Prescription Drug User Fee Act and the FDA Safety and Innovation Act

In response to growing concerns over the amount of time it took for new safe and effective medicines to reach patients, Congress passed the Prescription Drug User Fee Act (PDUFA) in 1992. Through PDUFA, Congress created a user fee program to provide the Food and Drug Administration (FDA) with additional resources that ensure new drug applications are reviewed in a timelier manner - ultimately allowing safe and effective drugs to reach patients faster.

Prior to PDUFA's implementation, it often took more than two years to review new drug applications--meaning patients had long waits before receiving access to new, potentially lifesaving medicines.

Thanks to PDUFA, the last 20 years have been America's most productive and innovative period for new drug development, resulting in timely review and approval of medicines that have helped millions of people live longer, healthier lives.

For example:

In 2012, Congress reauthorized PDUFA for the fifth time as part of a larger piece of legislation: the FDA Safety and Innovation Act of 2012 (FDASIA.) FDASIA was passed with overwhelming bipartisan support by both the House and the Senate, and President Obama signed it into law on July 9, 2012.

PDUFA contains a number of provisions which seek to make our regulatory environment more predictable and transparent. Hopefully this will encourage new innovation -- leading to continued approval of cutting-edge new medicines in the U.S.

PDUFA ensures that patients will continue to have access to the breakthrough cures and treatments they deserve, and that the U.S. will continue to lead the world in the discovery and delivery of cutting-edge medicines. It:

  • Establishes more communication during the drug review process between sponsors and the agency -- hopefully making it more predictable and efficient.

  • Provides the FDA with the resources it needs to review new treatments safely and efficiently, without compromising safety or efficacy.

  • Expands the transparency and predictability of the science-based review process for new drugs by implementing a consistent benefit/risk assessment for all new drugs.

  • Increases the FDA's accountability for reviewing new medicines in a timely manner by focusing on first-cycle approval rates for new drugs.

  • Modernizes the review process by expanding the FDA's capabilities in cutting-edge science like biomarkers and pharmacogenics into FDA review.

  • Encourages innovation, ensuring that the United States remains the world's leader in the discovery and delivery of new, lifesaving cures and treatments.

The PDUFA-related sections of FDASIA will be implemented over the next several years. Many of these implementation decisions invite - even require - an increased level of participation from patients and patient advocates. As these opportunities arise, the Campaign for Modern Medicines will make you aware of them and let you know how you can be part of the process.

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