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Advisory panel conflicts

This article was originally published in The Gray Sheet

Executive Summary

FDA could have done more to mitigate conflicts-of-interest among its advisory committee members by expanding outreach efforts to retired experts, academics and others, the Government Accountability Office concludes in a 1report released Oct. 9. FDA uses several methods to recruit panel members, but sometimes cannot find appropriate experts with no financial interests in the product or issue being discussed and must grant a waiver. Congress requested in 2005 that GAO investigate FDA's recruitment and waiver policies (2"The Gray Sheet" Sept. 26, 2005, p. 7). GAO reviewed 83 committee meetings convened by FDA's device, drug and biologics centers in 2004 and 2006, and interviewed consumer advocacy and trade groups, current and former FDA staff, and former panel members. About 16% of panel members received at least one conflict-of-interest determination, GAO found. In Aug. 28 comments, FDA questioned GAO's main criticism and highlighted four guidance documents on advisory panel policies, finalized Aug. 4, which are beyond the scope of the report (3"The Gray Sheet" Aug. 11, 2008, p. 3)
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