The past two decades have seen a flurry of enforcement activity surrounding pharmaceutical companies’ promotion of their drugs for uses other than those approved by the Federal Food and Drug Administration (FDA)—so-called “off -label” uses.1 At the heart of these criminal prosecutions is the allegation that the advertisements of the medications at issue resulted in misbranding.2 While several off -label advertisement defenses have focused on the advertising party’s First Amendment rights,3 these defenses have only been partially successful, since “commercial speech” is provided far less protection under the First Amendment than topics like political, scientific or purely opinion speech.4

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