As my predecessor noted, PDUFA is indeed a weird word worth knowing. The Prescription Drug User Fee Act (PDUFA), reauthorized last year as part of the Food and Drug Administration (FDA) Safety and Innovation Act, represents an agreement between the FDA and biopharmaceutical industry with significant input from patients and other stakeholders. It allows the FDA to collect user fees from biopharmaceutical companies so that the Agency has the resources it needs for a thorough and timely review of a medicine's safety and efficacy.
In the last 20 years, PDUFA has provided patients with timelier access to more than 1,500 new drugs and biologics and decreased review times for these treatments by more than 60 percent.
The implementation of PDUFA V began on October 1, 2012. If implemented successfully, it 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. There are a lot of milestones this year so stay tuned for implementation updates.
Want to learn more? Visit our PDUFA webpage for background information including a fact sheet explaining how PDUFA V is good for patients, continued biopharmaceutical innovation, and the U.S. economy.