.

If the exodus is suggested this -- because I am come the private sector. This is a priority. Please route the best way to get it done and get it done. We don't need to tell that Secretary how to do his job. It gets scary complex. It just get it done.

But remember that we have our recommendation a the like this and the oversight draft report. Don't we?

That is -- this committee is co trying to establish four or six committees. Come on.

Give them all work.

Okay. So as far as the language of this recommendation any suggestions? One, two, three.

I am just wondering. If it is that ecstasy as that recommended I am wondering if they think it is a good idea? I am not understanding how this would work or how it would relate. I don't know if others share --

I can only try to represent what was said. The idea was that there were members who thought it would be a useful recommendation because it would give them that is to pull together people from various side those that don't always have --

The secretary is requested to take all necessary steps.

Keep going.

I'm getting hurt type. Take all necessary steps to establish -- you know where you are now, established and reviewed and poorer judge, would average was.

Okay. So we have the secretary's request to take all necessary steps and assess whether and how monitor the progress and report back. We have to get rid of that. This secretary concerned as -- all right. This will be interesting kiss if we expect this FOB interesting to see what we think about the next recommendation.

We don't need that last recommendation.

We just basically made this over again the same way. Let's just see if everyone is happy with this. It looks like we have the general no. This may just be 15 in a minute. We move to a 15-be, our last recommendation. It should a says the level and adequacy of resources being devoted to support pharmacogenomics at the critical and public health practice. We need to be sure that cabs and opportunities as a divide are addressed.

I recommend this be a rout since it is implied by the first -- card at the get have a general sense of that. As the person drinking this discussion we should just turned this into volumes and volumes to read 59B is about to be gone. All right. It is Don. Now, before we take away -- before we move on to that next read is going to interject.

First of all, that was extraordinary. Kevin is extraordinary. Let's applaud Cavan.

We are not done yet.

That is why you are getting your applause now. They did when you can get it, my friend. So we have to things. We wanted to ensure before we vote public comment. And as we invite to come up to the microphone in the Miller of the medicine coalition who has a public comment germane to our discussion, let me read you -- [ indiscernible ].

I have been listening with interested to this broadcast of the report. Sorry, I am unable to touch you in person. Please accept this with my public comment. During their recommendation we question whether there was sufficient evidence of a to space effect development been devastated. We have ways to describe a fax assisted with the restoration. My earlier written statement also described the important test components necessary to prescribe other drugs. These examples illustrate the importance of this personalized medicine and illustrate the importance of a good development of diagnostics and truck development for the benefit of patient care for serious life-threatening illnesses. I copied it general references the though. Thank you, Robert Ryan are from in L.A., very reasoned and appropriate response. If you are still out there think you very much. Anyone else, thank you for taking the time to inform the committee's deliberations. With that do we have an end?

Go for it to Iraq.

Pinky.

My name is Amy Miller. I am part of a federation of of Ron Arad stations representing a pot spectrum of academic patient provider and peered communities that seek to advance the understanding and adoption of personalized Madison concepts and products for the benefits of patients. During the last meeting the [ indiscernible ] made public comments that we have been discussing and we also mentioned our part in developing business times for personalized medicine. We are pleased that many of our Kirs were contained in the conversation we had today, but I want to reiterate that is something which we believe is advanced personalized medicine. Federal funds should be appropriated to expand and accelerate to edit entity increasers through development grants to, FDA should put in place an accelerated approval process for personalized therapeutics and diagnostic developed together or developed separately that are designed to work together. This reiterates the comments just made by the person watching over the Web. And three practice governing new technologies which have a profound impact on both patient access and the incentives of industry to adopt new technologies. Therefore we are due to suggest the policies that expand coverage and reimbursement of personalized Madison, products and services focused on disease prevention and those that improve the efficiency and value of our health-care system. And that lempira developing ideas on reimbursed and models that for much personalized medicine and to know might. We expect to articulate these ideas through papers, work groups and public meetings and look forward to sharing our results for these efforts with.

