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

United States Constitution, art. I, sec. 8, clause 3.

“Drugs” are defined at 21 U.S.C. §321(g)(1), as amended.

“Interstate commerce” is defined at 21 U.S.C. §321(b), as amended.

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.

See generally Temin P. . Taking Your Medicine (1980); Pines , A Primer on New Drug Development, FDA Consumer (February 1974) at 12.

21 C.F.R. §312.1(a)(2) (1977).

Id.

21 C.F.R. §314.1(c)(2) (1977).

21 C.F.R. §56.111(a)(4) (1981). See comments at 46 Fed. Reg. 8942–44 (January 27, 1981).

The competing standards of required disclosure are discussed at notes 28-33, infra, and accompanying text.

21 C.F.R. §201.100(c), (d) (1977).

21 U.S.C. §352(n) (1976); 21 C.F.R. §202.1(d)(2), (e) (1977).

21 U.S.C. §355(d) (1976); 21 C.F.R. 314.115 (1977).

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).

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).

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.

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).

See, e.g., United States v. Evers, 453 F. Supp. 1141 (M.D. Ala., N.D. 1978).

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).

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.

Schloendorff v. Soc'y of New York Hosp., 105 N.E. 92 (N.Y. 1914).

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972).

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):407–564 (Spring 1980).

Rosoff A. . Informed Consent: A Guide for Health Care Providers, ch. 2 (1981).

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).

See generally, Halligan , The Standard of Disclosure by Physicians to Patients: Competing Models of Informed Consent, Louisiana Law Review 41:9 (1980).

See Hirsh , supra note 17, at 18.

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.

Shapiro , supra note 14, at 834-36.

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).

Canterbury v. Spence, supra note 22, at 789; Miller , Informed Consent. Part II, Journal of the American Medical Association 244:2347, 2348–49 (1980).

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.

Shapiro , supra note 14, at 836-37.

State Board of Medical Examiners of Florida v. Rogers, 387 So.2d 937 (Fla. 1980).