In a time when ever-increasing numbers of Americans rely on medical devices, legislation currently before Congress could weaken the standards the Food and Drug Administration (FDA) uses to determine a device’s safety and efficacy.
The 21st Century Cures Act would allow devices to reach the market using case-study evidence rather than clinical trial results to demonstrate the device’s safety and effectiveness. Current approval process requires one clinical trial (new drugs, in contrast, usually require two trials). Writing in an op-ed piece in the New York Times, cardiologists Rita Redberg and Sanket S. Dhruva warn that medical devices, some of which are permanently implanted in the patient’s body, should have stricter approval requirements. Only a small minority of medical devices undergo randomized, controlled, blinded clinical studies—considered the gold standard in trials.
Redberg and Dhruva point out that many devices are found to be dangerous only after they are on the market. The doctors cite the example of the Sprint Fidelis defibrillator, which had been implanted in hundreds of thousands of heart patients before it was recalled in 2009. The defibrillator frequently malfunctioned, harming many patients and leading to a number of deaths, according to the Times.
If the 21st Century Cures Act becomes law, it would create a faster approval process for “breakthrough technologies” that are believed to offer significant advantages over existing devices. On the theory that the need outweighs the risk, a device could be approved based on even lower standards of evidence than those currently used. Redberg and Dhruva say manufacturers will use the legislation’s loose definition of “breakthrough” to speed device approval and “breakthrough” will become a marketing gimmick for manufacturers.
The authors say the law will shift the burden of evidence to clinical studies that are conducted only after a device has come to the market, though studies are often delayed months or even years after a device is approved. Many studies are never completed, the authors say, and the findings from completed studies are seldom publicly available, according to the Times. The standard for “timely postmarket data collection,” needs to be clearly defined and enforced. A 2014 article in JAMA Internal Medicine, of which Redberg was a co-author, reveals that the FDA has never issued a warning letter or penalty for a postmarket study delay.
Redberg and Dhruva say it is difficult to remove a device from the market even if a postmarket clinical study finds it dangerous. A clinical trial of the Wingspan intracranial stent completed in 2011 found that patients with the device were more likely to have another stroke and to die than patients who were under medical management. The FDA narrowed the recommended uses for the stent, but did not require it to be withdrawn. The device continues to implanted, “putting patients at unnecessary risk,” Redberg and Dhruva write.
The authors are also critical of a provision of the act that would establish a third-party program of nongovernmental authorities to assess whether changes could be made to already approved devices. The manufacturer could select the third party from an approved list, and pay for the assessment, thus creating “flagrant conflict of interest” that would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices, according to the Times op-ed. Redberg and Dhruva call for stricter evidence standards and increased federal funding of the FDA to ensure that innovative medical devices “lead to better health.”