Traditionally, user fee negotiations, whether for PDUFA, GDUFA or BSUFA, have maintained that the negotiations are essentially for fee-for-service contracts. What this means is that the industry provides fees and the FDA provides services for those fees. The negotiations usually end with the commitment letter and any statutory changes that result from the negotiations. For years, the FDA has maintained the position that negotiations are not an opportunity to discuss policy. I’ve personally attended many of the negotiation sessions over the years during which the FDA has emphasized this point.
Yet, despite this stance, it appears as though a policy issue was introduced during the GDUFA negotiations on January 7, 2026 (see here for the meeting minutes).
The minutes state, in part:
FDA presented a proposal to update the Prioritization MaPP to add a new prioritization category consistent with the ANDA prioritization pilot to support U.S. generic drug manufacturing and testing that FDA launched in October 2025. Specifically, ANDAs could qualify for a priority review under this proposal if: pivotal bioequivalence testing is conducted in the U.S. or the ANDA qualifies for a waiver of bioequivalence testing; and the finished dosage form manufacturer is located in the U.S.; and the API supplier(s) is located in the U.S. FDA indicated this is intended to incentivize domestic manufacturing and testing to address risks associated with over-reliance on foreign drug manufacturing.
Industry asked questions about the ongoing pilot and indicated that it could provide a greater incentive to manufacture and test products in the U.S. if ANDA submissions could qualify for priority review under the proposal even if they only met a subset of the three criteria.
No agreements were made at this time.
Historically, the FDA has committed, typically within the commitment letter, to publish a new MaPP or guidance document, or to revise an existing MaPP or guidance document. However, to my recollection, the FDA has never committed to a specific policy position that it has agreed to during negotiations when writing or revising these documents.
That said, the FDA already has broad authority on which applications or supplements it can prioritize. The current MaPP, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (here), describes how ANDAs and supplements to ANDAs will be prioritized. The MaPP refers to the regulation at 21 CFR 314.70(b)(4) that gives broad discretion in prioritizing supplements (it states, in part, “An applicant may ask FDA to expedite its review of a supplement for public health reasons…” and it could be reasonably argued that the proposal is for a public health reason). Further, the FD&C Act at 505(j)(11)(D) states, “Nothing in this paragraph shall prevent the Secretary from prioritizing the review of other applications as the Secretary determines appropriate.” It could easily be argued that this proposal is something that the Secretary has determined to be appropriate.
So, where do we stand? One could argue that, if the FDA wanted to add this new prioritization category to the MaPP, it has the regulatory authority to do so, if it wished. And perhaps the FDA is merely looking for confirmation of the October 3, 2025 pilot proposal (see here) during these negotiations. In any event, this seems like policy creep to me.
Blog Master’s Note: Mike Jones is a former FDA official who was an expert in all things PDUFA and GDUFA during his time at the Agency. He maintains close ties with the UFAs as an ongoing matter. Thanks to Mike for providing his perspective on the current negotiations for GDUFA IV!
