Industry Ties Bind FDA Advisors
by Matthew Madia, 10/10/2008
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;
