As part of the deal when the FDA approves new drugs, sometimes it requires drug companies to promise to do followup studies of safety and effectiveness - post-marketing surveillance. Sometimes the promise is made in return for speedier FDA approval. But the New York Times reports that two-thirds of the studies had not even been started.
Dr. Alastair Wood, associate dean of Vanderbilt medical school, told the Times that the F.D.A. needed to get tougher on drug makers. "Who would turn in their homework if they didn't have to?" Dr. Wood asked.
Posted by schwitz at March 6, 2006 09:39 AM | TrackBack