Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following opening remarks today at a Subcommittee on Health hearing on “Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA:"
Today we will be examining the FDA’s Animal Drug User Fee program and the Animal Generic Drug User Fee program. These critical user fee agreements have helped to accelerate the development of animal drugs, reduce application review times at FDA, and create a more predictable and streamlined process for getting animal drugs to market to help improve the health of our pets and food-producing animals.
Last month this Committee, along with the HELP Committee in the Senate, released a bipartisan discussion draft that reauthorizes FDA’s authority to collect user fees from the animal drug and generic animal drug industries for an additional five years, as the current authorization for these programs will expire on September 30th of this year.
The discussion draft reflects bipartisan agreement and recommendations negotiated between FDA and the animal drug industry with input from farmers and ranchers, veterinarians, food and feed producers, and other public health stakeholders.
These agreements are critically important to pet owners, veterinarians, and farmers so they have access to safe, effective, and affordable medications for their animals. We want our pets to have the best care possible, and we must ensure that we keep our food supply safe. The animal drug user fee programs further both of these goals.
I expect we will also hear testimony today on FDA’s work to address antimicrobial resistance from the use of antimicrobials in food-producing animals. I’m very interested in what the Center for Veterinary Medicine is doing to ensure the continued effectiveness of antibiotics and how we can protect both animals and humans from the growing threat of antimicrobial resistance.
I look forward to helping to move these agreements through Congress in a timely fashion so the Center for Veterinary Medicine at FDA can continue its important work.
I yield back.
