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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Proposes Reauthorization of User Fees for Pioneer Drugs and Authorization of the First-Ever User Fees for Generic Drugs

by Jon F. Scheid, Editor
FDA Veterinarian Newsletter January / February 2008 Volume XXIII, No I

The Food and Drug Administration sent proposals to Congress April 23 for the reauthorization of the user fee program for “pioneer” animal drugs and for the first-ever generic user fee program for generic animal drugs.

The proposed program for pioneer drugs would generate an estimated $98 million in user fees over 5 years, with $15.2 million collected in FY 2009, the first year of reauthorization of the program.

The proposed generic drug program would generate an estimated $27 million in user fees over 5 years, with $4.8 mil-lion collected in FY 2009, the first year of the program.

The user-fee revenue would supplement appropriated funding for animal drug review and associated activities.

User fees for pioneer drugs

Congress first approved the user fee program for pioneer drugs under the Animal Drug User Fee Act (ADUFA) of 2003. FDA considers the program to be a success. ADUFA established a framework of sustained revenue through appropria-tions and user fees for sustained performance of the animal drug review program. When ADUFA was implemented, FDA set performance goals, including timeframes for drug reviews that were shortened each year of the 5-year ADUFA pro-gram. The additional funding helped FDA’s Center for Veterinary Medicine meet those performance goals, including the deadlines for timely drug application review.

The proposal for ADUFA reauthorization would maintain the FY 2008 review timeframe goals. In addition, the proposal would begin a new process of “end review amendments,” aimed at reducing the number of times a drug sponsor must resubmit an application for review due to the fact that CVM needed additional information to complete the review. The pro-posal would also establish processes to enhance communication between FDA and the animal drug industry, and it calls for the development of an electronic submission tool for industry submissions and online review.

The first (current) ADUFA program will sunset on October 1, 2008. The reauthorization would extend the program until the end of FY 2013.

Generic drug user fees

FDA believes that the availability of generic animal drugs gives consumers safe, effective, and lower cost alternatives to the pioneer drugs. Congress gave FDA the authority to evaluate and approve acceptable generic drugs in 1988 under the Generic Animal Drug and Patent Term Restoration Act.

The proposal for the generic user fee program, contained in the proposed Animal Generic Drug User Fee Act (AG-DUFA), would establish timeframe goals for FDA review of generic drug applications. In addition, CVM would implement programs to enhance its communication with industry.