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U.S. Department of Health and Human Services

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FY 2010 PDUFA Performance Report

Commissioner’s Report


I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2010 Prescription Drug User Fee Act (PDUFA) Performance Report to the President and Congress. This report marks the 18th year of PDUFA and the third year of PDUFA IV (FY 2008 through FY 2012).

Since the passage of PDUFA, user fees have played an important role in providing FDA with the resources necessary to more efficiently review new medicines, reduce review times for innovative drugs and biologics, and therefore provide patients and doctors with earlier access to breakthrough treatments. Since the beginning of PDUFA IV, FDA has been faced with an unpredictable workload that was further complicated by unanticipated challenges and increased commitments with the implementation of the Food and Drug Administration Amendment Act (FDAAA). Faced with increased workload and new commitments in FY 2008, FDA necessarily preserved the integrity of the review process and maintained a focus on the safety of prescription drugs, which resulted in temporary delays of some reviews and lower than expected performance in FY 2008 and FY 2009. In FY 2010, the number of original new drug applications (NDAs) and biologics license applications (BLAs) fell by over one-fourth when compared to FY 2009 levels, substantially easing FDA reviewer workloads, and allowing performance to begin returning to higher levels.
This report provides final performance for the second year of PDUFA IV (FY 2009) and preliminary performance for the third year (FY 2010). FDA either met or exceeded over half (7 of 12) of review performance goals in the second year of PDUFA IV (FY 2009), an improvement from FY 2008 when FDA met only one-third (4 of 12) of the review performance goals. In addition to the improvement in meeting performance goals, the estimated median approval times for priority and standard NDAs and BLAs, which both increased in FY 2008, improved and are lower for both types of applications. Additionally, preliminary results of reviews completed during FY 2010 indicate that FDA has the potential to meet or exceed almost all (11 of 12) FY 2010 review performance goals.
These results are encouraging, but FDA still has challenges to address. We are committed to meeting or exceeding all review performance goals, and FDA’s performance with FY 2010 procedural goals remained less than satisfactory. Therefore, FDA will strengthen efforts to improve performance in all areas. This will be done while maintaining a focus on ensuring that the safest, highest quality prescription drugs are approved in the shortest possible time.
                                                                        Margaret A. Hamburg, M.D.
                                                                        Commissioner of Food and Drugs

Printable Version of the FY 2010 PDUFA Performance Report