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Harkin Statement on Signing of Animal Drug User Fee Bill into Law

WASHINGTON—Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions Committee, applauded President Obama for signing the Animal Drug User Fee Agreement (ADUFA) and Animal Generic Drug User Fee Agreement (AGDUFA) reauthorizations into law today. 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 and passed in the Senate in May.

“Passage of the Animal and Animal Generic Drug User Fee Agreements marks a rare but welcome bipartisan victory for this Congress, and I applaud my colleagues on the HELP Committee and in the House, as well as the FDA and industry representatives, for working together on this bill,” Harkin said. “Now that President Obama has signed this bill, the FDA will have the resources it needs to ensure that animal drugs are safe, and to approve them in a timely fashion.”