Research & Development


The Prescription Drug User Fee Act VI: Promoting the timely availability of safe and effective medicines to patients

The Prescription Drug User Fee Act (PDUFA) provides the U.S. Food and Drug Administration (FDA) with resources to support the efficient and predictable regulatory review of new medicines. PDUFA is critical to ensuring America’s biopharmaceutical companies can continue scientific innovation and bring new treatments in a timely fashion to help patients live longer, healthier lives.
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PDUFA VI: Advancing a New Era of Medicine for Patients

   How Does PDUFA Enhance the Drug Development Process?

  • Facilitates science-based integration of the patient perspective into the development and regulatory review of innovative medicines.
  • Enhances the FDA’s access to the tools, processes and expertise necessary to keep pace with the latest scientific advances in drug development and regulation.
  • Helps accelerate the development and availability of new medicines to patients while providing scientific and regulatory predictability that will foster continued biopharmaceutical innovation.
  • Ensures that FDA can hire and retain a strong scientific and medical workforce to advance its public health mission.


History of PDUFA

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 percent of medicines were first approved outside of the United States.

In 1992, Congress passed the first PDUFA and now, more than 25 years later, the average approval time for a new medicine is just 10 months, and 78 percent of medicines are now first approved in the U.S.

To help make the review process more efficient, biopharmaceutical companies pay two different user fees under PDUFA VI:

  • Application fee: Fee due when a sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA).
  • Program fee: Post-approval annual fee for most prescription drug products approved by October 1 of each fiscal year for which no generic drug exists.
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 Accomplishing:

      PDUFA VI is strengthening the FDA’s human drug review program and helping the Agency remain the global “gold-standard” of medicine review through:

  • Real-World Evidence (RWE): By employing the data uncovered in the “real-world” practice of medicine – whether through electronic health records, payer administrative claims, or patient registries – the FDA can harness valuable information about the safety and efficacy of a medicine in a broader population than a clinical trial. PDUFA VI provides additional resources to the FDA to help develop a better understanding of how RWE can be used in regulatory decision-making.

  • Patient-Focused Drug Development: PDUFA VI boosts the FDA’s expertise and capacity to advance the science of patient input and to incorporate patient perspectives in the drug development and review processes. Understanding how medicines improve how a patient feels and functions is just as important as clinical benefit. Patients, family members, and caregivers can provide their unique and valuable perspectives on their disease condition and available treatment options to advance this understanding. These perspectives can help inform evaluations of a medicine’s benefits and risks, provide additional context for FDA’s regulatory decision-making, and help researchers better identify clinical outcomes that matter to patients and their caregivers.

  • Innovative Clinical Trial Design: Randomized controlled clinical trials (RCTs) have long been the industry-standard for assessing efficacy and safety of new medicines. However, as the drug development process adapts to bring innovative new treatments to patients faster, the clinical trial process must become nimbler. PDUFA VI enhances drug development by establishing processes to facilitate appropriate use of innovative clinical trial designs and novel statistical methods which will help to enhance their review and acceptance in the drug review process.