I am pleased to present the Food and Drug Administration’s (FDA’s) Fiscal Year (FY) 2012 Performance Report to Congress for the Animal Drug User Fee Act (ADUFA). On August 14, 2008, the reauthorization of ADUFA for an additional five years was signed into law. With this reauthorization, the first five-year period (FY 2004 through FY 2008) of ADUFA is now referred to as ADUFA I, and the additional five-year period (FY 2009 through FY 2013) is referred to as ADUFA II.
This report marks the ninth year of FDA performance review under ADUFA and finalizes performance results for FY 2011, the third year of ADUFA II. This report also presents FDA’s accomplishments for FY 2012. It is my pleasure to report that FDA exceeded all performance goals for FY 2011. FDA also met review-time goals for all FY 2012 cohort submissions reviewed or due for review by September 30, 2012. With reviews pending within the goal deadlines, FDA is on track to exceed all performance goals for FY 2012.
A key improvement under ADUFA II is the “end-review amendment” (ERA) process that allows FDA reviewers to work with the drug sponsor to amend certain pending submissions. The ERA process allows us to decrease the number of review cycles, ultimately leading to a shorter time to approval. Improved communication early in the process has the greatest potential to reduce review cycles. The greatest effect of this new tool under ADUFA II has been with submissions of investigational new animal drug (INAD) studies and study protocols.
FDA looks forward to the continued success and significant improvements in the animal drug review process made achievable by ADUFA.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs