FDA reveals reauthorization of Animal Drug User Fee programs

New Africa/stock.adobe.com

The Animal Drug and Generic Drug User Fee Amendment of 2023 was signed into law as part of HR 5860 on September 30, 2023. Through this signing, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) were reauthorized and will be administered by the FDA until 2028.¹

According to an organizational release,² each of the user fee programs will enhance the FDA’s ability to keep a predictable and timely animal drug review process that can help foster innovative drug developments and expedite access to new therapies for companion and food-producing animals.

At this time, the fee rates and payment procedures have not been published in the Federal Register for FY 2024. The FDA also disclosed that the user fee cover sheet creation system will remain closed for ADUFA and AGDUFA submissions that require a fee payment before the review and the page will be updated as soon as the fee rates become available.

Originally signed into law in 2003, ADUFA was then reauthorized in 2008, 2013, 2018, and 2023.¹ It authorizes the FDA to collect fees for animal drug applications and supplements, establishments, products, and sponsors for the application of animal drugs as well as investigating animal drug submissions.

The funding, supplemented by Congressional budget authority, will enhance the drug review process performance to ensure new animal drug products are safe and effective. ADUFA also helps to ensure that the food obtained from animals treated with products that are safe for consumption. The FDA will collect user fees from ADUFA V until 2028.

AGDUFA, designed to supplement the Congressional budget authority to strengthen the performance of generic animal drug review processes, was signed into law in 2008 and later reauthorized in 2013, 2018, and 2023.¹ The AGDUFA helps the FDA to make sure that generic new animal drugs are safe and effective.

The reauthorization of AGDUFA IV gives the FDA the ability to collect user fees for certain abbreviated applications for generic new animal drugs and products. This also will give the FDA the power to collect user fees from certain sponsors of abbreviated applications for generic new animal drugs or investigational submissions. The FDA will be able to collect user fees under AGDUFA IV through 2028.

Since ADUFA was originally passed in 2023, the FDA approved 524 animal drugs from original approvals and major enhancements, and 354 generic new animal drugs were approved since AGDUFA was passed in 2008.¹

Reference

FDA Announces Reauthorization of Animal Drug User Fee Programs. News release. FDA. October 2, 2023. Accessed October 3, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-reauthorization-animal-drug-user-fee-programs?utm_medium=email&utm_source=govdelivery