Report calls for blowing up key path for product approvals.
The prestigious scientific panel was supposed to fix flawed medical-device regulations. Instead, the Institute of Medicine experts recommended an unrealistic and unnecessarily harsh prescription: blowing up the current route to market for many moderate-risk products.
The stunning recommendation is nonbinding but could not be more ill-timed. Economic storm clouds are gathering again.
Instead of reducing the uncertainties faced by an industry providing well-paying jobs in Minnesota and across the nation, the panel amplified the unknowns with its call to scrap the decades-old 51-(k) clearance process and start over.
The process, concluded a panel of mostly academic experts, "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and ... cannot be transformed into one.''
So much for enticing already scarce venture-capitalist dollars back to this industry. Or stemming the tide of research and development jobs moving offshore -- something documented by a PricewaterhouseCoopers report earlier this year.
The panel's work also did nothing to enhance patient safety -- the most important concern of all. The U.S. Food and Drug Administration (FDA) began weighing changes to the process in part because of a small but highly publicized number of medical-device recalls.
Industry also has long been frustrated with the unpredictability of the process, its expense and lack of transparency.
Congress, given its political divisions and budget challenges, is unlikely to prioritize or agree on a device regulation overhaul. The FDA, which asked the IOM to help strike the best balance between patient safety and industry concerns, is on its own again after waiting nearly two years for clarity.
Good sense fortunately prevailed at the FDA after the report's release. That same day, the agency issued a statement saying the 510(k) process "should not be eliminated.''
The IOM remains one of the most respected organizations in the scientific world. But this panel bizarrely not only failed to answer some of the FDA's specific questions about process improvements, it didn't even outline what the replacement process would be.
The 510(k) pathway is designed for medical devices similar to existing ones and is thought to be the more expedient route to market. Among 510(k) products: angioplasty catheters and hospital pumps.
The scrap-the-system proposal certainly is an industry rebuke. Device manufacturers have done themselves no favors with questionable consulting payments to doctors. Industry advocates also sometimes seem opposed to all regulation.
But at a minimum, the IOM panel should have made a safety-based case for such a radical change. It did not, admitting that continued use of these devices provides reason for "a level of confidence in their safety and effectiveness.''
Recall data provided by University of Minnesota Law School Professor Ralph Hall underscores that. Just 0.45 percent of 510(k) clearances from 2005-2009 were subject to Class I recalls, the FDA's most serious recall category.
That drops to 0.22 percent when premarket issues only are considered. (Postmarket issues, such as manufacturing defects, likely wouldn't have been prevented by scrutiny before the device's sale.)
Perhaps a new system would improve upon this. But would the marginal gains justify the time and expense involved?
Not answering this fundamental question suggests the IOM panel chose idealism over pragmatism. The FDA and industry at least seem to agree on that. Leadership on both sides must now leverage this new common ground to find the best way forward.
* * *