The Food and Drug Administration Computed Prescription Drug User Fee Rates Accurately

The Prescription Drug User Fee Act (PDUFA) of 1992, P.L. No. 102-571, authorized the Food and Drug Administration (FDA) to collect prescription drug user fees from pharmaceutical and biotechnology companies seeking FDA approval of certain human drug and biological products to expedite the review of human drug applications. Congress must reauthorize the PDUFA every 5 years; it was renewed in 1997, 2002, 2007, 2012, and 2017. FDA expects to use the prescription drug user fees it collects under the PDUFA to meet its goals for the timely review of human drug applications. We performed this audit to determine whether FDA accurately computed prescription drug user fee rates.