WASHINGTON, D.C. — The Food and Drug Administration (FDA) recenlty announced the fee rates and payment procedures for fiscal year (FY) 2025 under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023. Published in the Federal Register, these amendments aim to enhance the performance of the review process for animal drugs and generic animal drugs.
The Animal Drug User Fee Act (ADUFA), first signed into law in 2003 and reauthorized multiple times, allows the FDA to collect user fees for certain animal drug applications and related submissions. These fees supplement Congressional funding to ensure that new animal drug products are safe and effective. ADUFA V extends the FDA’s authority to collect these fees through FY 2028.
Similarly, the Animal Generic Drug User Fee Act (AGDUFA) supports the review process for generic new animal drugs. First enacted in 2008 and also reauthorized several times, AGDUFA IV extends this authority through FY 2028. The user fees collected help ensure that generic animal drug products meet safety and efficacy standards.
These user fees are critical for maintaining the FDA’s capability to review and approve new and generic animal drugs. Since the inception of ADUFA, the FDA has approved 536 new animal drugs, including major enhancements. AGDUFA has facilitated the approval of 374 generic new animal drugs since its passage in 2008.
The amendments call for user fees to be prorated based on the number of approved applications a sponsor holds. This ensures a fair distribution of costs across the industry, fostering a more efficient review process.
The FDA’s commitment to animal drug safety and efficacy is underscored by these legislative measures, which provide the resources needed to keep pace with advancements in veterinary medicine.
Through these efforts, the FDA aims to maintain a robust review process that ensures the safety and effectiveness of animal drug products, contributing to the overall health and well-being of animals and the safety of food derived from treated animals.
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