Title

The FDCA as the Test for Truth of Promotional Claims

Document Type

Book Chapter

Publication Date

2015

Editor(s)

Holly Fernandez Lynch & I. Glenn Cohen

ISBN

9780231540070

Publisher

Columbia University Press

Language

en-US

Abstract

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.

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