Drug Safety: Improvement needed in FDA’s Postmarket decision-making and oversight process

This white paper by United States Government Accountability Office discusses the improvement needed in FDA’s postmarket decision making and oversight process. In 2004, several high-profile drug safety cases raised concerns about the Food and Drug Administration’s (FDA) ability to manage postmarked drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. This white paper describes FDA’s organizational structure and process for postmarket drug safety decision making. It assesses the effectiveness of FDA’s postmarket drug safety decision-making process, and assesses the steps FDA is taking to improve postmarket drug safety decision making. This paper also discusses organizational review and case studies of four drugs with safety issues: Arava, Baycol, Bextra, and Propulsid.

According to this white paper to improve the decision-making process for postmarket drug safety, GAO suggests that the Congress consider expanding FDA’s authority to require drug sponsors to conduct postmarket studies when needed. GAO also recommends that FDA systematically track postmarket drug safety issues, revise and implement its draft policy on major postmarket safety decisions, improve the dispute resolution process, and clarify Office of Drug Safety (ODS’s) role in scientific advisory committees. In its comments on a draft of this white paper, FDA stated that GAO’s conclusions were reasonable. FDA did not comment on GAO’s recommendations.

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