Assessing Drug Efficacy After Multiple Negative Trials—Gepirone’s Journey Through the FDA

The case of gepirone shows how the FDA evaluated an investigational drug with conflicting evidence. The FDA sometimes exercises “regulatory flexibility” and focuses on statistical (as opposed to clinical) significance in a few trials, allowing the approval of drugs with scant benefits. Product labeling should transparently report on all adequate and well-controlled trials relating to an FDA-approved indication, not just those with positive outcomes, so that clinicians can make better-informed prescribing decisions.

Corresponding Author: Erick H. Turner, MD, Department of Psychiatry, Oregon Health turnere@ohsu.edu).

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