FDA Wise To Duck High Court Off-Label Ruling, Attys Say

Law360, New York (January 24, 2013, 9:51 PM EST) -- The U.S. Food and Drug Administration has decided not to challenge the Second Circuit's decision that a sales representative's truthful off-label promotion of a drug was protected speech, a move experts say wisely avoids a U.S. Supreme Court showdown that could have expanded the ruling's reach and given drugmakers more room for off-label marketing.

The agency released a statement Tuesday saying it would not seek review of the appeals court's Dec. 3 decision, in which the majority of a three-judge panel reversed a verdict finding Orphan...
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