HHS' reconfigured panel on genetics policy places less focus on genetic test regulation than its predecessor, the Secretary's Advisory Committee on Genetic Testing.

On Oct. 23, the Secretary's Advisory Committee on Genetics, Health & Society replaced SACGT, whose charter expired in August. As the name suggests, SACGHS expands SACGT's scope beyond scientific and ethical issues to the social, legal and national security implications of genetic technology.

Bioterrorism, patent and licensing policy are among items extended to the committee's charter. SACGHS' mandate is to "provide a forum of expert discussion and deliberation and the formulation of advice and recommendations on the range of complex and sensitive medical, ethical, legal and social issues raised by new technological developments in human genetics."

The group's mission includes "assessing how genetic technologies are being integrated into health care and public health" and "studying the clinical, ethical, legal and societal implications of new medical applications, such as preimplantation genetic diagnosis and emerging technological approaches to clinical testing."

Explicit mention of pre-implantation genetic tests in the SACGHS charter may reflect the administration's interest in keeping a tighter rein on in vitro fertilization (IVF) regulation (see ¹ Also see "Research Regulations Draft Report To Be Completed By April 2003 – PCB" - Medtech Insight, 28 October, 2002.).

Examples of pre-implantation tests include the MultiVysion PB and PGT tests currently offered by Abbott/Vysis. The tests are regulated as analyte-specific reagents (ASRs), and are designed to identify chromosomal abnormalities in unfertilized and fertilized ovum destined for IVF. The ASRs rely on Vysis' fluorescence in situ hybridization (FISH) technology and the firm's proprietary DNA probes.

In addition to considering the ramifications of new technologies, SACGHS functions include "exploring the use of genetics in bioterrorism" and "examining current patent policy and licensing practices for their impact on access to genetic technologies."

By contrast, SACGT's charter emphasized discussion of policies related to "safe and effective incorporation of genetic technologies into health care," including "assessing the effectiveness of existing and future measures for oversight of genetic tests."

HHS has "a vital role in safeguarding public health while fostering the development of valid genetic tests and facilitating their availability," SACGT's charter said. The statement is omitted from the SACGHS' charter.

SACGT's progress on a regulatory framework for genetic tests had stalled before the advisory committee's charter expired (² Also see "HHS Begs Novel Approach To Genetic Tests Pending FDA Authority Verdict" - Medtech Insight, 20 May, 2002., p. 9). The committee had been waiting to hear whether FDA had legal authority to regulate genetic tests. In the interim, SACGT held several meetings on a planned premarket review template.

SACGT's charter also stipulated that membership should include representation from the Clinical Laboratory Improvement Advisory Committee and FDA's Medical Devices Advisory Committee. The new charter does not expressly require committee members with device or CLIAC backgrounds.

SACGT's nonvoting, ex officio government reps included officials from the Agency for Healthcare Research & Quality, CDC, FDA, the Centers for Medicare & Medicaid Services, the Health Resources & Services Administration and NIH.

SACGHS' ex officio roster, meanwhile, is considerably more expansive. In addition to the agencies mentioned in the SACGT charter, the SACGHS charter specifies inclusion of reps from the Assistant Secretary for Children & Families, the U.S. Attorney General, the Secretary of Defense, the Secretary of Education, the Secretary of Labor, the Secretary of Commerce, the Office for Civil Rights, the Office for Human Research Protections and the Equal Employment Opportunity Commission. Notably, CMS is not mentioned.

SACGHS retains SACGT's 13-member committee structure and specifies that meetings be held "at least two times per year." HHS says it is "actively working" on assembling the panel and indicates that the committee could retain previous members.

The appointment of new members to SACGHS will likely be watched carefully by Democratic legislators. Following HHS' decision to review SACGT's charter, Sens. Edward Kennedy (D-Mass.) and Hillary Clinton (D-N.Y.) wrote HHS Secretary Tommy Thompson a letter Sept. 19 expressing concern that the review may have been politically motivated (³ Also see "HHS Considering SACGT Expansion, Expected To Reconstitute Membership" - Medtech Insight, 23 September, 2002., p. 18).

Responding to the letter, Thompson said that the department was following procedure in advisory committee reviews and appointments. "As charters expire every two years...we review the charter to ensure that it properly focuses the committee on current issues and to ensure that the committee provides HHS with the most relevant professional counsel," he wrote.

Re-chartering SACGHS will allow the committee to "embrace new areas of focus," according to Thompson. New appointments are being made because the agency must replace members whose terms have expired.

"The professional standards of serving on boards and committees...have not changed," Thompson asserted. "To identify new members for boards and committees, we receive names from various sources, including members of Congress, the academic arena, as well as associations and organizations with a specific interest in a particular committee."

The HHS secretary said he does not believe that a "litmus test" has been applied to select members of secretarial advisory committees. "To determine the best candidates...we conduct a series of interviews with potential candidates, providing them with information on the requirements of service as well as ask them various questions designed to provide us with information on why they should be seriously considered for appointment," Thompson wrote.

An Oct. 21 letter to Thompson from Rep. Henry Waxman (D-Calif.) and 11 other lawmakers asks HHS to provide by Oct. 30 the name of each HHS advisory committee for which the Bush administration has replaced or plans to replace more than two members within a six-month period.

The letter also requests the names of members who will be replaced before their terms expire and the names of their replacements. "In each case, to the extent known, provide the names and qualifications of the individuals who will replace the removed members, and if they were recommended by any industry groups, or other outside organizations, from whom the recommendation was received," the letter says. HHS should provide rationales for any panels the department decides to terminate or fails to re-charter.

HHS Genetics Panel Replaces SACGT; Thompson Defends Membership Rules

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