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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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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 19 May 2022

Why FDA’s Ban on Off-Label Promotion Violates the First Amendment

Why FDA’s Ban on Off-Label Promotion Violates the First Amendment

A Study in the Values of Commercial Speech Protection

(p.219) Chapter Twelve Why FDA’s Ban on Off-Label Promotion Violates the First Amendment
FDA in the Twenty-First Century

Coleen Klasmeier

Martin H. Redish

Columbia University Press

This chapter explains why, given the fact that off-label use of prescription drugs is itself a purely legal activity, the prohibition on off-label promotion contravenes core notions of free expression guaranteed by the First Amendment. It demonstrates that under current standards of commercial speech protection the prohibition clearly fails, absent a finding that the promotion is false or misleading, because it constitutes suppression of truthful expression advocating a lawful activity. Such prohibitions are categorically deemed unconstitutional, because they represent the most invidious form of governmental manipulation of citizen behavior through the selective suppression of speech.

Keywords:   commercial speech, off-label advertising, free speech theory

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