The government should abandon a 35-year-old system for approving most medical devices in the U.S. because it offers little to no assurance of safety for patients, a panel of medical experts concludes in a report Friday.
The surprise recommendation from the Institute of Medicine panel calls for a massive reworking of how the government regulates medical devices, a $350 billion industry that encompasses everything from pacemakers to X-ray scanners to contact lenses.
The 12-member group's advice, commissioned by the Food and Drug Administration, is not binding. And there were immediate signs that the report would face tough headwinds in Washington, as both the FDA and device manufacturers disagreed with its conclusions.
Still, the stinging critique could eventually bring about tighter standards for medical device companies, which have long benefited from less safety scrutiny than their peers in the drug industry.
FDA requires that most new prescription drugs go through clinical trials to prove that patients fare better after receiving medication. Most devices only have to show that they are similar to devices already on the market. Only a handful of truly new devices must undergo extensive testing to prove they are safe and effective.
The FDA said Friday that it disagreed with the group's recommendations, but would hold a public meeting to discuss them. The FDA has been working for more than a year to make the 510(k) process more predictable and less bureaucratic, 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 FDA's device director Jeffrey Shuren, in a statement.
Manufacturers say some devices get tied up in red tape
The report arrives as the FDA fends off pointed 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. In the past year, companies have taken their arguments to Capitol Hill, where lawmakers have grilled FDA officials over device reviews.
The device industry's chief lobbying group immediately dismissed the proposal.
"The report's conclusions do not deserve serious consideration from the Congress or the Administration," said Stephen Ubl, president of the Advanced Medical Technology Association. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure."
Latham & Watkins attorney John Manthei, who represents device manufacturers, said it would be a mistake to pronounce the report "dead on arrival." Even if the FDA doesn't adopt its recommendations, he said members of Congress will likely use the findings to pressure both companies and the FDA.
"For those who feel like the 510(k) process is inadequate, this report definitely gives those folks ammunition," said Manthei.
In an email, Health Canada spokesperson Leslie Meerburg said her department revised its regulations for medical devices in 1998.
"This revision brought Canada's framework in line with those of its major trading partners (Europe, Japan, Australia)," she wrote.
But Toronto-based class-action lawyer Harvin Pitch said he expects Health Canada officials will be taking a close look at the report's findings.
"They'll have to ask themselves the question of whether they should be doing more," said Pitch, who works for Stevensons LLP and represents about 60 Canadians who had a metal-on-metal DePuy hip transplant before the device was recalled in 2010.
Pitch said some of his clients have had their hip replacements removed, requiring several months of recovery and the prospect of a new device being implanted. Others have opted to keep them in place and have them monitored.
"It's horrible to have something in your body that was recalled. It's scary," he said. "These people have suffered and should be compensated."
Hilary Berthelet, a 54-year-old Ottawa woman who is part of the class action suit, said she's pleased the panel advising the FDA says safety data is necessary for medical devices such as her hip replacement.
She has not had hers removed, but worries about the high levels of metals in her blood that she says are due to her artificial hip.
"Every time when my blood (work) is done, the blood level for metals are higher we don't know whether it will level off," said Berthelet.
The Institute of Medicine panelists, mostly doctors and researchers, appear to have overwhelmingly sided with public safety advocates who have argued for years that devices used to treat and detect illnesses must undergo real testing.
The FDA sought the group's advice as it updates the system used to clear more than 90 per cent of devices in the U.S. The so-called 510(k) system was created by Congress in 1976 to grant speedy approval to devices that are similar to products already on the market.
The pathway was originally intended as a temporary method to grandfather in devices that had been used for decades. Instead it has become the standard tool to launch new medical implants.
Panel recommends tracking device failure rates
The IOM generally recommends ways to improve or modify government programs, but instead the panel said the 510(k) system is "flawed" and should be eliminated completely.
"A system was put in place 35 years ago that does not really assess safety and effectiveness," said panel chair David Challoner, former vice president of health affairs at University of Florida. "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 group stressed that medical devices cleared through the pathway are not inherently unsafe — most probably are safe — but the approval system itself provides little assurance to doctors and patients.
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. Hip replacements, CT scanners and drug pumps are among the devices cleared by 510(k).
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.
"Originally there was this idea that the 510k would wither away and over time more and more new devices would go through the more onerous path. But instead there are more devices cleared this way than ever," Dr. Diana Zuckerman, director of the nonprofit National Research Center for Women & Families, said in an interview Thursday.
Earlier this month Zuckerman and other 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 per cent 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.
The IOM is a nonpolitical group of experts that advises the federal government on medical issues.
For months, medical device lobbyists and executives have downplayed the legitimacy of the IOM panel, pointing out that none of them have experience working in the device sector.
Dr. Jeffrey Lerner, who has studied medical technology for over 25 years, said device makers are still coming to grips with a new regulatory environment that demands greater safety — often at the expense of profits.
"The bottom line is that everybody has got to make adjustments in an era in which technology is changing and public expectations are changing," said Lerner, who is president of the Emergency Care Research Institute.