I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2010 Performance Report to Congress for the Animal Generic Drug User Fee Act (AGDUFA). On August 14, 2008, AGDUFA was signed into law. AGDUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by authorizing the first generic animal drug user fee program for FY 2009 through FY 2013. AGDUFA follows the Animal Drug User Fee Act (ADUFA) model and also is similar to the Prescription Drug User Fee Act (PDUFA) program.
It is my pleasure to report that FDA continued to make excellent progress in the second year of implementing AGDUFA and met virtually every review-time goal for reviews completed during FY 2010. In addition, FDA has addressed the entire backlog of abbreviated new animal drug applications (ANADAs) and generic investigational new animal drug (JINAD) submissions. The backlog was completely eliminated in August of 2010.
Each year under AGUDFA, the number of days to meet the review-time goals is decreased while the overall performance goal level of 90 percent of reviews is maintained. FDA agreed to these increasingly challenging goals as part of our commitment to improve the efficiency, quality, and predictability of the new animal generic drug review process. We look forward to the improvements in the animal generic drug review process that AGDUFA will make possible in the coming years.
The report that follows presents FDA’s accomplishments for FY 2010, the second year operating under AGDUFA.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs