A conservative think tank is taking aim at the FDA’s program for reviewing medical devices, accusing the federal watchdog agency and public safety advocates of smothering new medical technology.
The Competitive Enterprise Institute report, "Stifling Medical Device Innovation: A Response to Critics of the FDA’s 510(k) Clearance Process," was written by Larry Pilot, a lawyer and pharmacist who helped pioneer the FDA’s Office of Medical Devices in the late 1960s and early ’70s.
Pilot calls for stricter oversight of the FDA and its Center for Devices & Radiological Health, arguing that critics of the 510(k) program don’t understand its purpose. Furthermore, he writes, the FDA is too liberal in exercising its authority to require clinical trials.
"[T]he 510(k) review was designed to ensure that new products were assigned to the correct class. It was not intended to establish an independent safety or efficacy review process akin to premarket approval because the regulatory controls associated with the classification system itself are sufficient to provide a reasonable assurance of safety and effectiveness," Pilot writes (PDF). "During the past 20 years, the FDA has become more aggressive in using this authority, and it has required more and more devices to go through the full PMA process. This has drawn out both 510(k) and PMA review times and has created an atmosphere of unpredictability and uncertainty about what will be necessary to get products to market. Yet, critics have increasingly called for even more legislative and regulatory burdens."
Citing statistics detailing medical device recalls between 2005 and 2009, Pilot writes that 96 percent involved "little or no risk of harm to patients."
"Only 131 recalls were considered ‘high-risk.’ Yet even among these, more than half involved infractions such as labeling errors, inadequate instructions, or manufacturing glitches that could not have been prevented by a more thorough FDA review," he writes. "Roughly 87 percent of those high-risk recalls were of devices cleared through the 510(k) process. But the FDA cleared approximately 18,500 devices through the 510(k) process during the five-year study period, and approved just 150 through the PMA process. That means that fully approved devices were more than 30 times more likely to be recalled."
High-profile instances of improper clearances of devices that should have gone through the more rigorous PMA process have driven the agency to " yet another form of FDA mismanagement."
"Over the past decade, the FDA’s response to the increased public scrutiny over such mishaps has been to add new and more burdensome laboratory and clinical data requirements, and to repeatedly request additional information from manufacturers during the 510(k) review," according to Pilot.
Pilot is equally dismissive of the Institute of Medicine’s recommendation that the 510(k) program be scrapped.
"Strangely, the IOM report, published in July 2011, acknowledges that its committee found no reason to believe that any devices on the market are unsafe or ineffective, but it still concluded that the 510(k) process should be scrapped," he writes. "Rather than scrapping the entire process, a more effective approach to protecting consumers and promoting innovation is for Congress to engage in more vigorous oversight and investigation of the FDA’s performance."