AVMA testifies in support of improving new animal drug review efficiency
April 03, 2023
AVMA President Lori Teller urged Congress to reauthorize legislation allowing the Food and Drug Administration (FDA) to continue collecting user fees from sponsors of new and innovative animal drugs and generic animal drugs, while meeting specific performance metrics.
Dr. Teller appeared before the House Energy and Commerce Subcommittee on Health on March 30 to speak in support of the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), which Congress must reauthorize every five years.
The AVMA supports the collection and effective utilization of user fees to enhance the FDA Center for Veterinary Medicine’s (CVM) review of pioneer and generic animal drugs. Throughout 2022, the AVMA provided verbal and written comments to the CVM regarding the needs of veterinarians in the reauthorization of these programs.
“Veterinarians need additional new, innovative, and generic animal drugs that have been demonstrated to be safe and effective to help protect animal and public health,” Dr. Teller told the subcommittee. “We support the collection of user fees for new and generic animal drug applications when they are used to expedite the review process for these products.”
Veterinarians treat a multitude of species across an incredible range of sizes for a variety of diseases and conditions. Yet, there are far fewer FDA-approved drugs for veterinary use—about 1,600—than for human use, where there are approximately 20,000.
The user fee programs established under these laws, authorize the FDA to collect fees that are dedicated to the process for reviewing animal drug applications and used to supplement congressionally appropriated funds to improve the process. At the same time, the FDA agrees to meet performance metrics that are mutually developed with the animal drug industry.
During her testimony, Dr. Teller told the subcommittee that, under past animal drug user fee agreements, the FDA agreed to improve the efficiency of the animal drug review process; however, more can be done.
The AVMA supports:
The FDA CVM aligning review processes with similar regulatory agencies in other developed countries that may streamline and shorten the time to review products for the U.S. animal drug market. Approvals in the U.S. for the same drugs can lag behind other developed countries by up to a year.
Prioritizing the review of generic drug applications for indications where there is not already an approved generic drug.
“Ultimately, in order to provide the best care, we need a robust pipeline of innovative new animal drugs and a strong generic industry,” Dr. Teller said. “We look forward to working with the committee and FDA CVM to increase the number of FDA-approved animal drugs for the benefit of the animals under our care, their owners, and the public.”
AVMA President Teller testifies in favor of animal drug user fees