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Resignation of FDA Medical-Device Regulator

Daniel Schultz, the head of FDA’s Center of Device and Radiological Health for the past five years, has resigned. There’s no specific word about what prompted the resignation, but press reports detail that it was “by mutual agreement.” Of course, it is hard to avoid speculating that Dr. Schultz was asked to leave because of complaints from other FDA employees that he ignored science and favored requests from industry. He has been investigated at least twice in the past two years by the Senate, and last October nine FDA employees complained the House Energy and Commerce Committee that the FDA was approving devices even though formal safety and efficacy concerns were on file. And, some FDA scientists who opposed approval say they were retaliated against.
The Obama administration is working to bolster the FDA’s reputation and work product. President Obama previously named Dr. Margaret Hamburg to the post of Commissioner. She was formerly the health commissioner for New York City. She has a lot of work to do.

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