Prescription Drug User Fee Act

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) in response to growing concerns over the amount of time it took for new safe and effective medicines to reach patients. PDUFA created a user fee program to provide the FDA with additional resources that expedite the review process -- ultimately allowing safe and effective drugs to reach patients faster.

But rather than serve as a one-time, stop-gap measure, PDUFA is updated and offered for congressional approval every five years. Each renewed version of the bill focuses on different, but equally vital, components of the drug development and review processes that need attention. Previous versions addressed areas such as review management practices, multiple regulatory science initiatives and product safety. This adaptability makes PDUFA a versatile and incredibly effective, recurring opportunity to improve upon the current processes.

PDUFA ensures patients have continued access to the breakthrough cures and treatments they deserve and allows the U.S. to continue to lead the world in the discovery and delivery of cutting-edge medicines. The law provides the FDA with ample funding, increases its transparency and accountability and establishes a more direct line of communication between the agency and sponsors during the review process.

Prior to PDUFA, 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 timely reviews and approvals since the bill’s enactment have ushered in America's most productive period for new drug development.

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Congress will vote to reauthorize PDUFA VI in the fall of 2017. We need to advance the great strides already accomplished in patient care and drug review. We hope that the new version of the agreement will accomplish the following objectives:

  • 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 drug development tools, such as biomarkers and Patient Reported Outcomes (PROs), can accelerate drug development and produce treatments to fill unmet medical needs.

  • Streamline the existing evaluation methods for combination products, two or more components, i.e., medical devices, biologics, or medicines that are combined to produce a new treatment.

  • Encourage the use of adaptive trial designs and other scientifically rigorous statistical methods, which will render clinical trials more cost effective and medicines safer.

  • Integrate today’s myriad of digital health tools into the review process to put more quality medicines on the market faster.

  • Augment the financial foundation of the program to ensure that it remains sustainable, while also ensuring an understanding of FDA needs through transparent and accountable use of user fees.

As patient advocacy groups, pharmaceutical companies and regulators work toward the sixth consecutive renewal of PDUFA, we encourage you to stay involved. Be sure to check in with us to learn about new developments and ways that you can help PDUFA remain an effective and dynamic program.

Recent Updates

  • PDUFA: The Facts and Figures

    Every five years, Congress revises the Prescription Drug User Fee Act (PDUFA) to modernize the development, review and delivery of...

  • The History of PDUFA

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  • Back to School with PDUFA

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  • The Discussion on PDUFA VI Begins

    This week kicks off the first of a series of public forums on the Prescription Drug User Fee Act (PDUFA),...

  • PDUFA: Looking Back and Moving Ahead

    Since its initial passing in 1992, the Prescription Drug User Fee Act (PDUFA) has done wonders to improve the Federal...