Congress Inches Forward with Plans to Reauthorize ADUFA and AGDUFA

By: Dr. Ashley Shelton Morgan, assistant director, Governmental Relations Division

Congress continues to move forward with its plans to reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) before they expire on Oct. 1.  The programs, created in 2003 and 2008, respectively, authorize the Food and Drug Administration to collect fees to provide the necessary resources to enhance the animal drug review process.

Dr. Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine, testified late last month before the Senate Committee on Health, Education, Labor and Pensions on the FDA’s recommendations for the program, which were developed by the FDA along with input from the drug manufacturer industry and veterinary medical stakeholders.

“ADUFA and AGDUFA are widely regarded as extremely successful programs,” Dr. Dunham said in her testimony. “The recommendations we have submitted for reauthorization of these programs will ensure FDA has a stable workforce to provide the predictable and timely review process that drug sponsors need to foster innovation. They also will provide for expedited access to new therapies for food-producing animals and companion animals, while still ensuring that the drugs are safe and effective.”

AVMA supports the programs and provided official comments at both the November 2011 and December 2012 public meetings held by the FDA.

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