The GDUFA IV meeting held on January 7, 2026 (here) was a bit of a what-if session with the FDA introducing a few new concepts for consideration in the negotiation process.

First, the FDA suggested waiving GDUFA facility fees for a three-year period for new domestic manufacturing facilities that break ground to manufacture generic drug products or active pharmaceutical ingredients. This is obviously an effort, as described by the FDA, to reduce overreliance on foreign drug manufacturers. Industry questioned what breaking ground would mean as there would be no manufacture of product until after the facility is up and running. The Agency “explained it is proposing for the fee waiver to apply for the first three years a facility would incur a GDUFA facility fee, which would be after it is first referenced in an approved ANDA.” Industry noted that retrofitting an older facility would be a faster path to bringing domestic manufacturing back online. Industry also noted “that since waivers necessitate increasing fees on other facilities to compensate for the loss of revenue, this may subsidize new competition at the expense of existing domestic manufacturers that have already made investments in U.S. manufacturing.”

The second concept introduced was to raise the foreign inspection fee differential from its current $15,000 to $25,000 “to account for inflation since the fee was instituted in GDUFA I and adjust the fee for inflation going forward.” This would help to support the unannounced inspection pilot program. Industry asked a question about the effectiveness of the pilot and the FDA indicated that it was too early “to assess differences in outcomes from announced and unannounced inspections.” Industry expressed concern that “adjusting this fee for inflation could result in the fee becoming prohibitively costly over time, resulting in companies exiting the U.S. generic drug market.”

The third item addressed the proposal to update the MaPP on priority review “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 noted that firms should be able to “qualify for priority review under the proposal even if they only met a subset of the three criteria.” The view industry expressed is consistent with the previous view expressed in one of our blog posts here, in which we suggested that not many ANDA applicants would qualify for ANDA prioritization if all three criteria were required.

The last item was related to data fidelity issues, which we believe had to do with potential data integrity concerns. The FDA noted that data fidelity issues can increase the time for review of an application or can impact a number of applications (e.g., there is a problem with a CRO that impacts a number of sponsors), causing delays and missed goal dates. The FDA proposed a 180-day extension of the GDUFA goal date in these situations and, if the issue is still not resolved at the end of that time, a second notification letter would be sent to the applicant and the GDUFA goal date would be considered met. Industry seemed agreed with the importance of data fidelity. The FDA “explained that in addition to saving FDA resources, the proposal could provide incentives to contract with high quality CROs and manufacturers, which would be a step towards addressing the root cause. Industry acknowledged FDA’s response but emphasized that Industry already conducts extensive due diligence when selecting CROs and manufacturers.”

While all of these issues were raised and discussed, it is noted in the minutes that no agreement was reached on any of them.