FDA Urged To Revisit Panel Conflict Rules, Again

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conflictsofinterest.jpgLast month, the FDA declared that it would be difficult to create advisory committees free from conflicts of interest. The study, which cost taxpayers $60,000, according to FedSpending.org, also claimed the advisors granted conflict-of-interest waivers had greater expertise than those without conflicts serving on the committees.

But the Center for Science in the Public Interest went back and did its own reanalysis of the data and claims the FDA and the report should have drawn the opposite conclusions. The report examined four committees created during 2006 that granted 17 waivers. It took just 88 person-hours to identify 30 independent experts with all the expertise needed to fill those slots. Each of the 30 affirmatively declared in the medical literature that they had no conflicts of interest, according to CSPI. Moreover, the expertise of those potential candidates, according to the report’s own methodology, was greater than either the conflicted or unconflicted experts chosen to serve on the committees.

In a letter sent today to FDA commish Andy von Eschenbach, a coalition of consumer groups called on the FDA to reopen consideration of an agency proposal made last March that would forbid anyone who has financial ties with industry worth more than $50,000 from serving on advisory committees. It would also deny voting rights to advisers with lesser conflicts.

“While the FDA’s proposed guidance doesn’t go far enough, this study shows that those barred or restricted under its limited provisions could be easily replaced,” says Merrill Goozner, director of CSPI’s Integrity in Science Project. Recently passed legislation only requires the agency to reduce total waivers by 20 percent over the next five years, in contrast to the total ban on conflicts of interest sought by consumer groups.

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