The PDUFA VII goals letter expands upon the most recent iteration of the user fee agreements which expire in September of 2022 with a renewed focus on strengthening review fundamentals, enhancing accountability and transparency and advancing innovation for patients.
Key areas of the PDUFA VII goals letter include:
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 passed the first PDUFA and now, nearly 30 years later, the average approval time for a new medicine is just 10 months, and over the last five years, approximately 75% 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. To help make the review process more efficient and predictable, biopharmaceutical companies pay two different user fees under PDUFA:
The latest reauthorization of PDUFA (PDUFA VI) was signed into law on August 18, 2017 and took effect on October 1, 2017. It expires September 30, 2022.
PDUFA VI is strengthening the FDA’s human drug review program and helping the Agency remain the global “gold-standard” of medicine review through:
PDUFA is also helping FDA fulfill its central mission of protecting the public health as the Agency responds to the COVID-19 pandemic. Since the start of the pandemic, FDA has been working with biopharmaceutical companies to accelerate the development of safe and effective COVID-19 therapeutics and vaccines. The Agency has provided timely recommendations, regulatory guidance, and technical assistance to developers of potential treatments and vaccines for COVID-19, including on the use of novel approaches to clinical trials and drug review. FDA has also provided clarity to biopharmaceutical sponsors on how to continue to advance the development of new medicines during the current pandemic. PDUFA has helped support this engagement by ensuring FDA’s human drug review program has the infrastructure, scientific expertise and experience with cutting-edge drug development approaches needed to support continued innovation and inform efficient regulatory decision-making.
(Website updated as of August 24, 2021)