Prescription Drug User Fee Act PDUFA

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.

First enacted in 1992, PDUFA was conceived to overcome the “the drug lag” of the 1980’s by providing the FDA with resources to keep new medicines moving from the labs of drug research and development companies to American patients.

In the last 20 years, PDUFA has resulted in timelier patient access to more than 1,500 new drugs and biologics, decreasing review times for these treatments by more than 60 percent.


The fifth version of PDUFA, known as PDUFA V, was reauthorized in July of 2012 and refocuses the program on its original intent—patient access to life-saving medicines.

PDUFA V will:

  • help foster more timely patient access to new medicines
  • enhance FDA’s regulatory science capacity
  • encourage future innovation
  • strengthen the FDA’s high safety standards

PhRMA strongly supported the authorization of PDUFA V to give patients access to new medicines more effectively and efficiently.


  • Increases communication between the FDA and the pharmaceutical industry
  • Creates a more transparent and streamlined review process for new molecular entities
  • Strengthens the FDA’s already robust drug safety system by refining and maximizing existing tools and technology
  • Provides continuous engagement and assessment for all stakeholders allowing us to build toward the next round of PDUFA authorization in 2017.

Learn more! Download a PDUFA 101 pocket card.


More On PhRMA — powered by PhRMApedia

Most Read