Experts, Conflicts and the FDA

The Food and Drug Administration relies on 49 expert committees to advise it on policy matters and on whether particular drugs or other medical products are safe and effective. The agency has made substantial progress in reducing conflicts of interest among members, and it is now pledging to search “far and wide” for neutral experts and to make more information public about any waivers it grants.

That is all good news, provided the agency remains appropriately stingy in granting waivers as it struggles to fill a huge number of vacancies on those committees — roughly a third of more than 600 slots are open.

For many years now, critics have complained that the votes of some committee members could be swayed by financial conflicts — such as owning stock in or consulting for a company whose product is under consideration, or for one of its competitors. Although laws and regulations are supposed to screen out scientists with financial conflicts, the FDA routinely granted waivers to allow participation by specialists whose hard-to-find expertise was deemed essential.

Read more: http://www.nytimes.com/2010/05/05/opinion/05wed3.html
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