In today’s prepublication of the Federal Register (here), the FDA has announced the Generic Drug User Fees (GDUFA) for FY 2026. Every single one of the GDUFA for FY 2026 has risen, but the application fee rose more than 10% for a whopping increase of $36,327 for the submission of a new ANDA. In calculating the FY 2026 new application fee, the FDA estimated that the number of new ANDAs submitted to the Agency would be 618, down from the 651 that the FDA estimated for FY 2025. However, for the first eight months of FY 2025, the OGD has actually received only 357 ANDAs. By my estimation, the number of new ANDAs that will be submitted in FY 2025 (based on the monthly average thus far) will more likely be closer to 550; however, this is only if the September submission rate exceeds the current average monthly rate of submissions. The number of new ANDA submissions in September is typically higher as firms try to sneak applications into the Agency to avoid the increase in fees on October 1st.
The chart below compares the FY 2025 and FY 2026 GDUFA fees:
While the fees for new application submissions had the highest dollar increase (because the FDA is estimating fewer ANDA submissions in FY 2026), if the actual number of ANDA submissions decrease in FY 2025 and again in FY 2026, the FY 2027 fees will likely jump by a greater absolute amount.
So now, it’s up to the firms’ bean counters to crunch their numbers and get out their corporate checkbooks to prepare for the increase in FY 2026 fees and push their firms’ regulatory folks to get those ANDAs into the Agency prior to the beginning of FY 2026 on October 1, 2025. As the government tries to reduce the cost of medications, the continuing rise in user fees will place more pressure on generic manufacturers that currently are operating with razor-thin margins and will likely begin to raise prices. Thus, it will likely be the consumer who ultimately winds up paying for the increase in the user fees!
