United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2007-05-09 monographic deposited born digital 17 p. GA 1.13:GAO-07-856T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-856T P0b002ee1803a15f4 f:d07856t DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-07-856T machine generated eng fdlp REPORT GAOREPORTS-GAO-07-856T GAO-07-856T Consumer protection Decision making Drugs Pharmaceutical industry Pharmacological research Prescription drugs Product safety Safety regulation Safety standards Testimony A69367 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 were disagreements within FDA about how to address these issues. GAO was asked to testify on FDA's oversight of drug safety. This testimony is based on Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process, GAO-06-402 (Mar. 31, 2006). The report focused on the complex interaction between two offices within FDA that are involved in postmarket drug safety activities: the Office of New Drugs (OND), and the Office of Drug Safety (ODS). OND's primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS is focused primarily on postmarket drug safety issues. ODS is now called the Office of Surveillance and Epidemiology. For its report, GAO reviewed FDA policies, interviewed FDA staff, and conducted case studies of four drugs with safety issues: Arava, Baycol, Bextra, and Propulsid. To gather information on FDA's initiatives since March 2006 to improve its decision-making process for this testimony, GAO interviewed FDA officials in February and March 2007, and received updated information from FDA in May 2007. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-856T/html/GAOREPORTS-GAO-07-856T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-856T/pdf/GAOREPORTS-GAO-07-856T.pdf GAO-07-856T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-856T Testimony GAO-07-856T; Drug Safety: Further Actions Needed to Improve FDA's Postmarket Decision-making Process; Consumer protection Decision making Drugs Pharmaceutical industry Pharmacological research Prescription drugs Product safety Safety regulation Safety standards Volume 116 Page 687 116 Stat. 687