FDA just can't catch a break. Often criticized by medical device manufacturers for overly burdensome regulations that delay innovative medical technologies from coming to market in a timely manner, it is also routinely taken to task by other stakeholders for being too lax in its regulatory oversight. Two cardiologists have expressed the latter view in a strident op-ed piece in the New York Times, which calls on the Senate to oppose the 21st Century Cures Act. The bill passed the House with rare across-the-aisle support in a 344-77 vote on July 10 and is now with the Senate.
"The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices," write Rita F. Redberg, a cardiologist at the University of California, San Francisco, Medical Center, and Sanket S. Dhruva, a cardiologist and clinical scholar at Yale University. "Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective," they add.
The 21st Century Cures Act includes a number of provisions designed to accelerate the passage of medtech innovation to patients and make the drug approval process less burdensome. It also would provide the National Institutes of Health with an additional $8.75 billion in funding. Medical manufacturing association AdvaMed, which supports the bill, says it will improve "FDA's premarket program for medical devices—most significantly, the establishment of an expedited pathway for breakthrough, innovative technologies." And that is precisely one of the clauses Redberg and Dhruva object to.
"This act would create a new, faster approval process for 'breakthrough technologies' that are believed—but not necessarily proved—to offer significant advantages over existing alternatives," write Redberg and Dhruva. "This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines 'breakthrough' loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick," they add.
The cardiologists note that many high-risk medical devices, unlike drugs, are approved on the basis of just one clinical trial, and that they are rarely randomized, controlled and blinded. They wisely ignore addressing the practicalities of doing such studies with high-risk, i.e. implantable, devices, which is quite a different undertaking than a clinical trial involving drugs.
They also object to a provision that would allow a third party to review minor changes made to an existing device and ensure that these revisions do not affect the safety and efficacy of the device. "The act would enable the device manufacturer itself to select—and pay—the third party from an approved list," write Redberg and Dhruva, who consider this to be a "flagrant conflict of interest." This is not uncharted territory, however. Europe has been using a similar third party arrangement, called notified bodies, for decades. While a handful of incidents have been reported, they are typically a result of incompetence, rather than cronyism.
The fact of the matter is that technology is far outpacing the ability of regulators to approve devices in a timely manner. One hears this a lot from the digital health and tech communities, who routinely bemoan the glacial pace of FDA. 3D printing also is a prime example of a technology with tremendous potential, where FDA and other regulatory bodies are desperately playing catch up. It's not the fault of regulators necessarily, who have a profoundly important job to do—protecting patient safety—while maintaining a reasonable pathway for innovative technology to reach the marketplace.
As it stands, many medical device OEMs have adopted a Europe-first strategy, where a "light-touch" regulatory approach makes it significantly faster to get market clearance. There have been some missteps and one outright scandal overseas, notably the French-made breast implants that contained non-medical-grade silicone, and the European Commission is currently finalizing a new set of regulations that will strengthen oversight without blocking the innovation pipeline.
While it may not be perfect, the 21st Century Cures Act moves in the right direction. Redberg and Dhruva have some valid concerns, as do other stakeholders, but the good—accelerating patient access to lifesaving medical technologies—outweighs the bad.
We agree with Katie Couric, Mark McClellan of the Brookings Institution and Ellen Sigal, Chairperson and founder of Friends of Cancer Research, who wrote a blog post urging Congress to pass the act in the Huffington Post. "The approaches embodied in the 21st Century Cures Act are thoughtful and broad-based efforts to continue . . . strengthening the evidence and science used to develop and regulate medical products," they wrote on July 8. "The technology and scientific knowledge to support them didn't exist before. They do today, and we need to take advantage of them."