07-1532. Secretary's Advisory Committee on Genetics, Health, and Society

AGENCY:

Office of the Secretary, HHS.

SUMMARY:

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report to the Secretary of Health and Human Services (HHS) on pharmacogenomics. A copy of the draft report is available electronically at http://www4.od.nih.gov/​oba/​sacghs/​public_​comments.htm. A copy also may be obtained by e-mailing Ms. Suzanne Goodwin at [e-mail] or calling 301-496-9838.

DATES:

In order for public comments to be considered by SACGHS in finalizing its report to the Secretary, comments should be submitted by June 1, 2007.

ADDRESSES:

Public comments on the draft report should be addressed to Reed V. Tuckson, MD, SACGHS Chair, and transmitted via an e-mail to Ms. Goodwin at [e-mail]. Comments also may be mailed to SACGHS, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or faxed to 301-496-9839.

FOR FURTHER INFORMATION CONTACT:

Suzanne Goodwin, NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838, [e-mail].

SUPPLEMENTARY INFORMATION:

The Department of Health and Human Services (HHS) established SACGHS to explore, analyze, and deliberate on the broad range of policy needs associated with the scientific, clinical, public health, ethical, economic, legal, and social issues raised by the development, use, and potential misuse of genetic and genomic technologies and make recommendations to the Secretary of HHS and other entities as appropriate. More information about the Committee is available at http://www4.od.nih.gov/​oba/​sacghs.htm.

One area currently being explored by SACGHS is pharmacogenomics. SACGHS identified the emerging field of pharmacogenomics as a high study priority because it holds significant promise for improving the productivity of the drug development pipeline, increasing the safety and effectiveness of drugs by reducing adverse reactions, and ultimately resulting in a more efficient use of drugs. The draft report describes these opportunities while also identifying the challenges associated with pharmacogenomics product development and integration into clinical and public health practice. It presents information and recommendations in three major areas: (1) Issues associated with research and development; (2) “gatekeepers,” i.e., those who have major roles in directing the course of pharmacogenomic technologies; and (3) implementation of pharmacogenomics to improve outcomes in clinical practice.

SACGHS is requesting comments on all aspects of the draft report and recommendations. In particular, the Committee would welcome feedback on the following questions:

• Are the discussions of topics and issues accurate and complete?
• Have any significant opportunities, challenges, or other issues been missed?
• Does the report adequately describe the range of perspectives on the issues discussed in the report?
• Are the draft recommendations specific enough?
• Are there other strategies for addressing the issues?
• Which draft recommendations should be of highest priority for the Federal Government to address?
• Appendix A of the report identifies major pharmacogenomics activities in the public and private sector. Are there other relevant initiatives that should be included in the list?

Comments received by June 1, 2007, will be considered by SACGHS in preparing the final report. The draft report and the public comments will be discussed at a future SACGHS meeting.

Comments also will available for public inspection at the Office of Biotechnology Activities, Monday through Friday, between the hours of 9 a.m. and 5 p.m.

Dated: March 22, 2007.

Elias A. Zerhouni,

Director, National Institutes of Health.