Pharmaceutical & Drug Enforcement

Under the FDCA, a drug is misbranded if its labeling is false or misleading, it lacks adequate directions for use, or it is promoted for FDA-unapproved uses. Misbranding can be charged as a misdemeanor (strict liability) or felony (requiring intent to defraud or mislead). Individual employees can be criminally liable even without personal knowledge under the Park doctrine.

Potentially, but the First Amendment creates a significant defense. Under the Second Circuit's Caronia decision and subsequent cases, truthful, non-misleading promotion of off-label uses is constitutionally protected speech, meaning the government must prove that the promotion was false or misleading, not merely that it occurred. The practical defense strategy focuses on: whether the promoted use had genuine evidentiary support; whether the promotion was accurate and non-misleading; whether the company followed FDA guidance on scientific exchange; and whether individual employees acted in good faith reliance on counsel's advice about permissible communications. The Park doctrine, which can create strict criminal liability for supervisors who did not personally participate in the conduct, is the most significant risk for executives. Establishing that a supervisor had no personal knowledge of or involvement in the promotion is essential to a Park doctrine defense.