Thursday, October 15, 2009

An oldie but goodie

2006 study of the practices of the advisory panels for the FDA which are the front lines of the approval process for new drugs and devices

The results indicate that advisory committees recommended approval for 76% of new drugs and 82% of new medical devices. Some committees are more discriminating than others. Many panel members and some committee members recommended approval for every product they considered year after year. For example, 98% of the votes by members of the advisory committee reviewing arthritis drugs over the eight years of the study recommended approval; almost all, like Vioxx®, were recommended unanimously. The committee reviewing medical devices for vision correction and eye diseases unanimously recommended approval for every medical device they considered for the last six years of the study. About 96% of these drugs and devices were subsequently approved by the FDA.

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