Animal Generic Drug User Fee Act (AGDUFA)

On August 14, 2008, President Bush signed into law the Animal Generic Drug User Fee Act (AGDUFA) of 2008. This Act amends the Food, Drug and Cosmetic Act by authorizing the first ever generic animal drug user fee program. These fees will enhance the performance of the generic new animal drug review process and will enable FDA to better ensure that generic new animal drug products are safe and effective and give consumers a lower cost alternative to pioneer drugs.

The Animal Generic Drug User Fee Act (AGDUFA) is the first ever generic drug user fee program (for either human or animal drugs). The program will provide consumers with multiple sources of animal drugs, better ensuring an adequate supply of animal drugs.

Under the Animal Generic Drug User Fee Act, FDA agrees to meet review performance goals to improve the timeliness and predictability of the animal generic drug review process. These performance goals are intended to achieve progressive yearly improvements, shortening the time for FDA to review and act on submissions with each fiscal year. By the fifth and final year of the user fees, FDA would agree to review and act on 90 percent of the sentinel submission types within specified timeframes.

Following the ADUFA model, AGDUFA will provide funding for increased review staff, training and development for staff members, and for refining business processes and developing policies targeted at more efficient review.

FDA’s review of generic drugs is currently entirely funded through appropriations.

The Animal Generic Drug User Fee program will generate $27 million in user fees over five years (FY 2009 – FY 2013).