There is something about being in the room that cannot be gleaned just by reading the minutes of the meeting. Even journalists must guess sometimes. I often get questions from trade-press representatives and about what the FDA means or is thinking and many times I must also guess!
Anyway, the OGD and FDA discussed various issues at this GDUFA negotiation session. Industry asked the FDA whether, under certain circumstances, it could make determinations on the forfeiture or award of 180-day exclusivity earlier so that industry can better plan launches. The FDA appeared to be reticent about making any changes and asked industry to further outline its issue. The Agency “explained why its policy is to make forfeiture decisions in the context of specific ANDAs that are otherwise eligible for approval, as many factors influence eligibility for exclusivity up to the time an application is ready for approval and thus could render a premature eligibility determination incorrect, and noted the proposal would require a significant increase in resources for these determinations.”
Industry asked the FDA to hold a workshop on the Pre-Launch Activities Import Requests (PLAIR) program and for increased flexibility, especially as it relates to application supplements that have a shorter and more predictable review time (six months). The FDA asked clarifying questions.
Another area of discussion centered on post-approval quality commitments. As it stands today, very few post-marketing quality commitments are asked for in ANDAs, yet industry noted that other areas of the FDA (like new drugs and biologics) often permit post-approval quality commitments. The Agency “asked questions, including about the potential for the proposal to weaken the approval standard, the enforceability of the postmarketing commitments as proposed, as well as the potential for the use of such commitments to lead to inequitable treatment of similarly situated applicants.”
As is often the outcome of these meetings, no agreements were reached on any of the issues; as talks continue, agreements will come later in the negotiation game and be announced only in the final commitment letters. The FDA also went over some of the highlights of the December 9, 2025 stakeholders meeting. (Please see the full minutes for further details here.)
There was also a smaller meeting on finances during which “[i]ndustry asked clarifying questions to better understand FDA’s fee setting processes, structure, and timelines. The FDA provided additional details around the process and timeline requirements to Industry.” The minutes of that meeting can be found here.
