Devices

FDA, Industry Agree on MDUFA 5: RAPS

The Regulatory Affairs Professional Society (RAPS) says FDA and the medical device industry have reached an agreement on the MDUFA 5 user fee program that will bring the agency $1.784 billion in user fees over the next five years. The total reportedly could grow to $1.9 billion if FDA meets all its performance goals, RAPS says, or nearly twice the $1.1 billion FDA was authorized to collect under MDUFA 4.

Sources tell RAPS that the agreement includes funding for the agency’s proposed total product lifecycle program (TAP) that had been a major negotiating sticking point. That program would bring in outside stakeholders such as physician advisors and private health insurance providers, significantly increasing user fees. FDA had said the program would help product sponsors get a better idea of what key stakeholders want during product development and clinical trials, but the industry was initially resistant to the idea.

Under the agreement, FDA reportedly will use $110 million in MDUFA 4 carryover funds for a TAP pilot program plus $45 million from its base funds. There also will be a TAP mid-point assessment to allow FDA and the industry to evaluate how well it is working.

By 2023, FDA will have to hit an 85% hiring target for that fiscal year and then 90% in 2024. Failure to meet those targets would allow industry to claw back some of the user fees already paid under MDUFA 5.

The agreement will be sent to the relevant congressional committees for approval.

The agency and industry representatives declined to comment to RAPS for its story.

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