The big picture: When patients are waiting for new treatments, safety and speed both matter. For over 30 years, the Prescription Drug User Fee Act (PDUFA) has delivered both — helping establish the U.S. as the first stop worldwide for most new medicine approvals and helping support the FDA's reputation as the global gold standard for regulatory review.
What it is: PDUFA allows the FDA to collect user fees from biopharmaceutical companies to help ensure the agency has the expert staff, scientific resources and modern infrastructure needed to conduct timely, rigorous reviews of new medicines. In return, the FDA commits to meet certain performance goals, as outlined in the PDUFA goals letter.
- Importantly, the PDUFA agreement does not change the FDA's statutory requirements and scientific standards for drug review and approvals or independent regulatory decision-making.
- PDUFA user fees supplement, but do not replace, the FDA’s funding through Congressional appropriations.
- Every five years, the FDA and industry negotiate an agreement for the next reauthorization of PDUFA, with input from patient groups and other stakeholders.
What’s new?
- The negotiations process just concluded for PDUFA VIII and the FDA is preparing to transmit the commitment letter to Congress for reauthorization.
- Tomorrow, September 16, 2026, the FDA will hold a public meeting to discuss the proposed recommendations for the reauthorization of PDUFA VIII.
Why it matters: Since 1992 when patients led the charge with Congress to enact PDUFA, the program has helped create a more efficient, predictable and science-based prescription human drug review process. Before PDUFA, over 70% of medicines were first approved outside the U.S. Currently, close to 70% of new medicine are first approved here. The program benefits patients waiting for new treatment options and supports America's leadership in medical innovation.
What will PDUFA VIII do?
- Timely and more predictable reviews: PDUFA VIII will reduce avoidable delays and help identify potential issues earlier in the development and review process.
How:
- Provides opportunities for more timely FDA feedback during drug development and review.
- Enhances consistency, quality, and timeliness of FDA-sponsor interactions on pivotal clinical trial protocols, labeling and manufacturing that can affect review timelines.
- Establishes a new program intended to help address manufacturing and facility issues earlier, reducing the risk of late-stage setbacks.
- Keeps pace with scientific innovation: Medical innovation is advancing rapidly. PDUFA VIII helps enable the FDA to evolve alongside it.
How:- Incorporates modern evidence, technology and regulatory science tools, such as real-world evidence, innovative trial designs and patient-focused drug development, into standard review practice.
- Advances rare disease drug development, including for pediatric patients, through enhanced stakeholder engagement and scientific collaboration.
- Enhances FDA surveillance and capabilities, including through improving existing FDA tools for post-marketing safety data, with the aim of reducing the need for additional studies after approval.
- Greater accountability and transparency: PDUFA VIII includes new measures to help strengthen public trust and ensure the program continues delivering results.
How:- Improves transparency around how user fees are spent and how the program performs.
- Introduces independent third-party assessments to evaluate FDA performance and identify opportunities for improvement. For example, a third-party assessment will evaluate the new manufacturing facilities program's effectiveness as a more proactive approach to timely address manufacturing facilities deficiencies.
The stakes: The next breakthroughs patients need depend on a strong FDA. PDUFA VII expires on September 30, 2027. Congress must move quickly to reauthorize the PDUFA VIII program. Without it, American patients and innovation will fall behind.
The bottom line: PDUFA VIII builds on a proven framework that helps patients, supports innovation and strengthens America's regulatory ecosystem. It also builds on efforts to modernize clinical development, advance domestic manufacturing and maintain the FDA's position as the global gold standard for regulatory review. PDUFA VIII is how America keeps its promise to patients and its edge in global medicine.
Learn more at PhRMA.org/PDUFA.
Lucy Vereshchagina, PhD
Dr. Lucy Vereshchagina is executive vice president of science and regulatory advocacy at PhRMA. In this role, Dr. Vereshchagina leads PhRMA’s science and regulatory advocacy department supporting PhRMA’s policy, advocacy and science priorities, as well as global regulatory advocacy efforts, including the International Council for Harmonization (ICH). Dr. Vereshchagina was the lead PhRMA negotiator for both PDUFA VII and BsUFA III and testified before Congress on the agreements’ reauthorization.
Prior to joining PhRMA in 2012, Dr. Vereshchagina spent over 12 years with the FDA & Healthcare Practice at an international law firm and the Investigational Drug Branch at the National Cancer Institute. She has a master’s degree in Biochemistry and Chemistry, earned her Ph.D. in Chemistry at the Catholic University of America, and completed her post-doctoral studies in molecular biology and immunology at the Walter Reed Army Institute of Research.
Lucy Vereshchagina
https://www.linkedin.com/in/lucy-vereshchagina-phd-416b27a/
Executive Vice President of Science and Regulatory Advocacy