what is Prescription Drug User Fee Act (PDUFA)

The Prescription Drug User Fee Act (PDUFA) is a law that authorizes the FDA to collect fees from drug manufacturers to fund the drug approval process. Here are key points about PDUFA:

1. **Establishment and Purpose**: PDUFA was enacted in 1992 to allow the FDA to collect fees from drug manufacturers to fund the new drug approval process. It has been reauthorized several times, most recently by the FDA User Fee Reauthorization Act of 2022, which reauthorizes PDUFA through September 2027.
2. **Fees and Usage**: The fees collected through PDUFA are used to expedite the drug review and approval process. The FY 2026 PDUFA program fee invoices were emailed on August 18, 2025, with full payment due on October 1, 2025.
3. **Controversies and Challenges**: There have been controversies over the years, such as the authority to apply user fees to the monitoring of direct-to-consumer drug advertising and the increased fees for 505(b)(2) applications to switch drugs from requiring a prescription to being sold over-the-counter.
4. **Impact on Drug Development**: PDUFA has been crucial in expediting the drug review and approval process, promoting the timely availability of safe and effective medicines to patients. However, there are concerns about the potential impact on drug development costs and the overall pharmaceutical industry.

In conclusion, PDUFA is a critical component of the FDA's budget and plays a significant role in the drug development process. Its impact on the industry and the resulting costs are areas of ongoing debate and scrutiny.