News | November 18, 2008

Federal Lawmakers Investigate FDA's Medical Device Approval Process

November 19, 2008 - U.S. Reps. John Dingell (D-MI), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, yesterday launched an investigation into whether managers within the FDA Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications in violation of laws and regulations designed to assure the safety and effectiveness of medical devices.

The investigation was prompted by a letter sent in October, written on behalf of a large group of CDRH scientists and physicians who stated CDRH managers have "corrupted and interfered with the scientific review of medical devices."

"These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of America consumers," Dingell said. "I commend the FDA scientists for courageously sounding the alarm on what appears to be a serious problem. I look forward to pursuing the steps necessary to ensure that the medical devices Americans depend on are safe and effective."

"Our investigations have found that the FDA has allowed contaminated food and unsafe drugs to enter the market, and now serious allegations have been raised about the scientific integrity of the FDA medical device approval process," Stupak said. "Although the FDA has launched its own investigation into this matter, no corrective action has been taken. The committee intends to learn what action the FDA plans to take to ensure the integrity of the medical device approval process and prevent retaliation against the scientists who blew the whistle on these activities."

The lawmakers said the information they were sent from FDA employees showed what they considered 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 CDRH scientists also claim 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. They also claimed some information was not obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.

Documentary evidence reviewed by the Committee on Energy and Commerce Committee indicates CDRH scientists who raised concerns up their chain of command experienced reprisals for their insistence on adherence to a scientific and regulatory basis for medical device review. To protect these scientists who brought their concerns to the attention of the committee, their identities will not be disclosed.

Since January 2007, the committee and its subcommittee on oversight and investigations have been investigating the ability and commitment of the FDA to protect Americans from unsafe food, drugs, and medical devices.

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