Note Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Ashley A. Zborowsky

Off-label promotion and the U.S. Food and Drug Administration’s
(FDA, the Agency) current restrictions on commercial
“free speech” have garnered much attention in recent years
due to a district court ruling in United States v. Caronia1 and a
subsequent Supreme Court decision in Sorrell v. IMS Health.2
United States v. Caronia is currently pending review in the Second
Circuit following Sorrell—a highly anticipated ruling. The
outcome of the Caronia case could have a staggering effect on
FDA regulatory authority with respect to promotional activity,
and has been the topic of much scholarly debate. However,
First Amendment rights and commercial free speech are not
novel issues in the context of pharmaceutical and device law.
While many entities have challenged the constitutionality of
FDA’s ban on off-label promotion, in and out of the courtroom,
deference to Agency interpretations of relevant provisions of
the Food, Drug and Cosmetic Act (FDCA) has enabled FDA to
recover billions of dollars in penalties from manufacturers for
off-label promotional activities.3

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