FDA Needs To Track Actions Built On Supplement AERs

FDA Needs To Track Actions Built On Supplement AERs – GAO Report

27 Mar 2013

• By Lisa Gillespie

A GAO report says FDA “may be able to expand” its use of supplement adverse event reports if it can track its use of the data to support actions it takes to protect consumers. The report makes five key recommendations for the agency to improve its approach to AERs.

FDA needs to create a system to track its use of dietary supplement adverse event reports to prompt consumer protection actions to provide clear direction for its future use of the data, the Government Accountability Office finds.

GAO arrived at five recommendations in its March 18 report on FDA’s use of AERs in overseeing dietary...