Vol 22, 2013 Annals of Health Law 425
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
Collectively, these opinions give rise to serious questions about whether
the government’s current interpretation of the law could withstand
constitutional scrutiny. Recently, the Second Circuit has held that it does
not.121 In Caronia,122 the court found that a drug company representative’s
truthful statements about off-label uses for the pharmaceutical Xyrem were
protected under the First Amendment.123 Mr. Caronia was caught on tape
promoting Xyrem for off-label uses, including the treatment of excessive
pain associated with fibromyalgia.124 Because Xyrem was approved by the
FDA to treat only certain narcolepsy patients, the government charged Mr.
Caronia with two misdemeanor counts of introducing a misbranded drug
into commerce and conspiracy to introduce a misbranded drug into
commerce in violation of 21 U.S. C. §§ 331(a) and 333(a)(2).125 Echoing its
argument in Washington Legal Foundation,126 the government denied that it
was attempting to regulate speech.127 Rather, it claimed to introduce Mr.
Caronia’s off-label promotional speech simply as evidence of his intent to
conspire to sell a misbranded drug.128 After a jury trial, Mr. Caronia was
found guilty and sentenced to one year of probation, 100 hours of
community service and a twenty-five dollar special assessment.129
On appeal of Mr. Caronia’s conviction, the majority relied heavily upon
Sorrell and found that the FDCA’s misbranding provision must be subject
to heightened scrutiny because it is a content- and speaker-based restriction
and involves a criminal penalty.130 Applying the four-pronged Central
Hudson analysis, the Second Circuit held that the FDA misbranding
regulations are too broad to support the government’s objective of
promoting drug safety and public health and that government interests can
be served equally well through more limited and targeted restrictions on
speech.131 Accordingly, even if speech can serve as evidence of a drug’s
intended use, the court interpreted the misbranding provisions of the FDCA
to not prohibit or criminalize “the truthful off-label promotion of FDA-approved prescription drugs.”132 Therefore, “the government cannot
121. United States v. Caronia, 703 F.3d 149, 168 (2d Cir. 2012).
124. Id. at 156.
125. Id. at 155, 157.
126. See Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 59 (D. C. Cir. 1998),
amended by 36 F. Supp. 2d 16 (D. C. Cir. 1999) and amended by 36 F. Supp. 2d 418 (1999),
appeal dismissed sub nom. Wash. Legal Found. v. Henney, 202 F.3d 331 (D. C. Cir. 2000).
127. Caronia, 703 F.3d at 160-61.
128. Id. at 160.
130. Id. at 165.
131. Id. at 165-68.