|| 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
- 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.