Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process

Overview:

In 2004, several high-profile drug safety cases raised concerns about the FDA's ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. In this report GAO (1) describes FDA’s organizational structure and process for postmarket drug safety decision making, (2) assesses the effectiveness of FDA’s postmarket drug safety decision-making process, and (3) assesses the steps FDA is taking to improve postmarket drug safety decision making.