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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

Chapter:
(p.184) Chapter Ten Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection
Source:
FDA in the Twenty-First Century
Author(s):

Aaron S. Kesselheim

Michelle M. Mello

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0014

The FDA prevents prescription drug manufacturers from directly promoting their products for uses that the FDA has not validated (“off-label” uses), but in the recent case of United States v. Caronia, the United States Court of Appeals for the Second Circuit held that the First Amendment supports manufacturers’ freedom to advertise off-label uses. Since unfettered off-label promotion will lead to substantial public health risks, this chapter discusses how the government could make a stronger case that its current regulatory framework for off-label promotion satisfies the criteria of the First Amendment’s protection of commercial speech.

Keywords:   Commercial speech, First Amendment, off label, FDA, pharmaceutical promotion, adverse effects

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