FDA Scientists Claim Coercion in Medical Device Approval Process

November 18, 2008 – The House Energy and Commerce Committee launched an investigation yesterday 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.

The investigation was prompted by a letter released publicly on Monday from “a large group of scientists and physicians” within the FDA's Center for Devices and Radiological Health (CDRH), dated October 14, 2008, said Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) According to the statement, the letter describes CDRH managers that have “corrupted and interfered with the scientific review of medical devices.”

The statement went on to say that the Committee has been “provided with compelling evidence to support the charges that senior managers within CDRH ‘ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law.'”

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 scientists claim that they were threatened with removal or negative performance reviews if they did not modify their scientific data to obscure unscientific clinical and technical data submitted by device companies and legal violations, including a lack of informed consent from study participants.

According to CongressDaily, "Potential changes to FDA's medical device review process that could stem from the investigation could be addressed next year when Dingell and Stupak plan to propose legislation they have released in draft form to help the agency better police products." In the letter, the scientists asked Congress to consider overhauling FDA's review process that allows approval of medical devices that have not been fully proven effective, reported the New York Times today.

For more information: www.energycommerce.house.gov