Panel Democrats will probe charges from FDA scientists

House Energy and Commerce Committee Democrats are investigating allegations that surfaced last month by Food and Drug Administration scientists in the agency's device division that their superiors twisted their arms to clear medical devices for approval despite serious safety and effectiveness concerns.

At least eight FDA scientists wrote Energy and Commerce Committee Chairman John Dingell, D-Mich., Oct. 14 in a letter released Tuesday that the coercion reaches all the way to the top of FDA's Center for Devices and Radiological Health and represents "a silent danger that may only be recognized after many years."

The scientists claimed they were intimidated into changing scientific reviews and recommendations to obscure unscientific clinical and technical data submitted by device companies and legal violations -- including a lack of informed consent from research subjects. They claim being threatened with removal and negative performance reviews for resistance.

"Managers at CDRH have failed to follow the laws, rules, regulations and agency guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices," the scientists wrote. "This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE)."

A committee aide said lawmakers would not release the extent of the problem or specific devices affected by the allegations until investigators learn more.

An FDA spokeswoman said the agency did not have a response to the charges and would respond directly to Dingell and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich. Dingell and Stupak wrote FDA Commissioner Andrew von Eschenbach Monday to urge the commissioner to get his management in line and request an interview with William McConagha, the assistant commissioner for integrity and accountability.

"Certainly, our preliminary witness interviews and document review confirm that sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists," Dingell and Stupak wrote.

McConagha was tasked with reviewing the scientists' allegations when they first brought them to von Eschenbach's attention in May. While McConagha determined the scientists produced compelling and convincing evidence to warrant disciplinary action, CDRH Director Daniel Schultz did not dole out any reprimands and told the scientists to "move forward," according to their October letter to Dingell.

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.

The scientists specifically asked the lawmakers to change the agency's review procedures that allow devices into the marketplace that have not been fully vetted.