Manufacturers of pacemakers, drug pumps and other implants could be the latest industry due for a safety overhaul, as the Food and Drug Administration takes a second look at how many devices are approved.
Government regulators spent much of the last decade revamping their oversight of pharmaceuticals, following safety recalls of several best-selling drugs.
But medical device makers like Medtronic and Boston Scientific attracted less scrutiny from Congress, despite recalls of their heart-pacing devices. Lawmakers focused most of their attention on preventing another Vioxx, the blockbuster painkiller recalled in 2004 due to heart risks, five years after the FDA said it was safe and effective,
But as Obama-appointed FDA leaders try to bolster the agency's safety record, they appear ready to raise the bar for devices — a move analysts say could mean more time and money for companies looking to market everything from heart valves to hip replacements.
The FDA will hear from manufacturers, physicians and consumer advocates at an all-day, public meeting Thursday.
At the center of discussion will be a nearly 35-year-old system the FDA uses to grant speedy approval to devices that are deemed similar to products already on the market.
The so-called 510(k) system is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing.
About 3,500 devices are cleared every year under the 510(k) system. Meanwhile, about 50 devices are approved each year under the more stringent system.
But the process has drawn scrutiny from the Government Accountability Office, which last year identified 20 types of high-risk devices that slipped through FDA under the less stringent approval process. High-risk devices tend to be ones that are implanted in the body or that are life-sustaining, such as drug pumps.
Lawmakers, consumer advocates and even former FDA staff say such devices were not meant to be approved under the same system used for things like tongue depressors and wheel chairs.
They also say device makers have used 510(k) to get around clinical testing by comparing their products to devices already on the market, even when the similarities were minuscule.
Dr. Larry Kessler, who spent 13 years at FDA's device center, says the problem does not constitute a crisis, "but there are reasons to take a hard look at the 510(k) process."
"The device world codified by the Medical Device Amendments of 1976 is dramatically different than where are today 35 years later," said Kessler. "The pace of innovation has really ramped up and the 510(k) process has been used, and in some cases people would say misused, to clear very advanced technology."
Kessler joined the faculty of the University of Washington last year, after serving as director of science and engineering for FDA's device center.
The device lobbying group AdvaMed says the 510(k) process works well for the vast majority of devices.
"It's an appropriate pathway to market for devices whose risks are well known," said Janet Trunzo, the group's executive vice president for technology. While the group doesn't see the need for an overhaul, it has proposed improvements to the program, including more detailed safety standards for certain devices with moderate risks.
The FDA has formed an internal panel to review and improve the medical device approval process. But with no major controversy to drive reform — as Vioxx did with drug safety — it could be years before any major changes are put in place. Last year the FDA asked the Institute of Medicine to weigh in on the issue of device approvals — a common prerequisite to drafting new regulations. Its report isn't expected until March 2011.
The nonpartisan institute advises the federal government on medical issues.
While the details of reform are still unclear, Wall Street expects them to take a toll on company balance sheets.
Wells Fargo analyst Larry Biegelsen predicts companies will have to submit more data to win approval — requiring larger research and development budgets.
"Increased complexity of submissions and heightened expectations around submitted clinical data could increase the time required to prepare, discuss and review submissions," Biegelsen stated in a recent investment note.
Smaller manufacturers of orthopedic implants like Wright Medical and Orthofix International could be the most challenged by new regulation, according to Biegelsen.
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