FDA officials should prepare themselves for more appearances — and a less welcoming audience — on Capitol Hill in the coming months as its record on approval times for medical devices comes under close scrutiny.
Medical Device Manufacturing Assn. president Mark Leahey guaranteed more hearings before Congress over the way the Food & Drug Administration approves medical devices. Agency officials were grilled before a House health subcommittee over approval times last month.
“If you’re here for a message of peace, tranquility and all is well, then I’m not the speaker for you,” Leahey told the audience at the Merrimack Valley Venture Forum in Tewksbury, Mass., March 2.
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Citing a laundry list of items that will likely require more testimony on the Hill, including new Republican control of the House and the foofaraw over the 510(k) program, Leahey said the lynch-pin will be the impending re-authorization of the Medical Device User Fee and Modernization Act.
“MDUFMA will be the train that everything will be attached to, ” he said. “Our position is clear: Without improvements in performance, industry would be hard-pressed to approve more fees.”
The business association, which represents more than 200 small to mid-sized medical device manufacturers, is currently at the “negotiating table” with other players over the user fee issue, Leahey added.
He also took a hard-line stance on the 510(k) reform issue, saying that problems with the program have been overstated in the media, with some outlets echoing allegations made by a “vocal minority of disgruntled ex-FDA staffers” who called the program unsafe in an open letter during the fall of 2009. Leahey rejected their stance and said the FDA has over-reacted.
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“It’s no longer about looking for reasonable safety and effectiveness. They’re looking for absolute safety and effectiveness,” Leahey said. “Eighteen months ago, the reviewers were told the system was broken and then management isn’t telling them to proceed.”
And industry should feel no comfort in the fact that the FDA didn’t institute several of the proposed changes it wanted to make to the 510(k) program last January, he said.
“I’m concerned that FDA deferred seven of the 10 recommendations to the IOM,” Leahey said, pointing out that the committee investigating the program for the IOM is short on medical device experience.
Other experts agreed with Leahey that more congressional action is in the works. Casper Uldriks, a former legislative affairs official at the FDA’s Center for Devices & Radiological Health said that there would be “a lot of hearings coming.”
In many ways, the current fight is similar to past dust-ups over the 510(k) program, Uldriks noted, describing it as a never-ending “soap opera story.”
“The 510(k) program was never meant to be a primary way to market,” he said. “That’s not what it was intended to do.”
Most medical devices are approved via the 510(k) protocol. Uldriks said the current political climate, with Republicans gaining significantly more leverage in the Senate and complete control of the House, means a more pro-industry stance. Even compared with the early 90s, when Democrats controlled Congress and patient safety was at the forefront, there’s one constant, he said.
“If you want to make changes at the FDA, do it through the press,” Uldriks said.
[Capitol Hill by Flickr user Will Palmer]
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
