Par Pharmaceutical vs USA - Off-Label Promotion and the First Amendment

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Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early dismissal, not addressing the First Amendment issues, but on grounds that the claims are not ripe because ipse dixit of FDA concludes that the conduct Par complains of in its complaint “would not establish Par’s objective intent” of criminal conduct. But FDA cites no statute, regulation or guidance to explain this conclusion. While FDA may be comfortable relying on enforcement discretion as a guiding principle, manufacturers are left with uncertainty. It is not yet clear whether this case will reach the important First Amendment issues it raises. What is clear is that significant constitutional challenges remain unresolved and FDA's intrasigence suggests that the issues will remain unresolved until a court or congress provides much needed clarity to this area of the law.

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