FDA Holds Meeting Examining Agency’s Evaluation Process

Months after scientists at the U.S. Food and Drug Administration (FDA) first complained to legislators and then-presidential candidate Barack Obama that the medical device approval process is flawed, the agency is holding a meeting today to address that issue head on. The meeting is expected to include all scientists within the device evaluation division.

The scientists have sent many e-mails to Joshua Sharfstein, the agency’s principal deputy commissioner, pleading for action.

A congressional investigation into the scientists’ concerns is under way, and in January the Government Accountability Office released a report that was critical of the FDA’s Center for Devices and Radiological Health.

This week, lawmakers are expected to be propose legislation that would ask the Institute of Medicine–a nonprofit organization in Washington, D.C., that provides science-based advice on matters of biomedical science, medicine, and health–to investigate concerns surrounding the device division.