Committee Members Unveil Animal Drug User Fee Legislation

April 5, 2013

WASHINGTON, DC – Reps. John Shimkus (R-IL) and Cory Gardner (R-CO) today unveiled legislation to reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). Together, these two pieces of legislation will give livestock and poultry producers, pet owners, and veterinarians the tools necessary to keep animals healthy, assist drug producers with a stable and predictable FDA review process, and keep consumers safe. The two programs will expire on October 1, 2013, unless reauthorized by Congress.

Rep. Shimkus, author of the Animal Drug User Fee Act, said, “With this legislation, veterinarians will be able to better treat, control, and prevent diseases. And livestock and poultry producers will be able to keep food animals healthy. Farmers, consumers and pet owners will all benefit.”

Rep. Gardner, author of the Animal Generic Drug User Fee Act, said, “The AGDUFA program has been a success story at FDA, and this legislation will create new performance enhancements that will allow for a more predictable approval process for generic animal drugs.”

On Tuesday, April 9, the Health Subcommittee will hold a hearing to review the success of the user fee programs and how the proposed new agreements will build on that success. Click here for more information.

Click here to view a discussion draft of the Animal Drug User Fee Act of 2013 and Animal Generic Drug User Fee Act of 2013.

Companion legislation, S. 622, has been introduced in the Senate by Senator Tom Harkin (D-IA).

 

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