US devices centre falls under scrutiny of Congress, "gross violations" alleged
Friday 21 November 2008 Peter Rixon - Editor, North America

An investigation has been launched into allegations that managers within the FDA’s Center for Devices and Radiological Health (CDRH) corrupted and interfered with the scientific review of medical devices.

Congressmen John Dingell, chairman of the House committee on energy and commerce, and Bart Stupak, chairman of the subcommittee on oversight and investigations, launched the investigation on November 17 after receiving a letter containing the allegations.

The letter, written by a large group of CDRH scientists and physicians, claims that senior managers within the CDRH “ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law". 

A deep layer of line management: The current management structure within CDRH Graphic: FDA/CHRH

The CDRH scientists also claim 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”.

FDA spokeswoman Siobhan DeLancey told Clinica that the agency would be responding directly to Congress about the allegations. Congressman Dingell said the allegations were “deeply concerning”. “We intend to uncover whether any FDA activity has compromised the health and safety of American consumers,” the Michigan Democrat 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.”

The Congressman also alleges that documentary evidence reviewed by his committee indicated that CDRH scientists who raised concerns up their chain of command had experienced reprisals for “their insistence on adherence to a scientific and regulatory basis for medical device review”.

Representative Dingell wrote to FDA Commissioner Andrew von Eschenbach on November 17 asking the Commissioner what action he would be taking to resolve the issues. With a change of Commissioner expected to be made soon by the new Obama Administration, Dr von Eschenbach may be handing over this – one of many FDA hot potatoes – to someone else.

In his letter, Representative Dingell and co-author Representative Stupak, wrote: “We urge you to take seriously these allegations of the CDRH scientists and physicians and take the necessary immediate actions with respect to management, procedural and organisational changes necessary to assure the safety and effectiveness of medical devices and a restoration of the FDA’s mission.”

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