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Expert Analysis

Prosecuted For Truthful Off-Label Promotion: Part 2

Law360, New York (October 20, 2016, 3:00 PM EDT) -- The interplay of off-label use of drugs and medical devices, manufacturer statements about off-label use, the First Amendment, and U.S. Food and Drug Administration enforcement is complex. The disconnect between the FDA's policy and the government's position in litigation highlighted in our first installment continued in our second case, U.S. v. Facteau, Crim. No. 15-10076-ADB (D. Mass.), which was tried to a jury verdict in June....

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