First Amendment Protects Pharmaceutical Sales Rep's Off-Label Promotion of Drug, Court Says
A pharmaceutical sales representative’s conviction for conspiracy to introduce a misbranded drug into interstate commerce violated his rights to free speech under the First Amendment, according to the Second Circuit’s ruling in United States v. Caronia, No. 09-5006-cr, slip op. (2nd Cir., Dec. 3, 2012). The court held that the representative’s speech, consisting of the off-label marketing of a drug, was the principal basis for the government’s criminal case, and that the regulations regarding such marketing were overbroad for the goal of maintaining safe drug labeling. The decision adds an interesting and important dimension of constitutional law to the issue of drug safety and medication errors.
The drug at the center of the case is Xyrem, a central nervous system depressant used for narcolepsy. It has a reputation as a “date rape drug” because its active ingredient, gamma hydroxybutrate, can cause abrupt loss of consciousness in sufficiently large doses. It is therefore subject to strict regulations as to its approved uses. The U.S. Food and Drug Administration (FDA) has only approved it for two uses, both related to narcolepsy: excessive daytime sleepiness and cataplexy, a sort of temporary paralysis associated with the condition. Xyrem was developed by Orphan Medical, which is now part of Jazz Pharmaceutical.
Before a pharmaceutical company may introduce a new drug into the marketplace, it must obtain approval from the FDA for specified uses, and the law states that its marketing may only reference these approved uses. The federal Food, Drug, and Cosmetic Act (FDCA) prohibits drug companies and their representatives from introducing “misbranded” drugs into the marketplace, which may include information that is “false or misleading,” or that suggests uses that are “dangerous to health.” Caronia, slip op. at 7, n. 4. The law does not, however, prohibit “off-label” promotion of drugs by physicians when speaking directly to patients. For pharmaceutical companies and their sales representatives, the FDCA imposes criminal penalties for misbranding drugs, but it does not specifically criminalize “off-label” promotion of drugs.
Alfred Caronia, the defendant, was convicted in October 2008 of one misdemeanor count of conspiracy to introduce a misbranded drug into interstate commerce. He had begun working for Orphan in March 2005 as a Xyrem “specialty sales consultant.” A physician cooperating with federal investigators taped several conversations with Caronia, in which Caronia could reportedly be heard promoting Xyrem for “off-label” uses not approved by the FDA, including chronic fatigue, chronic pain, fibromyalgia, and muscle disorders. He also allegedly promoted the drug for use with patients younger than sixteen. This led to two misdemeanor charges by federal prosecutors, and Caronia’s conviction on one charge.
On appeal to the Second Circuit, Caronia cited the First Amendment in arguing that his promotion of Xyrem was “truthful and non-misleading,” id. at 25, and that the government’s criminalization of his conduct was improper when it did not criminalize similar conduct by others, specifically physicians. The court vacated the conviction, but applied narrower constitutional grounds in its decision. It noted that the FDCA does not prohibit mere off-label promotion, and it found that the charges against Caronia were based solely on his “promotion” activities. The misbranding statute, however, requires proof of more than just “promotion,” which the court held is constitutionally-protected speech under these circumstances.
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Photo credit: By Ben Mills (Own work) [Public domain], via Wikimedia Commons.