As is the case with most negotiation sessions, no agreements were made at this time on the issues discussed. This is a back-and-forth process and the norm as negotiations proceed; the ultimate FDA decision-makers must weigh in on the issues prior to agreement. The full minutes of the meeting can be found here, and some of the issues discussed at this meeting are outlined below.
Update Prioritization MaPP
Some movement towards agreement appears to have been made as the FDA indicated it would consider that “original ANDAs could qualify for a priority review under this new prioritization factor during the first three years of GDUFA IV (i.e., until October 1, 2030) if they met two of the three following criteria: (1) the pivotal bioequivalence (BE) testing was conducted in the U.S. or the ANDA qualifies for a waiver of bioequivalence testing; (2) the finished dosage form (FDF) manufacturer(s) is located in the U.S.; and (3) the active pharmaceutical ingredient (API) supplier(s) is located in the U.S. After October 1, 2030, original ANDAs would need to meet all three criteria to qualify for a priority review.” The FDA then said that “supplements would need to meet all three criteria.”
Industry requested “that prior approval supplements that contain a BE study and involve a tech transfer to a new US facility be included in the exception that affords prioritization if 2 of the 3 criteria are met during the first three years of GDUFA IV. FDA indicated that it would consider this.”
Meetings/Complex Generics
The haggling continued regarding meeting timelines for complex generics. While it appears that the sides are getting closer, there are some issues on which the FDA cannot agree. The meeting minutes on the discussions of this topic are not exactly clear to this outsider so I’ll leave it for you to form your own opinion on the written words.
Controlled Correspondence
The issue of administrative corrections requested by the FDA and the stopping of the clock on CC reviews was discussed. Industry indicated that there is a clock reset to the full Agency response time when there is a correction required. The FDA is worried about needing to meet its goals if industry takes too long to respond to an administrative correction or Information Request (IR), and I believe that industry worries that the goal dates are, in some cases, extended inappropriately by the corrections, especially if the initial FDA request is not accurate or appropriate.
Industry asked whether the FDA thought that the new Q1-Q2 legislation, IID, and MMD enhancements would significantly reduce the number of CCs coming into the OGD. The Agency responded that it did expect some decrease in the number of CCs submitted, and that it did not expect that there would be enough of a decline to consider revising CC response times. The FDA did say it might consider adding a 90-day tier for some types of CC requests that fell under the 120-day response time. Industry asked the FDA to delineate the categories to which a 90-day review time would apply.
Stay tuned and be sure to keep up with the negotiations!
