FDA advisory panels almost always recommend approval for new drugs and devices

Eleven randomly selected FDA advisory committees recommended approval for 79% of prescription drugs and medical devices that they considered during a seven-year period, according to a study released on Monday by the National Research Center for Women & Families, Bloomberg/Houston Chronicle reports.

FDA convenes advisory committees to provide outside recommendations on applications for prescription drugs or medical devices (Bloomberg/Houston Chronicle, 8/28). For the study, researchers examined the votes of six of the 16 FDA prescription drug advisory committees and five of the 18 agency medical device advisory committees from January 1998 through December 2005. The 11 advisory committees included in the report met 89 times during the study period. According to the study, the prescription drug advisory panels recommended approval 76% of the time, and the medical device advisory committees recommended approval 82% of the time (AP/San Diego Union-Tribune, 8/28). The study also finds that FDA is 10 times more likely to follow the recommendations of advisory committees when they recommend approval for prescription drugs and medical devices than when they recommend against approval. FDA follows the recommendations of advisory committees 96% of the time when they recommend approval for prescription drugs and medical devices, according to NRCWF President Diana Zuckerman (Vedantam, Washington Post, 8/29).

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"Our sense is that the advisory panels have been assumed to be this important, independent voice," Zuckerman said, adding, "But they don't seem very independent; they seem more like a rubber stamp" (AP/San Diego Union-Tribune, 8/28). Zuckerman said, "Some of these committees have never met a product they don't like. From a consumer point of view, this is not good news" (Bloomberg/Houston Chronicle, 8/28). Zuckerman also said that potential conflicts of interest among advisory committee members might affect their votes. However, Randall Lutter, associate commissioner for policy and planning at FDA, said that a recent agency analysis found potential conflicts of interest among advisory committee members does not affect their votes. Lutter said, "To say they serve as a rubber stamp is not a way of contributing to informed debate," adding, "First and foremost, it is an advisory committee process, and in that sense panels do not make decisions, they offer advice." In addition, FDA in some cases convenes advisory committees to provide recommendations on issues such as products labels and usage for prescription drugs or medical devices previously scheduled for approval, Lutter said (Washington Post, 8/29).