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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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The FDCA as the Test for Truth of Promotional Claims

The FDCA as the Test for Truth of Promotional Claims

(p.204) Chapter Eleven The FDCA as the Test for Truth of Promotional Claims
FDA in the Twenty-First Century

Christopher Robertson

Columbia University Press

Physicians often prescribe drugs and devices for “off-label” uses not reviewed or approved by the FDA, but the makers of those products are not allowed to promote those uses, as that would evince an intent contrary to their approved labels. This regulatory equilibrium is precarious under an expanding conception of the First Amendment, but such judicial and scholarly analyses turn on unwarranted presumptions about the truth of the manufacturers' promotional claims, a truth that is unknowable until tested by the FDA or courts.

Keywords:   off-label, promotion, First Amendment, scientific testing, institutional capacity, incentives

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