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.
Recommended Citation
Christopher Robertson,
The FDCA as the Test for Truth of Promotional Claims
,
in
FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
204
(Holly Fernandez Lynch & I. Glenn Cohen ed.,
2015).
Available at:
https://scholarship.law.bu.edu/faculty_scholarship/1820
