June 17, 2013
Last week President Barack Obama signed legislation to reauthorize the U.S. Food and Drug Administration’s Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). These two user fee programs enhance FDA’s ability to maintain a predictable and timely animal drug review process, foster innovation in drug development, and expedite access to new therapies for food-producing and companion animals.
Congress first approved the user fee program for new animal drugs under the Animal Drug User Fee Act of 2003, and the user fee program for generic new animal drugs under the Animal Generic Drug User Fee Act of 2008. Both programs must be reauthorized every five years. These two programs authorize FDA to collect fees to enhance the new animal drug review process and the generic new animal drug review process and will enable FDA to better ensure that new animal drug and generic new animal drug products are safe and effective for animals, and for humans with respect to animals intended for food production. During the reauthorization process, FDA held two public meetings and worked with stakeholders including representatives of patient and consumer advocacy groups, veterinary professionals, scientific and academic experts, and industry associations in developing proposals for reauthorization of ADUFA and AGDUFA. FDA also solicited public comment on these proposals.
The programs are reauthorized for fiscal years 2014 through 2018.