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

United States. Government Accountability Office.

United States. Government Accountability Office.

关键词: Government accountability -- United States.;    health care;    drug safety;    letter report;   

RP-ID  :  GAO-06-402
RP-ID  :  249543

美国|英语

来源: UNT Digital Library

【 摘 要 】

A letter report issued by the Government Accountability Office with an abstract that begins "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, Baycol, Bextra, and Propulsid."