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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
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
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.).


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