Vol 22, 2013 Annals of Health Law 411
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
Labeling includes all “written, printed, or graphic” materials that
accompany the drug.18 The FDA’s authority in the area of off-label
marketing arises from its expansive definition of “label.”19 The FDA
regulations have been interpreted to sweep more broadly than the plain
language of the statute in prohibiting communications by the manufacturer
in many contexts. The regulations have been used to control advertising
and even discussions between the drug manufacturer and physicians.20
Indeed, “in combination with its authority over promotional labeling, the
FDA’s regulatory oversight of prescription drug marketing extends to
practically every type of material and media imaginable.”21 One
commentator noted that “FDA regulations restrict company activities in this
area to a much greater extent than the FDCA’s statutory scheme. For
example, the FDA defines ‘labeling’ to include virtually anything that a
company or its employees might produce or present . . .”22 Thus, the
manufacturer may not make statements or provide information about its
drug—even if true—without the approval of the FDA.
In addition to the prohibition on selling “new drugs,” the FDCA prohibits
the sale of a “misbranded” drug.23 A drug is considered misbranded if it
includes inadequate directions for use, or if the labeling bears false and
misleading information.24 In practice, if the manufacturer provides
information to a prescriber relating to an off-label use, the government will
argue that the approved label is inadequate and/or misleading because that
labeling does not address the safety and efficacy of the drug for that off-label use.25 As with defining what a new drug is, the misbranding
provisions have been interpreted as constituting any false or misleading
statements in the labeling or materials provided with the drug, including
directions for use.26 The “intended use” of the product has been interpreted
to include any use that the manufacturer intends based on the label,
advertisements or any statements made to physicians.27 Thus, arguably if
18. 21 U.S. C. § 321(m) (2009).
19. 21 U.S. C. § 321(k) (2009).
20. See 21 C.F.R. § 208.1 (1998); 21 C.F.R. 208.20 (2008); 21 C.F.R. 202.1 (1998).
21. Girard, supra note 10, at 123.
22. John E. Osborn, Can I Tell You the Truth? A Comparative Perspective on
Regulating Off-Label Scientific and Medical Information, 10 YALE J. HEALTH POL’Y L. &
ETHICS 299, 308 (2010). See also Kordel v. United States, 335 U.S. 345, 350 (1948)
(defining literature that “accompanies” drugs).
23. 21 U.S. C. §§ 331(a), (b) (2013); 21 U.S. C. § 352(a) (2012).
24. 21 U.S. C. §§ 352 (f) and (a) (defining “inadequate directions for use” and “false and
misleading label,” respectively).
25. 21 U.S. C. §§ 352 (f) and (a).
26. 21 C.F.R. § 201.128 (2012).