JAMA editors call for increased postmarket surveillance
This article was originally published in The Gray Sheet
Executive Summary
"Independent agency for drug safety, specifically to oversee postmarket surveillance of drugs and devices," should be established, Journal of the American Medical Association editors Phil Fontanarosa, MD, Drummond Rennie, MD, and Catherine DeAngelis, MD, state in the Dec. 1 issue. A growing number of incidents involving a lack of postmarket vigilance by FDA and manufacturers, such as Merck's recent withdrawal of Vioxx, indicate an overdue need for system restructuring, the JAMA editors stress...