Congress Sends President ADUFA Legislation

AVMA News Bulletin

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

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 antibiotic resistance, he said, and added that the president is expected to sign the bill.

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 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, enhancing training, focusing on business process improvements and developing and disseminating guidance, policy and procedural documents.