GAO: FDA Lacks Clear Drug Safety Policies, Authorities

The Food and Drug Administration (FDA) lacks a clear and effective process for making decisions about and providing management oversight of post-marketing drug safety issues, the Government Accountability Office (GAO) said today. There is a lack of criteria for determining what safety actions to take and when to take them,” GAO stated. Squabbling between FDA’s Office of New Drugs (OND), the office that approves the marketing of medications, and the Office of Drug Safety (ODS), which oversees post-marketing safety reviews, has hindered the agency’s drug safety decision-making process, investigators asserted.