U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES SECRETARY'S ADVISORY COMMITTEE ON GENETICS, HEALTH, AND SOCIETY Eighth Meeting Friday, October 20, 2005 Brookside Room A/B Marriott Bethesda North Hotel and Montgomery County Conference Center 5701 Marinelli Road North Bethesda, Maryland IN ATTENDANCE: Acting Chair Cynthia E. Berry, J.D. Partner Powell Goldstein LLP 901 New York Avenue, N.W., 3rd Floor Washington, D.C. 20001 Members Sylvia Mann Au, M.S., C.G.C. State Genetics Coordinator Hawaii Department of Health Genetics Program 741 Sunset Avenue Honolulu, HI 96816 Chira Chen Staff Research Associate Comprehensive Cancer Center University of California, San Francisco 2340 Sutter Street, Suite N171 San Francisco, CA 94115 James P. Evans, M.D., Ph.D. Director of Clinical Genetics and the Bryson Program in Human Genetics University of North Carolina, Chapel Hill Medical Bioinformatics Research Building, Suite 4200 CB# 7264 103 Mason Farm Road Chapel Hill, NC 27599-7624 Kevin T. FitzGerald, S.J., Ph.D. Dr. David P. Lauler Chair in Catholic Health Care Ethics Research Associate Professor Department of Oncology Georgetown University Medical Center Building D, Suite 236 4000 Reservoir Road, N.W. Washington, D.C. 20057 IN ATTENDANCE: Julio Licinio, M.D. Professor of Psychiatry and Medicine/Endocrinology Neuropsychiatric Institute David Geffen School of Medicine at UCLA University of California, Los Angeles Gonda Center, Room 3357A 695 Charles Young Drive South Los Angeles, CA 90095-1761 Agnes Masny, R.N., M.P.H., M.S.N. Adjunct Assistant Professor of Nursing Temple University College of Allied Health Professionals Research Assistant and Nurse Practitioner Family Risk Assessment Program Fox Chase Cancer Center Prevention Pavilion 7701 Burholme Avenue Philadelphia, PA 19111 Joseph Telfair, Dr.P.H., M.S.W., M.P.H. Associate Professor Department of Maternal and Child Health School of Public Health University of Alabama at Birmingham 1665 University Boulevard, Room 320 Birmingham, AL 35294-0022 Emily S. Winn-Deen, Ph.D. Vice President Strategic Planning and Business Development Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 IN ATTENDANCE: Ex Officio Members Agency for Healthcare Research and Quality Francis D. Chesley, Jr., M.D. Director Office of Extramural Research, Education, and Priority Populations Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Centers for Disease Control and Prevention Muin J. Khoury, M.D., Ph.D. Director Office of Genomics and Disease Prevention Centers for Disease Control and Prevention 4770 Buford Highway, MS K-89 Atlanta, GA 30341 Centers for Medicare and Medicaid Services James Rollins, M.D. Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244-1850 Department of Energy Daniel Drell, Ph.D. Biologist Life Sciences Division Office of Biological and Environmental Research Department of Energy 1000 Independence Avenue, S.W. Washington, D.C. 20585-1290 Department of Labor Amy Turner U.S. Department of Labor 200 Constitution Avenue, N.W. Washington, D.C. 20210 IN ATTENDANCE: Department of Veteran Affairs Sherrie Hans, M.D. U.S. Department of Veteran Affairs 810 Vermont Avenue, N.W. Washington, D.C. 20420 Equal Employment Opportunity Commission Peter Gray, J.D. Senior Attorney Advisor Office of Legal Counsel Equal Employment Opportunity Commission 1801 L Street, N.W. Washington, D.C. 20507 Food and Drug Administration Steven Gutman, M.D., M.B.A. Director Office for In Vitro Diagnostic Device Evaluation and Safety Food and Drug Administration 2098 Gaither Road, MSC HFZ 440 Rockville, MD 20850 Health Resources and Services Administration Suzanne Feetham, Ph.D., R.N., FAAN Senior Program Manager Center for Quality Health Resources and Services Administration Parklawn Building, Room 7-100 Rockville, MD 20857 National Institutes of Health Alan E. Guttmacher, M.D. Deputy Director National Human Genome Research Institute National Institutes of Health Building 31, Room 4B09 31 Center Drive, MSC 2152 Bethesda, MD 20982 IN ATTENDANCE: Office for Civil Rights Robinsue Frohboese, J.D., Ph.D. Principal Deputy Director Office for Civil Rights 200 Independence Avenue, S.W., Room 515F Washington, D.C. 20201 Office for Human Research Protections Michael A. Carome, M.D. Associate Director for Regulatory Affairs Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 Executive Secretary Sarah Carr Secretary's Advisory Committee on Genetics, Health, and Society NIH Office of Biotechnology Activities 6705 Rockledge Drive, Suite 750, MSC 7985 Bethesda, MD 20892-7985 C O N T E N T S PAGE Call to Order Cynthia E. Berry, J.D. Acting SACGHS Chair 10 Vote on Coverage and Reimbursement Report 10 Genetic Discrimination Session Update on the Status of the Genetic Information Nondiscrimination Act of 2005 (S. 306/H.R. 1227) Frank Swain