Drugs

Changes Expected in User Fee Reauthorizations

ML Strategies senior director Aaron Josephson says changes are likely to be made in the medical product user fee programs that are starting the reauthorization process this year. In an online post, Josephson highlights some changes made to the programs when they were last reauthorized through the 2017 FDA Reauthorization Act and then looks at issues that may be addressed in upcoming user fee reauthorization talks.

He reports that for PDUFA, FDA has said that it requires additional funding to better regulate regenerative medicine products and manufacturing facilities. He says that industry has grown significantly in the last few years and may be willing to pay user fees to gain clarification from FDA on manufacturing standards and marketing exclusivity for non-traditional product types.

For GDUFA, the agency has said that many ANDAs are not lawfully approvable at the time they are submitted because the reference product still has market exclusivity. Thus, the ANDA has to undergo several review cycles before it gains final approval and FDA, industry, and Congress may have to find potential solutions to the challenge.

FDA still is not meeting the performance goal of scheduling BsUFA type 2 meetings with industry sponsors within 90 days of the request (increased in the last reauthorization from 75 days). Josephson also says the agency has not provided existing staff with enough resources to research and review biosimilar applications for approval. And FDA has struggled to hire highly educated, experienced, and talented employees for the program.

The post says ML Strategies expects to see the National Evaluation System for health Technology as a subject of continued discussion in the MDUFA 5 negotiations. They also expect that the FDA de novo and pre-submission performance goals will be refined based on experience and data gathered during the MDUFA 4 period.

New and emerging user fee programs, Josephson says, could include OTC drug monographs, laboratory-developed tests, and digital health.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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