Saturday, December 8, 2012

Off label Drug Promotion is Free Speech - 2d Circuit

It is going to take some time for me to explore the implications of this opinion by local hero Denny Chin, Circuit Judge, who has overturned a conviction on ground that promoting off-label use of a drug is protected by the First Amendment.  Judge Debra Ann Livingston dissents - an opinion I almost instinctively accept.  Maybe there is a deeper logic, but I fear it is Citizens United redux - "drug companies are people too".  - GWC
United States of America v. Alfred Caronia

Chin, Circuit Judge
"Defendant-appellant Alfred Caronia appeals from a judgment of conviction entered in the United States District Court for the Eastern District of New York (Eric N.Vitaliano, J.) on November 30, 2009, following a jury trial at which Caronia was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. §§ 331(a) and 333(a)(1). Specifically, Caronia, a pharmaceutical sales representative, promoted the drug Xyrem for "off-label use," that is, for a purpose not approved by the U.S. Food and Drug Administration (the "FDA").  Caronia argues that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment.  We agree." 

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