Prescription Drug User Fee Act

History of PDUFA

First enacted in 1992, the Prescription User Fee Act (PDUFA) was conceived to overcome the “the drug lag” of the 1980’s by providing the Food & Drug Administration (FDA) with resources to keep new medicines moving from the labs of biopharmaceutical research companies to American patients. 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 the last 20 years, PDUFA has resulted in timelier access to more than 1,500 new drugs and biologics and decreased review times for these treatments by more than 60 percent.

However, the broad FDA authorities provided by PDUFA combined with the increasing complexity of submissions further strained FDA resources and challenged the agency’s ability to meet review deadlines.

PDUFA-V

The fifth reauthorization of PDUFA, known as PDUFA-V, refocuses the program on its original intent – patient access to life-saving medicines. If implemented successfully, PDUFA-V will help foster timely patient access to new medicines, enhance FDA’s regulatory science capacity and encourage future innovation while strengthening the agency’s high safety standards.

Some highlights of PDUFA-V include:

• An enhanced review model for new molecular entities (NMEs) that increases communication between the FDA and drug sponsors and enhances the efficiency of reviews.
• Advancement of regulatory science through resources to validate the use of new scientific tools (pharmacogenomics, biomarkers) and meta-analyses that will help decrease drug development time.
• Development of a structured framework for consistently evaluating the benefits and risks of new medicines that includes perspectives from experts in industry, academia and, most importantly, patients.
• Strengthen FDA’s robust drug safety system by refining and maximizing the existing framework, tools and technology.

The unprecedented inclusiveness and accountability built into PDUFA-V provide the foundation to foster innovation and empower our evolving healthcare ecosystem for the future. FDA, industry, stakeholders and lawmakers will have better, timelier information about Agency performance and the progress of the regulatory science initiatives. And the architecture of PDUFA-V provides continuous engagement and assessment for all stakeholders that will allow us to build toward the next round of PDUFA authorization in 2017.

For additional information on the FDA, please visit the FDA section of the PhRMA web site. And, to learn more about the U.S. drug oversight process, please visit the Drug Safety page of our site.

News

PhRMA's Views On PDUFA Reauthorization
Dr. David E. Wheadon, PhRMA's senior vice president for science and regulatory affairs, testifying to the FDA: PDUFA "can play a critical role in making more life-saving medicines available to patients in a timely manner, strengthening the scientific base of the FDA and providing a steady, reliable stream of resources for agency scientists."

Resources

PDUFA Pocket Card
This small, portable pocket card provides a brief “101” on PDUFA generally, and highlights key provisions of PDUFA-V.

PDUFA-V Implementation Milestones
This chart maps public milestones over the next five years for provisions within PDUFA-V.

FDA Information on PDUFA-V
Background information on PDUFA reauthorization and performance goals and procedures for FYs 2013-2017 are available here.

PDUFA Annual Reports And Plans
The FDA must submit annual performance and financial reports on PDUFA to Congress and the president each fiscal year. The agency publishes those reports online here.