First Amendment Protection of Evidence-Based Promotion of Prescription Drugs: A Study of Published Clinical Evidence Supporting Off-Label Promotion in the USA

A heated debate surrounds pharmaceutical companies’ proactive dissemination of information about uses of their drugs beyond those approved by the US Food and Drug Administration (FDA), a practice commonly referred to as “off-label promotion”. At the core of this debate is an underlying assumption that pharmaceutical company speech about off-label uses is inherently false and misleading and not in the best interests of patients. If, however, the...