FY 2013 PDUFA Performance Report
I am pleased to present to the President and Congress the Food and Drug Administration’s (FDA) fiscal year (FY) 2013 Prescription Drug User Fee Act (PDUFA) Performance Report. This report marks the 21st year of PDUFA and the 1st year of PDUFA V (FY 2013 through FY 2017).
This report details FDA’s final performance for the fifth and final year of PDUFA IV (FY 2012) and preliminary performance for the first year of PDUFA V (FY 2013). FDA met or exceeded 11 of 12 performance goals in FY 2012. Similarly, preliminary results of reviews completed in FY 2013 indicate that FDA has the potential to meet or exceed almost all (11 of 12) review performance goals again for FY 2013.
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, with median priority application review times at or less than 6 months for both FY 2011 and FY 2012. The percentage of standard applications approved during the first review cycle also increased to the highest levels ever recorded in FY 2012.
We are committed to meeting all PDUFA performance goals related to human drug review. Although FDA realized higher performance levels and met more procedural goals than ever before in FY 2012, FDA continues to strengthen efforts to improve performance in these areas while maintaining a focus on ensuring that safe, effective, and high-quality new drugs and biologics are reviewed in an efficient and predictable time frame.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs