In the news

Just before the change of administration in the US, Donna Shalala, outgoing Secretary for Health and Human Services (HHS), released the HHS response to the report Enhancing the Oversight of Genetic Tests, produced by the Secretary's Advisory Committee on Genetic Testing. Her response indicated that HHS accepted essentially all of the SACGT's recommendations, and planned to push forward on several fronts in implementing them. The overall plan involves coordinating the activities of the Health Care Financing Adminstration in certifying laboratories undertaking genetic testing, the Food and Drug Administration in reviewing, approving and labelling all new genetic tests that have moved beyond the basic research stage, and the Centers for Disease Control and Prevention in collecting information to evaluate the analytical validity, clinical validity and clinical utility of genetic tests. The Secretary's response also stressed that procedures for obtaining informed consent are essential for all research protocols for genetic tests in which individually identifiable samples are used. Incoming HHS Secretary Tommy Thompson has not yet indicated his view on the proposals for oversight of genetic tests, but it seems likely that the Bush administration's approach will be broadly in line with that of its predecessor on this issue.