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Wednesday, August 06, 2008

Will New FDA Guidelines Really Reduce Conflicts of Interest?

The Food and Drug Administration has finalized guidelines it contends will improve the independence of the expert panels it uses to receive advice on pending decisions for both food and drug policy. But the final guidelines are weaker than the proposed version first unveiled in March 2007.

The guidelines define new FDA policies for financial conflicts of interest. If a potential member of an advisory committee has a financial interest in the issue the panel is considering — for example, ties to a pharmaceutical industry which has a new drug under review — that person's objectivity is compromised.

Under the March 2007 proposal, potential members with a financial conflict totaling more than $50,000 would be prohibited from serving on panels except in the rarest of cases. That part of the guidance has gone unchanged.

But potential members with a conflict of less than $50,000 will potentially have more influence under the final guidance than they would have under the proposed version. Originally, persons with a financial interest less than $50,000 would have been allowed to serve but prohibited from voting. FDA decided to strip the voting prohibition in the final version.

Allowing members with a financial conflict to cast deciding votes could have real consequences, especially in the area of drug approval. A 2006 study published in the Journal of the American Medical Association finds "the overall amount of conflict in a meeting could have an influence on overall voting behavior." The study finds, in hearings held on specific drugs where the advisory committee contains members with a financial interest in the approval of the drug, the committee is likely to recommend approval.

Moreover, even the strict $50,000 cutoff won't have much impact on the number of conflicted panel members providing the agency with advice. An investigation by the Center for Science in the Public Interest found the $50,000 threshold "would eliminate just one of every ten panelists who currently gets a waiver" to serve despite a financial conflict.