Wednesday, December 09, 2009

GAO report finds FDA lacking in development of drug surveillance office.

The AP (12/9, Perrone) reports the Food and Drug Administration "still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal." According to a report by the Government Accountability Office that will be released on Wednesday, FDA officials "have made some changes to drug oversight," although the agency "continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market." The GAO "calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office." In response, the FDA "said major decisions about drug safety are delegated to the new drugs division because that is 'where staff with the broadest expertise and experience' on product safety issues reside."

No comments: