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Choof.org "News"

December 17, 2004

Update on Graham, FDA Drug Approval

I blogged earlier on David Graham (here and here), the FDA scientist who did the unthinkable--he said something of consequence at a Congressional hearing. In a hearing on Vioxx, Graham testified that five other drugs should be aggressively addressed by the FDA: Crestor, Meridia, Bextra, Accutane, and Serevent.

Today's Wall Street Journal reports that "About two-thirds of Food and Drug Administration scientists lack confidence in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey:"

The survey was conducted by the Department of Health & Human Services Office of Inspector General, or OIG, but the full results were released to the public only after an advocacy group filed a Freedom of Information Act petition...

About 66% of the experts surveyed said they were not at all confident or only somewhat confident that the FDA adequately monitors the safety of prescription drugs once they are on the market...

The survey also asked the scientists if they had ever been pressured to approve a drug even though they had reservations about its safety, efficacy or quality. Of 360 responses, 297, or 82%, of the scientists said they did not feel they had been pressured. Sixty-three, or 18%, said they did come under such pressure.

You can read the report here.

Posted by chris at December 17, 2004 08:29 AM

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