The recent withdrawals of Vioxx, Celebrex, and other drugs from the market have spurred high-profile hearings in Congress and increased concern over the state of drug regulation in consumer protection and academic circles. This renewed focus on national drug safety has translated ineluctably into new legislation designed to mitigate that outcry. The most notable example, the passage of the Food and Drug Administration Amendments Act (FDAAA) this past September, is at least partly intended as a response to an apparent lack of public confidence in existing drug safety practices.

Of the many provisions in the FDAAA, perhaps none carries greater implications for drug safety than the reauthorized Prescription Drug User Fee Act (PDUFA). Now in its fourth iteration, the newest PDUFA differs in important respects from the statute it supersedes.