The question presented in this case is whether the Federal Food, Drug, and Cosmetic Act precludes terminally ill cancer patients from obtaining Laetrile, a drug not recognized as “safe and effective” within the meaning of § 201(p)(1) of the Act, 52 Stat. 1041, as amended, 21 U.S.C. § 321 (p)(1).
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Terminally ill cancer patients and their spouses brought this action to enjoin the Government from interfering with the interstate shipment and sale of Laetrile, a drug not approved for distribution under the Federal Food, Drug, and Cosmetic Act (Act). Section 505 of the Act prohibits interstate distribution of any “new drug” unless the Secretary of Health, Education, and Welfare approves an application supported by substantial evidence of the drug’s safety and effectiveness. Section 201 (p) (1) of the Act defines a “new drug” to include “any drug . . . not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.” Finding that Laetrile, in proper dosages, was nontoxic and effective, the District Court ordered the Government to permit limited purchases of the drug by one of the named plaintiffs. While not disturbing the injunction, the Court of Appeals instructed the District Court to remand the case to the Food and Drug Administration (FDA) for determination whether Laetrile was a “new drug” under 201 (p) (1), and, if so, whether it was exempt from premarketing approval under either of the Act’s two grandfather clauses. After completion of administrative hearings, the Commissioner of the FDA found that Laetrile constituted a “new drug” as defined in 201 (p) (1) and fell within neither grandfather provision. On review of the Commissioner’s decision, the District Court concluded that Laetrile was entitled to an exemption from premarketing approval under the Act’s 1962 grandfather clause and, alternatively, that the Commissioner had infringed constitutionally protected privacy interests by denying cancer patients access to Laetrile. The Court of Appeals, without addressing either the statutory or constitutional rulings of the District Court, held that the Act’s “safety” and “effectiveness” standards have “no reasonable application” to terminally ill cancer patients and approved intravenous injections of Laetrile for such individuals.
Held:
The Act makes no express exception for drugs used by the terminally ill and no implied exemption is necessary to attain congressional objectives or to avert an unreasonable reading of the terms “safe” and “effective” in 201 (p) (1). Pp. 551-559. [442 U.S. 544, 545]
(a) Nothing in the legislative history suggests that Congress intended protection only for persons suffering from curable diseases. Moreover, in implementing the statutory scheme, the FDA has never exempted drugs used by the terminally ill. The construction of a statute by those charged with its administration is entitled to substantial deference particularly where, as here, an agency’s interpretation involves issues of considerable public controversy, and Congress has not acted to correct any misperception of its statutory objectives. Pp. 552-554.
(b) The Court of Appeals erred in concluding that the safety and effectiveness standards of 201 (p) (1) could have “no reasonable application” to terminal patients. For purposes of 201 (p) (1), the effectiveness of a drug does not necessarily denote capacity to cure; in the treatment of any illness, terminal or otherwise, a drug is effective if it fulfills, by objective indices, its sponsor’s claims of prolonged life, improved physical condition, or reduced pain. Nor is the concept of safety under 201 (p) (1) without meaning for terminal patients; a drug is unsafe for the terminally ill, as for anyone else, if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit. Finally, construing 201 (p) (1) to encompass treatments for terminal diseases does not foreclose all resort to experimental cancer drugs by patients for whom conventional therapy is unavailing. That 505 (i) of the Act makes explicit provision for carefully regulated use of certain drugs not yet demonstrated to be safe and effective reinforces the conclusion that no exception for terminal patients may be judicially implied. Pp. 554-559.
582 F.2d 1234, reversed and remanded.
MARSHALL, J., delivered the opinion for a unanimous Court.
Solicitor General McCree argued the cause for the United States et al. With him on the briefs were Assistant Attorney General Shenefield, Deputy Solicitor General Barnett, Elinor Hadley Stillman, Barry Grossman, and Richard M. Cooper.
Kenneth Ray Coe argued the cause for respondents. With him on the brief were Kirkpatrick W. Dilling and Dennis M. Gronek. *
[ Footnote * ] Briefs of amici curiae urging reversal were filed by Francis X. Bellotti, Attorney General, and Jonathan Brant, Assistant Attorney General, [442 U.S. 544, 546] for the Commonwealth of Massachusetts et al.; and by Grace Powers Monaco for the American Cancer Society, Inc.
Briefs of amici curiae urging affirmance were filed by David H. Gill II for the Committee for Freedom of Choice in Cancer Therapy; by Stephen Tornay for the McNaughton Foundation of California; by Kirkpatrick W. Dilling and Dennis M. Gronek for the National Health Federation; and by Daniel H. Smith for the Northwest Academy of Preventive Medicine.
Briefs of amici curiae were filed by George Deukmejian, Attorney General, Robert Philibosian, Chief Assistant Attorney General, Daniel J. Kremer, Assistant Attorney General, and Harley D. Mayfield and Robert M. Foster, Deputy Attorneys General, for the State of California; by Dennis S. Avery for the American Academy of Medical Preventics; by David Laufer for the Cancer Control Society; and by David S. King for the Save the United States Movement, Improving Public Health and Physical Fitness of the United States Citizens. [442 U.S. 544, 546]
