The federal government launched an investigation into the off-label promotion of Xyrem and obtained audio recordings of Caronia with potential physician-customers promoting Xyrem for unapproved uses, including unapproved indications and unapproved subpopulations. In the recordings, Caronia stated that Xyrem’s properties can address insomnia, fibromyalgia, restless leg, and other disorders, and that there were reports of patients as young as 14 and older than 65 using Xyrem. The government charged Caronia under the Food, Drug, and Cosmetic Act (FDCA) and its prohibition on misbranding of drugs, which the government contends includes pharmaceutical representatives’ marketing of drugs for unapproved, or off-label, uses.
Prior to trial, Caronia moved to dismiss the case on the basis that the First Amendment protected his off-label promotional statements. The trial court denied the motion on the basis of the commercial speech doctrine, finding that the FDCA restriction as interpreted by the government was not more extensive than necessary to achieve the FDA’s objectives. Following trial, a jury convicted Caronia of conspiracy to introduce a misbranded drug into interstate commerce.
Off-Label Marketing Protected by First Amendment
Caronia, on appeal, claimed that the provisions of the FDCA prohibiting off-label promotion unconstitutionally restricted his truthful, non-misleading speech. The Second Circuit held that the FDCA does not criminalize “the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” The court disagreed with the government’s statutory interpretation, construing the misbranding provisions of the FDCA “as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” The court, therefore, vacated Caronia’s conviction.
The Second Circuit declined to address whether the government could introduce evidence of off-label promotion in the prosecution of a case founded on intent to misbrand. The government attempted to assert that Caronia was not convicted for his speech but that his speech was introduced instead to establish that off-label uses of the drug were its intended uses. The Second Circuit rejected that position, finding that the government prosecuted Caronia solely for his promotion of off-label uses and not a conspiracy to place false or deficient labeling on a drug. Had the government approached Caronia’s prosecution as being founded on intent to misbrand, his statements may have been admissible and not protected by the First Amendment.
Refinement of Government Position and Industry Response
The Second Circuit’s opinion may lead the government to adjust its prosecution of off-label marketing cases. “I think that what we’ll see going forward are more careful prosecutors in terms of what cases they bring, for example choosing cases where the language or promotion is false or misleading,” predicts Bryan K. French, Boston, cochair of the Health Care Fraud Subcommittee of the ABA Section of Litigation’s Criminal Litigation Committee. “I also believe that prosecutors will be more exacting in their language to ensure that they are prosecuting the misbranding offense and that any off-label promotion is presented simply as evidence of the intended use of the product and not what they are actually prosecuting,” says French.
As for the impact of Caronia on the industry going forward, “I think that pharmaceutical companies and pharmaceutical representatives will now feel freer to discuss off-label uses that are truthful and can be supported” says Jan P. Miller, St. Louis, cochair of the Section of Litigation’s Health Law Litigation Committee. “But they better tread lightly,” he adds. “This case has no impact on civil enforcement, administrative enforcement, or civil lawsuits.” “I think the safe course is for the company that is promoting any off-label use to be the follower, not the leader; the leader needs to be the medical community” cautions Miller.
Companies seeking to engage in off-label promotion should be cautious, agrees Dylan J. Steinberg, Philadelphia, cochair of the Section’s Pharmaceutical and Medical Device Subcommittee of the Health Law Litigation Committee. “It’s hard to imagine that this issue doesn’t end up before the United States Supreme Court, through either granting certiorari on Caronia or waiting for a circuit split to develop.” “Until the Supreme Court gets involved, it’s still too unpredictable for industry to change the way it conducts business,” he adds. For instance, Steinberg observes that it is unclear if the government will continue to pursue off-label promotion outside the Second Circuit or what standards the government will use to evaluate if speech is truthful or misleading.
Jonathan B. Stepanian is an associate editor for Litigation News.