The new Generic Drug User Fees for FY 2025 have been published (see Federal Register Notice here) and, with ANDA submission rates dipping, fees for submission of new ANDAs are soaring. The individual ANDA submission fee will be going up by $69,467 next year. Remember that October 1st (the beginning of FY 2025) is right around the corner; my guess is that the race to submit new ANDAs before the end of September is going to be a crowded field.
The Agency looked at the FY 2023 total of ANDA submissions (685) as well as the number of ANDAs received in FY 2024 to date plus projected submissions through the end of the fiscal year, then waved its magic wand and projected a submission rate of 651 ANDAs for FY 2025, which will be the lowest number since the Generic Drug User Fee Act (GDUFA) went into effect.
All of the other user fees are increasing as well, but none as greatly as the ANDA fee with the exception of program fees, which have been adjusted by the number of firms in each group to reach the required total fee. Consolidation of the number of firms through mergers and acquisitions has likely also contributed to the program fee increases.
There are likely to be some significant grumbles about the new fees from sponsors, especially those that have transitioned from a lower to a higher program fee category. Program fees are supposed to make up 36% of the required funding for the GDUFA program. The FDA says that “[t]he list of original approved ANDAs from the Generic Drug Review Platform as of April 30, 2024, in addition to CBER’s database, shows 241 applicants in the small business tier, 74 applicants in the medium size tier, and 81 applicants in the large size tier. Factoring in all the variables, we estimate there will be 194 applicants in the small business tier, 68 applicants in the medium size tier, and 75 applicants in the large size tier for FY 2025.”
So, sharpen your pencils and count your beans and, as the fee structure rises, let’s hope that folks know that the increased costs have to be borne by the consumer! And, if the number of ANDAs continues to decrease over the coming years, it will, without a doubt, make it more difficult for small startups to enter the generic drug market. The real question to ponder is, when the fees reach a certain point, will their value be equal or greater to their benefit to industry? In my opinion, this can only come from increased efficiency in the generic drug program and faster ANDA approvals.
