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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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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>.