September 15, 2008


 President reauthorizes animal drug program

Posted Sept. 1, 2008

President Bush signed legislation Aug. 14 reauthorizing the Animal Drug User Fee Program. The House of Representatives voted in favor of reauthorizing ADUFA June 30, and the Senate did likewise Aug. 1. The AVMA was part of a coalition seeking congressional support for the program.

Since ADUFA became law in November 2003, the program has enabled the Food and Drug Administration to reduce its review time of new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and efficacy.

The only amendments to the bill were for reporting requirements, which were carefully negotiated by Congress and the coalition, according to Dr. Mark Lutschaunig, director of the AVMA Governmental Relations Division.

The amendments will provide additional drug data that will help in monitoring antimicrobial resistance, Dr. Lutschaunig said.

The program has, according to the FDA, contributed $43 million in user fees over a five-year period. In that time, the agency has met or exceeded all of the review performance goals established under ADUFA, the agency said. This has been accomplished by such measures as hiring additional staff, training, focusing on business process improvements, and developing and disseminating guidance, policy, and procedural documents.