Cliff Stearns Lights a Fire Under the FDA on Medical Devices

From his perch as chairman of the U.S. House Energy and Commerce Committees subcommittee on oversight and investigations, Florida Republican U.S. Rep. Cliff Stearns on Wednesday will be looking at the role of the federal Food and Drug Administration (FDA) in regard to medical devices.

The United States has led the global medical device industry for decades, and the industry directly employs 400,000 Americans and indirectly supports 2 million total jobs, said Stearns on Tuesday. Numerous reports, case studies and firsthand accounts indicate that a lack of consistency, predictability and transparency in the Food and Drug Administration review process is undermining patient care and our leadership position in medical devices.

Stearns and his subcommittee will be hearing from witnesses on Wednesday, including Dr. Jeffrey E. Shuren, a doctor and attorney who is the director of the Center for Devices and Radiological Health in the FDA; Michael Mandel of the Progressive Policy Institute; and Dr. Gregory Curfman, executive editor of the New England Journal of Medicine.