Washington, D.C. — Subcommittee on Health Chair Brett Guthrie (R-KY) delivered the following opening statement at today’s Health Subcommittee hearing titled “Reauthorization of the Animal Drug User Fee Programs.”

Excerpts and highlights below:

ANIMAL HEALTH IS IMPORTANT TO HUMAN HEALTH

“Today we take the first step to reauthorizing the Animal Drug User Fee Agreements through 2028.

“These must pass agreements play important roles in keeping our pets and our farm animals healthy and happy.

“This process gives Congress the unique ability to help ensure brand name animal drugs and their generic equivalents are able to reach the market as quickly and as safely as possible.

“Animal health is also important to human health.

“For example, there’s currently a severe bird flu outbreak going on around the world.

“One way to prevent that virus from potentially mutating and becoming potentially infectious in humans is to prevent or cure the disease in animals.”

THE HISTORY OF ADUFA AND ITS FUTURE

“Originally established in 2004, the first animal drug user fee agreement transformed the drug review process for these drugs.

“Before the establishment of these agreements, it took roughly seven to ten years to get new animal drugs approved.

“This backlog made it more difficult for veterinarians to treat house pets for treatable and non-life threatening conditions.

“Food was also delayed getting to grocery store shelves because of delays in determining that antibiotics given to food producing animals did not jeopardize the safety of that food for human consumption.

“The first ADUFA agreement eliminated the backlog of applications sitting with the FDA Center for Veterinary Medicine and decreased the review times for New Animal Drug Applications from over 600 days to 180 days.”

THE ADUFA AGREEMENT TODAY

“The ADUFA agreement we are considering today will allow the agency to collect $174 million in fees from industry from 2024 to 2028 and make critical program enhancements to streamline the review process for both the regulators and industry.

“These include more stringent reporting requirements for the FDA on review times and outcomes of Investigational New Animal Drug applications.

“The agreement also includes a third-party review process of these applications to increase oversight and help identify ways this process can be more predictable for drug sponsors.

“Today we are also considering the Animal Generic Drug User Fee Agreements (AGDUFA).

“Since Congress passed AGDUFA in 2009, these agreements have been instrumental in reducing long wait times for drug reviews and getting more lower cost generic drugs onto the market.

“The AGDUFA agreement we are examining would permit the FDA to collect up to $130 million in user fees through 2028 on the review of generic animal drugs.

“This also includes improved transparency requirements for FDA that will help sponsors more effectively work with regulators to address outstanding issues with the file for which sponsors use to share information about an abbreviated new animal drug application.

“It also includes a commitment from the FDA to take action on 90% of these requests within 100 days of submission.

“Overall, both of these agreements will significantly enhance our ability to keep household pets and farming animals healthy, while continuing to promote human health in the process.

“I would also like to thank my subcommittee colleagues Representatives Pence and Schrier for their work in introducing the legislation before us today that would reauthorize these programs.

“As subcommittee chair, I want to ensure we are taking care of business by getting this legislation to the President’s desk well before its September 30 deadline.”