David Lin, Politico Pro: October 27, 2020
FDA Commissioner Stephen Hahn said Tuesday that medical-device makers will have to pay higher user fees to ensure regulators have the tools they need to oversee the rapidly developing field and protect the public.
Speaking at the kickoff of fee negotiations for fiscal years 2023-2027, known as MDUFA V, Hahn said that the Covid-19 pandemic has placed “significant strain” on the FDA’s staff and its ability to continue to meet existing user fee goals.
“It is no exaggeration to say that the work I’ve witnessed from my colleagues over the past eight months has been nothing short of heroic,” Hahn said. “But it is also a level of effort that cannot be sustained in perpetuity.”
Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, said that “sound, strategic investments” of the current user fee have allowed FDA to make improvements to its regulatory program.
“We should engage in a dialogue about where we want the medical device ecosystem to be at the end of MDUFA V and then consider how the user fee program can best be used to support achieving that future state,” Shuren said.
Industry weighs in: Medical Device Manufacturers Association CEO Mark Leahey argued industry has already contributed substantial cash under past user fee agreements and that congressional funding should be the main source of support for FDA operations.
“It was always intended the user fees were supplemental in nature, not to be the primary source of funding,” Leahey said. “We think that’s a critical tenet to maintain as we enter the MDUFA V discussions.”
But Hahn argued new investments into FDA staffing and programs will pay off by enabling the agency to interact with device sponsors earlier and more frequently — ultimately resulting in safer medical devices reaching patients more quickly.
Consumer advocates raise regulatory capture concerns: Michael Abrams, a health researcher at Public Citizen, warned that FDA reliance on user fees is not a good development. He argues they “too often cause the agency to place the interests of the regulated industry over those of the public.”
“The agency we believe thus should be careful to avoid expanding dependency on direct industry financing, as it can compromise their ability to remain objective judges of device safety and efficacy,” Abrams said.
And Diana Zuckerman, president of the National Center for Health Research, argued user fees should be used to support FDA evaluation safety of medical devices and enforcement of clinical trial requirements.
“MDUFA performance goals need to be more patient centered by including specific metrics pertaining to safety and effectiveness, both premarket and post-market, and improving patients and consumer advocates’ access to meet with FDA decision-making officials,” Zuckerman said. “This will be a great step forward in helping to make sure the safeguards are there that patients and consumers deserve.”
What’s next: The current fee agreement, MDUFA IV, expires on Sept. 30, 2022. The FDA and medical-device industry will hold several rounds of negotiations before finalizing a MDUFA V commitment letter and sending it to Congress. Legislation is required to renew user fees and is often a vehicle for other FDA bills.
FDA is collecting written comments from the public for 30 days following the first public meeting, which will then be published on its website.
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