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Capitol Health Call
January 14, 2009

FDA Whistleblowers

JAMA. 2009;301(2):152. doi:10.1001/jama.2008.878

A group of scientists within the Food and Drug Administration's (FDA’s) Center for Devices and Radiological Health (CDRH) said some of their managers corrupted the scientific review process and approved or cleared medical device applications in gross violation of federal laws and regulations.

The unidentified scientists made their claim in an October 14 letter (released November 17) to Rep John D. Dingell (D, Mich), chairman of the House Committee on Energy and Commerce, and Rep Bart Stupak (D, Mich), chairman of the Subcommittee on Oversight and Investigations (http://energycommerce.house.gov/Press_110/110-ltr-101408.CDRHscientists.pdf). The scientists wrote that they had contacted then–FDA Commissioner Andrew C. von Eschenbach, MD, about their concerns on May 31, and that von Eschenbach ordered an investigation that went nowhere. Finally, the scientists were told of the need to “move forward,” allowing managers to avoid accountability and disciplinary actions.

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