The U.S. Food and Drug Administration (FDA) has issued a statement stating that it will not seek review of a Second Circuit decision, which held that a pharmaceutical representative’s “truthful” off-label promotion of a narcolepsy drug was protected speech. In U.S. v. Caronia, the Second Circuit vacated a criminal conviction that found a Oprhan Medical Inc. sales representative guilty of “conspiring to introduce a misbranded drug into interstate commerce.”

In Caronia, the pharmaceutical representative told physicians that the narcolepsy drug, Xyrem, could be used for off-label purposes, such as for treating chronic fatigue, chronic pain, or Fibromyalgia. In noting that the employee’s speech was “not misleading” and “related to a lawful activity,” the Second Circuit held that the criminal conviction violated the representative’s First Amendment right to freedom of speech.

In its statement after the ruling, the FDA stated that the “[Caronia] decision does not strike down any provision of the [Food, Drug, and Cosmetic Act] or its implementing regulations, nor does it find a conflict between the act's misbranding provisions and the First Amendment or call into question the validity of the act's drug-approval framework." Through its statement, the FDA evades bringing this issue before the U.S. Supreme Court, which has traditionally taken a broad approach to First Amendment jurisprudence and could have potentially expanded the Second Circuit’s ruling.

For more information, please refer to U.S. v. Caronia, No. 09-5006, in the U.S. Court of Appeals for the Second Circuit.