Tuesday, May 7, 2013

Off-Label Promotion of Drugs is Now a Matter of Free Speech

In recent years, the pharmaceutical industry has experienced numerous lawsuits alleging illegal promotion of off-label drugs, resulting in the payment of billions of dollars to the federal government. But a recent decision by the federal appeals court has ruled that such promotion, in fact, is actually a matter of free and protected speech, and could potentially change the way prescription drugs are marketed and promoted in the United States.

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Caronia v. United States focused on Alfred Caronia, a former sales representative of Orphan Medical who was criminally prosecuted for promoting off-label uses for Xyrem, a Food and Drug Administration-approved drug to treat narcolepsy (Fauber). Caronia was reported to have promoted Xyrem for off-label uses for other conditions such as fibromyalgia and insomnia, which were uses that were not approved by the FDA. While physicians are free to prescribe an approved drug for any use, it is illegal for drug manufacturers to market off-label uses for drugs that have not been specifically authorized by the FDA under the Food, Drug, and Cosmetic Act 21 U.S.C. § 301 et seq (2002). The very act of promoting off-label uses could serve as evidence that a manufacturer had directly intended to sell a “misbranded” drug that would “be used for purposes not listed in the label” (Thomas).

In 2005, Caronia was under federal investigation for his statements. He was later caught on tape promoting the off-label uses of Xyrem to a doctor who was working with the government. He was convicted in 2008 and appealed the charges to the Second Circuit Court of Appeals in Manhattan (Thomas). He claimed that his truthful and non-misleading off-label promotions constituted protected speech under the First Amendment and that these charges ultimately sought to restrict and criminalize his speech (Fauber).
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On December 3, 2012 in a 2-1 decision, the Second Circuit Court of Appeals agreed, stating that “the government clearly prosecuted Caronia for his words––for his speech,” and that his rights under the First Amendment had been violated (Thomas). In reaching their decision, the court cited the Supreme Court case Sommell v. IMS Health 564 U.S. _____ (2011) which also dealt with the restriction of speech and information in the medical world. The Vermont law prohibited the sale of physician drug records so that the information could not be used by drug companies to more directly market and target particular drugs to physicians. This restriction of the flow of information to physicians regarding other drug possibilities silenced the marketed speech of the drug companies and the law was overturned (Thomas). The topic of commercial speech was also contested in the case Citizens United v. Federal Election Commission 558 U.S. _____ (2010) when the Supreme Court ruled that the restriction of expenditures from corporations and unions had the same effect as directly restricting political speech (558 U.S. 4 (2010)).

The final decisions in both of these cases worked to secure First Amendment protections to manufacturers and corporations, while providing the foundation for Caronia’s appeal. The majority concluded that Caronia did not possess an intent to deliberately promote misleading or false information regarding Xyrem, and that simply promoting truthful, off-label uses for a drug was protected speech and did not violate the FDCA (Kelton and Fauber). Through this decision, the Second Circuit Court of Appeals became the first court to recognize truthful and non-misleading off-label promotion as constitutional, while false off-label speech could constitute a criminal offense (Sack).

Gerald Masoudi, a former chief counsel of the FDA, noted that the truthful discussion of off-label uses of drugs is quite legitimate within the medical community and that the decision in Caronia will force the FDA to focus on off-label cases in a new way. “It’s going to make the FDA focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing, versus something that is not approved.” The Pharmaceutical Research and Manufacturers of America also agreed with the court’s decision and believe that this ruling will help to provide a more current and accurate flow of information from professionals to patients (Thomas).

Yet others disagree. While the decision in Caronia may prove to be a great victory for the pharmaceutical company, some doctors worry about the increased health risks that this decision could pose to the public. Because off-label uses for drugs can now be freely promoted within the Second Circuit, side effects and risks to patients could be an even greater unknown since the drug was not approved by the FDA for that particular use. Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, explains that this issue is simply not a matter of free speech but “is the medical equivalent of yelling fire in a crowded auditorium.” This sentiment echoes the potential danger this decision could bring to public health, while the overall strength of the FDA could weaken over time if the off-label promotion of drugs is legally permitted (Fauber).

So what does this mean for the future of free speech as it applies to the pharmaceutical industry? Because off-label promotion is no longer illegal in the Second Circuit, drug manufacturers are free to market their drugs for uses not approved by the FDA. There will be less restrictions and potentially less fear of criminal prosecutions, as long as the information provided is considered truthful. But this decision could also pose problems to future cases as what is deemed “truthful” and “non-misleading” may be considered too broad (Sack). It is believed that the government will most likely ask for the case to be heard again in the federal appeals court and the case could make its way up the Supreme Court in time. While the Second Circuit’s decision only reaches New York, Vermont, and Connecticut, it could have even greater national effects on public health and safety, as well as on how drug promotion will be approached in the future, if it does reach the Supreme Court (Thomas).


Fauber, John. "Off-Label Drug Marketing Is 'Free Speech,' Court Rules." ABC News. ABC News Network, 05 Dec. 2012. Web. <http://abcnews.go.com/Health/Drugs/off-label-drug-marketing-free-speech-court-rules/story?id=17883930>. 

Kelton, Erika. "Off-Label Pharma Prosecutions Won't Be Silenced By First Amendment Decision." Forbes. Forbes Magazine, 04 Jan. 2013. Web. <http://www.forbes.com/sites/erikakelton/2013/01/04/off-label-pharma-prosecutions-wont-be-silenced-by-first-amendment-decision/>.

Sack, Jonathan. "Does Misdemeanor Misbranding Survive Caronia?" Forbes. Forbes Magazine, 11 Dec. 2012. Web. <http://www.forbes.com/sites/insider/2012/12/11/does-misdemeanor-misbranding-survive-caronia/>.

Thomas, Katie. "Ruling is Victory for Drug Companies in Promoting Medicine for Other Uses." The New York Times. The New York Times, 03 Dec. 2012. Web. <http://www.nytimes.com/2012/12/04/business/ruling-backs-drug-industry-on-off-label-marketing.html?_r=1>.

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