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November 18, 2008 Eye On FDA: Dissension in the Ranks at FDA - More Fuel for Energy and Commerce Full article here: http://www.eyeonfda.com/eye_on_fda/2008/11/dissension-in-t.html NYT article: "F.D.A. Scientists Accuse Agency Officials of Misconduct" here: http://www.nytimes.com/2008/11/18/health/policy/18fda.html The FDA may be hitting a new low in terms of the image-bashing it has taken during the past six years. Today, the New York Times reports FDA Scientists Accuse Agency of Misconduct. One almost doesn't want to read further, but like a train wreck, it is hard to look away. A letter from FDA scientists to the Committee on Energy and Commerce alleges that the FDA knowingly approved devices that were unsafe or ineffective. The specific devices that are the subject of the letter are apparently not named, which will necessarily cause scrutiny to fall on all devices recently approved. Manufacturers, get your talking points lined up now. The letter from the scientists to the Committee on Energy and Commerce was posted on the site of the Committee, omitting the names of the scientists who signed the letter. The allegations contained in it are fairly damning and the letter to the Committee follows a letter last spring sent by the scientists to Dr. Andrew C. von Eschenbach which was sent after the scientists approached leadership at the Centers for Devices and Radiological Health (CDRH). You can read the full letter for yourself, but this sentence kind of sums things up - "[t]here is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices." ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn