New Legislation Weakens FDA Regulation of Medical Devices, Presents Greater Risks to Patients

Last week, the House of Representatives passed legislation that would dampen the U.S. Food and Drug Administration’s (FDA’s) regulatory authority over medical devices. The legislation, entitled the 21st Century Cures Act, would lower the standard for manufacturers attempting to show that their high-risk devices are safe and effective. The proposed law also seeks to create an expedited approval process for “breakthrough technologies”.

In an opinion piece published in The New York Times, two respected cardiologists raise concerns that new legislation will give device makers the opportunity to take advantage of loosened regulations and ultimately present risks to patients. The authors of the article are Rita F. Redburg, a cardiologist at the University of California, San Francisco Medical Center, and Sanket S. Druva, a cardiologist and clinical scholar at Yale University. They emphasize that the FDA has issues regulating medical devices as is, and the legislation will only worsen the situation.

The FDA was tasked with regulating medical devices in 1976, but the article points out that “oversight has not kept pace with the increasing complexity of this technology”. In many cases, high-risk devices make it onto the market with only one clinical trial to demonstrate its safety and efficacy. Furthermore, most of these trials do not meet the gold standard of randomized, controlled and blinded studies. With new drugs, these standards are usually applied and two trials are typically required. Dr. Redberg and Dr. Dhruva assert that because of these lax standards, the dangers of many devices were only discovered after they were approved and implanted in patients. They also state that many defects are likely to go undetected because the FDA’s postmarket authority is also weak.

Now, the 21st Century Cures Act seeks to give manufacturers the ability to use anecdotal evidence and other non-clinical trial data to gain approval for their devices. Additionally, the proposed law would implement an expedited process for supposedly innovative products that are believed to offer greater benefits compared to what is currently available. The NYT op-ed points out that this route would give manufacturers incentive to take advantage, since “breakthrough” is loosely defined. The authors state that “The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions.”

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