Advancing Innovation and Access for Patients

The Prescription Drug User Fee Act (PDUFA) is a cornerstone of the U.S. regulatory framework that helps ensure patients have timely access to safe and effective new medicines. Enacted by Congress in 1992, PDUFA allows the Food and Drug Administration (FDA) to collect user fees from biopharmaceutical companies to support the review of new therapies. These resources fund scientific staff, modernize review systems, and strengthen drug safety monitoring – without changing FDA’s standards for safety or effectiveness.

PDUFA was created in response to significant delays in drug review, when patients often waited years for new treatments and many medicines were approved overseas first. Since its enactment, PDUFA has helped transform the review process into one that is more predictable, efficient, and globally competitive – while maintaining rigorous scientific evaluation. 

Why It Matters
 

PDUFA directly impacts how quickly new therapies reach patients. By providing FDA with critical resources, the program supports:

• Timely and predictable reviews of new medicines

• Enhanced scientific and regulatory capacity across the drug lifecycle

• Stronger patient engagement and communication

• Continued U.S. leadership in biomedical innovation 

Today, review times for new medicines have fallen from more than two years before PDUFA to less than one year, helping patients access innovative therapies sooner.
 

Reauthorization and What’s at Stake 
 

PDUFA operates on a five-year cycle and must be reauthorized by Congress to continue. The current authorization (PDUFA VII) runs through September 30, 2027.

If PDUFA is not reauthorized on time, FDA would lose a significant source of funding for its drug review program. This could lead to hiring freezes, staff reductions, and review delays – ultimately slowing patient access to innovative therapies and disrupting the development pipeline. 
 

Explore PDUFA Resources: 

To support deeper understanding, explore the following resources:

• PDUFA Frequently Asked Questions – Key answers on how the program works, what it funds, and its impact on patients and innovation.

• PDUFA Background – A more detailed history of PDUFA’s development, evolution, and role in improving the drug review process.

• PDUFA At-a-Glance – A quick reference highlighting core facts, key takeaways, and the program’s value to patients, FDA, and the biotech ecosystem.