PDUFA Reauthorization — Drug Safety's Golden Moment of Opportunity?

“This [is] a golden moment of opportunity to improve fundamentally the way FDA regulation considers and responds to the evolving understanding of risks and benefits of drugs.” So claims the September 2006 Institute of Medicine (IOM) report entitled The Future of Drug Safety, which paints a dismal picture of the U.S. system for ensuring the safety of drugs after they have been approved by the Food and Drug Administration (FDA).1 Among the more easily remediable shortcomings identified by the IOM are the severe underfunding of the FDA, the particularly poor funding for postapproval monitoring of safety, and the “troubling imbalance” . . .