Safety Culture Clashes Continue At FDA, Despite Reform Efforts

Executive Summary

FDA's efforts to improve communications between the Office of New Drugs and the Office of Surveillance and Epidemiology may need to be enhanced, based on a confrontation between OND staff and OSE Associate Director for Science and Medicine David Graham during an April 12 meeting of FDA's Arthritis Drugs Advisory Committee concerning Merck's COX-2 inhibitor Arcoxia. The agency has been touting its ongoing efforts to improve internal communication processes after an Institute of Medicine report on FDA's drug safety oversight expressed concern about cultural conflicts between the agency's new product review and postmarket safety oversight units (1"The Pink Sheet" Feb. 12, 2007, p. 17).