Vol 22, 2013 Annals of Health Law 412
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
any statement is made regarding a use that is not included in the FDA-approved labeling, then the drug has been “misbranded.”28
Another commentator argues that: “[m]any regard this interpretation as
awkward at best and untenable at worst.”29 On the other hand, courts have
held that it is a question of fact whether labeling is false or misleading.30
Therefore, expert testimony regarding safety and efficacy could show that
information communicated regarding an off-label use was not, in fact
If a company introduces a drug into interstate commerce, a misdemeanor
violation occurs if the drug qualifies as either a new drug or misbranded
under the FDCA.32 For a misdemeanor, the regulations do not require any
specific intent to mislead.33 To prove a felony, the government must show
intent to defraud or mislead.34
The government’s broad interpretation of the regulatory framework
would seem justified in contexts where there is strong evidence that the
pharmaceutical company made blatantly false statements to physicians to
encourage increased use of a drug for an unapproved purpose. However, as
will be discussed infra, the evidence is not always so clear; yet, companies
are not in a position to battle the government to a conclusion on the merits
when exclusion from participation in government-funded healthcare
programs is threatened. For example, in United States ex rel. Franklin v.
Parke-Davis, drug company Parke-Davis argued that the FCA relator failed
to show that Parke-Davis made any material false statement.35 The court
held that to pursue the prosecution, the government need not show that
Parke-Davis lied to physicians about safety or efficacy to induce
prescriptions.36 Rather, it was enough that the company promoted an
In sum, when a drug company promotes in a way that is inconsistent with
28. Osborn, supra note 22, at 309.
29. Id. at 310; see also Allison D. Burroughs, et al., Off-Label Promotion: Government
Theories of Prosecution and Facts that Drive Them, 65 FOOD & DRUG L. J. 555, 563 (setting
forth an untested but clear argument regarding why drugs should be exempt from the
“adequate directions for use” provision of the misbranding statute).
30. E.g., United States v. An Article of Drug Consisting of 47 Bottles, More or Less,
Jenesol RJ Formula ‘60’, 320 F.2d 564, 571 (3d Cir. 1963); Colusa Remedy Co. v. United
States, 176 F.2d 554, 561 (8th Cir. 1949).
31. United States v. Sene X Eleemosynary Corp., 479 F. Supp. 970, 980 (S.D. Fla.
32. 21 U.S. C. § 331 (2012).
33. United States v. Mitcheltree, 940 F.2d 1329, 1351 (10th Cir. 1991).
35. U.S. ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39, 52 (D. Mass. 2001).