Paso and tab six of your box you will see a letter from the meat to the committee as well that defines some of these.

Hi Paul, you Dr. Miller. Do you feel like the recommendations that we've discussed this morning -- I know you have been attentive and the back there. Do they speak to the issues raised?

ID they speak quite well to the federal funds is to. I think it is appropriate the way you Mr. to the Secretary to get it done and the bed open to the Secretary and Director as to how to get that done.

Great. Anybody on the committee would like to read Dr. Bella?

On the federal funds issue a I understand your answer. We had a lot of discussion on reimbursement. Does it deal with the issues that you were talking about in terms of creatively thinking about new approaches?

One specific recommendation is that be covered. I think that would go a long way to get into the be impressed and issue but I think it is a long step. I'm not sure they fought to to lead the issue which is partly why we will be dedicating it considerable amount of time and effort to more fully articulate ways that reimbursement can drive the adoption of personalized medicine.

Well, thank you very much for both your public comments and your letter that he wrote.

Thank you for your time.

Is there any other public comment that wants to be heard prior to our taking this vote? All right. With that what we are going to do is -- you are not voting. Here is that deal. We are going to be okay. We are going to could please approve the recommendations just so everyone can see them one more time. Be thinking about the totality of what we have done. I would like for our club members of the committee to our ad hoc today and cannot vote formally which is all the new folks, and some of the old folks. I have a list somewhere of who can vote. Syllogistic you know here is a list. We have a tip, Kevin, Holyoke, but right, Kevin, assistive, Steve and mark. Those are the voting people but we do want to make sure that all of the rest of you if you have any strong feelings, let us know through these last couple of seconds said that nobody feels like they are shut out. But we brought you to feel like you are part of it even though you don't get to vote formally. So why don't use it was through. Nobody is going to mess this up too much. We will take some okay. Just to remind everyone, what you are going to see on the screen will be the only copy of our file versions right now. So nothing in your report unless you wrote down all the changes yourself. Do you want to just --

Just to Ed, I will be putting together a word document with all the final recommendations this evening. You will have that tomorrow.

And for those of you who have sat difficulties, I am going to read each and every one as we go through. Number one, Po Po -- there we go, that is better.

[ indiscernible ]

