Prescription Drug User Fee Act (PDUFA)

The Prescription Drug User Fee Act (PDUFA) is a U.S. federal law enacted in 1992 that allows the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies submitting new drug applications. The funds generated from these fees are used to expedite the review process for new medications, ensuring that safe and effective drugs reach the market more quickly.

PDUFA has been reauthorized multiple times, with enhancements aimed at improving the efficiency of the drug approval process while maintaining rigorous safety standards. The act requires that a portion of the fees be allocated towards improving the FDA’s resources and capabilities for drug review.

For example, under PDUFA, the FDA commits to reviewing new drug applications within a specified time frame, typically 10 months for standard applications and 6 months for priority applications. This has helped speed up the introduction of critical therapies for various medical conditions.

Notable cases include the approval of breakthrough therapies for diseases like cancer and rare conditions, where expedited review has significantly impacted patient access to necessary treatments.