Congress to investigate FDA's medical device approval process

Congress to investigate FDA’s medical device approval process

Reps. John Dingell (D-MI) and Bart Stupak (D-MI) have launched an investigation into the FDA's process for reviewing medical devices, following an accusatory letter from FDA scientists and physicians.

Ben Comer

November 17, 2008

11:50 pm

Reps. John Dingell (D-MI) and Bart Stupak (D-MI) have launched an investigation into the FDA’s process for reviewing medical devices.

The investigation was prompted by a letter from “a large group of scientists and physicians” within the FDA’s Center for Devices and Radiological Health (CDRH), dated Oct. 14. The letter describes CDRH managers that have “corrupted and interfered with the scientific review of medical devices,” according to a release from the office of Rep. Dingell, chairman of the Committee on Energy and Commerce.

The statement goes 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.’”

The individuals comprising the group of scientists and physicians at CDRH are being kept anonymous to protect them from additional reprisal and mistreatment, according to the Commitee statement.

In a letter (found here in pdf format) to FDA commissioner Andrew von Eschenbach—written by Stupak, chairman of the Subcommittee on Oversight and Investigations, and Dingell—the duo cite further allegations made in the CDRH letter: “The CDRH scientists…state that CDRH managers ordered them ‘to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, 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.'”