Durbin, Waxman Ask GAO to Examine Dietary Supplement Adverse-Event Reporting

December 9, 2011

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:

  • How many adverse-event reports have been filed since 2007, the year AER requirements went into effect?

  • What kinds of supplements are most commonly implicated in AERs?

  • What kinds of adverse events have typically been reported?

  • What proportion of AERs are submitted by manufacturers, health providers, and consumers?

  • What steps is FDA taking to ensure that supplement manufacturers are reporting adverse events, as required by law?

  • How is FDA utilizing the AER system to inform its efforts to protect consumers?

  • To what extent has FDA implemented the recommendations GAO made in its 2009 report on dietary supplements?

Read the full letter here.

Nutritional Outlook thanks Harry Rice, PhD, for the tip.

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