In an effort to shore up its conflict-of-interest policies, the Food and Drug Administration has finalized policies for publicly disclosing the financial ties of advisory board members whose votes can prove crucial to approval of new drugs and medical devices. In its guidance, the FDA included a pair of templates that it intends to use when screening members and releasing information about business relationships that could cast doubt on their impartiality.
The agency essentially stuck to that policy, making clear that though some details may be disclosed, they will remain under lock and key if they are exempt from the Freedom of Information Act. As an example, the FDA said it wouldn’t provide any financial ties that could reveal confidential commercial information. The overarching goal, according to the guidance, is to “increase the transparency, consistency and clarity of the advisory committee process,” which provides nonbinding recommendations prior to FDA approval decisions.
A draft version of the guidance emerged in March 2012, shortly after reports that three members of an advisory panel found that the benefits of Bayer AG oral contraceptives outweighed their risks. Interestingly, none of them publicly disclosed having worked for Bayer in various roles. That support proved key to securing a 15-11 vote in favor of the pills. In response, the FDA said it had been aware of the members’ ties but that it “did not identify any financial interests that would have precluded their participation.” Not included in the new guidance was a separate process that vets members for certain “covered relationships,” such as a spouse’s work for a company or past financial ties, which the FDA screens separately. We will watch future developments on this front.
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