You are going to dinner tonight? I'll set next to you. All right. NIH should receive and put more resources into basic research on the biochemical pathways associated with a drug metabolism that action, teens and teens variations and often these pathways that the functions of those genes related to the safety and effectiveness of treatments and diagnostics. And not hypothesis based approaches to the understanding or relationship between genetic variation an individual's response to drugs. That is the first one. Second, as knowledge of the underlying morality accrues will need to be [ indiscernible ] useful technologies and to assess the critical validity and utility. Agencies should facilitate the development that is clinically useful by investing more resources into all components, and stress this our research including that translation of basic research findings into clinical trials as well as the translation of clinical research findings into critical and public health practice, insurance coverage, and policy. What 3-8. A study results will be used to test its safety and efficacy to support a pre-market review the petition. Sponsors and researchers should be encouraged to consult with hefty plate early. This would help to ensure that these studies have adequate clinical study designed. Sufficient statistical power and quality controls in place should the research later be submitted for regulatory review. As appropriate -- ended you should consider making this standard as a component of their scientific merit submissions. In situations where pharmacogenomics diagnostics are resettled to critical Truckee's HHS should require contractors to participate in voluntary data submission programs during the exploratory phase of a drug development and/or they pre I T E review process. Tsk to enable the intestines and the bottom workers assistive a response HHS should encourage sponsors of federally funded drug trials to obtain appropriate biological samples from we should develop guidance and standards on how this and other data will be collected, stored, shared, and used. We will reference the earlier large populations of the report. 4-A. FDA's to develop and implement Data as of the code development of pharmacogenomics diagnostics. And we should clarify the review process. It also shift to the collaboration between drug and diagnostic developer's. FDA Office of combination products should coordinate review of farmer could genetic tests and drugs to minimize delays and approvals of code developed products and to ensure timely access to such products. It aids as shipping dates all stakeholders in identifying, providing incentives and encourage the development of farm workers to limit test and diagnostics especially for small patient populations or market. HHS should identify and address evidence gaps in the analytic validity, clinical levity, clinical utility talk cost effectiveness and value. Progress will require high-quality data Resources Committee approved methodologies in the design, conduct an analysis of observational study and empirical research on the evidence and standards necessary for making decisions for various purposes. Coverage, clinical guidelines, performance probably driven health-care and different chemical context. HHS should initiate and facilitate collaborations' between public and private entities like health insurance plans, pharmacy benefits, benefits, health care facilities the electronic medical records, clinical research databases are genetic repositories to advance the generation and a sharing of knowledge on the analytic validity, clinical levity, clinical utility, cost-effective is and value of fraud and genetics. HHS should encourage and facilitate [ indiscernible ] and the dissemination of findings including negative findings through publications, meetings an information clearinghouse. We should provide mechanisms to promote interaction among basic translation all, chemical and out, researchers for the identification of and presented elements to be measured. The goal with each of maximize the value and utility of basic and translation of resources for downstream assessment of the clinical validity and utility of pharmacogenomics tests. HHS should encourage private sector entities including academic institutions to share proprietary data voluntarily to advance the development and cut development of pharmacogenomics products. The manufacturers should be encouraged to make their data publicly available to allow others to conduct research and published such studies. 6-D, HHS should work with the private sector to identify obstacles and develop solutions to overcome these obstacles. For example an intellectual property of funding of databases and help information technology. HHS should work with other relatives departments and the private sector to improve the sharing and interrupt ability among the databases, specifically we should work with existing organizations to create a uniform to Numic Data Standards, explore ways to harmonize these analysis, methodologies and develop an infrastructure to facilitate the exchange. The sharing and at it dropped the ability of claims data bases will facilitate the study of the molecular pathogenesis of disease. The it indication of targets for drug development, validation of pharmacogenomics Technologies and assessment of the outcomes associated with the use of and determination of the cost effectiveness and economic impact of using these technologies. 6-B, FDA should add that I and initiate Research rigidities and public-private partnerships to encourage development and the development of products. For example, the critical path initiative and by a markers consortium. Seven customer data security measures will be needed as more pharmacogenomics researchers access patient data.

