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Second Meeting

Washington, DC

Wednesday, October 22, 2003

Opening Remarks

9:00 a.m. - 9:05 a.m. Edward R.B. McCabe, M.D., Ph.D.

 SACGHS Chair

Oversight of Genetic Technologies, Marketing, and Laboratoriesand the Role of Pharmacogenetic

Tests in Therapeutics

9:05 a.m. – 9:25 a.m. Oversight of Genetic Testing Laboratories Through the Clinical Laboratory Improvement Amendments (CLIA)

Judith A. Yost, M.A., M.T.
Director, Division of Laboratories and Acute Care
Centers for Medicare & Medicaid Services

9:25 a.m. – 9:45 a.m. Plans for Augmenting CLIA to Specifically Address Genetic Testing Laboratory Issues and Concerns

D. Joe Boone, Ph.D.
Associate Director for Science, Division of Laboratory Systems
Public Health Practice Program Office
Centers for Disease Control and Prevention

9:45 a.m. – 10:15 a.m. Roundtable Discussion
Facilitator: Dr. Winn-Deen

10:15 a.m. – 10:30 a.m. BREAK

 10:30 a.m. – 10:50 a.m.Impact of Pharmacogenomics on Prescription Drug Labeling
Lawrence J. Lesko, Ph.D.                                     Director, Office of Clinical Pharmacology and  Biopharmaceutics                                                 Center for Drug Evaluation and Research                Food and Drug Administration

10:50 a.m. – 11:10 a.m. FDA's Current Approach to the Review, Labeling and Marketing of Genetic Tests

Steven I. Gutman, M.D.
Director, Office of In Vitro Diagnostics
Center for Devices and Radiological Health
Food and Drug Administration

11:10 a.m. – 11:30 a.m. FDA's Future Plans to Enhance Oversight of High Risk Genetic Tests

David W. Feigal, Jr., M.D., M.P.H.
Director, Center for Devices and Radiological Health
Food and Drug Administration

11:30 a.m. – 12:30 p.m. Roundtable Discussion

Facilitator: Dr. Leonard

12:30 p.m. – 1:30 p.m. LUNCH

1:30 p.m. – 1:50 p.m. FTC's Regulation of the Advertising and Promotion of Consumer Products and Its Application to Genetic Technologies

Matthew Daynard, J.D.
Senior Attorney, Advertising Practices Division
Bureau of Consumer Protection
Federal Trade Commission

1:50 p.m. – 2:45 p.m. Roundtable Discussion Regarding FDA and FTC Regulation of Advertising and Promotion of Genetic Technologies

Facilitator: Ms. Zellmer

2:45 p.m. – 3:00 p.m. BREAK

Public Comment Session

3:00 p.m. – 3:30 p.m. Members of the Public

Continued Discussion of Oversight and Pharmacogenetics

3:30 p.m. – 5:00 p.m. Committee Members

 

Genetic Discrimination in Health Insurance and Employment

5:00 p.m. – 5:30 p.m. Update on theStatus of Federal Legislation to Prohibit Genetic Discrimination

Report from the U.S. House of Representatives

 Ms. Kristin Fitzgerald
 Professional Staff Member
U.S. House Committee on Education and the Workforce

Roundtable Discussion
Facilitator: Ms. Berry