Ed Silverman - Grassley Probes FDA Over Employee Whistleblowers

How does the FDA treat employees who blow the whistle? US Senator Chuck Grassley, a long-standing agency nemesis, wants to know. And so he has written FDA commish Margaret Hamburg to explain the circumstances surrounding a controversial episode in which several current and former agency employees say they were harassed and dismissed after complaining about device reviews to Congress. 

Their charges were contained in a sensational lawsuit filed last month, in which they accused the agency of secretly reading their personal email accounts, while the agency maintained they illegally disclosed confidential business information after writing to Congress to complain they were being coerced to approve devices that posed unacceptable risks (back story).

For instance, the employees, who are all scientists and doctors and worked in the Center for Devices and Radiological Health, charged three devices could have missed signs of detecting breast cancer; one device risked falsely diagnosing osteoporosis, and an ultrasound device could malfunction while monitoring pregnant women in labor.

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