FDA Scientists Allege Coercion In Medical Device Approval Process, House Panel Investigates

Medical News Today -- The House Energy and Commerce Committee on Monday launched an investigation into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns, CongressDaily reports (Edney, CongressDaily, 11/18). Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) said that the investigation was prompted by an Oct. 14 letter “written on behalf of a large group of Center for Devices and Radiological Health scientists and physicians who state that CDRH managers have ‘corrupted and interfered with the scientific review of medical devices’” (Reichard, CQ HealthBeat, 11/17). The letter to the committee, released publicly on Monday, did not include the names of the FDA scientists or information on which device approvals the scientists questioned (Harris, New York Times, 11/18).

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