Mechanisms such as privacy and Cal facility or group should develop guidance on how to develop the confidentiality of personal data with access to these is the fourth pharmacogenomics research. 8-8. FT Asia develop guidance that encourages the factors that may be better biological predictors of individual differences in drug response than the broad categories such as race, ethnicity, and gender. When drugs are shown to be more effective in certain racial and ethnic Serb populations FDA should encourage manufacturers to conduct additional post in our cities to identify biological, social, behavioral call environmental markers that may underlie the differential drug effects. 9-8, CMS should develop a guidance document detailing current Medicare, Medicaid and coverage and reimbursement of pharmacogenomics. It also should severe public and private health plans about their decision making processes and coverage policies to help and for its future pharmacogenomics coverage and reimbursement decisions. 9-B, and of the issues, coverage and reimbursement supporters to correct. HHS must act on the report's recommendations. HHS and other agencies catalog and disseminate case studies and practice models relating to the use of pharmacogenomics Technologies. 10-be taught to drop should assist professional organizations to help their members achieve competencies' on the appropriate use of technologies. HHS should also encourage and facilitate collaborations' between the organizations and the federal government around these entities. 10-seat, as evidence of chemical validity and utility for pharmacogenomics accrues to talk to support the conduct that systematically fuse and Technology Assessment to summarize the read these reviews and assessments should be disseminated to facilitate the development of clinical practice guidelines. Dan-be, to choke should facilitate the development of chemical based ad buys and testing guidelines by supporting consensus building efforts. These efforts should include development of standards that define the minimal level of evidence required to support guideline decisions. These standards should take into account the critical context. For example, prevention, diagnosis, treatment in which pharmacogenomics tests may be offered. They you. Tenney eat. To inform the development of pharmacogenomics tests and testing guidelines HHS should provide critical studies the provide evidence on whether it is clinically useful. Tenet-aft, the secretary should encourage organizations to submit clinical practice guidelines that they developed for pharmacogenomics testing to our national guideline clearing house to facilitate implementation and use. 10-G, FDA should work with many factors to ensure are relevant information is included in triples in a timely manner. When a test is mentioned in a troubled information should be included about the tests analytic validity, critical validity, clinical utility, doesn't, adverse events and art drug selection or places to use when making treatment decisions based on farmer coaching on the test results. FDA should provide guidance on the status of evidence that must be met for information to be included. NIH should continue expanding the Internet basted the project would provide up today real-time prescription dark little packets its interracial pro people with Internet access. To ensure all sectors of the public have access to this information FDA and NIH should develop alternate ways of dissemination. It to inform the public about the availability benefits, risks and implementations HHS should ensure the equitable resources are widely available through federal websites and other media 11-speed HHS should use existing mechanisms to a dialogue on the potential benefits, risks, and limitations of technologies. This dialogue should include an assessment of their perception and of receptiveness to the pharmacogenomics and their willingness to use these technologies. We a minute. That does not start right. His perception, the public? Okay. Next. The office of the national coordinator for health of Russian technology through the activities of the American Health Information committee should study have currently validated pharmacogenomics test results are being incorporated into electronic health records. In consultation with the DOD and DVA also should take steps to ensure the necessary infrastructure is in place to support representation of the pharmacogenomics data in electronic health records for use in decision support Systems and tools. NIH Export Development of studies that examined the impact of critical decision support systems technologies on clinical practice at the point of care to maximize evidence based Best practices. There is no 12-B and 13 is Don. This will be 13 now, I presume. NIH said support policies that afford access to technologies in the ways that reduce health and health care disparities, improve quality of health care and prevent genetic discrimination. To this end we should encourage -- should continue to encourage and fund research and support of the school. 15-8 -- 15, the secretary has requested to take all necessary steps to review and prioritize these recommendations, assess whether and how upset implement and monitor the progress and report back to SACGHS.

A quick score card. This is just kind of giving us some broad categories. We have two categories where you are saying spanned out red dollars. So that two out right expenditures, you have 24 recommendations that said either develop, facilitate, in Gates, coordinate, encourage, correct. You get a lot of developing, facilitating, engaging, urging, and considering. You had three where you require or insurer that the Secretary do something, and you had five words he said identify and address or study something. So that is not a bad actual makes when you think about it. To find answers, 24 developed and coordinated urges -- [ indiscernible ] and that five identify the best studies.

So in general --

Did you go back 41 seconds? I think we may have missed a concept that would be important.

I know that. I think as opposed to still current I would say are relevant recommendations in this report is, we don't have to have the still.

Can I ask a question? There was an awkward moment before, for us to people if we haven't identified which report this is can you highlight the key points of what that said? We are telling the Secretary to go back --

There were a series of recommendations that like the barriers to a reimbursement and coverage and layout and the very reasonable way what the issues are and how they could be addressed. So essentially what this recommendation is saying is that this needs to expand and include, could genetic testing and as some of these recommendations have not yet been acted on. It is a reinforcement. And there is in fact an ongoing dialogue that will be taking place over the next month to specifically address these issues and get a progress report. This is not outside of context of the work of the committee.

Do you want more information?

I can read you what is in it.

Okay.

My concern is on reimbursement without this we aren't taking a stand. We are just saying, explain what happens. I wanted to understand.

Recommendations cover a range of topics including evidence based coverage, decision making, Medicare coverage, the adequacy of current procedural terminology and codes for genetic tests and services, building by non physician genetic counseling providers and genetics education of providers.

