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Articles Posted in First Amendment

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Does Constitution Prevent FDA from Regulating Off-Label Promotion?

First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated.  Case law now appears to be more settled in the wake of…

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First Amendment Protection and Off-Label Promotion: What Drug Companies Can and Can’t Say

The First Amendment of the United States Constitution protects the freedom of speech.  Not all forms of speech, however, receive total protection, such as yelling “fire” in a crowded theater if doing so is likely to cause injury.  So-called “commercial speech” is a category of speech afforded partial, but not…

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