United States v. Caronia The Increasing Strength of Commercial Free Speech and Potential New Emphasis on Classifying Off-Label Promotion as 'False and Misleading'

摘要

On December 3, 2012, the Court of Appeals for the Second Circuit sitting in New York City issued an unexpected opinion in United States v. Caronia. At issue was Mr. Caronia's appeal of his misdemeanor criminal conviction of "misbranding" under the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA provides the United States Food and Drug Administration (FDA) with the authority to regulate medical products and the manner in which they are marketed and promoted. In Caronia, a pharmaceutical representative, or detailer, orally promoted the narcolepsy drug Xyrem, in a recorded meeting with a prescribing physician, to treat insomnia, Fibromyalgia, and also its use in young and elderly patients, which were all unapproved uses; the latter being contraryto a boxed warning. The court tackled the issue of whether the FDCA could prohibit promotional speech related to drug products for uses not indicated on their approved labeling. The Caronia court reiterated, and expanded, the bedrock principle that truthful, non-misleading communication about a lawfully marketed product regarding "off-label" uses, by itself, is protected by the commercial free speech doctrine under the First Amendment of the U.S. Constitution.