Second Circuit Rules Off-Label Promotion Is Protected Speech

On December 3, 2012, the United States Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, who had been found guilty of promoting off-label uses for a drug product, holding that the conviction violated his First Amendment free speech rights. The 2-1 decision by a three-judge panel of the Second Circuit could potentially affect future government prosecutions in the off-label promotional arena, but it is too early to conclude whether this ruling will have broad applicability and, thus, ultimately slow down off-labeling enforcement by the Department of Justice or the Food and Drug Administration (FDA). It is not yet known whether the government will request an en banc rehearing before the entire Second Circuit or appeal the case to the United States Supreme Court.

Background

The case, U.S. v. Caronia, involved the conviction of Alfred Caronia, a sales representative for a pharmaceutical company, who was found guilty of conspiracy to introduce a misbranded drug into interstate commerce by promoting an off-label use of an approved drug product. Caronia claimed that he was convicted solely 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.

The Second Circuit agreed, vacated the judgment, and remanded the case to the district court.

Highlights of the Court Decision

The majority opinion is based on the determination that the Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit the “promotion” or “marketing” of drugs for off-label uses. The court pointed out that off-label drug usage by physicians and patients is not unlawful, and FDA’s drug approval process anticipates potential off-label uses. The court acknowledged that FDA regulations do recognize the promotional statements of a pharmaceutical company or its representatives can serve as proof of a drug’s intended use and, therefore, off-label promotional statements could presumably constitute evidence of an intended use of a drug which FDA has not approved, in violation of the FDCA. However, the court took issue with FDA’s authority to prohibit speech about off-label uses – standing alone – as “misbranding” under the FDCA. Indeed, the court framed the principal question on appeal as follows: whether the government’s prosecution of Caronia under the FDCA only for promoting an FDA-approved drug for off-label use was constitutionally permissible.


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