Missing in action: An FDA plan for postmarket drug safety


"There have been long-standing concerns regarding the Food and Drug Administration's (FDA) oversight of postmarket drug safety." So begins a Government Accountability Office (GOA) report released on Wednesday that examines the steps the FDA has taken since making its own 2006 recommendations on the matter. In the eyes of many, the GAO's finding may be an understatement.

The GAO's main recommendation was that the FDA separate responsibilities between the Office of New Drugs and the Office of Surveillance and Epidemiology -- the first would approve new drugs, and the second would follow up on postmarket drug safety issues. When those approving the drugs in the first place are also responsible for tracking them postmarket, potential conflicts could arise, the GAO found. Those who approved the drug -- obviously finding it safe enough -- may find themselves in an awkward position if the drug is later found to be lacking.