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 2021 alone, approximately 76% of novel drugs 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.
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: