Vol 22, 2013 Annals of Health Law 410
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
scientific and educational material to physicians. One can reasonably
question whether the government’s goal is to induce a change in industry
conduct, as opposed to continuing to generate a windfall and substantial
revenue stream for government, with no reasonable expectation that
conduct is actually being modified. The practice “may enrich the United
States Treasury at the expense of consumers from whom the costs will be
I. FDCA REGULATION OF INFORMATION ABOUT
OFF-LABEL USES OF DRUGS
Regulations regarding the approval process and subsequent sale of
pharmaceuticals are set forth in the Federal Food, Drug, and Cosmetic Act
of 1938, as amended (“FDCA”).11 The United States Food & Drug
Administration (“FDA”) is the agency authorized to regulate the promotion
of prescription drugs.12 The FDCA does not discuss whether a drug
manufacturer may distribute or communicate any information about
potential off-label uses of its approved drugs.
However, the FDCA provision regarding new drugs, coupled with
regulations promulgated by the FDA, essentially acts to regulate off-label
promotion.13 The FDCA expressly prohibits the introduction of a “new
drug” into commerce.14 A new drug is defined as one which is “not
generally recognized . . . as safe and effective for use under the conditions
prescribed, recommended, or suggested in the labeling.”15 Further,
regulations make it clear that a drug that has been approved for use to treat
some condition in some population, may nonetheless be a new drug
depending on its label: “the newness of a drug may arise by reason (among
other reasons) of . . . [t]he newness of use of such drug in diagnosing,
curing, mitigating, treating, or preventing a disease, or to affect a structure
or function of the body, even though such drug is not a new drug when used
in another disease or to affect another structure or function of the body.”16
If a manufacturer distributes a drug with a label other than that approved by
the FDA, it is considered a new drug.17
10. Vicki Girard, Punishing Pharmaceutical Companies for Unlawful Promotion of
Approved Drugs: Why the False Claims Act Is the Wrong Rx, 12 J. HEALTH CARE L. & POL’Y
119, 130 (2009).
11. Federal Food, Drug, and Cosmetic Act, 21 U.S. C. §§ 301-399 (2006).
12. 21 U.S. C. §§ 352(a), 352(n), 393(a)-(d) (2006).
13. 21 U.S. C. A. § 331; 21 C.F.R. Pt. 314.
14. 21 U.S. C. § 355; 21 C.F.R. § 201.100(d); 21 U.S. C. § 352(a).
15. 21 U.S. C. § 321(p) (2006) (emphasis added).
16. 21 C.F.R. § 310.3 (1999).