Drug Safety : Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process

Summary: In 2004, several high-profile drug safety cases raised concerns about the Food & Drug Admin.'s (FDA) ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. This report: (1) describes FDA's organizational structure & process for postmarket drug safety decision making; (2) assesses the effectiveness of FDA's postmarket drug safety deci...sion-making process; & (3) assesses the steps FDA is taking to improve postmarket drug safety decision making. An organizational review was conducted. In addition, there are case studies of 4 drugs with safety issues: Arava, Baycol, Bextra, & Propulsid. Includes recommendations. Illustrations. [read more]