All About PDUFA

Over the last twenty-five years, there’s one piece of legislation that has quietly made an enormous difference in the speed at which new medicines come to market: the Prescription Drug User Fee Act, or PDUFA. PDUFA’s goal is simple but powerful: give the Food and Drug Administration (FDA) more resources in order to expedite review of potential new treatments, ultimately allowing safe and effective medicines to reach people faster.

Prior to PDUFA’s introduction in 1992, it often took more than two years to review new drug applications—meaning patients endured long waits before receiving access to new, potentially lifesaving medicines. But additional resources have enabled the FDA to hire more researchers and reviewers, expand its scientific expertise to keep up with modern medicine, and improve communication and transparency. More timely reviews and approvals have ushered in our country’s most productive period for new medicines.

PDUFA must be reviewed and reauthorized by Congress every five years, and it is currently being reviewed by the House and Senate committees who oversee our nation’s health policy. We need to advance the great strides already accomplished in patient care and drug review by passing a swift reauthorization of this important bill. We hope the new version of the agreement will: 

  • Deepen the involvement of patients through the use of the Patient Focused Drug Development tools and the evolving Benefit/Risk assessment (B/R) frameworks.
  • Explore ways in which tools such as biomarkers and Patient Reported Outcomes can accelerate drug development and produce treatments that fill unmet medical needs.
  • Streamline evaluation methods for combination products, which are two or more components, i.e., medical devices, biologics, or medicines that are combined to produce a new treatment. 

Learn more about PDUFA’s impact on the FDA in the infographic below, and stay tuned for more as PDUFA makes its way through Congress over the next few months.

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