The Food and Drug Administration has often failed to share information on how it determines whether its advisory committee members have financial conflicts of interest and whether those individuals should participate in committee meetings, according to a review by the Government Accountability Office.
A key issue is that the agency never finalized guidance 13 years after a law required it to do so, the watchdog found. Meanwhile, the FDA has never posted on its website how it makes these decisions and does not publicly share how it decides whether guest speakers have financial conflicts or situations where there appears to be a conflict.
As a result, the GAO recommended the FDA establish a timeframe for issuing and publicly sharing required financial conflicts-of-interest guidance. The watchdog also suggested the FDA should disclose how it decides conflicts for committee members in the interim and publicly disclose how it determines conflicts and appearance issues for guest speakers.
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