Vol 22, 2013 Annals of Health Law 424
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
According to the Court, the government had argued that speech restrictions
are justified because there is fear that advertising compounded drugs would
lead to people getting them even if they do not need them.112 Tellingly, the
Court rejected this logic:
Aside from the fact that this concern rests on the questionable
assumption that doctors would prescribe unnecessary
medications . . . this concern amounts to a fear that people would
make bad decisions if given truthful information about
compounded drugs . . . . We have previously rejected the notion
that the Government has an interest in preventing the
dissemination of truthful commercial information in order to
prevent members of the public from making bad decisions with the
In the end, the Supreme Court held that the FDA ban on advertising of
compounded drugs was unconstitutional because it did not satisfy the
Central Hudson114 test setting forth the protections governing commercial
speech. After these challenges, and presumably because of them, the FDA
often has not aggressively enforced the off-label promotion rules. Thus, the
DOJ false claims prosecutions have taken precedence.
Another case, Sorrell v. IMS Health, Inc.,115 considered a Vermont
statute that attempted to restrict pharmaceutical companies from using
prescription data for marketing purposes when doctors and other parties are
permitted to use the same data.116 The Supreme Court found that this
restriction was content- and speaker-based, and rejected the state’s
argument that it constituted mere commercial regulation.117 “[S]peech in
aid of pharmaceutical marketing, however, is a form of expression protected
by the Free Speech Clause of the First Amendment. As a consequence,
Vermont’s statute must be subjected to heightened judicial scrutiny.”118
Vermont argued that its statute was intended to diminish the likelihood that
marketing efforts would lead to prescription decisions that were in neither
the patients’ nor the state’s best interests.119 Though significant, the Court
found that these interests did not satisfy the heightened scrutiny standard
and could not justify the restrictions imposed.120
112. Id. at 370.
113. Id. at 374.
114. Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980).
115. Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011).
116. Id. See also VT. STAT. ANN. tit.18, § 4631(d) (2012).
117. Sorrell, 131 S. Ct. at 2663-67.
118. Id. at 2659.
119. Id. at 2658.