In 2002, SACGT
was replaced by the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), which held its inaugural meeting in 2003.
During consultations with the public SACGT heard from many Americans
14) From a letter from SACGT to Secretary Tommy Thompson, May 3,
Promoting Safe and Effective Genetic Testing in the United States: Final Report of the Task Force on Genetic Testing (Baltimore: Johns Hopkins University Press, 1997); SACGT Report, supra note 3; UK, Advisory Committee on Genetic Testing, Code of Practice and Guidance on Human Genetic Testing Services Supplied Direct to the Public (1997), online: United Kingdom Department of Health <http://www.
The SACGT Report, supra note 3, states: "FDA has stated that it has authority, by law, to regulate such tests, but the agency has elected as a matter of enforcement discretion to not exercise that authority, in part because the number of such tests is estimated to exceed the agency's current review capacity" at 10.
See SACGT RECOMMENDATIONS, supra note 2, at 13 ("In light
The definition of genetic testing from the SACGT reflects
The SACGT issued a report on the oversight of genetic tests and recommended that the FDA supervise the development and marketing of these tests to ensure safety and effectiveness.
SACGT = Secretary's Advisory Committee on Genetic Testing
See "Appendix B: Public Comments on Preliminary Conclusions and Recommendations on Oversight" in SACGT
Report, supra note 3; U.
came up with a template, to be completed by the submitter, for submission to the FDA.