Off-Label, Not Off-Limits: The Fda Needs To Create a Safe Harbor For Off-Label Drug Use

On December 3, 2012, the U.S. Court of Appeals for the Second Circuit issued a landmark ruling in United States v. Caronia,[1] which, if confirmed on a near-certain appeal to the Supreme Court, will have a profound impact on pharmaceutical promotion in the United States. In its decision, the Second Circuit overturned the federal prosecution of a pharmaceutical sales representative who had communicated truthful information about a drug used in a manner not formally reviewed by the Food and Drug Administration (FDA)—i.e., "off label." The court ruled that "criminalizing the truthful off-label promotion of FDA-approved prescription drugs" was an unconstitutional limitation on free speech in violation of the First Amendment.[2]

The Caronia case highlights two major emerging trends in medicine and law: the widespread prescription of FDA-approved medications for off-label uses; and the increasing application of federal criminal law to regulate pharmaceutical promotion. However the Supreme Court ultimately decides the First Amendment question in Caronia, the FDA needs to rethink its off-label speech regulations, which have become overly broad and unnecessarily opaque. This paper looks briefly at the incidence of off-label drug prescription and at federal application of criminal law to enforce rules on pharmaceutical promotion and proposes that the FDA should adopt a "safe harbor" to allow drug companies to communicate truthful information about off-label drug use to physicians. Our preferred approach is not about helping drug companies but rather to improve medical research and public health by increasing learning about what happens after drugs are licensed and making the best use of pharmaceuticals on the market.

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