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Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac ("Zack") D. Buck

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While the American public remains preoccupied with the lurching implementation of the Affordable Care Act, the regulation of pharmaceutical companies for their off-label marketing and promotion of drugs is a regulatory environment within the health industry that seems to be in wild flux. Following the Second Circuit’s decision in U.S. v. Caronia, commentators and providers seem unclear about the future of federal regulation in this area, with the FDA seeking to minimize the opinion, and pharmaceutical companies celebrating its impact. Much of the understandably spirited reaction to the Caronia case has omitted a discussion of the relevant and applicable state-law …