First Amendment Protects Certain Truthful, Non-Misleading Statements about Off-Label Drug Uses

3 min

The Food and Drug Administration (FDA), along with other federal authorities, has been zealous in prohibiting drug companies from making promotional statements about their drugs with respect to uses (indications) for which FDA has not granted approval. FDA's long-held view has been that "off-label" promotion is unlawful, even if the statements are truthful and non-misleading. A new court decision casts a dark First Amendment cloud over FDA's absolutist position.

On August 7, 2015, Judge Paul A. Engelmayer of the U.S. District Court for the Southern District of New York entered a preliminary injunction against FDA, allowing Amarin Pharma to engage in truthful and non-misleading speech regarding an off-label use of Amarin's Vascepa. Judge Engelmayer ruled that Amarin's planned truthful and non-misleading speech is afforded protection under the First Amendment, relying heavily on the decision of the United States Court of Appeals for the Second Circuit in United States v. Caronia.

The ramifications of the Amarin decision are substantial. First, and perhaps most importantly, the court rejected FDA's core argument that Amarin's challenge was a "frontal assault on the framework for new drug approval." In FDA's view and notwithstanding the First Amendment, a drug company should not be allowed to make truthful, non-misleading statements about unapproved uses of a drug, because to do so undermines the integrity of the drug approval process. Because a drug is approved only for certain uses, so the argument goes, a drug company should not be allowed to promote the drug for any other uses, even if, as in the Amarin case, the statements are truthful and non-misleading. Second, Amarin is a significant extension of the Second Circuit's decision in Caronia. While Caronia upheld a First Amendment defense to a criminal prosecution for off-label promotion, Amarin sustained an affirmative preemptive suit challenging FDA's asserted authority to prohibit off-label promotion. The First Amendment was a shield in Caronia and a sword in Amarin.

Finding the proper reconciliation—both as a matter of law and as a matter of policy—between FDA's regulatory authority and the First Amendment rights of FDA-regulated entities is a work in progress.

After Amarin and Caronia, however, FDA's view that a company's speech about the uses of its product is constrained entirely by the uses for which FDA has granted approval is not one that the courts are accepting. The First Amendment applies to the promotional activities of drug companies (as it does to the activities of other FDA-regulated entities), and drug companies are not categorically prohibited from making truthful, non-misleading statements about the uses of their products, even when those uses are not FDA-approved.

If you have questions regarding the issues raised in this alert, please contact one of the authors.