FDA Drug 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.
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Report Highlights | Report Abstract
News Alert
FDA's drug safety process needs more work - GAO report
Food Consumer, IL -
... 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 ...
Hinchey: GAO report confirms FDA needs to be overhauled
WSTM-TV, NY -
... an Ulster County Democrat -- says the Government
Accountability Office report details problems ... told a
Binghamton radio station (WNBF) that the FDA has long
...
Report faults FDA drug-safety unit
Boston Globe, United States -
... 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 -
... 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 ...