E8-8216. Secretary's Advisory Committee on Genetics, Health, and Society

AGENCY:

Office of the Secretary, HHS.

ACTION:

Request for suggestions on new SACGHS priority issues.

SUMMARY:

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is updating its study priorities. SACGHS requests suggestions on possible new topics for the Committee to address.

DATES:

Written or electronic comments should be submitted by May 16, 2008.

ADDRESSES:

Comments can be sent by mail to the following address: Secretary's Advisory Committee on Genetics, Health, and Society, attn: Suzanne Goodwin, NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. Comments also can be sent via e-mail to Suzanne Goodwin at [e-mail] or via facsimile 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 serve as a public forum for deliberations on the broad range of policy issues raised by the development and use of genetic technologies and, as warranted, to provide advice on these issues to the HHS Secretary or other Federal entities as requested. The scope of the Committee's charge includes assessing how genetic and genomic technologies are being integrated into health care and public health; studying the clinical, public health, ethical, economic, legal, and societal implications of genetic and genomic technologies and applications; identifying opportunities and gaps in research and data collection and analysis efforts; examining the impact of current patent policy and licensing practices on access to genetic and genomic technologies; analyzing uses of genetic information in education, employment, insurance, and law; and serving as a public forum for discussion of issues raised by genetic and genomic technologies. For more information about the Committee, please visit its Web site: http://www4.od.nih.gov/​oba/​sacghs.htm.

In March 2004, SACGHS identified 11 issues relating to its charge and developed a report that classified the relative priority of these issues (the report is available at http://www4.od.nih.gov/​oba/​sacghs/​reports/​SACGHSPriorities.pdf). The Committee has produced several work products related to these 11 issues, and other projects are near completion or underway:

1. Coverage and reimbursement of genetic technologies. SACGHS issued a report, Coverage and Reimbursement of Genetic Tests and Services, in February 2006. The report describes the current state of coverage and reimbursement of genetic tests and services, highlights concerns that affect patient access to tests and services, and identifies nine steps that HHS and the private sector could take to help improve access to and appropriate utilization of health-related genetic tests and services.

2. Large population studies. In March 2007, SACGHS issued a report, Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease. The report delineates the questions that need to be addressed for policymakers to determine whether the U.S. Government should undertake a large population project to elucidate the influence of genetic variation and environmental factors on common, complex diseases.

3. Genetic discrimination. SACGHS has written three letters to the HHS Secretary championing the enactment of Federal legislation to prohibit discrimination based on genetic information by health insurers and employers. The Committee also provided the Secretary with a legal analysis of the adequacy of current law regarding genetic discrimination, a compendium of public comments documenting public fears and concerns about genetic discrimination, and a 10-minute DVD of testimonies received from the public.

4. Genetics education and training of health professionals. SACGHS issued a resolution that urged the HHS Secretary to take a series of steps to ensure the adequacy of genetics education and training of health care and public health professionals. Because of continuing needs in this area, SACGHS created a Genetics Education and Training Task Force in November 2007 to develop a plan to identify the education and training needs of health professionals, lay health educators, and the general public; outline the steps required to meet these needs; and evaluate the effectiveness of existing educational and training efforts.

5. Direct-to-consumer marketing of genetic technologies. SACGHS wrote two letters to the HHS Secretary urging greater collaboration among Federal agencies in addressing the advertising of laboratory-developed genetic tests. These efforts led to the issuance of a Federal Trade Commission Consumer Alert that cautions consumers that at-home genetic tests have not been evaluated by FDA and urges them to be wary of the claims made by companies marketing such tests.

6. Oversight of genetic technologies. In March 2007, the Office of the HHS Secretary charged SACGHS with identifying the steps needed for evidence development and oversight of genetic and genomic tests. A final report on the issue is expected in May 2008.

7. Pharmacogenomics. In May 2008, SACGHS will issue its final report on the opportunities and challenges associated with pharmacogenomics research, development of pharmacogenomic applications, and integration of these applications into clinical practice and public health.

8. Patents and access. SACGHS is currently studying the positive and negative effects of gene patent and licensing practices on patient access to genetic tests and the public's health. A final report is expected in 2009.

9. Access to genetic technologies. This was designated as an overarching issue that cuts across all SACGHS work.

10. Public awareness and understanding of genetic technologies. This was designated as an overarching issue that cuts across all SACGHS work.

11. Genetic exceptionalism. This was designated as an overarching issue that cuts across all SACGHS work.

SACGHS's work products can be found at: http://www4.od.nih.gov/​oba/​sacghs/​reports/​reports.html.

As described above, SACGHS has completed several major projects related to these 11 issues, and other projects are near completion. In the coming months, the Committee will be identifying new priority issues to address. SACGHS would welcome public perspectives about issues within SACGHS's charter that are in need of attention and study. Members of the public who wish to suggest an issue are asked to submit a statement (approximately one paragraph in length) that:

(1) Describes a problem or policy challenge that needs exploration; and (2) proposes actions the Committee could take to address the issue. The submission of references or other background materials related to the topic is encouraged.

The issues suggested should take into consideration the charge of SACGHS, outlined above, and the following points:

• The urgency and national importance of the issue.
• The extent to which the Federal Government has jurisdiction/authority over the issue.
• The need for Federal guidance or regulation on this issue.
• Whether the issue raises concerns that only the Federal Government can address.
• Whether the issue raises moral or ethical concerns that warrant Federal Government involvement/leadership.
• Whether SACGHS's policy advice on this issue would significantly benefit society.
• Whether failure to address the issue would prolong any negative impact the issue may be having on society.
• Whether sufficient data about the issue exist for SACGHS to develop informed policy advice.
• Whether another body is already addressing the issue or is better equipped to address it.

Public comments received by May 16, 2008 will be considered by SACGHS and discussed at its next meeting on July 7-8, 2008 in Washington, DC.

Dated: April 7, 2008.

Sarah Carr,

SACGHS Executive Secretary, National Institutes of Health.