PDUFA I to PDUFA III: An Evolution in Review Progress

FY 2008 PDUFA Performance Report Table of Contents

Overview of PDUFA

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.

Since the implementation of PDUFA I, FDA has utilized PDUFA resources to significantly reduce the time it takes to evaluate new drugs without compromising FDA’s rigorous standards for safety and efficacy. This has allowed the American people to gain quicker access to valuable therapies and has increased the economic incentive for sponsors to develop innovative drug and biological products. Without the funds derived from PDUFA fees, the substantial progress FDA has achieved in improving and expediting the review of human drug applications would not have been possible.

• Speeding Up Application Review (FY 1993 through FY 1997). During the first few years of PDUFA I, FDA eliminated backlogs that had formed in earlier years when FDA had fewer resources. With increased resources under PDUFA I, FDA was able to commit to and achieve review performance targets that applied to an increasing percentage of complete application submissions.
• Speeding Up Drug Development (FY 1998 through FY 2002). Under PDUFA II, a number of review performance goals were shortened. Additionally, new goals expanded the scope of work to improve communication between FDA and application sponsors during the drug development process. These goals specified time frames for scheduling meetings and responding to various sponsor submissions, such as special protocol assessments and responses to clinical holds.
• Refining the Process - From Drug Development through Application Review to Postmarket Surveillance (FY 2003 through FY 2007). PDUFA III established several new initiatives to improve application submissions and FDA-sponsored interactions during drug development and application review. In addition, PDUFA III authorized FDA to spend user fee funds on certain aspects of postmarket risk management, including surveillance of products approved after October 1, 2002, for up to 3 years after approval.

Next page: PDUFA IV: Changes to Implement and Challenges to Meet