This US Government Accountability Office’s (GAO) current report (2007) gives a brief history and overview of the 2 FDA branches – Office of New Drugs (OND), and the Office of Drug Safety (ODS) – mandated to oversee postmarketed drug safety. OND’s primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS (now called the Office of Surveillance and Epidemiology) is focused primarily on postmarket drug safety issues. In its March 2006 report, the GAO found that the FDA lacked clear and effective processes for making decisions about, and providing management oversight of, postmarket drug safety issues. Updates on FDA’s progress on a variety of initiatives to improve its postmarket drug safety decision-making process, including the establishment of the Drug Safety Oversight Board, is reviewed. This article, which is the most recent update posted on the GAO website, gives a historical perspective on why ongoing initiatives were enacted.
Source: Government Accountability Office.