Prescription Drug User Fee Act

The Issue

The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and revised in 1997 and 2002, is a program under which the pharmaceutical/biotechnology industry pays certain "user fees" to the Food and Drug Administration (FDA). In return, the FDA has reduced the approval time for New Drug Application and Biological License Applications.

Our Position

We monitor the application of PDUFA at the FDA and support ongoing efforts to ensure quick but sufficient reviews of new drugs.

« View all Federal Issues