Vol 22, 2013 Annals of Health Law 420
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
in Medicare, Medicaid and other Federal health care programs.82
III. THE GOVERNMENT AGGRESSIVELY PURSUES OFF-LABEL
MARKETING DESPITE TWO SERIOUS CONCERNS
A. The Off-Label Prescription of Drugs is Legal and
Sometimes Medically Necessary
Off-label uses include the prescription of the drug at a dose not
approved in the label, to a patient population not approved, or to treat a
condition either not considered or considered and rejected by FDA. What is
essential to understand, and difficult to accept analytically, is that
physicians can legally prescribe FDA-approved drugs for any therapeutic
use that is appropriate in their medical judgment.83 Given the expansive
regulatory interpretations,84 it might seem surprising that the courts and
government expressly recognize that off-label use is “an accepted and
necessary corollary of the FDA’s mission to regulate in this area without
directly interfering with the practice of medicine.85 Off-label use is
widespread in the medical community and often is essential to giving
patients optimal medical care . . . .”86 As the statute itself reflects, “nothing
in the Food and Drug and Cosmetic Act shall be construed to limit or
interfere with the authority of a healthcare practitioner to prescribe or
administer any legally marketed device to a patient for any condition or
disease. . . .”87 “ A physician may prescribe a legal drug to serve any
purpose that he or she deems appropriate, regardless of whether the drug
has been approved for that use by the FDA.”88 This arrangement leads to a
“certain ‘asymmetry’ in the regulation of off-label uses: while physicians
may lawfully prescribe drugs for off-label uses, the FDCA generally
prohibits manufacturers from marketing these uses to physicians.”89
Off-label drug prescriptions are very common in medical practice. By
one account, over twenty percent of all prescriptions are off-label.90 In
some fields, off-label use is even more prevalent. For example, The
82. Notice for Potential Monitors for Quality-of-Care Corporate Integrity Agreements,
74 Fed. Reg. 52,964, 52,964-65 (Oct. 15, 2009).
83. Use of Approved Drugs for Unlabeled Indications, 12 FDA Drug Bull. 1 at 4-5
84. See discussion supra Part I.
85. Buckman v. Plaintiffs Legal Comm., 531 U.S. 341, 350 (2001).
87. 21 U.S. C. § 396.
88. Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D. C. Cir. 2000).
89. In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235,
240 (3d Cir. 2012).
90. A. Kesselheim, Off-label Drug Use and Promotion: Balancing Public Health Goals
and Commercial Speech, 37 A. J. L. & Med. 225, 233-234 (2001).