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Second Circuit Concludes Truthful Off-Label Promotion Is Not Unlawful: Free Speech, But Not A Free Pass (Yet)
December 5, 2012
Mark P. Goodman, Maura Kathleen Monaghan, Andrew M. Levine, Kristin D. Kiehn

  • In a significant decision affecting the pharmaceutical industry, the Second Circuit Court of Appeals in United States v. Caronia has rejected the FDA's long-held interpretation of the Food, Drug, and Cosmetic Act by concluding the Act does not prohibit or criminalize truthful and non-misleading off-label promotion of FDA-approved drugs.
  • The Caronia court vacated the conviction of a former sales representative on the ground that criminalizing truthful off-label promotion violates the First Amendment's guarantee of free speech under Supreme Court precedent.
  • Caronia has potentially far-reaching implications for pharmaceutical companies' promotional practices, but the decision is only authoritative in three states and may be subject to review or modification by the full appeals court or Supreme Court. Companies should therefore consider awaiting further developments in the law before implementing changes to policies and procedures relating to off-label promotion as a result of this decision.


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