Comment from Generic Animal Drug Alliance (GADA)
AnonymousSupportTrade association
Summary: The Generic Animal Drug Alliance (GADA) supports the Animal Generic Drug User Fee Act (AGDUFA) but argues that the current fee structure places a disproportionate financial burden on generic sponsors compared to pioneer sponsors. They recommend reducing the industry's contribution to program costs, recalibrating fee-setting to align with actual costs, and modifying regulations regarding selective species labeling and review timelines to improve market access.
The Generic Animal Drug Alliance (GADA) appreciates the opportunity to provide feedback to the Request for Comments related to the Animal Generic Drug User Fee Act (AGDUFA) issued April 17, 2026. GADA is the only U.S.-based trade association representing the interests of generic animal health product sponsors, manufacturers, and associated businesses. Generic animal drugs are an essential part of the pharmaceuticals and medicated feed additives used in modern food production and companion animal care. They provide important, lower-cost treatment options that support animal health, public health, food security, the veterinary profession, and animal caretakers.
As GADA noted during the 2022 AGDUFA IV reauthorization process, the program should continue to support an efficient, predictable, timely, and scientifically rigorous approval process that increases the availability of high-quality, safe, effective, and affordable FDA-approved generic animal drugs.
GADA would like to specifically call out the professionalism and perseverance of the FDA Center for Veterinary Medicine Office of Generic Animal Drugs (OGAD) staff during a challenging period. The people of OGAD have demonstrated a diligent commitment to their work and engagement with industry on important topics concerning generic animal drugs throughout the AGDUFA program.
In the Federal Register notice the Agency asked for feedback on two specific questions regarding the user fee program for generic animal drugs. The attached document contains the response from GADA to these questions.