A small group led by Mark has been reviewing the comments. There will be a meeting in December with Barry.

Let me just ask one specific question on this code piece. Was the recommendation that it was or was not adequate?

No.

Okay. I am with you. I now know what it does, but I don't know if you went thumbs up or down and that is what I'm trying to understand.

Are right. We are going to make sure that everyone is comfortable. Do we accept the changes to the augmentation?

Yes.

Is everyone get?

Now, we are going to the vote on this package. We are not going to go one by one but a vote on the packet.

No line item be does. I want to make sure again that we aren't rushing through this. Even the members who can't vote, I assume that we kind of have a consensus that everyone is feeling comfortable about this three imported report. So I'm looking around.

Has eight new be or whatever you called me earlier first of all I want to say and express my regrets to four be put up this discussion. It was quite an amazing toward the forest by the committee members. There are a couple of issues that may be buried in the deliberations of the committee which I guess for the record more than anything else would like to address it seems to me that what we have learned from the provision of pharmacogenomics so far, four restaurants on the issue of a point of care testing versus Lab based testing or on the oval loaf [ indiscernible ] testing versus a genotype testing PA PA or on the question of whether the six tests should become a gate for access to certain drugs for that matter. There is data already present in the health-care system for these things. And the report is a relatively silent I wonder whether the report is a court test of her because of that. So I just raise those issues again. I mounted them at the beginning and I raise them now.

I think it is appropriate to raise them again. I know that Saddam will insure that the [ indiscernible ] will reflect on this important topic. So it needs to remind all of us that we aren't starting with a blank piece there is a history and that is a very important comment. Anybody want to work with you on that connection I am looking around the table. I think that we are going to ask the people for the record whose hands will raise are not will be Soviet, gemma, Andrea, Kevin, Cleo, Steve, Mark. So with that, all in favor of the recommendations as summarized in the last iteration please say I.

Eye.

All opposed? All those abstaining in so moved. You guys have done a hard day's work. Wait until you get to the Andrea tomorrow. I just want to say again -- I will let cabinet do whatever could as he needs, but once again given, you have done just terrifically and wonderfully.

Thank you. Thank you. Just like a continual effort to live up to you.

Before we end this I would like to take an opportunity to set think some people. We did some of that at the beginning, but there were some people that we didn't have time to to. So first of all, I would like to think everybody on the task force. Obviously this is a group effort, and that is what makes it so rich and what makes it so sensitive. So I take all of you. In particular I think Suzanne. Her fears have lost several centimeters in length from being crammed on a keyboard. And I would also like to think Sandra Howard. Is Sandra here? And as I mentioned before the line group should get some specific recognition. Glickman, Crystal River rapids, Iran Caryn's, Lindsay will, showing can, Eric Faulkner and Amanda Thomas. Thank you again. Finally, think you to the public commentators. We really did listen to what you had to say, and it was very important in our understanding of how to go ahead. So in all of these, thank you for your the issue.

As we close offered is still out there by the way. He said as another e-mail. So Robert too hung in there until the end -- also I want to take our transcriber who is working diligently over there despite the fact that we keep forgetting to put these buttons, and I also want to acknowledge the translators who are working so hard over there to try to make all this make sense as well as our colleague from Gallaudet who had sat through this. We are pleased that you have come to be here. And also finally we want to thank the folks who are -- good. Good. I also want to thank the folks who are manning the cameras to make sure that this gets on the Internet. You guys are terrific back there. So with that we go to dinner tonight. Well, I will always think Abbey. I have not gotten there. I am talking about dinner. They don't think I am going to think at the. Eddie, I know if you can hear me out there. But she has as going to the old girl. We are to meet according to Abbey's instructions at 6:15 p.m. in the lobby of that J.W. Marriott and it is a short walk. No fooling around, to market 8:30 a.m., and to know we aren't going to start. So we will be following who is lead. Thanks, everybody, again. She left her sons, and the split. Don't leave your thoughts.

[Event concluded.]