A federal law governing fees the Food and Drug Administration (FDA) can collect to supplement its congressional appropriations funding. Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992 to expedite the drug and biologic approval process by allowing user fees to be collected and used for drug approval activities in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The continued collection of these fees is contingent on the FDA meeting certain performance benchmarks primarily related to the speed of the approval processes.

The current law has two fees that are recalculated each year:

PDUFA must be reauthorized every five years and have been renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), 2012 (PDUFA V), and 2017 (PDUFA VI), which is effective through September 2022.