The PDUFA user fee program was first created in response to a bottleneck of new medicine approvals that left patients waiting for years for an under-staffed and under-funded FDA to review new drug applications. 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.
In 1992, Congress passed the first PDUFA and now, more than 25 years later, the average approval time for a new medicine is just 10 months, and 78 percent of medicines are now first approved in the U.S.
To help make the review process more efficient, biopharmaceutical companies pay two different user fees under PDUFA VI:
- Application fee: Fee due when a sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA).
- Program fee: Post-approval annual fee for most prescription drug products approved by October 1 of each fiscal year for which no generic drug exists.
The latest reauthorization of PDUFA (PDUFA VI) was signed into law on August 18, 2017 and took effect on October 1, 2017. It expires September 30, 2022.