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Congress Probes 'Corrupted' FDA Device Approvals
By Pharmalot
November 17, 2008
The House Energy and Commerce Committee received a letter dated October 14 from a ‘large group’ of scientists and physicians at the FDA’s Center for Devices and Radiological Health division, who complained that CDRH managers have “corrupted and interfered with the scientific review of medical devices.”
In a statement, John Dingell, who chairs the committee, and Bart Stupak, who chairs the Subcommittee on Oversight and Investigations, say they are probing allegations that the FDA “approved or cleared medical device applications in gross violation of laws and regulations….such activity could allow potentially unsafe and ineffective medical devices into the US market.”
The CDRH allegedly “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.” The CDRH staffers also claim they were forced to use “unsound evaluation methods, and accept clinical and technical data that is not scientifically valid or obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.”
And in a letter to FDA commish Andy von Eschenbach, the lawmakers note that the same CDRH employees wrote last May to FDA officials to complain, and that William McConagha, assistant commissioner for integrity and accountability, investigated the allegations and recommended removing some CDRH managers.
Although McConagha called the “evidence is ‘compelling,’ ‘convincing,’ and ‘sufficient’ to justify disciplinary and curative actions,” Dingell and Stupak say no action has been taken, and that retaliatory behavior against the employees occurred.
