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Doctors Warn that Legislation Before Congress Would Weaken Testing and Regulation of Medical Devices

Jul 23, 2015

In an op-ed piece this week in the New York Times, two prominent cardiologists warn that legislation currently before Congress could dangerously weaken the standards the Food and Drug Administration (FDA) uses to determine the safety and efficacy of medical devices.

The FDA has regulated medical device approval since 1976, and the approval process usually requires one clinical trial to demonstrate safety and effectives (new drugs, in comparison, normally require two trials). The 21st Century Cures Act would allow approval based on case-study evidence reports from doctors. In their op-ed piece in the Times, Drs. 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 than anecdotal reports. Currently, only a small minority of medical devices ever undergo randomized, controlled, blinded clinical studies, the gold standard in trials.

Many devices are found to be dangerous only after they are on the market. Redberg and Dhruva 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.

Even when a postmarket clinical study finds a device dangerous, Redberg and Dhruva say it can prove difficult to remove the device from the market. For example, a 2011 clinical trial of the Wingspan intracranial stent, found that patients implanted with the device were more likely to have another stroke and to die than patients who were under medical management. Though FDA narrowed the recommended uses for the Wingspan stent, the agency did not require the device to be withdrawn. The stent continues to implanted, "putting patients at unnecessary risk," Redberg and Dhruva write.

The authors criticize a provision of the act that would establish a 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 trust the safety or effectiveness of updated medical devices, according to the Times op-ed. Redberg and Dhruva say stricter evidence standards are needed along with increased federal funding for the FDA to ensure that innovative medical devices actually "lead to better health."

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