House, Senate pass animal drug user fee legislation

Legislation would expand conditional approvals beyond minor uses and minor species. The U.S. House and Senate have passed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (HR 5554/S 2434), which are vital to increasing veterinary access to drugs approved by the U.S. Food and Drug Administration (FDA), according to the American Veterinary Medical Association.The House passed the bill on July 16, and the Senate passed the bill on July 31. The legislation includes language that would expand conditional approvals beyond minor uses and minor species.The animal drug user fee amendments will reauthorize the FDA’s Center for Veterinary Medicine to continue collecting animal drug and animal generic drug user fees from the drugs’ sponsors. These fees, coupled with annual appropriations, support FDA’s animal drug review processes and ultimately improve veterinary access to FDA-approved drugs. Conditional approval of new animal drugs will incentivize the development of new and innovative products for conditions that prove particularly difficult to study, according to the AVMA.