Regulating Off-Label Promotion — A Critical Test image

NEJM, November 2, 2016
Christopher Robertson, JD, PhD (Academic Fellow Alumnus) and Aaron S. Kesselheim, MD, JD, MPH (Faculty Affiliate)


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Petrie-Flom Academic Alumnus Christopher T. Robertson and Faculty Affiliate Aaron S. Kesselheim have coauthored a new Perspective article in NEJM on recent judicial decisions regarding off-label promotion of pharmaceuticals. From the article:

In recent years, the U.S. Supreme Court has expanded the conception of what counts as “speech” in the eyes of the law and has generally increased its legal protections. For example, in a 2011 case, the Court held that protected speech included sales data used by pharmaceutical manufacturers to more efficiently target marketing to physicians. 

Still, the Caronia decision subverted decades of presumptions about how the government could oversee the behavior of the pharmaceutical and medical device industries. For over 50 years, the FDCA has required that drugs (and later, high-risk devices) be labeled for all uses intended by their manufacturers and that their safety and efficacy for those uses be first demonstrated in clinical trials. The FDA created “safe harbors” allowing companies to distribute peerreviewed literature or answer physician questions. However, until the Second Circuit’s Caronia decision, if a company promoted intended uses that had not been FDA-approved, that promotion would be clear evidence that the product was misbranded and that its sale for those uses was illegal. The fact that the work of pharmaceutical sales representatives involved speech did not matter before Caronia.

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criminal law fda health care finance health law policy judicial opinions pharmaceuticals public health regulation