FDA Drug Safety Report

In 2004, several high-profile drug safety cases raised concerns about the Food and Drug Administration's (FDA) 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. GAO conducted an organizational review and case studies of four drugs with safety issues: Arava, Rezulin, Bextra, and Propulsid.

To Read the Entire GAO Report, click here [PDF]

Report Highlights  |  Report Abstract

News Alert

Report: FDA drug safety tools lacking
Chicago Tribune, United States - Apr 24, 2006
... In preparing their report, GAO investigators interviewed FDA scientists and managers and reviewed documents usually not provided to the public. ...

Report faults FDA drug-safety unit
Boston Globe, United States - Apr 25, 2006
... US Representative Rosa DeLauro, a Connecticut Democrat on a House subcommittee with jurisdiction over the FDA, said. She said she hopes the GAO report will get ...

Report: FDA slow to address drug safety
Concord Monitor, NH - Apr 24, 2006
... Alastair Wood of Vanderbilt University, a prominent voice on on the FDA's advisory panel on drug safety and risk management, said the GAO report "confirmed a ...

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