In the past, CVM review of generic animal drugs was funded by Congressional appropriations only. With the passage of AGDUFA in 2008, and reauthorization of AGDUFA II in 2013 and 2018, 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.
The existing statutory timeframe for generic animal drug application review is 180 days. With Congressional appropriations alone funding CVM’s reviews prior to 2009, the review times were approaching 700 days — nearly two years to review and approve ANADAs. Even with the implementation of user fees, CVM review times are only expected to reach 270 days by the year 2018 — 240 days by the end of federal fiscal year 2022, 60 days longer than the current statutory timeframe.
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.