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69 Food & Drug L.J. 161 (2014)
Origins of the Prohibition against Off-Label Promotion

handle is hein.journals/foodlj69 and id is 181 raw text is: Origins of the Prohibition Against Off-Label Promotion TERRY S. COLEMAN* I. INTRODUCTION In recent years the federal government has collected billions of dollars from pharmaceutical and medical device companies in criminal and civil penalties for off- label promotion of their drugs and devices, off-label meaning that the therapeutic claims or other information that they disseminated about their products had not been authorized by the Food and Drug Administration (FDA), although the products themselves had been approved or otherwise cleared for marketing by FDA. The offense of off-label promotion, however, is barely visible in the statute and regulations administered by FDA.' Instead, FDA points to relatively obscure regulatory provisions and statutory interpretations that, it contends, establish the prohibition against off-label promotion. The prohibition against off-label promotion came about indirectly as a by-product of two initiatives begun by FDA shortly after enactment of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) in 1938. To cleanse the market of false claims that encouraged inappropriate self-medication and self-treatment, FDA attempted through litigation and administrative actions to obtain authority over drug and device advertising despite the congressional decision to give that authority to the Federal Trade Commission (FTC). FDA's effort led to a broad definition of labeling, which made the new-drug provisions in the FDCA usable against off-label promotion. It also resulted in a requirement that product labeling identify all intended uses of a drug, which was devised by FDA to attack quack drugs but has proved to be a formidable weapon against off-label promotion. In the second initiative, FDA instituted a prescription-only drug system to stifle self-medication with inappropriate drugs and for inappropriate conditions, although it had no apparent statutory authority for such a system. The regulatory structure that FDA created to support its prescription drug system ostensibly allowed FDA to impose requirements on prescription drugs, and pursuant to that authority FDA created a misbranding violation for off-label promotion that might not otherwise violate the Act. In 1951 Congress codified the prescription-only drug system in the FDCA, but remnants of the administrative system persist and are essential parts of the rules establishing the prohibition against off-label promotion. This article outlines the history of those two FDA strategies and explains how the rules relied on by the government to prohibit off-label promotion came to be. While the prohibition against off-label promotion applies to both drugs and medical devices, for purposes of simplicity I will generally refer only to drugs. Terry S. Coleman retired from Ropes & Gray LLP. See, e.g., United States v. Caronia, 703 F.3d 149, 154 (2d Cir. 2012) (The FDCA and its accompanying regulations do not expressly prohibit the 'promotion' or 'marketing' of drugs for off-label use.). 161

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