I am pleased to present to Congress the Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2016 Performance Report to Congress for the Animal Generic Drug User Fee Act (AGDUFA). On August 14, 2008, AGDUFA was signed into law. AGDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by authorizing the first generic animal drug user fee program from FY 2009 through FY 2013. On June 13, 2013, AGDUFA was reauthorized for an additional 5 years (FY 2014 through FY 2018), referred to as AGDUFA II. This report marks the third year of AGDUFA II.
This report details FDA’s preliminary performance for FY 2016, and finalizes performance results for FY 2015. It is my pleasure to report that FDA exceeded all performance goals for FY 2015. The Agency also met review-time goals for all FY 2015 cohort submissions reviewed or due for review by September 30, 2016. FDA is on track to exceed all performance goals for FY 2016.
The timely approval of generic animal drugs continues to be a critical component of animal health because it provides quicker access to additional sources of more affordable animal drugs for ranchers, farmers, and pet owners. Since AGDUFA was enacted, FDA has been able to dramatically reduce average review times from 700 days to less than 270 days. We look forward to the continued success in the generic animal drug review process that the AGDUFA program will make possible in the coming years.
Robert M. Califf, M.D.
Commissioner of Food and Drugs