New law supports FDA approval of more animal drugs
This article is more than 3 years old
A new federal law includes language to expand conditional approval of animal drugs beyond minor uses and minor species, while reauthorizing the collection of fees from drug sponsors to support the review of new animal drugs and generic animal drugs.
On Aug. 14, President Donald Trump signed the Animal Drug and Animal Generic Drug User Fee Amendments of 2018. The law authorizes the Food and Drug Administration's Center for Veterinary Medicine to continue collecting user fees from drug sponsors and specifies goals to ensure a predictable review process. Annual funding from Congress also supports the FDA process for reviewing animal drugs.
The law contains language to expand the FDA conditional approval process to include certain new animal drugs intended to treat serious or life-threatening diseases or to treat 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.
Certain requirements will apply for conditional approval of 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 by Sept. 30, 2019, to clarify which new animal drugs may now qualify for conditional approval.
The AVMA was a vocal proponent of reauthorizing the FDA's ability to collect user fees as well as the expansion of conditional approvals. On March 14, Dr. Michael Topper, then AVMA president, testified in favor of the user fees before the Subcommittee on Health of the House of Representatives Committee on Energy and Commerce.
Dr. Topper testified: "By providing new animal drugs with a predictable pathway to market, these fees help provide veterinarians with access to new and additional tools that can potentially improve treatment outcomes, provide alternatives to existing therapies, fill unmet medical needs in veterinary medicine, and ultimately improve patient care, which is the center of veterinary practice."