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December 4, 2012

MISBRANDING (FOOD, DRUGS, AND MEDICAL DEVICES)-2d Cir.: Conviction for promotion of off-label use violated First Amendment

By Michelle L. Oxman, JD, LLM

The conviction of Alfred Coronia for conspiracy to introduce misbranded drugs into commerce violated his rights under the First Amendment to the United States Constitution because it was based entirely on his promotion of the off-label use of Xyrem (United States v Coronia, December 3, 2012, Chin). Criminal laws punishing speech based on its content or the identity of the speaker violate the First Amendment unless they promote a substantial government interest and are narrowly drawn to limit their application to the extent necessary to accomplish the government's objective. The government's interpretation of 21 U.S.C. sec. 331(a) to criminalize truthful statements by a manufacturer about lawful off-label uses of a drug does not advance its interests in maintaining the integrity of the drug approval process or in limiting patients' exposure to unsafe or ineffective drugs. Therefore, the conviction was set aside.

The uses and risks of Xyrem. Xyrem is a central nervous system depressant. The FDA approved it in 2002 for the treatment of narcolepsy patients with cataplexy, a condition involving weak or paralyzed muscles. In 2005, the FDA approved Xyrem for treatment of narcolepsy patients with excessive daytime sleepiness. The drug can cause serious side effects, including difficulty breathing while asleep, abnormal thinking, depression, nausea, and vomiting. Abuse can lead to seizures, coma, and death. The active ingredient is federally classified as the "date rape" drug. The FDA required a "black box" warning label for Xyrem stating that: (1) it was approved only for patients between the ages of 16 and 65, (2) there was limited experience with use for patients over 65, and (3) it had not been tested on children.

The promotion of Xyrem. Coronia and a codefendant made statements to a physician posing as a prospective customer promoting the use of Xyrem to treat fibromyalgia, muscle disorders, chronic pain, and chronic fatigue syndrome. Caronia stated that the drug had been used with patients as young as 14 and, more frequently, with patients over 65.

The charges against Coronia. Coronia was charged with: (1) conspiracy to introduce a misbranded drug into interstate commerce; and (2) introducing a misbranded drug into interstate commerce, both involving violations of 21 U.S.C. secs. 331(a) and 333(a)(2). The first charge required the jury to make two findings: (1) knowingly and intentionally conspiring with others to market Xyrem when it was misbranded; and (2) as part of the conspiracy, marketing Xyrem for uses not approved by the FDA, with knowledge that the labeling did not carry adequate directions and warnings for the unapproved uses, where the uses could be dangerous to patients' health. The jury found Coronia not guilty of introducing Xyrem into commerce. As to the conspiracy charges, the jury found Coronia guilty of conspiracy to market the drug while it was misbranded but not of marketing with knowledge that the labeling and warnings were inadequate.

The appeal. The government argued that it had used Coronia's statements as evidence of his intent to market the misbranded drug but did not prosecute him for his statements alone. The court rejected the government's argument because the prosecution never argued or presented evidence that Coronia committed any act related to misbranding other than promoting the drug to physicians for off-label uses; it referred only to his statements.

First Amendment protections. The United States Supreme Court held in Sorrell v IMS Health that commercial speech, including speech related to the marketing of drugs, is protected under the First Amendment as long it is not false or misleading. The court reasoned that Sorrell requires heightened scrutiny of laws that penalize protected commercial speech based on its content or the identity of the speaker. The statutes involved both. They specifically prohibited speech about off-label use by representatives of the manufacturer, but they did not affect speech by physicians or researchers.

The statutes failed to meet constitutional requirements because they did not effectively advance the government's interest and were not written to minimize the effect on speech. The government's interests were protection of the integrity of the drug approval process and the protection of patients from unsafe drugs. The statutes did not advance the interest in the drug approval process because the Food, Drug and Cosmetic Act allowed, even expected, that physicians would prescribe drugs for uses not approved by the FDA. The government has no interest in preventing truthful speech about lawful conduct, and the prosecution never claimed that Coronia's statements were false or misleading. In addition, the government's interests could be accomplished by a statute or other guidance that addressed false or misleading statements directly or regulated off-label uses.

The dissent. Judge Livingston disagreed. First, she emphasized the definition of misbranding. A drug is misbranded if the labels do not contain adequate directions or adequate warnings about the intended use of the drug. Whether the instructions or warnings are adequate depends on the intended use. She reasoned that the agency's regulations at 21 C.F.R. sec. 201.5 define adequate instructions as directions under which a lay person can use the drug safely for its intended purposes; they must describe all purposes for which the drug may be used and the typical dosages for each use. In addition, the regulations at 21 C.F.R. sec. 201.128 require manufacturers to provide adequate labeling for additional uses of drugs when they have notice that the drugs are prescribed for those uses. She noted that Coronia did not argue that the labels for Xyrem were adequate for the uses he promoted, and that Coronia described the drug as "very safe," but the government proved that Xyrem was dangerous under some circumstances. Therefore, she did not accept the majority view that Coronia was prosecuted solely because of his speech.

The case number is 09-5006-cr.

Douglas Letter and Martin Coffey, Office of the United States Attorney, E.D.N.Y., for United States, Appellee. Jennifer L. McCann (Law Offices of Thomas J. Liotti) for Defendant-Appellant Alfred Caronia. Eric E. Murphy (Jones Day) for Washington Legal Foundation, Amicus Curiae.

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