On August 18, 2017, the President signed into law the FDA Reauthorization Act of 2017 (FDARA), which included the reauthorization of the Prescription Drug User Fee Act (PDUFA) for 5 additional years (FY 2018 through FY 2022, referred to as PDUFA VI). 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 high standards for approval.
PDUFA I to PDUFA VI: An Evolution in Review Progress
Since the implementation of PDUFA I in 1993, FDA has used PDUFA resources to significantly reduce the time it takes to evaluate new drugs without compromising the statutory standards for safety and effectiveness. The shorter and more predictable review times enabled by PDUFA resources have allowed the American people to gain quicker access to new medicines. Without the funds derived from PDUFA fees, the substantial progress FDA has achieved and subsequent benefits to the American public health would not have been possible.
- PDUFA I: Reducing Application Review Time (FY 1993 to 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 goals that incrementally increased to 90 percent levels.
- PDUFA II: Facilitating the Drug Development Process (FY 1998 to FY 2002). Under PDUFA II, a number of review performance level commitments were shortened. Additionally, new procedural goals expanded the scope of work to improve communication between FDA and 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.
- PDUFA III: Refining the Process - From Drug Development to Application Review to Postmarket Surveillance (FY 2003 to 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 three years after approval.
- PDUFA IV: Enhancing Drug Safety (FY 2008 to FY 2012). PDUFA IV increased user fees to enhance drug safety and established goals that focused on securing FDA’s sound financial footing, enhancing premarket review, and creating a modern postmarket safety system. Specific changes included adjusting user fees based on inflation and workload to ensure FDA had the resources needed for the timely review of new drugs, expanding the implementation of Good Review Management Practices and creating additional initiatives designed to help expedite drug development, and allowing FDA to allocate user fees to ensure drug safety across the full life cycle of drug products in the postmarket setting.
- PDUFA V: Innovation and Modernization in the Drug Review Process (FY 2013 to FY 2017). PDUFA V continues the rigorous performance goals established under PDUFA IV while adding a new program to enhance the review of new molecular entities and biologics and increasing the utilization of the electronic submissions system.
- PDUFA VI: PDUFA VI (FY 2018 to FY 2022) built upon the successes of PDUFA V and committed the agency to numerous initiatives to ensure the continued success of the human drug review program. These activities include, but are not limited to, enhancements in regulatory science and in regulatory decision-making tools such as patient-focused drug development, increased use of a benefit-risk framework, and pilot programs for model-informed drug development and complex innovative trial designs. Additionally, PDUFA VI also helped FDA expand its efforts to modernize its approach to long-term capacity and financial planning.
Annual performance reports are prepared by FDA's Office of Planning and Evaluation in collaboration with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
*FY 1993 and FY 1994 reports can be obtained through the contact information provided below.
For additional information on these reports, please contact:
Office of Planning
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
PDUFA Performance Reports
Performance reports for previous years are available in the FDA Archive.