The U.S. House this week passed by voice vote legislation reauthorizing the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA).
The legislation authorizes the U.S. Food and Drug Administration to collect from animal health companies fees for reviewing animal drug applications, thereby supplementing the agency’s budget for the rigorous appraisal of animal drugs.
The measure, passed by the House Energy and Commerce Committee in May, includes a new provision that expands FDA authority for conditional approval of new animal drugs, addressing serious and life-threatening unmet medical needs for major animal species. Conditional approval allows an animal drug to be available for use before all necessary data for approval is collected but after the drug is deemed effective and safe for use.
The provision expands FDA’s authority to conditionally approve new animal drugs from minor use and minor species to major use and major species. With the laws set to expire Sept. 30, renewal of ADUFA and AGDUFA will avoid disruption in the availability of new animal drugs to the livestock production industry.