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Sunday, December 30, 2012

Appeals Court Overturns Off-Label Marketing Conviction.


On the front page of its Business Day section, the New York Times Share to FacebookShare to Twitter (12/4, B1, Thomas, Subscription Publication) reports, "In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration." In its decision, the "three-judge panel of the Court of Appeals for the Second Circuit in Manhattan" wrote that the ban on "off-label marketing" violated the First Amendment and "cited as precedent a 2011 Supreme Court decision, Sorrell vs. IMS Health," in which the "high court, citing freedom of speech, overturned a Vermont law restricting pharmaceutical companies from using prescription data for marketing purposes."
        Reuters Share to FacebookShare to Twitter (12/4, Stempel, Ingram) explains that in 2005, Federal prosecutors accused Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical, of promoting the company's narcolepsy treatment, Xyrem (sodium oxybate), for off-label uses ranging from chronic fatigue and excessive daytime sleepiness to muscle disorders and persistent pain. Caronia was convicted in 2008 of violating the Federal Food, Drug & Cosmetic Act (FDCA). Monday's ruling by 2nd US Circuit Court of Appeals in New York overturned that conviction.
        The Wall Street Journal Share to FacebookShare to Twitter (12/4, Burton, Subscription Publication) reports that the three-judge panel voted 2-1 to overturn the conviction. The Journal quotes the dissenting Judge Debra Ann Livingston as saying she supported the 2008 conviction "because the First Amendment has never prohibited the government from using speech as evidence of motive or intent" and that Monday's ruling "calls into question the very foundations of our century-old system of drug regulation." The Journal says the Federal government could appeal to the Supreme Court, but by doing so, the FDA would risk having its off-label marketing rules struck down en masse. The Journal adds that an FDA spokesperson declined to comment, noting that the litigation is ongoing.
        The Wall Street Journal Share to FacebookShare to Twitter (12/4, Jones) "Law Blog" notes that Caronia was convicted in 2008 for violating the FDCA by conspiring to introduce a misbranded drug into interstate commerce. In the majority opinion on Monday, the Appeals Court judges stressed that although the FDCA does prohibit off-label drug promotion, the Act does not penalize physicians who prescribe drugs for off-label uses.
        According to Bloomberg News Share to FacebookShare to Twitter (12/3, Fisk), Judge Denny Chin wrote in the majority opinion that the Federal "government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug." Chin opined that the "proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing." Bloomberg adds that Justice Department spokesperson Dean Boyd declined provide comment at this time.

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