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A pharmaceutical representative's promotion of a U.S. Food and Drug Administration-approved drug's off-label use is speech. Speech in aid of pharmaceutical marketing is a form of expression protected by the Free Speech Clause of the First Amendment. The government cannot prosecute pharmaceutical manufacturers and their representatives under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., for speech promoting the lawful, off-label use of a U.S. Food and Drug Administration-approved drug.
Defendant-appellant Alfred Caronia appealed from a judgment of conviction entered in the district court following a jury trial at which defendant was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. §§ 331(a) and 333(a)(1). Specifically, defendant, a pharmaceutical sales representative, promoted the drug Xyrem for off-label use, that is, for a purpose not approved by the U.S. Food and Drug Administration. Defendant argued that he was convicted for his speech for promoting an FDA-approved drug for off-label use in violation of his right of free speech under the First Amendment.
Was the defendant’s conviction for his speech in promoting an FDA-approved drug for off-label use in violation of his right of free speech under the First Amendment?
Yes. The court agreed with the defendant’s argument and thus, the judgment of conviction was vacated, the case was remanded to the district court.
The court held that, while the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., made it a crime to misbrand or conspire to misbrand a drug, the statute and its accompanying regulations did not expressly prohibit or criminalize off-label promotion. Rather, the FDCA and FDA regulations referenced promotion only as evidence of a drug's intended use. Thus, under the principle of constitutional avoidance, the court construed the FDCA as not criminalizing the simple promotion of a drug's off-label use because such a construction would raise First Amendment concerns. Therefore, the court held that the judgment of conviction had to be vacated because plaintiff government prosecuted defendant for mere off-label promotion, and the district court instructed the jury that it could convict on that theory. The court found that plaintiff government had not established a reasonable fit among its interests in drug safety and public health, the lawfulness of off-label use, and its construction of the FDCA to prohibit off-label promotion.