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.

In addition, the FDA has issued warnings about so-called bladder slings, surgical mesh products used to repair organ tears. In 2008, the FDA alerted the public that in the previous three years, it had received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with the devices. In 2011 it updated the warning, to notify patients that such complications were not rare. Almost every synthetic mesh device on the market today won its approval based on the ProteGen mesh, manufactured by Boston Scientific, even though it was recalled in 1999.

The vast majority of medical devices are approved for sale in the U.S. based on a manufacturer’s claim that the new product is “substantially similar” to an already approved device. Although medical devices have been regulated by the FDA since 1976, rules designed to streamline the approval process, called Pre-Market Notification or 510k, have allowed designs and materials combinations to enter the marketplace with no clinical testing or proof of efficacy.

Under Pre-Market Notification or 510k, new medical devices that were “substantially equivalent” to devices – called “predicates” – could be approved if the predicate was already on the market by 1976. Many new versions of older Class III devices, the most invasive and life-supportive devices, such as hip implants, were grandfathered by the Medical Device Amendments, and are regulated under the 510k process until the FDA can provide complete a more rigorous scientific review, called a Pre-Market Approval (PMA). In 2002, the aggressive deregulation of the George W. Bush presidency resulted in a further loosening of the 510k process. The FDA was directed to take “the least burdensome approach to medical device regulation,” and the definition of “substantially equivalent” now included products made using different materials and mechanics than the predicate device. Predicates no longer had to be in the marketplace in 1976; any device already cleared – either by 510k or PMA – applied. In result, 510k became the de facto route to FDA approval, with 99 percent of all devices approved under this scheme. The regulations now allowed patients to be exposed to devices that had never been subjected to clinical trials, testing or any standards.

The FDA gives wide latitude to what may be considered substantially equivalent. A medical device manufacturer could submit a 510k if the device has a different intended use than the predicate. It can seek approval under 510k “if there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.”

Many clinicians, public health advocates have been highly critical of the 510k process, and have documented the increased risk of patient harm created by the release of problematic health devices.

The SOUND Devices Act would give the FDA the authority to review and reject a 510K based on a predicate that has been recalled or is being removed from the market for safety reasons. It would requires companies to inform FDA if any of the new device’s past predicates have caused serious harm and to explain how the new device would not cause the same harm. Under this provision, the FDA would have to maintain a publicly accessibly database so that companies can determine if a device can be used as a predicate. Finally, the SOUND Devices Act would strengthen recall reporting requirements.

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