Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients. Even more surprising, FDA summarily dismissed the idea.
The Institute of Medicine's panel said in a report that the U.S. government should abandon the 35-year-old system used to clear medical devices because it provides little assurance that the implants are actually safe.
The 12-member group's advice, commissioned by the Food and Drug Administration, is not binding. And experts questioned its real-world impact after the FDA immediately distanced itself from the advice it had requested.
The FDA has been working for more than a year to improve the so-called 510(k) process, efforts that would go to waste if the system is abandoned.
"FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches," said the agency's device director Jeffrey Shuren, in a statement. The FDA said it would convene a public meeting on the report.
The agency requires that most new prescription drugs go through clinical trials to prove that patients fare better after receiving medication. But through the 510(k) system, medical devices just have to show that they are similar to devices already on the market. Only a handful of truly new devices undergo extensive testing to prove they are safe and effective.
The device industry's chief lobbying group also dismissed the proposal, saying its conclusions "do not deserve serious consideration from the Congress or the administration," in a statement.
The IOM panel's chairman took the tough reception in stride at a news conference Friday, saying it would take time to develop a new system to replace the one that has been in place for over three decades.
"This is a public discussion and it's going to take time," said panel chair David Challoner, former vice president of health affairs at University of Florida. "The 510(k) process needs to be modified to make it as good as possible in the interim, but there is logic there that is fundamentally flawed and must to be fixed."
The report arrives as the FDA fends off criticism from manufacturers who say the agency has become too slow and bureaucratic in clearing new devices, driving up costs for companies and forcing some out of business. Despite the relative speed of the 510(k) process, they point out that some devices still get tied up in red tape, ultimately reaching the U.S. market two years after launching overseas.
Latham & Watkins attorney John Manthei, who represents device manufacturers, said that even if the FDA doesn't adopt the recommendations, they could help lawmakers and FDA critics who favor tougher regulation of devices.
"For those who feel like the 510(k) process is inadequate, this report definitely gives those folks ammunition," said Manthei.
The 510(k) system was originally created by Congress in 1976 to "grandfather in" devices that had been used for decades but never formally reviewed by the FDA. Instead of being phased out over time, it became the standard tool to launch new implants.
"A system was put in place 35 years ago that does not really assess safety and effectiveness," said Challoner. "We need something different for the next 35 years. We're dealing with a whole new world: new technology, new materials and new data."
Challoner and the other panelists recommend the FDA develop a new system based on safety metrics and tracking device failure rates in the real world. He said better tracking of device complications could take the place of premarket testing, which would be unfeasible for all new devices.
The IOM is a nonpolitical group of experts that advises the federal government on medical issues.
The 510(k) system is popular among manufacturers because it is a faster path to market than the review process for first-of-a-kind devices, which must undergo rigorous medical testing.
But as generations of devices have been cleared year after year, FDA critics say dangerous devices have slipped through because they vaguely resemble products approved decades ago.
Earlier this month safety advocates seized on new reports of painful complications with pelvic surgical mesh as the latest example of the shortcomings of the abbreviated review system. Reports of pain, bleeding and infection are up 500 percent since 2008 among women who've had surgery to support the pelvic wall. The FDA cleared the device for that use in 2002 via 510(k).
About 4,000 devices are cleared every year under the 510(k) system, while just 50 devices are approved under the more stringent system that requires human testing. It costs the FDA roughly $800,000 per device when utilizing the more rigorous system.
Maria Hougas of Towanda, Ill., said Friday she wished she'd known about the shortcomings of FDA device approvals before she received a DePuy hip implant in 2007. She underwent four surgeries to treat pain, scar tissue and fluid before having it removed two years later. Hougas recently learned she needs a replacement for the other hip.
"I'm not going to get it replaced until the pain is so severe that I can't stand it anymore," she said in an interview. "I'm just very leery after everything I've gone through with the other one."