The Prescription Drug User Fee Act (PDUFA) VI

The Prescription User Fee Act (PDUFA) Provides a Transparent and Efficient Process for FDA Review of New Medicines and Treatments

History of PDUFA

Before the Prescription User Fee Act (PDUFA), it often took the Food and Drug Administration (FDA) more than two years to review new medicines, and more than 70 percent of medicines were first approved outside of the United States.

PDUFA has played a critical role in bolstering the FDA’s ability to regulate safe and effective medicines for patients. PDUFA was created in response to a bottleneck of new drug approvals in the late 1980s and early 1990s that left patients waiting while an under-staffed and under-funded FDA struggled to review applications for new medicines. In 1992, Congress passed the first PDUFA to meet urgent patient demands for more timely approvals of life-saving treatments and cures.

For more than 20 years, PDUFA has helped the FDA fulfill its central mission – to protect and promote the public health by allowing the Agency to keep pace with the rapid increase in the number and complexity of innovative drugs and biologics entering the drug development and regulatory review pipeline.

How it works

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

  • Application fees: Fee due when a sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA).
  • Product fees: Annual fee for marketed drugs for which no generic versions are approved.
  • Establishment fees: Annual fee for each manufacturing site that manufactures at least one approved prescription drug for which no generic versions are approved.

Regulatory Timeline


PDUFA VI Priorities

  • Better Integrate the Patient Perspective in Drug Development and Regulatory Decision-Making
  • Enhance the Scientific Expertise, Processes, and Tools FDA Uses to Make Regulatory Decisions
  • Promote Long-Term Stability of the PDUFA Program: Resource and Workforce Management

Reauthorization of PDUFA is critical to ensuring America’s biopharmaceutical companies can continue scientific innovation and bring new treatments to help patients live longer, healthier lives. To learn more visit the FDA’s PDUFA resource page. To learn more about the drug development process check out


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