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U.S. Department of Health and Human Services

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FY 2012 PDUFA Performance Report

Commissioner’s Report

I am pleased to present the President and Congress the Food and Drug Administration’s (FDA) fiscal year (FY) 2012 Prescription Drug User Fee Act (PDUFA) Performance Report. This report marks the 20th year of PDUFA and thefifth year of PDUFA IV (FY 2008 through FY 2012).
Since the enactment of PDUFA IV, we have seen improvements in the number of goals met each year. In the first year of PDUFA IV (FY 2008), FDA met or exceeded four of 12 review performance goals. In the second year of PDUFA IV (FY 2009), FDA met or exceeded seven of 12 review performance goals. In PDUFA IV’s third year (FY 2010), FDA met or exceeded 11 of 12 review performance goals. This report details FDA’s final performance for the fourth year of PDUFA IV (FY 2011) and preliminary performance for the fifth year (FY 2012). FDA exceeded almost all (11 of 12) review performance goals in FY 2011, and preliminary results of reviews completed in FY 2012 indicate that FDA has the potential to meet or exceed almost all (11 of 12) review performance goals again for FY 2012.
In addition to meeting performance goals, FDA’s estimated median approval times for priority and standard New Drug Applications (NDAs) and Biologics License Applications (BLAs) continued to improve. The percentage of applications approved during the first review cycle in FY 2011 increased to the highest levels ever recorded for both priority and standard NDAs and BLAs, and with applications still pending within the PDUFA goal date, these levels have the potential to reach even higher.
FY 2012 also saw an increase in the number of submitted original NDAs and BLAs while the number of resubmissions and supplements decreased. Increasing original submissions along with decreasing resubmissions, improving median approval times, and increasing percentages of first-cycle approvals indicate that more potentially life-saving drugs and biological products are reaching the market faster as more applications are approved during the first-cycle without requiring additional resubmissions.
We are committed to meeting all PDUFA performance goals, including the procedural goals related to human drug review. FDA has seen great improvement in recent years, and this year we saw higher performance levels and met more procedural goals than ever before. FDA will continue to strengthen efforts to improve performance in these areas while, as always, maintaining a focus on ensuring that safe and effective drugs are reviewed in an efficient and predictable time frame.
                                                                        Margaret A. Hamburg, M.D.
                                                                        Commissioner of Food and Drugs

Printable Version of the FY 2012 PDUFA Performance Report