NYT to FDA: Abolish 510(k), Fix other Device Loopholes
The New York Times editorial board is urging FDA to abolish the 510(k) medical device clearance process and fix other device regulatory loopholes amid growing reports of devices that were allowed on the market for decades without proper vetting. Just last month, FDA decided that surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse have not demonstrated a reasonable assurance of safety and effectiveness (see earlier story).
“It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy,” writes the board in a 5/4 article. “But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact... When trouble does arise, device makers often equivocate, regulators dither and patients seeking redress are forced into lengthy and expensive court battles. In the end, faulty products can remain on the market for years.”
Last week, FDA declined to order textured breast implants off the market, and instead it announced several steps to improve communication on the risks of breast implants and focus on evidence generation. “Like mesh, the breast implant was approved years back, based on meager safety evidence,” the editorial board says. “Regulators now say there is not enough proof of harm to justify reversing that decision.” To further illustrate needed change to the device clearance/approval process, the board points to Bayer’s controversial birth control implant Essure and other high-risk devices removed from the market by manufacturers and not by the regulators after safety concerns affected sales.
“In operating rooms,” the editorial board writes, “there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients. In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.”
Faced with growing outcries from patient advocates, the media, and Capitol Hill, among others, FDA has promised to make “transformative” changes to medical device regulation, the board notes. “But so far, the agency’s suggestions have been meager at best. And in the meantime, regulators have accelerated the device approval process, not slowed it down.”
The board recommends some “reasonable changes” to greatly improve the current system, like abolishing the 510(k) program, which the Institute of Medicine recommended in 2011, a recommendation FDA dismissed. They also suggest improving post-market surveillance, and building a medical device registry “where patient outcomes for all medical devices are openly monitored, and where doctors and patients can log concerns and obtain information.”
And, the board says FDA has to take a step back and stop being too close to industry. User fees inherently push regulators and industry into cozy relationships, it says. “The medical device industry funds 35% of the office’s work, and by law, that funding is contingent upon the agency’s approving devices quickly, and through the least restrictive pathway possible,” the board writes. “Medical institutions and professional societies should establish, or amplify, guidelines discouraging such payments. Stronger laws that provide more funding for the work of device regulation — so that the FDA is not as reliant on industry dollars — would also help the agency to fulfill its mission.”