FDA proposes generic animal drug funding

WASHINGTON, April 24 (UPI) -- The U.S. Food and Drug Administration said it has sent the U.S. Congress recommendations for funding the review of pioneer and generic animal drugs.

The FDA said, if adopted by Congress, the Animal Drug User Fee Act, or ADUFA, reauthorization would provide funding for the review of new animal drug applications for the next five years.

In addition, the first generic user fee program -- the Animal Generic Drug User Fee Act, or AGDUFA -- would support the review of generic animal drug applications and maintain current standards of safety and effectiveness.

The agency said all funding is tied to meeting specific performance goals "that will ensure efficient scientific evaluation of the safety and effectiveness of animal drugs."

The ADUFA, which must be reauthorized by Congress every five years, is expected to generate $98 million in user fees during the next five years, the FDA said.

The AGDUFA would, among other things, place time frames on the review of generic animal drug applications. The proposed legislation would generate an estimated $27 million in user fees during the five-year period, the agency said. Currently, the FDA's review of generic animal drugs is entirely funded through appropriations.