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Expert Analysis

Prosecuted For Truthful Off-Label Promotion: Part 1

Law360, New York (October 19, 2016, 4:10 PM EDT) -- We have been following issues related to 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 (FDA) enforcement for a long time. The court battles that have garnered so much attention recently can be traced back to at least the 1990s, with the famed decision in Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81, 85 (D.D.C. 1999), vacated as moot by 202 F.3d 331 (D.C. Cir. 2000)....

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