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Improvements in FDA adverse events monitoring system needed

  At a May 27 hearing, seven major problems with the adverse events (AE) monitoring system for supplements were identified:

  • Insufficient follow-up by FDA to verify that a product was actually responsible for the adverse reaction.
  • No evaluation of whether adverse events are mild, moderate, or serious.
  • Excessive delays in fulfilling company requests for information about specific AE reports, required under the Freedom of Information Act.
  • Inappropriately naming a company and product before confirming a causal relationship between the product and the AE.
  • Failure to delete incorrect information from the FDA website.
  • Failure to keep the website adequately updated.
  • Lag time in entering reports for AE's.

Joseph Levitt, Director of the Center for Food Safety and Applied Nutrition's Adverse Event Monitoring System, concurred that some of the industry's complaints are justified. Recently, $2.5 million in additional funds were earmarked for enhancing the AE monitoring system. The funds will be used to hire additional staff to review AE's and to fulfill company requests for information about specific complaints.

  The Tan Sheet, May 31, 1999.  
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