Harkin Statement on Senate Passage of Animal Drug User Fee Bill
WASHINGTON, D.C.—Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions Committee, applauded the Senate’s passage of the Animal Drug User Fee Agreement (ADUFA) and Animal Generic Drug User Fee Agreement (AGDUFA) reauthorizations. ADUFA and AGDUFA allow the U.S. Food and Drug Administration (FDA) to collect user fees from sponsors of animal drug and animal generic drug applications, and the agency uses those fees to help fund the review of animal drug applications. The bills were approved by the HELP Committee in March.
“I am pleased that the Senate has acted to reauthorize the Animal and Animal Generic Drug User Fee Agreements, a bipartisan legislative package that the HELP Committee worked on in a collaborative manner,” Harkin said. “This legislation will make certain that the Food and Drug Administration has the resources it needs to ensure the safety of animal drugs, and to approve products in a timely fashion. Fast, predictable approval of animal drugs, and their generic equivalents, benefits both the animals themselves and the people who depend on them. I urge the House to take up and pass this bill so that the President can sign it without delay.”