After the release of the Institute of Medicine report this morning, we now know why FDA officials have spent the last few weeks putting some distance between the agency and the findings of the report; they just can’t afford to fight a losing battle right now.
As part of eight recommendations it made to the agency, the IOM called for the FDA to scrap the program by which the lion’s share of medical devices are cleared for market.
The recommendation to ditch the 510(k) program is a dilly of a pickle for the agency, which is facing a multi-pronged and sustained attack from industry and GOP congressional leaders to improve decision times on 510(k) program as part of any plan to renew medical device user fees. Telling congress now that they want to spike the program and start anew is as unlikely as a Obama/Boehner family fishing trip.
The agency, which by its own admission is struggling to fulfill its mandate in light of high turnover and rapidly increasing workloads at the Center for Devices & Radiological Health, desperately needs to hike user fees in order to meet its mandate; adding this new wrinkle would be a non-starter on Capitol Hill, where leaders are already viewing any movement by the agency through the lens of user fee negotiations.
“I am reviewing the IOM recommendations in the context of MDUFMA reauthorization, with a critical eye on how these recommendations could further add to the uncertainty in the FDA regulatory process for the medical device industry,” Sen. Scott Brown (R-MA) wrote in a statement to MassDevice. “I will continue to closely follow and monitor these discussions, and listen to the device industry in Massachusetts about the proposed changes to the 510k process.”
The FDA knows the political climate in Washington all too well; agency leaders have made repeated trips to Capitol Hill to testify before congressional panels that have amounted to little more than partisan squabbling, including a Senate hearing yesterday where Sen. Richard Burr (R-N.C.) all but promised FDA commissioner Margaret Hamburg that he would block approval of any new user fees that didn’t include some sort of promise of to improve decision times on the 510(k) program.
“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.'”
Perhaps that’s why the FDA spent the last few months trying to quell fears in a series of public statements that the FDA would follow suit with any calls for sweeping changes and that the FDA will follow suit.
Agency officials said earlier this month that it 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.
Officials kept that posture this morning when it the agency told the IOM that it politely disagreed with its findings about the 510(k) program.
“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Shuren said in a prepared release.
There’s no doubt the FDA will make good on holding public meetings on the subject, it’s highly unlikely that the industry will ever see anything like the kind of changes being proposed by the IOM in this political climate.