Panel offers recommendations for monitoring adverse events from dietary s...( voluntary postmarket surveillance is un...),Health

The Study
Proposed changes in federal regulation of the dietary supplement industry have spurred some manufacturers to consider their monitoring systems. Taking this first step was Metabolife International Inc. (MET), which retained LSRO. LSRO was asked to determine how a system for handling consumer inquiries could be tailored to the task of monitoring the safety of dietary supplements.

The LSRO in conjunction with an Expert Committee of scientists completed this study in two phases:

• Phase I examined 200 postmarket surveillance Individual Data Records (IDRs) collected by the FDA and 200 IDRs reports collected by MET relating to Metabolife 356 and other ephedrine alkaloid-containing supplements. The goal of Phase I was to determine how useful these data were as signals in detecting product problems.

• Phase II examined noteworthy postmarket surveillance programs currently in use for other products regulated by FDA with an eye to making recommendations for the design and implementation of an effective monitoring system for adverse events relating to dietary supplements.

Results
In their Phase I review, the Committee found that the records collected by MET were qualitatively less informative than those collected by the FDA and posed a greater challenge for application in public health-related analyses. As the MET IDRs were not intended to support an adverse event reporting system, consumer complaints were collected in most cases during a single telephone contact at a customer service center. The researchers found that while both the FDA and the MET IDRs had sufficient information to permit the preliminary step in detection of potential product problems (signal detection), a substantially greater number of FDA IDRs had sufficient information to permit prioritizing the signals, because
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Contact: Donna Krupa
djkrupa1@aol.com
703-527-7357
Life Sciences Research Office
15-Nov-2004