Health Care Law

Caronia: A Serious First Amendment Rebuke to Federal Off-Label Marketing Prosecutions

, The Legal Intelligencer

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An unfortunate aspect of our legal system is that many important legal issues are not resolved by the courts because a controversy is not only too big to try, but also too big to be filed. A good example is federal-government-threatened civil and criminal claims against pharmaceutical manufacturers for "off-label" promotion, i.e., promotion of pharmaceutical products for uses other than those described on their FDA-approved labeling.

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