Currently, the CVM review of generic animal drugs is funded by Congressional appropriations only. With the passage of AGDUFA, CVM will now have access to user fees paid by industry that will 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. Currently, with Congressional appropriations alone funding CVM’s reviews, the review times are approaching 700 days. Even with the implementation of user fees, CVM review times are only expected to reach 270 days by the year 2013 – 90 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.