FY 2009 PDUFA Performance Report
I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2009 Prescription Drug User Fee Act (PDUFA) Performance Report to the President and Congress. This report marks the 17th year of PDUFA and the second year of PDUFA IV (FY 2008 through FY 2012).
In the first 2 years under PDUFA IV (FY 2008 and FY 2009), FDA faced new challenges with implementation of the Food and Drug Administration Amendment Act (FDAAA) that initially affected our ability to meet performance goal commitments. In addition to previous responsibilities with PDUFA, FDAAA mandated new performance commitments and process improvements. At the same time, FDA faced increased workloads of original submissions. Faced with these new challenges, FDA necessarily preserved the integrity of the review process and maintained a focus on the safety of prescription drugs, and that resulted in temporary delays of some reviews. Consequently, FDA did not meet many of the FY 2008 PDUFA performance review goals. Although FDA was close to meeting the majority of review performance goals, we either met or exceeded the 90 percent performance levels for one-third (4 of 12 goals) of the review performance goals. In addition to the decline in meeting performance goals, the estimated median approval times for priority new drug applications (NDAs) and biologics license applications (BLAs) showed an increase for the first time in 5 years.
FDA remains committed to achieving the key goals for PDUFA IV that include placing PDUFA on a sound financial footing, enhancing premarket review capacity, and creating a modern postmarket drug safety system. Early indicators for FY 2009 suggest that FDA review performance is on track to return to traditionally high performance. Preliminary results of reviews completed during FY 2009 indicated that FDA has the potential to meet or exceed five-sixths (10 of 12) of review performance goals for the cohort submitted in FY 2009.
FDA’s efforts to improve will continue as we strive to fully restore our performance to meet or exceed all review performance goals. FDA will continue to help ensure access to the safest, highest quality prescription drugs in the world, as quickly as possible.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Printable Version of the FY 2009 PDUFA Performance Report