Health Law News From Arnold & Porter
Health Law News From Arnold & Porter
December 04, 2012
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BLOG: Landmark appeals court opinion could have far-reaching implications for off-label promotion activities

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From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

Yesterday, the U.S. Court of Appeals for the Second Circuit issued a long-anticipated and potentially very important decision in United States v. Caronia, No. 09-5006-cr. In a 2-1 opinion authored by Judge Denny Chin, the court held that a prosecution based solely on speech about unapproved uses of a prescription drug raises serious constitutional concerns under the First Amendment and therefore cannot stand.

Jeffrey L. Handwerker

Caronia involves the prosecution of a sales representative for Orphan Medical (now Jazz Pharmaceuticals) for making statements to doctors about unapproved uses of Xyrem. The jury convicted Mr. Caronia of misbranding under the Food Drug & Cosmetic Act (FDCA). The Second Circuit reversed, applying the First Amendment analysis set forth by the Supreme Court in Sorrell v. IMS Health Inc., a case that Arnold & Porter handled at the trial and appellate stages, including in the Supreme Court. The Caronia court reasoned that FDCA prosecutions premised on off-label promotion impermissibly discriminate against pharmaceutical companies based on the content of their speech. Under Sorrell, such content-based restrictions of speech are subject to “heightened scrutiny.”


The Second Circuit then proceeded to apply the test for commercial speech set out in Central Hudson, and found that prosecution of drug manufacturers based on promotional activities does not advance the government’s interests in an appropriately tailored way. Accordingly, the Court reversed the conviction. In so holding, the Court emphasized that the First Amendment bars the government from prosecuting pharmaceutical companies for engaging in truthful and non-misleading speech about off-label uses. This landmark ruling may prompt FDA to revisit the various guidance documents that it has issued recently concerning speech about unapproved uses of prescription drugs.

Jeffrey L. Handwerker, JD, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202-942-6103; email: Jeffrey.Handwerker@aporter.com.