United States v. Rutherford

• Decision Date: 18 June 1979
• Docket Number: No. 78-605,78-605
• Citation: 99 S.Ct. 2470,442 U.S. 544,61 L.Ed.2d 68
• Parties: UNITED STATES et al., Petitioners, v. Glen L. RUTHERFORD et al
• Court: U.S. Supreme Court

442 U.S. 544

99 S.Ct. 2470

61 L.Ed.2d 68

UNITED STATES et al., Petitioners,

v Glen L. RUTHERFORD et al.

No. 78-605.

Argued April 25, 1979.

Decided June 18, 1979.

Opinion after remand, 10 Cir., 616 F.2d 455.

Syllabus

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. (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.

Wade H. McCree, Jr., Sol. Gen., Washington, D. C., for petitioners.

Kenneth Ray Coe, Oklahoma City, Okl., for respondents.

Mr. Justice MARSHALL delivered the opinion of the Court.

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).

I

Section 505 of the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1052, as amended, 21 U.S.C. § 355, 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.¹ As defined in § 201(p)(1) of the Act, 21 U.S.C. § 321(p)(1), the term "new drug" includes

"[a]ny drug . . . not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling . . . ."

Exemptions from premarketing approval procedures are available for drugs intended solely for investigative use ² and drugs qualifying under either of the Act's two grandfather provisions.³

In 1975, 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 Act.⁴ 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. 399 F Supp. 1208, 1215 (WD Okl. 1975).⁵ On appeal by the Government, the Court of Appeals for the Tenth Circuit did not disturb the injunction. However, it instructed the District Court to remand the case to the Food and Drug Administration 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 grandfather clauses. 542 F.2d 1137 (1976).

After completion of administrative hearings,⁶ the Commissioner issued his opinion on July 29, 1977. 42 Fed.Reg. 39768 (1977). He determined first that no uniform definition of Laetrile exists; rather, the term has been used generically for chemical compounds similar to, or consisting at least in part of, amygdalin, a glucoside present in the kernels or seeds of most fruits. Id., at 39770-39772. The Commissioner further found that Laetrile in its various forms constituted a "new drug" as defined in § 201(p)(1) of the Act because it was not generally recognized among experts as safe and effective for its prescribed use. See 42 Fed.Reg. 39775-39787 (1977). In so ruling, the Commissioner applied the statutory criteria delineated in Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 629-630, 73 S.Ct. 2469, 2483, 37 L.Ed.2d 207 (1973), and concluded that there were no adequate well-controlled scientific studies of Laetrile's safety or effectiveness. 42 Fed.Reg. 39775-39787 (1977).⁷

Having determined that Laetrile was a new drug, the Commissioner proceeded to consider whether it was exempt from premarketing approval under the 1938 or 1962 grandfather provisions. On the facts presented, the Commissioner found that Laetrile qualified under neither clause. See id., at 39787-39795. First, there was no showing that the drug currently known as Laetrile was identical in composition or labeling to any drug distributed before 1938. See 21 U.S.C. § 321(p)(1); n. 3, supra. Nor could the Commissioner conclude from the evidence submitted that, as of October 9, 1962, Laetrile in its present chemical composition was commercially used or sold in the United States, was generally recognized by experts as safe, and was labeled for the same recommended uses as the currently marketed drug. See § 107(c)(4), 76 Stat. 789; n. 3, supra.

On review of the Commissioner's decision, the District Court sustained his determination that Laetrile, because not generally regarded as safe or effective, constituted a new drug under § 201(p)(1). 438 F.Supp. 1287, 1293-1294 (WD Okl. 1977). The court also approved the Commissioner's denial of an exemption under the 1938 grandfather clause. However, concluding that the record did not support the Commissioner's findings as to the 1962 grandfather provision, the District Court ruled that Laetrile was entitled to an exemption from premarketing approval requirements. Id., at 1294-1298. Alternatively, the court held that, by denying cancer patients the right to use a nontoxic substance in connection with their personal health, the Commissioner had infringed constitutionally protected privacy interests. Id., at 1298-1300.

The Court of Appeals addressed neither the statutory nor the constitutional rulings of the District Court. Rather, the Tenth Circuit held that "the 'safety' and 'effectiveness' terms used in the statute have no reasonable application to terminally ill cancer patients." 582 F.2d 1234, 1236 (1978). Since those patients, by definition, would "die of cancer regardless of what may be done," the court concluded that there were no realistic standards against which to measure the safety and effectiveness of a drug for that class of individuals. Id., at 1237. The Court of Appeals therefore approved the District Court's injunction permitting use of Laetrile by cancer patients certified as terminally ill. However, presumably because the Commissioner had found some evidence that Laetrile was toxic when orally administered, see 42 Fed.Reg....