Number: RL33914
Title: The Prescription Drug User Fee Act (PDUFA): Background and Issues for PDUFA IV Reauthorization
Authors: Susan Thaul, Domestic Social Policy Division 
Abstract: This report begins with a history of FDA's prescription drug user fee program. The program was originally authorized for five years, and Congress extended it in two subsequent five-year reauthorizations. The current authority expires October 1, 2007. FDA released its proposal for a reauthorized program in January 2007. The Senate and the House have each passed multipart FDA bills, S. 1082 and H.R. 2900, that include the Prescription Drug User Fee Amendments of 2007, which would reauthorize the prescription drug user fee program through FY2012. This report summarizes the pros and cons that academics, government and industry policy analysts, and consumer and other interested groups raise over what many are calling "must-pass" legislation to ensure that there is no interruption in FDA's collection and use of the fees to expedite market approval and postmarket monitoring of drugs and biologics.
Pages: 16
Date: July 12, 2007