Thursday, February 02, 2012

Whistleblower Lawsuit Puts Spotlight On FDA Technical Reviews - ScienceInsider


The lawsuit filers include two licensed doctors, one M.D./Ph.D., one other scientist, an engineer, and a statistician, all of whom sat on scientific review committees for the Center for Devices and Radiological Health, which judges the efficacy of cancer-screening devices. The lawsuit alleges that senior FDA officials approved certain devices despite poor scientific reviews. The lawsuit mentions just a few devices—most prominently, one for colon cancer and one for breast cancer—but the complaints stretch to more than 10 different devices overall, says Stephen Kohn, the lead counsel for the filers and the director of the National Whistleblowers Center. Kohn added that in at least one case, officials pressured an engineer to change the warning labels on a device, removing negative language. (The FDA declined to comment on any aspect of the allegations because the lawsuit is pending.)

Posted via email from Jack's posterous

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