Recent Settlements Suggest Off-Label Cases Aren't Extinct

Law360, New York (August 30, 2017, 12:30 PM EDT) -- The courts in recent years have handed the U.S. Department of Justice and the U.S. Food and Drug Administration a string of defeats in cases involving government efforts to prosecute companies and individuals for so-called off-label promotion. While many hoped that these rulings would usher in an era where companies could safely engage in truthful and nonmisleading discussions without fear of enforcement, a review of recent government activity suggests that the government remains committed to aggressively pursuing off-label cases, even if limited to using civil remedies.

The takeaway from recent settlements is that promotional activities continue to be a significant compliance...

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