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MEDICAL DEVICES
FDA scientists say approval process for new medical devices is rushed and politically influenced

January 14, 2009 - Last May, nine agency scientists complained to the outgoing commissioner of the Food and Drug Administration (FDA) that political influences frequently overrule scientists to tilt policy decisions on medical devices.

The latest concern involves an FDA official who overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman.

The device - the iCAD SecondLook Digital Computer-Aided Detection System for mammography - is used with screening equipment made by Fujifilm Medical Systems. Fujifilm Medical is based in Stamford, Conn., the heart of the congressman’s former district.

The legislator’s phone call and its effect on what is supposed to be a science-based approval process is only one of many accusations made in documents, recently obtained by The New York Times. According to the Times, internal documents show that FDA scientists criticized the process by which many medical devices gain approval, even without extensive testing. Scientists charge that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.

In October, scientists wrote a letter to Congress requesting a formal investigation. The House Committee on Energy and Commerce said in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.

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