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Drug safety monitoring

This article was originally published in The Tan Sheet

Executive Summary

Development of safety monitoring independent of FDA review divisions urged by Thomas Moore, George Washington University Center for Health Policy Research, et al., in the May 19 JAMA. The "discovery of serious adverse effects not detected in preapproval testing can be unwelcome news to both the drug's sponsor and the FDA division that evaluated and approved the drug," Moore et al. note. The agency's Division of Pharmacovigilance & Epidemiology "is limited to reporting its information and conclusions back to the FDA review division, even if these findings call into question the original decision to approve the drug," Moore et al. say. A 1993 FDA program review by outside consultants called for independent safety monitoring, the article notes, also pointing to the U.K. system, under which product reviews and surveillance are handled by separate offices. Moore was a frequent witness at FDA reform hearings...
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