MODERNIZING DRUG SAFETY LAWS

Abstract

THE PRESCRIPTION Drug User Fee Act (PDUFA), the law that allows the Food & Drug Administration to collect fees from pharmaceutical companies to help expedite drug reviews, is set to expire in September 2012. But as Congress begins to deliberate on reauthorizing PDUFA, an event that has occurred every five years since 1992, some lawmakers are taking the opportunity to address prescription drug shortages and safety concerns related to the globalization of the U.S. drug supply chain. This broadening of focus beyond user fees was evident at a recent Senate hearing and promises to garner continued attention as the reauthorization of PDUFA moves forward. In draft recommendations released last month, FDA proposed raising drug user fees by 6% above the current level, bringing the total drug user fee budget to about $693 million in fiscal 2013 (C&EN, Sept. 12, page 17). Such fees provide about 60% of FDA’s drug review budget. It is now up ...