The medical device industry and the FDA came to a tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act – for double the price.
Although negotiations seemed stagnant and the agency quietly missed its Jan. 15 deadline to submit a proposal to Congress, the two sides announced a preliminary accord today that would double user fees over the next 5 years, to $595 million.
"The tentative new user fee agreement puts in place a framework that will benefit FDA and industry, but most importantly patients by accelerating the development and approval of safe and effective treatments and diagnostics," industry lobby AdvaMed’s president & CEO Stephen Ubl said in prepared remarks. "The improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process.”"
The additional funding will allow the agency to hire more reviewers and lower the ratio of managers to reviewers, according to a press release.
In return, the agency promised to streamline its review process, including achieving reductions in total review times, improving performance on pre-market approval and 510(k) applications, implementing third-party consultation to improve the review process and an initiative dubbed "leave no submission behind."
News of the agreement came as a bit of a surprise, as the most recent meeting minutes from the negotiations gave little indication of common ground between the industry and the watchdog agency.
The FDA had asked for an increase from the $295 million agreed to in the last series of negotiations, to $730 million to $805 million over the next 5 years. The industry balked at that number, proposing to pay $447 million instead.