PDUFA: Essential to America’s edge in drug development and patient access

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PhRMA recently participated in the U.S. Food and Drug Administration’s (FDA) public meeting to discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA), where we shared how the program continues to benefit countless patients by ensuring they are afforded timely access to safe and effective innovative medicines.

The big picture: PDUFA was first enacted by Congress in 1992 as a uniquely bipartisan initiative, initially geared toward combating the ongoing HIV/AIDS epidemic by providing resources to speed the FDA’s review backlog of drug applications. At the time, it took the FDA more than two years to review new medicines, which sparked patient activists to call for faster review times so that all Americans could receive timely access to safe and effective medicines.

PDUFA has supported patient access to new medicines that meet FDA’s rigorous standards for safety and efficacy, while helping the agency keep pace with the number and complexity of innovative medicines entering the review pipeline.

Today, the United States leads the world in the introduction of new medicines. The FDA is the global gold standard for regulatory review, and the average review time for a medicine is now just 10 months for a standard application and 6 months for priority applications. In fact, 33 of the 50 newly-approved medicines in 2024 used one or more expedited program to expedite drug review.
But before PDUFA was enacted in 1992, more than 70% of medicines were first approved outside of the United States. In 2024, close to 70% of new medicines were first approved in the United States.
To maintain America’s global competitiveness in biopharmaceutical innovation, it is more important than ever that the FDA is properly resourced, staffed and equipped.

Zoom in: PDUFA has helped enable access to more than 1,700 new drugs and biologics, including treatments for conditions like cancer, cardiovascular, neurological and rare diseases, which are improving the quality of life and health outcomes for patients nationwide.

PDUFA has supported the review of regenerative medicines, like Chimeric Antigen Receptor (CAR) T-cell therapies, which harness patients’ own cells to fight tumors.
It has supported regulatory science advancements that have contributed to the development of new Alzheimer’s treatments that help slow disease progression.

Go deeper: The program supports innovative clinical trial designs, as well as the use of real-world evidence and digital health tools – all of which have resulted in faster patient access to transformative medicines. These tools and approaches to drug development must continue to advance and are integral to keeping the United States competitive in biopharmaceutical research and development.

What’s next: The program has historically received strong bipartisan support from policymakers on Capitol Hill, and it is crucial that it continues to be reauthorized in the years ahead. The most recent PDUFA (PDUFA VII) was signed into law on September 30, 2022, and runs through September 30, 2027.

We will continue to work with the FDA and other stakeholders to ensure the timely negotiation and reauthorization of this important program through PDUFA VIII. It’s vital that PDUFA VIII enhances the FDA’s ability to keep pace with the volume and complexity of innovative medicines entering the review pipeline by being efficient, pro-innovation, patient-centric and accountable. PDUFA VIII should further cement America’s place as the global leader in biopharmaceutical research and development and timely patient access to innovative medicines.

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

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