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News & Analysis | REG•WATCH Blog | Press Room
Friday, October 10, 2008
Industry Ties Bind FDA Advisors
The Government Accountability Office (GAO) has released a new report describing how the Food and Drug Administration handles conflicts of interest on its advisory panels. Financial conflicts plague a significant number of FDA advisors and FDA panels, according to the report.
FDA advisory committees can provide valuable advice to decisionmakers inside the agency "particularly concerning controversial issues or new products," according to GAO. Committees can weigh in on the safety and efficacy of a pharmaceutical awaiting approval or the safety of chemicals found in every day products — as FDA's science board did in September when it considered the safety of bisphenol-A. "The advisory committees' recommendations are not binding on the agency, but the agency usually follows the advisory committees' advice," GAO says.
But committee members, or potential members, sometimes have financial conflicts (such as owning stock in a company with a product before the committee) that call into question their ability to provide unbiased input. In those cases, FDA can provide a waiver if it believes a person's service is critical to the operation of an advisory panel.
FDA is not doing a good job of filling panels with impartial experts and issuing too may waivers. GAO examined a sample of advisory committee meetings and made these key discoveries:
- At least one member on 49 of the 83 meetings examined had a conflict;
- Two hundred of the 1,218 participants had a conflict — about 16 percent;
FDA officials acknowledge that their source for expertise is the same as industry's:
FDA contended that it sought the same leading experts to serve on its advisory committees as industry sought to conduct its research and product trials. As a result, the experts FDA deemed most qualified to serve on its advisory committees often had industry ties, according to the agency.
GAO says that FDA needs to improve its efforts to recruit committee members. FDA's primary vehicle for recruitment is word-of-mouth which means committee members tend to be those experts known to agency officials or to an industry with a product under review. "[I]t may lead to self-perpetuating committee membership, in which a limited group of peers continually comprise an advisory committee."
The report is available here: FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest
Posted by Matt Madia
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