Drug Safety: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process

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 2007-03-22 monographic deposited born digital 17 p. GA 1.13:GAO-07-599T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-599T P0b002ee18038b17c f:d07599t DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-07-599T machine generated eng fdlp REPORT GAOREPORTS-GAO-07-599T GAO-07-599T Consumer protection Data collection Data integrity Decision making Drugs Pharmaceutical industry Pharmacological research Prescription drugs Product safety Safety regulation Safety standards Testimony A67129 Drug Safety: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process GAO was asked to testify on the effectiveness of the Food and Drug Administration's (FDA) postmarket decision-making process. This testimony is based on Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process, GAO-06-402 (March 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 and reviewed FDA documents in February and March 2007. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-599T/html/GAOREPORTS-GAO-07-599T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-599T/pdf/GAOREPORTS-GAO-07-599T.pdf GAO-07-599T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-599T Testimony GAO-07-599T; Drug Safety: FDA Needs to Further Address Shortcomings in Its Postmarket Decision-making Process; Consumer protection Data collection Data integrity Decision making Drugs Pharmaceutical industry Pharmacological research Prescription drugs Product safety Safety regulation Safety standards