PDUFA
The Prescription Drug User Fee Act: Promoting the timely availability of safe and effective medicines to patients
The Prescription Drug User Fee Act (PDUFA) has helped the U.S. Food and Drug Administration (FDA or Agency) fulfill its central mission – to protect and advance public health – by allowing the Agency to keep pace with the number and complexity of innovative medicines entering the review pipeline. In large part because of PDUFA, the United States leads the world in the introduction of innovative new medicines, and the FDA’s human drug review program is the global gold standard for regulatory review and approval.
Since 1992 when the program was first enacted, PDUFA has helped enable timely access to more than 1,000 novel new drugs and biologics including treatments for cancer, rare diseases, cardiovascular, neurological and infectious diseases.
PDUFA continues to play a critical role in strengthening the FDA’s ability to review human drug applications. The program also provides biopharmaceutical companies with greater regulatory predictability, which fosters industry investment in research and development. At each five-year reauthorization of PDUFA, FDA and the biopharmaceutical industry can advance initiatives that further support innovation and enhance the regulatory review process and that are captured in the PDUFA goals letter.
The Prescription Drug User Fee Act (PDFUA VIII)
PDUFA VII
History of PDUFA
The PDUFA user fee program was first created in response to a bottleneck of new medicine approvals that left patients waiting for years for an under-staffed and under-funded FDA to review new drug applications. Before PDUFA, it often took the FDA more than two years to review new medicines, and more than 70% of medicines were first approved outside of the United States.
In 1992, Congress, recognizing these challenges, passed the first PDUFA and now, 30 years later, the average approval time for a new medicine is 10 months for standard applications and eight months for priority review applications, and in 2023 alone, approximately 64% of novel drugs reviewed by the Center for Drug Evaluation and Research, were approved in the United States before any other country. PDUFA has played an essential role in strengthening FDA’s ability to support innovation while maintaining the Agency’s high standards for scientific rigor and patient safety.
History of PDUFA
PDUFA user fees graphics
PDUFA VII supports the development and timely regulatory review of innovative medicines to the benefit of patients
PDUFA VII was signed into law on September 30, 2022. The associated PDUFA VII goals letter was negotiated by the FDA, with input from patient advocacy groups and industry stakeholders and builds upon previous iterations with a renewed focus on strengthening FDA’s critical capabilities, improving efficiencies in drug review and driving innovation for patients. The PDUFA VII goals letter addresses new areas such as advancing digital health technologies, enhancing product quality reviews and facilitating increased utilization of innovative manufacturing technologies. The current user fee authorization expires September 2027.
Key areas of the PDUFA VII goals letter include:
PDUFA is Accomplishing
areas of PDUFA VII
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Website Updated as of March 2023