As Harry Truman opined, “I have found the best way to give advice to your children is to find out what they want and then advise them to do it.”
If only it were that easy with FDA advisory committies.
Matt Herper (Forbes) reports that an analysis of FDA advisory committee recommendations compared to actual FDA actions (from 2007 through 2010) shows that FDA followed adcomm advice 74% of the time. The study, by Concept Capital, looked at a total of 120 product-specific advisory committee votes and the ensuing FDA actions.
Interestingly, the FDA overruled “no” votes only three times: (Tarceva for maintenance therapy in lung cancer, Avastin for breast cancer, and Micardis to lower blood pressure.)
As Herper writes, “In other words, a no vote from an advisory panel is likely to stick, but a yes vote does not mean the product will be approved.”
“Advice is judged by results, not by intentions.”
-- Cicero
