Research & DevelopmentPDUFA

The Prescription Drug User Fee Act VI

The Prescription Drug User Fee Act (PDUFA) provides the U.S. Food and Drug Administration (FDA) with necessary resources to meet performance goals for the regulatory review of new medicines. PDUFA is critical to ensuring America’s biopharmaceutical companies can continue scientific innovation and bring new treatments to help patients live longer, healthier lives.

History of PDUFA

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.

PDUFA has played a critical role in bolstering the FDA’s ability to regulate safe and effective medicines for patients. The user fee was first 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 25 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.

The FDA released the PDUFA VI performance goals letter in July 2016, and Congress voted to reauthorize the program in August of 2017. It was signed into law on August 18, 2017 and takes effect on October 1, 2017.

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.

PDUFA VI Accomplishments

  • 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.

The PDUFA VI agreement is an important step forward in ensuring patient safety, maintaining the FDA’s high standards of regulatory review and promoting timely access to safe and effective medicines for patients.