The U.S. Government Accountability Office (GAO) says that the FDA "lacks a clear and effective process" for monitoring and dealing with postmarket drug safety issues.
This claim was made in a report requested by Congress members in 2004, in the wake of concerns over the FDA's handling of Vioxx, a painkiller that has been shown to cause heart attacks, and also antidepressants, some of which have been connected to suicidal behavior in children.
The report indicates that "there is a lack of criteria [in the FDA] for determining what safety actions to take and when to take them."
A bill was introduced in Congress a year ago that would create an FDA Center for Postmarket Drug Evaluation and Research. The GAO additionally recommended that Congress consider increasing the FDA's ability to compel drugmakers to conduct postmarket safety studies.