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.
PDUFA has played a critical role in bolstering the FDA’s ability to regulate safe and effective medicines for patients. The user fee was first created in response to a bottleneck of new drug approvals in the late 1980s and early 1990s that left patients waiting while an under-staffed and under-funded FDA struggled to review applications for new medicines. In 1992, Congress passed the first PDUFA to meet urgent patient demands for more timely approvals of life-saving treatments and cures.
For more than 25 years, PDUFA has helped the FDA fulfill its central mission – to protect and promote the public health by allowing the Agency to keep pace with the rapid increase in the number and complexity of innovative drugs and biologics entering the drug development and regulatory review pipeline.
The FDA released the PDUFA VI performance goals letter in July 2016, and Congress voted to reauthorize the program in August of 2017. It was signed into law on August 18, 2017 and takes effect on October 1, 2017.