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Dec 10, 2012
 |  BC Week In Review  |  Company News  |  Other News

Jazz Pharmaceuticals neurology news

The U.S. Court of Appeals for the Second Circuit said in a 2-1 ruling in United States v. Caronia that the "government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug." In the ruling, Judge Denny Chin wrote that so long as the off-label use of the FDA-approved drug is legal, the government's interpretation of FDCA's misbranding provisions to prohibit and criminalize the promotion of off-label use "unconstitutionally restrict[s] speech." FDCA prohibits misbranding, but does not...

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