Stating that “to date…it is unclear how the AER system is working in practice,” the letter asks GAO to address several questions.
Senator Richard Durbin (D-IL) and Representative Harry Waxman (D-CA) in November sent a letter requesting that the Government Accountability Office (GAO) examine FDA’s adverse-events reporting system, specifically as it relates to dietary supplements.
Since the Dietary Supplement and Nonprescription Drug Consumer Protection Act became law in 2006, manufacturers, packers, and distributors of dietary supplements in the United States are required to report to FDA adverse events associated with dietary supplement use.
Stating that “to date…it is unclear how the AER system is working in practice,” the letter asks GAO to address the following questions:
Read the full letter here.
Nutritional Outlook thanks Harry Rice, PhD, for the tip.