According to a study published online in The New England Journal of Medicine (May 16, 2012), the FDA approved more new drugs in less time—about 15% faster—than the European Medicines Agency and Health Canada. The analysis compared drug review performance for the three agencies from 2001 to 2010. The majority of the new agents were first approved for use in the United States.
“[T]he vast majority of the novel therapeutics first received approval for use in the United States,” the investigators reported. “Furthermore, both first-review and total review times at the FDA were essentially the same for applications submitted during the [Prescription Drug User Fee Act (PDUFA)] III and PDUFA IV periods. These findings contradict recent criticisms of the speed of review by the FDA and question whether review speed is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers.” ■