House Committee Reauthorizes Animal Drug Approval Laws
USAgNet - 05/14/2018
The House Energy and Commerce Committee approved legislation reauthorizing the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act, which authorize the U.S. Food and Drug Administration to collect from animal health companies fees
for reviewing animal drug applications and allow the agency to supplement its budget for the rigorous appraisal of animal drugs.
The measure 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 safe for use, so long as it is expected to be effective.
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.