Two congressional representatives announced they are launching an investigation into whether managers within the Food and Drug Administrations Center for Devices and Radiological Health corrupted the scientific-review process and violated product-safety regulations by approving or clearing medical devices that werent properly vetted, according to a news release.
The inquiry was prompted by an Oct. 14 letter written by a group of CDRH scientists and physicians who said CDRH managers have interfered with the medical-device scientific-review process and that reviewers experienced reprisals from management when they insisted on adhering to regulatory-review rules.
The investigation is being conducted by Reps. John Dingell (D-Mich.), chairman of the Energy and Commerce Committee, and Bart Stupak (D-Mich.), chairman of the panels Oversight and Investigations subcommittee. This 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, according to the two lawmakers.
Dingell and Stupak have sent a letter to FDA Commissioner Andrew von Eschenbach requesting a briefing on what actions the agency has taken to resolve issues raised by CDRH scientists and physicians. The inquiry broadens an ongoing investigation launched in early 2007 into the scientific integrity of the FDA approval process. -- by Shawn Rhea