GAO Says FDA's Oversight of Drug Safety is 'Lacking'

WASHINGTON, D.C. - In a recently released report, the U.S. Government Accountability Office said the FDA needs to improve its decision-making process for post-market drug safety.

In a March 2006 report, the GAO said the FDA "lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues."

"The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints," the report states. "GAO observed that there is a lack of criteria for determining what safety actions to take and when …