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.