FY 2011 PDUFA Performance Report
I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2011 Prescription Drug User Fee Act (PDUFA) Performance Report to the President and Congress. This report marks the 19th year of PDUFA and the fourth year of PDUFA IV (FY 2008 through FY 2012).
This report provides final performance for the third year of PDUFA IV (FY 2010) and preliminary performance for the fourth year (FY 2011). FDA either met or exceeded almost all review performance goals in the third year of PDUFA IV (FY 2010), an improvement from FY 2009 when FDA met over half of the review performance goals. In addition to the improvement in meeting performance goals, the estimated median approval times for priority and standard New Drug Application (NDA) and Biologics License Application (BLA) were lower for both types of applications. Preliminary results of reviews completed during FY 2011 indicate that FDA has the potential to meet or exceed almost all FY 2011 review performance goals.
Since the passage of PDUFA, user fees have played an important role in providing FDA with the resources necessary to reduce review times for innovative drugs and biologics, and, therefore, provide patients and doctors with earlier access to breakthrough treatments. Under PDUFA IV, FDA has faced an unpredictable workload that was further complicated by increased commitments with the implementation of the Food and Drug Administration Amendment Act (FDAAA). Under Titles IV and V of FDAAA, additional reviews of pediatric assessments, written requests for pediatric studies, and increased focus on evaluating pediatric adverse events reports have resulted in increased time and resources devoted to pediatric functions. Submissions mandated under Title VIII have required increased staff review and follow-up to ensure compliance. Addressing drug safety issues required under Title IX, particularly with respect to risk evaluation and mitigation strategies and other postmarketing safety issues, has involved additional staff resources, public meetings, assessment of adverse event signals, and increased public reporting of FDA activities.
We are committed to meeting all PDUFA performance goals, including the procedural goals related to human drug review. The goals that apply to thousands of sponsor-requested meetings each year remain a challenge, and FDA will continue to strengthen efforts to improve performance in these areas. This will be done while maintaining a focus on ensuring that safe and effective drugs are approved in a short and predictable time frame.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs