FY 2008 PDUFA Performance Report
I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2008 Prescription Drug User Fee Act (PDUFA) Performance Report to the President and Congress. This report marks the 16th year of PDUFA and the beginning of PDUFA IV (FY 2008 through FY 2012).
PDUFA IV marks a milestone for FDA and provides important new benefits related to the safety of prescription drugs. With expanded responsibilities and funding to cover postmarket safety provided under the Food and Drug Administration Amendments Act of 2007 (FDAAA), and new requirements related to premarket pediatric drug review, FDA was provided with new tools to enhance the safety of prescription drugs available to the American public.
The transition to PDUFA IV also provided unprecedented challenges to FDA. Expanding the work force, training and mentoring new staff, and adapting to new requirements including the new broad authorities under FDAAA have limited FDA’s ability to review as high a percentage of applications and submissions on time as in previous years. Our priorities and focus remained on ensuring reviews were completed with the quality expected from the public and from our dedicated workforce. However, performance in many traditionally strong PDUFA goal areas decreased in FY 2008; and, therefore, this report presents a picture of mixed success. Many goals were exceeded or met, while many others were not. And potential performance for FY 2008 submissions still under review at the end of the fiscal year was not as high as in past years.
Despite these setbacks, FDA will not back down from its commitments to the public and those made under PDUFA IV. The agency has taken steps to improve performance and will continue to work to expand its ability to review drugs in a timely manner. Through these efforts, FDA will continue to improve premarket review and postmarket safety to provide the American public with the safest and highest quality prescription drugs in the world.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Printable Version of the FY 2008 PDUFA
Overview of PDUFA
On September 27, 2007, the President signed into law FDAAA, which includes the reauthorization and expansion of PDUFA (PDUFA IV) for 5 more years (FY 2008 through FY 2012). PDUFA provides FDA revenue to hire additional reviewers and support staff, and upgrade its information technology systems to maximize the efficiency of the application review process for new drugs and biological products without compromising FDA’s traditionally high standards for approval.
Report on FY 2007 and FY 2008 PDUFA Goals
Report on FY 2007 and FY 2008 PDUFA Goals Review Performance Presented in the Report Annual On-Time Review Performance for FY 2008 Performance Goals At-A-Glance: FY 2007 and FY 2008 Original Applications Resubmitted Applications Efficacy Supplements Resubmitted Efficacy Supplements Manufacturing Supplements First Cycle Filing Review Notification
Report on FY 2008 PDUFA Procedural and Processing Goals, Initiatives, and Commitments
Report on FY 2008 PDUFA Procedural and Processing Goals, Initiatives, And Commitments Performance At-A-Glance for FY 2008 Procedural and Processing Goals – Meeting Management Procedural and Processing Goals – Special Protocol Assessments Procedural and Processing Goals – Responses to Clinical Holds Procedural and Processing Goals – Major Dispute Resolutions First Cycle Filing Review Notification PDUFA IV Management Initiatives Accomplishments PDUFA IV Electronic Applications and Submissions Accomplishments