Regulatory News In Brief

Diagnostics oversight report finalized: In a final 1report released April 30, an HHS advisory committee recommends that FDA "address" all diagnostic tests, genetic or otherwise, using a risk-based framework to determine the appropriate level of regulatory oversight. Diagnostics are currently subject to various levels of oversight from FDA, CMS's 1988 Clinical Laboratory Improvement Amendments (CLIA) and state agencies. FDA, CMS and other agency oversight procedures should be harmonized, the report says. In March 2007, HHS Secretary Michael Leavitt asked the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) to draft a genetic test oversight report; the draft was released last November. The final report reflects discussions held this February on how best to expand test oversight and health education to address significant gaps that put the public at risk (2"The Gray Sheet" Feb. 25, 2008, p. 14). Lab groups, however, are wary that expanded FDA oversight over all lab-developed tests could lead to redundancies between FDA and CLIA requirements and stifle innovation