Regulacje i polityka gospodarcza · 7.12.2000

Secretary's Advisory Committee on Genetic Testing

The Secretary's Advisory Committee on Genetic Testing (SACGT) was chartered to advise the Department of Health and Human Services on the medical, scientific, ethical, legal, and social issues raised by the development and use of genetic tests. SACGT recently completed its first report, Enhancing the Oversight of Genetic Tests (available at http://www4.od.nih.gov/oba/sacgt.html). One of SACGT's major recommendations was that all new genetic tests be reviewed by the Food and Drug Administration (FDA) before they are used for clinical care or public health purposes through "new and innovative oversight mechanisms that will not limit the development of new tests or inordinately delay their availability." SACGT also recommended that FDA correlate the level of review applied to each genetic test with the level of scrutiny warranted by the test. To assist FDA in determining which tests warrant greater scrutiny, SACGT is developing a classification methodology. A SACGT Working Group on Genetic Test Classification, composed of SACGT members and ad hoc experts, met on August 3, 2000, to identify criteria for assessing the risks and benefits of genetic tests that could serve as the basis for