Reauthorization of the Animal Drug User Fee Programs March 30, 2023

Testimony | In Person

• Testimony of: Tracey H. Forfa, J.D., M. Div. ; Director - Center for Veterinary Medicine

INTRODUCTION

Good morning, Chairman Guthrie, Ranking Member Eshoo, and Members of the Subcommittee. I am Tracey Forfa, Director of the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA or the Agency), under the Department of Health and Human Services (HHS). I have also had the honor of serving as the Deputy Director of CVM for the last 15 years. I am grateful for this opportunity to discuss FDA’s proposals for reauthorization of the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act for an additional five years (ADUFA V and AGDUFA IV). 

With the enactment of ADUFA in 2003 and AGDUFA in 2008, Congress brought CVM the needed infusion of funds to resolve a long-standing backlog of animal drug applications and created efficiencies and predictability in the review process. Congress also created an opportunity – at five-year intervals – for CVM and industry to assess these user fee programs with the intention of advancing the animal drug review process to accommodate new developments and address new challenges. These are highly successful programs that facilitate the availability of approved products for food-producing and other animals, and foster a reliable review framework to accommodate drug development. Both programs help FDA maintain a stable scientific and technical workforce, improve timely communications with drug sponsors, and achieve other efficiencies such as reduced review times in the drug application review process while maintaining science-based regulatory standards for animal drug safety and efficacy.  

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