Veterinarians received good news from Washington recently: lawmakers passed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018
(H.R. 5554), and President Trump signed it into law on August 14.
The law authorizes the FDA Center for Veterinary Medicine to continue collecting fees from drug sponsors for use in the review of new animal drug and animal generic drug products, and specifies goals that ensure a predictable review process. The user fees, in addition to annual funding from Congress, support FDA staff and processes to improve veterinary access to FDA-approved drugs.
The law also includes language to expand the U.S. Food and Drug Administration’s (FDA) conditional approval process to include certain new animal drugs intended to treat serious or life-threatening diseases, or diseases that are particularly difficult to study. Drug companies are able to market a conditionally-approved drug after proving its safety and a reasonable expectation of effectiveness, while gathering the additional efficacy data required for full approval. The conditional approval process previously was limited to drugs labeled for minor uses and minor species. Expanding it will create incentives to develop new and innovative products.
Certain requirements will apply when conditional approval is applied to drugs for major uses and major species, and antimicrobials will be excluded from conditional approval. The FDA is required to issue further guidance or regulation to clarify what new animal drugs may qualify by Sept. 30, 2019.
The legislation also includes a requirement for FDA to submit a report identifying how the department will incorporate veterinary oversight for all medically important antimicrobial drugs administered to animals that are not yet subject to such oversight.
AVMA was a vocal proponent of reauthorizing FDA’s ability to collect animal drug user fees and the expansion of conditional approval. FDA’s approval process is the gold standard for animal drugs, and there are roughly 25 times more labeled indications approved for human use than for animal use. In addition to consistent lobbying on the issue, AVMA Immediate Past-President Dr. Michael Topper testified before the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health in favor of the user fees this spring.
We encourage you to learn more about AVMA’s advocacy work and how we advance veterinary medicine in Congress.