Coalition for Genetic Fairness 15 Public Attitudes Toward Advances in Genetics, Genetic Privacy, and the Misuse of Genetic Information Christy White Cogent Research 20 Q&A and Committee Discussion 31 Pharmacogenomics Session Update from the SACGHS Task Force on Pharmacogenomics Emily S. Winn-Deen, Ph.D. SACGHS Task Force Chair 41 Update from the Food and Drug Administration Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostics, FDA 45 Allen Rudman, Ph.D. Associate Director Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and Research, FDA 51 Q&A and Committee Discussion Facilitator: Emily S. Winn-Deen, Ph.D. 59 Public Comments Jean F. Jenkins, Ph.D., R.N., FAAN International Society of Nurses in Genetics 66 Pharmacogenomics Session Feasibility of Integrating Pharmacogenomics into Drug Development from an Economic Perspective Thomas A. Metcalfe Head of Biomarker Program F. Hoffman-La Roche, Ltd. 70 Economic Challenges of Integrating Pharmacogenomics into Clinical Practice Kathryn Phillips, Ph.D. Professor of Health Economics and Health Services Research Director, Program in Pharmacogenomics and Population Screening University of California, San Francisco 85 Q&A and Committee Discussion Facilitator: Emily S. Winn-Deen, Ph.D. 92 Ethical and Social Issues Associated with Using Race and Genetics in the Study of Differential Drug Response Wylie Burke, M.D., Ph.D. Professor and Chair Department of Medical History and Ethics University of Washington 102 Q&A and Committee Discussion Facilitator: Emily S. Winn-Deen, Ph.D. 116 Discussion of Next Steps, Work Plan, and Final Work Product for Pharmacogenomics Facilitators: Emily S. Winn-Deen, Ph.D., and Cynthia E. Berry, J.D. 124 Planning for March, 2006 SACGHS Meeting and Concluding Remarks Cynthia E. Berry, J.D. 136 P R O C E E D I N G S (8:33 a.m.) MS. BERRY: Good morning. In keeping with our new tradition of reviewing military history, I'll tell you that today, on this day in 1944, keeping his "I shall return" pledge to the people of the Philippines, General Douglas MacArthur waded ashore, and just like General MacArthur, the SACGHS has returned on its second day of our October meeting. (Laughter.) DR. EVANS: Hopefully there will be less carnage. (Laughter.) MS. BERRY: Yes, a lot less carnage. Sort of a clean-up item to begin with. Yesterday we mentioned the coverage and reimbursement report and the recommendations that were edited and distributed to you. There was the original version, and then the edited version, members of the committee were supposed to take a look at those. What we're going to do is not have a protracted discussion and try to edit and reedit, because that just takes too long. What we'll have is essentially an up or down vote. Will we accept the staff recommendations for some of the editorial comments, the green- line version that you have? Yes or no? If it's no, we will go back to the original language that the committee approved at our last meeting. So we'll just go around the room. Do we have everybody here? Yes, I think so. So the question will be on approval of the edited version of the recommendations for the Coverage and Reimbursement Task Force, the green-line version that you all have. I guess we'll start with Jim. DR. EVANS: I vote for approving the edited version. MS. BERRY: Chira? MS. CHEN: I would do the same. DR. FITZGERALD: Yes to the edited. MS. BERRY: Agnes? MS. MASNY: I would say yes to the edited. The only thing is I do have a question, sort of a concern that came up to me, especially in view of yesterday's discussion. That is for item number seven, just a clarification point where we say genetic counseling to be able to provide full access of genetic counseling services for all Americans, and then it goes on to identify a body who would oversee to determine who is appropriate to provide this kind of counseling. I think that, and I don't know if the committee would like to look at using the word not just "genomic," but "genetic counseling." I think that if we leave just genetic counseling, I think genetic counseling implies specifically genetic counseling for single-gene disorders, and I think the information that we heard, specific profession and a specific specialty. I think with the information that we heard yesterday, that we need to have prepared health professionals who will be able to provide and possibly bill for genetic, genomic counseling, and education services. So I just think that we should have a little bit of foresight. I don't know if the task force would want to address that, or if in fact this was just intended for genetic counseling. MS. BERRY: Suzanne? MS. GOODWIN: You guys don't have a full copy of the report, but at the beginning, we had, at your request, added some definitions of some of the terminology used throughout the report.