I am pleased to present the Food and Drug Administration’s (FDA’s) Fiscal Year (FY) 2009 Performance Report to Congress for the Animal Drug User Fee Act (ADUFA). Congress reauthorized ADUFA for an additional 5 years on August 14, 2008. With this reauthorization, the first 5-year period (FY 2004 through FY 2008) of ADUFA is now referred to as ADUFA I, and the additional 5-year period (FY 2009 through FY 2013) is referred to as ADUFA II.
This report marks the sixth year of FDA performance review under ADUFA and finalizes FY 2008 performance results under ADUFA I. This report also presents FDA’s accomplishments for FY 2009, the first year of ADUFA II. It is my pleasure to report that FDA exceeded all ADUFA I performance goals for FY 2008. FDA completed action on approximately two-thirds of ADUFA II submissions and met almost all individual submission review time goals. While actions are still pending, FDA is on track to exceed all performance goals for FY 2009.
FDA performance under ADUFA demonstrates our commitment to improving the efficiency, quality, and predictability of the new animal drug review process. We are dedicated to exploring new approaches and technologies that offer high quality and cost-effective improvements in the review of new animal drug applications (NADAs) and investigational new animal drug (INAD) submissions. The enhancements provided in ADUFA II will help us continue to improve the efficiency of the approval process and enhance communication between FDA and the industry. 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 and potentially reduce the number of review cycles.
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