Institute of Medicine Calls for Overhaul of Device Regulation

July 31, 2011
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The Institute of Medicine committee that’s been reviewing medical device regulation for the past two years called recently for a sweeping overhaul of Food and Drug Administration rules that allow some implanted devices to enter the market without adequate safety and effectiveness testing. The process — known as 510(k) — provides for minimal testing of devices if they are deemed “substantially equivalent” to a device that is already on the market.

The Institute of Medicine committee that’s been reviewing medical device regulation for the past two years called recently for a sweeping overhaul of Food and Drug Administration rules that allow some implanted devices to enter the market without adequate safety and effectiveness testing. The process — known as 510(k) — provides for minimal testing of devices if they are deemed “substantially equivalent” to a device that is already on the market.

“Reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective,” the committee concluded. “The majority of the devices used as the basis for comparison were never reviewed for safety and effectiveness.”

As reported by the New York Times yesterday and independent journalist Allison Bass last February, the medical device industry has launched a major public relations offensive to cast doubt on the conclusions of the IOM report. They have also claimed members of the commtitee, most of whom are academicians without financial ties to the industry, are biased against the industry. Republicans on Capitol Hill have provided a venue for the attacks by holding hearings on how FDA regulations are holding back innovation in the industry. An editor at the New England Journal of Medicine testified at a recent hearing that the studies used to justify those claims would not pass peer review at his medical journal — in essence, dubbing them advocacy studies.

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The emphatic conclusions offered by the IOM report will put intense pressure on the FDA to follow through. It has been reconsidering its device regulation rules since it was revealed in 2008 that a small New Jersey-based device company had enlisted politicians to pressure the agency to approve a product under the 510(k) rules even though it represented a significant change in materials. Medicare subsequently decided not to pay for the device. The FDA has been awaiting the IOM report before making its next move.

With the Obama administration relaxing regulations to assauge business and the device industry on the warpath, FDA Commission Margaret Hamburg is clearly on the hot seat. Will she follow the advice of this prestigious scientific committee and move quickly to overhaul the rules? Or will she bury the FDA’s internal deliberations in a cloak of bureaucratic procedures that will postspone any decisions until after the next election? One thing is for certain, if she says that only Congress can change the rules under which the FDA operates, it’s the same as saying nothing will be done.

As they say, only time will tell.