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Reading The Labels Of Par And Harkonen

Law360, New York (March 29, 2013, 10:44 AM EDT) -- Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under the federal Food, Drug and Cosmetic Act.[1]

In December 2012, the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce, holding that Caronia’s conviction based on promotion of off-label uses of a U.S. Food and Drug Administration-approved...
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