GDUFA IV: Sticking points emerge as negotiations press on

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, while other topics, such as drug master files (DMFs) and forfeiture determinations are still being discussed.

According to meeting minutes from 4 and 6 March, FDA and industry—represented by the Association for Accessible Medicines (AAM), the Pharma & Biopharma Outsourcing Association (PBOA), and the Bulk Pharmaceuticals Task Force (BPTF)—agreed on draft commitment letter language on topics including a policy for prioritizing abbreviated new drug applications (ANDAs), maximum daily dose (MDD) enhancement, and updates to the inactive ingredient database. Additionally, industry withdrew a proposal to expand the pre-launch activities importation requests (PLAIR) process, which FDA felt was outside the scope of the GDUFA negotiations.

During the 4 March meeting, FDA and industry discussed the industry's request to broaden the use of drug master files for prior assessments. While FDA has stated in the past that it's not feasible to broaden its use to all types of applications, the industry has asked the FDA to allow its use for abbreviated new drug applications (ANDA) submissions where the patent or exclusivity of the original product is set to expire within 24 months of the submission date. The agency said that would likely be feasible. (RELATED: GDUFA IV: Negotiations address DMFs, internal consultations, imminent actions, Regulatory Focus 24 March 2026)

Industry and FDA eventually reached an agreement on an industry proposal after some tweaks to the number of prior assessment requests FDA would accept under the domestic active pharmaceutical ingredient (API) and complex API criteria.

"Industry proposed alternative timelines to FDA’s proposal related to the timeframe for complex APIs submitted in DMFs to be reviewed, requesting that these be reviewed in the same 6-month timeframe as other prior assessments," the meeting minutes noted. "Industry also requested that [information request (IR)] comments be due 4 months after receipt of the prior assessment request as opposed to FDA’s proposal of 1 month prior to the planned ANDA submission date.

"FDA indicated that the shorter timeframe for complex APIs is not feasible due to resource constraints unless a smaller cap is placed on the total number of submissions that would be accepted under the complex API criterion," the minutes added. "Industry indicated they would consider this trade-off."

FDA noted that it provided responses to industry about its structured review proposal. More specifically, the agency said that, regarding filing IR response timeframes, it would be willing to receive responses within 8 calendar days, rather than the industry's request of 7 business days.

During the 4 March meeting, FDA also told the industry that it would not address industry's proposal to possibly expand the Pre-Launch Activities Importation Requests (PLAIR) process because it is outside the scope of the GDUFA program. Instead, the agency said it has provided a final guidance, and industry should consider submitting comments to the guidance docket or to the office responsible for the PLAIR process with any requests. While industry disagreed with the assessment, it withdrew the request.

FDA also noted that the agency and industry generally agreed on timeframes regarding ANDA meetings and the due date for preliminary written responses. The agency also agreed to some of the proposed meeting type changes from industry for three specific meetings but noted some of the proposals are challenging.

"Industry also raised concerns about meeting format preferences, indicating that industry and FDA appear to have different perspectives on when face-to-face meetings (i.e., in-person or videoconference) versus Written Responses Only (WROs) are appropriate, requesting additional guardrails on conversion and a reconsideration opportunity be considered," the meeting minutes stated. "FDA indicated the agency generally honors applicants’ meeting format requests for meeting requests involving complex, novel issues when the meeting package is complete, though the agency needs discretion to manage workload.

"Industry raised procedural questions regarding conversions of meeting requests to Controlled Correspondence, including when FDA would make such decisions and what guardrails exist on FDA's discretion," the minutes added. "FDA and industry agreed that there are a few remaining points for discussion, including a characterization of what FDA refers to as 'novel' issues in the meeting context."

Another area where FDA and industry made significant progress was in a public database for MDD values. The agency said it would populate the database with at least 500 values by the end of FY2028 and would provide an assessment by the end of FY2030 of what it would need to maintain a full-coverage database. Industry noted that certain MDD values are harder to calculate than others and asked the agency for opportunities to help it determine which 500 MDD values it should start with. By the 6 March meeting, both sides indicated they had come to an agreement on the MDD values issue.

During the 6 March meeting, industry presented an updated proposal on forfeiture determinations and reemphasized the challenges manufacturers face with receiving information that allows them to assess their potential for forfeiture and noted that clarity from past forfeiture determinations can help them avoid problems.

"In the revised proposal, industry proposed a mechanism by which, in certain specific circumstances, subsequent applicants can request that FDA make a forfeiture determination under the failure to obtain tentative approval provision, and the agency would then make such determinations within 90 days of receipt of the request and post the outcome of the determination on the Paragraph IV Certification List," the meeting minutes stated. "FDA asked clarifying questions and also noted that the 90-day timeframe would not be feasible.

"With respect to this proposed timeframe, industry explained that they are seeking to know the outcome of the forfeiture determination 5-6 months prior to the potential earliest lawful approval date for the drug to provide sufficient time to undertake activities necessary for launch," the minutes added. "FDA indicated that it would need to discuss the revised proposal internally."

Meeting minutes