Vol 22, 2013 Annals of Health Law 443
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
is beneficial in many circumstances for patients, and that physicians are
qualified to and should interpret the science independently after receiving as
much information from the manufacturer as they like, then this changed
conduct could be a bad result from a public health standpoint. This author
concludes that if the government chooses not to stop the off-label
prescription of drugs by physicians, then it has no place regulating honest
dialogue pharmaceutical companies may choose to have about such uses.
Indeed, in a world where many off-label prescriptions are paid for by the
government knowingly and willingly in the context of Medicare and other
federal programs, it is illogical to stop discussion about that prescribing
Further, if other courts follow the view taken by the Second Circuit in
Caronia,241 that “truthful” speech is protected even in the context of off-label promotion of FDA-approved drugs, the government will be hard
pressed to continue its prosecution of pharmaceutical companies and
representatives for statements that plainly are permissible if made by any
other individual. However, the critical question for government prosecutors
and prospective defendants alike then becomes what constitutes a “truthful”
statement about an off-label use versus a false or misleading promotion of
that use. The court in Caronia cautioned that “some off-label information
could certainly be misleading or unhelpful” and underscored that the case at
hand did “not involve false or misleading promotion.”242 In a footnote, the
court went a step further, stating that “[o]f course, off-label promotion that
is false or misleading is not entitled to First Amendment protection,” and
“under 21 U.S. C. § 331(a), a defendant may be prosecuted for untruthfully
promoting the off-label use of an FDA-approved drug.”243
Absent clear guidance from the courts, where will the government draw
the line between truthful statements and false or misleading promotion?
For instance, simply providing a copy of a specific study that supports the
use of the drug in a particular population may be dissemination of truthful
information, assuming the study itself is not tainted by fraud, and protected.
But would it be considered “truthful” for the representative to then
characterize the use of the drug in that population as “appropriate,”
particularly if there are other, contradictory findings? Proving the scientific
“truth” of a statement regarding the safety or efficacy of a product used for
off-label purposes might present challenges for defendants.244 Therefore, it
241. Caronia, —- F.3d —-, Docket No. 09-5006-cr, 2012 WL 5992141 (2nd Cir. Dec.
242. Id. at *14.
243. Id. at *13 n.11.
244. For instance, InterMune, Inc. executive Scott Harkonen is appealing his conviction
for wire fraud, a conviction that was based on issuing a press release that preliminary results
of a study “demonstrated” that the company’s medication prolonged survival for patients