Kyle Faget Comments on AI, User Fees Ahead of MDUFA Negotiations
Foley & Lardner LLP partner Kyle Faget weighed in on the role of user fees and artificial intelligence as stakeholders prepare for the next Medical Device User Fee Amendments (MDUFA) reauthorization in the Medtech Insight article, “Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?“
Faget explained that U.S. Food and Drug Commissioner Marty Makary sees AI as a strategic priority and is positioning it as a defining area of progress, adding that this will depend on stable funding to retain AI expertise and rebuild staffing levels after recent cuts. “Makary understands that AI is the future and that to keep pace the FDA will need to maintain a solid stable of AI experts — which requires the funds to pay them,” she noted.
Faget also suggested that securing broader support for increased user fees could involve a compromise. One possibility, she said, would be including “some type of ethics reform” in the final MDFUA package, such as a requirement that agency reviewers adhere to a waiting period before entering industry roles.
“I think at the very least we’re going to see status quo user fee funding, if not increased funding,” Faget said. “And I would argue it’s going to be increased funding because I think Makary will push really hard for it.”