Congress Asks GAO to Examine Adverse Event Reporting for Dietary Supplements

By Riëtte van Laack –

On November 8, 2011, Senator Durbin and Representative Waxman requested that the U.S. Government Accountability Office ("GAO") determine how the adverse event reporting ("AER") for dietary supplements system is working.  Since December 22, 2007, pursuant to the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers, packers, and distributors of dietary supplements in the United States have been required to report information about serious AERs to FDA.  Congress requested that GAO collect information about the AERs reported thus far, e.g., number of AERs, dietary supplements associated with AERs, nature of AERs and who submits AERs.  In addition, GAO is to report on FDA’s efforts to ensure compliance with the law requiring serious AER reporting and whether, and to what extent, FDA has implemented the recommendations GAO made in its 2009 report.