GAO Testifed on Failings of FDA Medical Device Approval Program

Federal analysts testified this week that the FDA is failing to protect the public from defective medical devices by allowing them on the market with little testing through an industry-exploited fast-track approval program.

Marcia Crosse, from the health care division of the Government Accountability Office (GAO) testified before the U.S. Senate’s Special Committee on Aging on Wednesday about the FDA’s medical device approval process. In 2009, the GAO wrote a scathing report that determined that the FDA was unable to protect patients from bad medical devices. The GAO’s report to the Senate (pdf) said there has been little improvement.

The 2009 report came in the wake of a Supreme Court decision, Riegel vs. Medtronic, in which the court held that medical device lawsuits against manufacturers for injuries caused by defective products may be barred if the device was approved by the FDA.

Since then, the GAO reports that the FDA has made progress toward reforming its controversial 510(k) market approval process, but that progress has been limited and has had little effect on the quality of medical devices. The 510(k) approval process only requires that the device be “substantially equivalent” to an existing medical device, allowing the devices to go on the market without rigorous testing or review. But of the 27 types of medical devices the GAO said should be reviewed to determine if they should be barred from the 510(k) process, the FDA has only reviewed one.

According to the GAO report, there were 3,510 voluntary medical device recalls from 2005 through 2009, averaging more than 700 per year. A study published in February in the Archives of Internal Medicine found that 70% of all medical devices recalled since 2005 received 510(k) approval.    

William Maisel, deputy center director for Science and the chief scientist of the FDA’s Center for Devices and Radiological Health, testified on behalf of the agency. Maisel told the committee that there are a number of initiatives in the works at the FDA which will improve its approval process once they come to fruition. However, Maisel said the FDA needs more support from medical device manufacturers.

“Industry also shares a responsibility for the success of the review process and safety of medical devices,” Maisel said in his written testimony (pdf). “Data show that some companies submit poor quality applications, ask to meet with us but then ignore our feedback, or conduct poor quality clinical studies. This leads to unnecessary delays, wastes time and money for both industry and FDA, and exposes patients to unnecessary risks.”

Problems with the program have been brought to light via a string of recalls involving defective medical devices that sometimes crippled or killed the recipients.

Last year the FDA revealed that the inferior vena cava (IVC) filters, implanted to prevent a pulmonary embolism, was prone to fracturing in the body, sending debris into the heart, lungs and other organs.The Bard G2 IVC filter was approved under the controversial 510(k) premarket approval process after the FDA deemed them to be substantially equivalent to the Bard Recovery IVC filter, which had a 16% failure rate. However, the Bard Recovery IVC filter was also approved under the 510(k) process and the only clinical data submitted to FDA on the Bard Recovery filter was data supporting that it could be safely removed. The Bard G2 filter has since logged a 12% failure rate.

According to an alert issued by the FDA on August 9, the federal regulatory agency has received 921 reports of problems with IVC filters, with 328 of those cases involving an IVC filter that migrated through the body, 146 involved components breaking loose, 70 involved the IVC being perforated and 56 reports involved an IVC filter fracture.

Also approved through the 510(k) process, and recalled last year, are DePuy ASR metal hip implants. They will be a topic at today’s hearing. More than 90,000 DePuy ASR XL Acetabular Systems and DePuy ASR Hip Resurfacing Systems were sold before a DePuy ASR hip recall was announced. The manufacturers have acknowledged that data so far has shown that about 12% to 13% of these hips will fail within five years. However, as individuals with one of the recalled hip replacements continue to be monitored by their doctors, it is expected that the rate of DePuy ASR hip replacement problems will ultimately be much higher.

Last year also saw the FDA rescind approval of the Menaflex Collagen Scaffold knee replacement because the device was improperly pushed through the program before it could truly be determined to be safe for consumers.

The GAO is far from the only critic of the fast-track approval program. Another report, published in November in the British Medical Journal, lambasted the FDA over allowing some devices which may be deadly to stay on the market after having gone through the process with little oversight.