FDA PDUFA VI 'goals' expected to slow rate of user fee increases

The US Food and Drug Administration, at a public meeting on Friday, issued a document that contains the performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018-2022, known as PDUFA VI. It is commonly referred to as the “goals letter” or “commitment letter.”

The current legislative authority for PDUFA expires in September 2017. Without new legislation, the FDA will no longer be able to collect user fees for future fiscal years to fund the human drug review process.

The new proposal aims to make the FDA’s funding more predictable, and is expected to slow the rate of increase on user fees. As a result of changes in the way the FDA's workload and costs are measured, the annual increase in user fees is expected to slow to 2%-4% during PDUFA VI from about 11% in FY2016.