Lawmakers Try to Close FDA Loopholes

A quartet of legislators has introduced a measure to give the U.S. Food and Drug Administration more authority in the medical device approval process to keep potentially harmful products from coming to market. The Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act) would allow the FDA to reject a manufacturer’s application for a new medical device based on the approval for a similar product already in the marketplace – if that device has been subject to a safety recall.

The bill was submitted by Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.), all of whom serve on the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations. The fourth sponsor, Rep. Rosa DeLauro (D-Conn.), is a member the appropriations committee’s Subcommittee on Agriculture, Rural Development, the FDA and related agencies.

The legislation is in response to the recent recalls, civil lawsuits and warnings about defective medical devices, like metal-on-metal hip implant devices and synthetic surgical mesh products. To date, two metal-on-metal total hip replacements and one metal-on-metal hip resurfacing system have been recalled in the U.S. in 2008 and 2010 because they had a high rate of replacement in patients.  New research being presented today at the American Academy of Orthopaedic Surgeons annual meeting in San Francisco shows that these faulty hip joints pose adverse health effects for some patients even after they are removed.