CVM review of generic animal drugs prior to 2008 was funded solely by Congressional appropriations. With the passage of AGDUFA in 2008, and reauthorization of AGDUFA in 2013, 2018 and 2023, CVM now has access to user fees paid by industry that enable CVM to increase the number of application reviewers and improve review systems, leading to improvement in application review times without affecting the quality of reviews. However, current appropriations and user fees will not be enough to enable CVM to obtain the results that both they and the generic animal drug industry desire.
GADA believes it is crucial that CVM decrease review times to those previously established by Congress, but recognizes that this can only be done with additional Congressional appropriations. Without enough Congressional funding for CVM’s generic drug reviews, the generic animal drug industry cannot efficiently provide drug alternatives to veterinarians and animal owners. We urge Congress to increase CVM appropriations to enable CVM to meet the statutory review timeframes and allow our industry to provide more animal drug options.