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510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release

July 28, 2011 by MassDevice staff  Source: click here

FDA commissioner Margaret Hamburg reiterates at Senate panel on medical device user fees that the upcoming Institute of Medicine report on the 510(k) program provides recommendations only, not policy.

Margaret Hamburg

Officials at the U.S. Food & Drug Administration continue to try and put some distance between the agency and how an upcoming Institute of Medicine report on the agency’s 510(k) premarket review program will affect policy regarding the way a majority of medical devices come to market in the U.S.

FDA commissioner Dr. Margaret Hamburg told a Senate committee today that the institute’s report, due out tomorrow, will provide guidance only and should not be seen as a blueprint for future changes to the program.

“We review their recommendations as just that, recommendations. We will review them internally and get feedback from key stakeholders [before making any changes],” Hamburg told the U.S. Senate’s Committee on Health, Education, Labor and Pension (HELP) hearing on the reauthorization of the Medical Device User Fee Act.

Read more of our comprehensive coverage of changes being made to the 510(k) program

Hamburg said she had not read the report, which is still under embargo until Friday, but acknowledged that there was concern within industry circles that the IOM’s panel did not include representatives from the medical device industry.

The IOM was tasked by the FDA to do a soup-to-nuts review of the progra

m in late 2009 and many in the industry are fearful that the institute will call for sweeping changes and that the FDA will follow suit.

However, the FDA has tried to quell those fears in a series of public statements on the IOM’s report. Agency officials said earlier this month that the FDA was “not bound” by the IOM’s recommendations, and that it “will consider them and make its own decisions,” according to minutes of a June 17 meeting between medical device industry and agency officials.

The committee hearing, which was convened to discuss reauthorization of the medical device user fee act, was mostly cordial with the exception of three tough exchanges between Hamburg and Sen. Richard Burr (R-N.C.), who continually challenged Hamburg that the FDA was acting outside of its governing statutes in both removing language about acting in a “least burdensome” process without seeking approval from lawmakers and moving the goal posts on safety requirements for the 510(k) program.

Hamburg countered that the agency wasn’t changing the way it reviewed devices and was working to create a system that was “as consistent and transparent as possible.”

Burr also took aim at the agency’s use of “FDA days” rather than calender days, asking Hamburg if she would be in favor of changing the measurement to create a better understanding of how long it takes to get therapies to market. When Hamburg began to answer that the FDA shouldn’t be held accountable for delays caused by industry, Burr cut her off.

“My attempt is that policy makers understand how damn long it takes to approve something,” he said. “I know you like that measurement but in defense of my colleagues we all know what calender days are; so do the American people.”

He added a warning to the FDA that if they didn’t come up with some measurement tools to determine whether a fee system would create better outcome then he was prepared to stand in the way of MDUFMA’s passage.

“No matter what you negotiate with industry it has to pass through Congress,”Burr said. “If there’s not something that meets, to my satisfaction, the ability to measure goals this will be a very slow and laborious process. I’m bewildered industry has even been willing to talk given what they’ve gotten for the money this far. It’s disturbing when the answer is ‘provide us more money and we’ll do a good job.'”