The Animal Drug User Fee Act (ADUFA), which establishes the payment schedule for drug sponsors and how they get new animal drugs approved, was passed on September 30, but did not include the Innovative Feed Enhancement and Economic Development (FEED) Act of 2023.
The Innovative FEED Act, which was not included in the U.S. House of Representatives’ bill that passed, would have modernized the approval process for animal feed with drug claims by establishing a new pathway for manufacturers to receive approval for feed additives that improve efficiency in meat and dairy production while also reducing byproducts. The legislation also established strict guardrails to ensure only qualifying products are eligible for this pathway while also ensuring products are safe to use.
AFIA disappointed, but will continue work on legislation
The American Feed Industry Association (AFIA) had lobbied for passage of the Senate’s version of ADUFA, which included the Innovative FEED Act.
“While we were disappointed that ADUFA passed without the Innovative FEED Act in the continuing resolution this weekend, we congratulate Congress for reaching a bipartisan compromise to keep the government temporarily funded and reauthorize the animal drug user fee program, both critical for animal food safety and health,” said Leah Wilkinson, AFIA’s vice president of public policy and education, in a statement.
Wilkinson said AFIA would continue to work to find ways to move the Innovative FEED Act forward.
“The need for producers to get access to new feed technologies that help them improve animal health, food safety and the environment has not changed,” she said. “We will continue to work with the over 135 animal agriculture organizations and companies in support of the Innovative FEED Act to find other vehicles for moving this critical legislation this fall.”
ADUFA, as well as the Animal Generic Drug User Fee Act (AGDUFA) were passed as part of the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 and were signed into law as part of H.R. 5860. These two user fee programs enhance the U.S. Food and Drug Administration’s (FDA) ability to maintain a predictable and timely animal drug review process, foster innovation in drug development, and expedite access to new therapies for food-producing and companion animals, FDA said in a press release.
Background on ADUFA, AGDUFA
ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013, 2018 and 2023, authorizes the FDA to collect fees for certain animal drug applications and supplemental applications, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources supplement funding provided by congressional budget authority to enhance the performance of the drug review process ensuring that new animal drug products are safe and effective for animals, and that food derived from treated animals will be safe for consumption. ADUFA V reauthorizes the FDA to collect user fees through FY 2028.
AGDUFA, originally signed into law in 2008 and reauthorized in 2013, 2018 and 2023, was designed to supplement the congressional budget authority to enhance the performance of the generic new animal drug review process, which enables the FDA to ensure that generic new animal drug products are safe and effective. AGDUFA IV reauthorizes the FDA to collect user fees for certain abbreviated applications for generic new animal drugs, generic new animal drug products, and from certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. AGDUFA IV reauthorizes the FDA to collect user fees through FY 2028.