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Prescribing Approved Drugs for Nonapproved Uses: Physicians’ Disclosure Obligations to Their Patients

Published online by Cambridge University Press:  27 April 2021

Extract

A large part of the everyday practice of medicine consists of prescribing drugs for the purpose of curing or alleviating patient ills. In most cases, a drug must be approved for specific uses by the federal government before it becomes available to be prescribed by a physician. However, once a drug has received regulatory approval for a specific medical use, the physician may prescribe it for any purpose, approved or not. The prescribing of drugs for nonapproved uses is a common medical practice. This article discusses the informed consent implications raised by this practice, and argues that the physician should disclose to the patient the legal status of a drug prior to prescribing it for a purpose which has not been governmentally approved.

Relying upon the Constitution's Commerce Clause, Congress has vested jurisdiction over all “drugs” involved in “interstate commerce” in the federal Food and Drug Administration (FDA), a division of the Public Health Service (PHS) of the Department of Health and Human Services (DHHS).

Type
Pharmacy and the Law
Copyright
Copyright © American Society of Law, Medicine and Ethics 1981

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References

United States Constitution, art. I, sec. 8, clause 3.Google Scholar
“Drugs” are defined at 21 U.S.C. §321(g)(1), as amended.Google Scholar
“Interstate commerce” is defined at 21 U.S.C. §321(b), as amended.Google Scholar
Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended, codified at 21 U.S.C. §301 et seq.Google Scholar
See generally Temin, P.. Taking Your Medicine (1980); Pines, , A Primer on New Drug Development, FDA Consumer (February 1974) at 12.Google Scholar
21 C.F.R. §312.1(a)(2) (1977).Google Scholar
21 C.F.R. §314.1(c)(2) (1977).Google Scholar
21 C.F.R. §56.111(a)(4) (1981). See comments at 46 Fed. Reg. 8942–44 (January 27, 1981).Google Scholar
The competing standards of required disclosure are discussed at notes 28-33, infra, and accompanying text.Google Scholar
21 C.F.R. §201.100(c), (d) (1977).Google Scholar
21 U.S.C. §352(n) (1976); 21 C.F.R. §202.1(d)(2), (e) (1977).Google Scholar
21 U.S.C. §355(d) (1976); 21 C.F.R. 314.115 (1977).Google Scholar
See Kessler, , Regulating and Prescribing of Human Drugs for Nonapproved Uses Under the Food, Drug, and Cosmetic Act, Harvard Journal on Legislation 15(4):693 (1978); Shapiro, S. A., Limiting Physician Freedom to Prescribe a Drug for Any Purpose; The Need for FDA Regulation, Northwestern University Law Review 73(5):801–72 (December 1979).Google Scholar
Notice of Proposed Rulemaking, Legal Status of Approved Labeling for Prescription Drugs; Prescribing for Uses Unapproved by the Food and Drug Administration, 37 Fed. Reg. 16,503 (1972).Google Scholar
Editorial, Eternal Vigilance – The Price of Liberty, Journal of the American Medical Association 222:1553 (1972); FDA's Growing Influence on Your Practice, Medical World News (March 1, 1974) at 46.Google Scholar
Mulder v. Parke Davis & Co., 181 N.W.2d 882 (Minn. 1970); Stanley, R.E., Evidentiary Aspects of Manufacturer Recommendations in Establishing Physicians’ Standard of Care, Arkansas Law Review 31(3):477, 482–91 (Fall 1977); Comment, Package Inserts for Prescription Drugs as Evidence in Medical Malpractice Suits, University of Chicago Law Review 44:398, 400–05 (1977); Hirsh, H., The Medicolegal Implications of the Package Insert, Case and Comment 82:14, 15 (January/February 1977); Temple, Legal Implications of the Package Insert, Medical Clinics of North America 58:1151, 1158 (1974).Google Scholar
See, e.g., United States v. Evers, 453 F. Supp. 1141 (M.D. Ala., N.D. 1978).Google Scholar
See Lasagna, L., The Development and Regulation of New Medications, Science 200:871 (1978). See also General Accounting Office, FDA Drug Approval—A Lengthy Process that Delays the Availability of Important New Drugs (HRD-80-64, May 28, 1980).Google ScholarPubMed
See Stanley, , supra note 17, at 478; Hirsh, , supra note 17, at 18; Kessler, , supra note 14, at 724-26; Temple, , supra note 17, at 1155-57.Google Scholar
Schloendorff v. Soc'y of New York Hosp., 105 N.E. 92 (N.Y. 1914).Google Scholar
Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972).Google Scholar
See, e.g., N.Y. Pub. Health Law §2805-d (1976); Wash. Rev. Code §4.24.290 (Supp. 1975); see also Meisel, A. Kabnick, L.D., Informed Consent to Medical Treatment: An Analysis of Recent legislation, University of Pittsburgh Law Review 41(3):407564 (Spring 1980).Google Scholar
Rosoff, A.. Informed Consent: A Guide for Health Care Providers, ch. 2 (1981).Google Scholar
Id. at 41-51; Meisel, Kabnick, , supra note 23, at 426-38; Hinkle, , Informed Consent and the Family Physician, Journal of Family Practice 12:109–10 (1981).Google Scholar
See generally, Halligan, , The Standard of Disclosure by Physicians to Patients: Competing Models of Informed Consent, Louisiana Law Review 41:9 (1980).Google ScholarPubMed
See Hirsh, , supra note 17, at 18.Google Scholar
Wooley v. Henderson, 418 A.2d 1123 (Me. 1980); Scott v. Wilson, 396 S.W.2d 532 (Tex. Civ. App. 1976). See Hinkle, , supra note 25, at 111; Miller, , Informed Consent, Part I, Journal of the American Medical Association 244:2100, 2101 (1980); Rosoff, , supra note 24, at 34-38; Shapiro, , supra note 14, at 832-34.Google Scholar
Shapiro, , supra note 14, at 834-36.Google Scholar
See, e.g., Helling v. Carey, 519 P.2d 981 (Wash. 1974); Gates v. Jensen, 595 P.2d 919 (Wash. 1979); see also Hirsh, H., Judicially Imposed Standard of Care – Prophecy in Medicine, Medical Trial Technique Quarterly 21:1 (1980).Google Scholar
Canterbury v. Spence, supra note 22, at 789; Miller, , Informed Consent. Part II, Journal of the American Medical Association 244:2347, 2348–49 (1980).Google Scholar
See, e.g., Canterbury v. Spence, supra note 22; Cobbs v. Grant, 502 P.2d 1, 104 Cal. Rptr. 505 (1972); Riedinger v. Colburn, 361 F. Supp. 1073 (D. Idaho 1973); Rosoff, , supra note 24, at 38-41; Hinkle, , supra note 25, at 111; Miller, , supra note 28, at 2101-03.Google Scholar
Shapiro, , supra note 14, at 836-37.Google Scholar
State Board of Medical Examiners of Florida v. Rogers, 387 So.2d 937 (Fla. 1980).Google Scholar