Lawmakers press Woodcock for MDUFA update

Regulatory NewsRegulatory News | 01 February 2022 |  By 

Leaders from the House and Senate health committees wrote to Acting FDA Commissioner Janet Woodcock on Friday after the agency missed the 15 January deadline to transmit the commitment letter for the next iteration of the Medical Device User Fee Amendments (MDUFA V) to Congress.
The letter, signed by Senate Health, Education, Labor and Pensions committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC), as well as House Energy & Commerce committee Chair Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA), calls on FDA and industry to brief Congress on the status of the negotiations and the expected timeline for the process by 9 February.
“It is important that Congress have sufficient time to review each commitment letter and to evaluate the agreements,” the lawmakers wrote. “The FDA and medical device industry’s significant delay in transmitting the MDUFA commitment letter jeopardizes our ability to thoroughly review the commitments under the letter.”
Last month, FDA transmitted the final commitment letters for its user fee programs for prescription drugs, generic drugs and biosimilars (PDUFA, GDUFA, and BsUFA) to Congress after months of negotiation with industry. Each of the user fee programs is set to expire at the end of this fiscal year unless they are reauthorized.
However, media reports last month indicated that FDA and the medical device industry remain split on increasing the scope of the program. From outset of the negotiations, industry has insisted that MDUFA V focus on refining the program, while FDA has sought to expand the program and increase its funding. (RELATED: MDUFA V: Industry wants fine tuning while FDA seeks expansion, Regulatory Focus 27 October 2020; MDUFA V negotiations press on with breakdown over TPLC proposal, Regulatory Focus 7 July 2021)
Formal meetings between FDA and industry on MDUFA reauthorization have also stalled, with the last industry discussion taking place in June 2021.
The House Energy & Commerce committee also announced last week that it will kick off the legislative process for the user fee reauthorization this Thursday, with a hearing on PDUFA, GDUFA, and BsUFA reauthorization.
Statement, Letter


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