FDA device division review is high priority
Margaret Hamburg, the new commissioner of the US Food and Drug Administration, has said that her first priority is to reinvigorate the troubled agency. Doing so, she said, will restore its credibility with the public and policy makers.
In an interview with The Wall Street Journal, the commissioner said that she is taking a “hard look” at the medical device division and a “fresh look” at the abbreviated framework it uses to approve many riskier and implantable products. “This is a high priority,” she said.
Scientists at the FDA’s Center for Devices and Radiological Health have sent letter to Congress and the White House alleging that political and corporate influence have trumped science at the division. The device industry is concerned that the FDA or Congress might toughen standards in applying the abbreviated approval process, called 510(k), to devices that would otherwise go through a lengthy review involving more clinical trials and safety data.
A government report in January said that the 510(k) process has been overused.
Dr. Hamburg said that a new transparency task force at the FDA is weighing the need to transmit emerging data about potential drug side effects against claims by corporations that want to keep commercial information confidential.