How Hard Should It Be to Imprison Someone For Telling The Truth: FDA Advertising Regulation Enforcement by Frederick R. Ball, Erin M. Duff y, and Nina L. Russakoff


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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Published In: Administrative Agency Updates, Antitrust & Trade Regulation Updates, Constitutional Law Updates, Criminal Law Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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