FDA’s Medical Product User Fees Reauthorized for Five Years
Margarita Valdez Martínez & Caitlin McCombs, MBA - October 06, 2022
The bill, signed last week, included the reauthorization of the Prescription Drug User Fee Authorization (PDUFA) Act.
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Last week, the bipartisan Health, Education, Labor, and Pension (HELP) and Energy and Commerce (E&C) Committees, along with House and Senate leadership, committed to reauthorizing FDA’s medical product user fees for the full five years as part of a short-term government funding package.
The bill passed the Senate (72-25) on Thursday and passed the House (230-201) Friday, largely along party lines. The bill was signed by President Biden that same day, averting a government and FDA shutdown.
The bill included the reauthorization of the Prescription Drug User Fee Authorization (PDUFA) Act, which allows FDA to collect fees from companies that produce certain human drug and biological products, including gene and cell therapies.
Ahead of the September 30 deadline for reauthorizing PDUFA, negotiations had stalled in Congress, causing concern that a deal would not be reached to fund FDA before PDUFA VI expired.
Draft text of the continuing resolution (CR) to fund the government through mid-December was released Sept. 26 and included the authorization of PDUFA VII as well as FDA’s three other human medical product user fee programs through 2027. It also incorporates all changes to program financing and the new commitment letters negotiated between the Agency and the regulated industries. The CR does not include any FDA policy riders that were part of the Food and Drug Act of 2022 or the FDA Safety and Landmark Advancements Act, such as reforms to the accelerated approval pathway or clinical trial diversity provisions. It did include short-term reauthorizations of minor FDA programs.
When the CR expires December 16, other FDA policy provisions previously associated with the user fee bills mentioned above, PREVENT Pandemics Act, and CURES 2.0, will be fair game for inclusion in the December package. What is still unknown is exactly which, if any, pieces will ultimately be included, and in what form. ASGCT will continue to engage on these issues as they arise later this year and will reiterate the importance of such provisions for the gene and cell therapy field.
Ms. Valdez Martínez is ASGCT's Director of Policy and Advocacy and Ms. McCombs is ASGCT's Advocacy Program Specialist.