Source: http://www.law.cornell.edu/supremecourt/text/442/544/
Timestamp: 2013-12-20 00:37:53
Document Index: 74808466

Matched Legal Cases: ['§ 201', '§ 201', '§ 201', '§ 201', '§ 201', '§ 201', '§ 107', '§ 505', '§ 201', '§ 201', '§ 201', '§ 201', '§ 505', '§ 201', '§ 201', '§ 201', '§ 505', '§ 201', '§ 201', '§ 505', '§ 201']

UNITED STATES et al., Petitioners, v. Glen L. RUTHERFORD et al. | Supreme Court | LII / Legal Information Institute
Supreme Court aboutsearch liibulletin subscribe previews UNITED STATES et al., Petitioners, v. Glen L. RUTHERFORD et al.
442 U.S. 544 (99 S.Ct. 2470, 61 L.Ed.2d 68)
[HTML] 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.
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).
* 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.
As defined in § 201(p)(1) of the Act, 21 U.S.C. 321(p)(1), the term "new drug" includes
"any 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
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).
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).
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).
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.
The Federal Food, Drug, and Cosmetic Act makes no special provision for drugs used to treat terminally ill patients. By its terms, § 505 of the Act requires premarketing approval for "any new drug" unless it is intended solely for investigative use or is exempt under one of the Act's grandfather provisions. See nn. 2, 3, supra. And § 201(p)(1) defines "new drug" to encompass "any drug . . . not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." See supra, at 546-547.
Nothing in the history of the 1938 Food, Drug, and Cosmetic Act, which first established procedures for review of drug safety, or of the 1962 Amendments, which added the current safety and effectiveness standards in § 201(p)(1),
suggests that Congress intended protection only for persons suffering from curable diseases. To the contrary, in deliberations preceding the 1938 Act, Congress expressed concern that individuals with fatal illnesses, such as cancer, should be shielded from fraudulent cures. See, e. g., 79 Cong.Rec. 5023 (1935) (remarks of Sen. Copeland, sponsor of the Act); 83 Cong.Rec. 7786-7787, 7789 (1938) (remarks of Reps. Phillips and Lea). Similarly, proponents of the 1962 Amendments to the Act, including Senator Kefauver, one of the bill's sponsors, indicated an understanding that experimental drugs used to treat cancer "in its last stages" were within the ambit of the statute. See, e. g., 108 Cong.Rec. 17399 (1962) (remarks of Sen. Kefauver); id., at 17401 (comments of Sen. Eastland). That same understanding is reflected in the Committee Reports on the 1962 Amendments. Both Reports note with approval the FDA's policy of considering effectiveness when passing on the safety of drugs prescribed for "life-threatening disease."
In implementing the statutory scheme, the FDA has never made exception for drugs used by the terminally ill. As this Court has often recognized, the construction of a statute by those charged with its administration is entitled to substantial deference. Board of Governors of FRS v. First Lincoln wood Corp., 439 U.S. 234, 248, 99 S.Ct. 505, 513, 58 L.Ed.2d 484 (1978); Bayside Enterprises, Inc. v. NLRB, 429 U.S. 298, 304, 97 S.Ct. 576, 581, 50 L.Ed.2d 494 (1977); Udall v. Tallman, 380 U.S. 1, 16, 85 S.Ct. 792, 801, 13 L.Ed.2d 616 (1965). Such deference is particularly appropriate 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. See Red Lion Broadcasting Co. v. FCC, 395 U.S. 367, 381, 89 S.Ct. 1794, 1801, 23 L.Ed.2d 371 (1969); Zemel v. Rusk, 381 U.S. 1, 11-12, 85 S.Ct. 1271, 1278, 14 L.Ed.2d 179 (1965).
So too, the concept of safety under § 201(p)(1) is not without meaning for terminal patients. Few if any drugs are completely safe in the sense that they may be taken by all persons in all circumstances without risk.
For the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit. Indeed, the Court of Appeals implicitly acknowledged that safety considerations have relevance for terminal cancer patients by restricting authorized use of Laetrile to intravenous injections for persons under a doctor's supervision. See 582 F.2d, at 1237; supra, at 551.
Moreover, there is a special sense in which the relationship between drug effectiveness and safety has meaning in the context of incurable illnesses. An otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect. See 107 Cong.Rec. 5640 (1961) (comments of Sen. Kefauver). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible.
Cancers vary considerably in behavior and in responsiveness to different forms of therapy. See 42 Fed.Reg. 39777 (1977).
Even critically ill individuals may have unexpected remissions and may respond to conventional treatment. Id., at 39777, 39805. Thus, as the Commissioner concluded, to exempt from the Act drugs with no proved effectiveness in the treatment of cancer "would lead to needless deaths and suffering among . . . patients characterized as 'terminal' who could actually be helped by legitimate therapy." Id., at 39805.
It bears emphasis that although the Court of Appeals' ruling was limited to Laetrile, its reasoning cannot be so readily confined. To accept the proposition that the safety and efficacy standards of the Act have no relevance for terminal patients is to deny the Commissioner's authority over all drugs, however toxic or ineffectual, for such individuals. If history is any guide, this new market would not be long overlooked. Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and "Fountain of Youth" mixtures of spices, oil, and suet.
We note finally that 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. Section 505(i) of the Act, 21 U.S.C. 355(i), exempts from premarketing approval drugs intended solely for investigative use if they satisfy certain preclinical testing and other criteria.
An application for clinical testing of Laetrile by the National Cancer Institute is now pending before the Commissioner. Brief for United States 35 n. 23. That the Act makes explicit provision for carefully regulated use of certain drugs not yet demonstrated safe and effective reinforces our conclusion that no exception for terminal patients may be judicially implied. Whether, as a policy matter, an exemption should be created is a question for legislative judgment, not judicial inference.
Section 505, as set forth in 21 U.S.C. 355, provides in part:
The requirements for investigative use are set forth in § 505(i) of the Act, 21 U.S.C. 355(i). See n. 1, supra.
In the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1041, Congress exempted from the definition of "new drug" any drug that was subject to the Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768, if its labeling retained the same representations concerning conditions of use made prior to 1938. This exemption is currently contained in § 201(p)(1) of the Act, as codified in 21 U.S.C. 321(p)(1). The Drug Amendments of 1962 added a second grandfather clause, which provides:
The Act does not define what constitutes general recognition of a drug's safety and effectiveness under § 201(p)(1). However, based on the structure and purpose of the statutory scheme, this Court in Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S., at 629-634, 93 S.Ct., at 2483-2485, interpreted § 201(p)(1) to require an "expert consensus" on safety and effectiveness founded upon "substantial evidence" as defined in § 505(d) of the Act, 21 U.S.C. 355(d). See n. 1, supra.
Under the 1938 Act, a "new drug" was one not generally recognized by qualified experts as safe for its recommended use. § 201(p)(1), 52 Stat. 1041. The Drug Amendments of 1962, Pub.L. 87-781, 76 Stat. 789, redefined the term to include drugs not generally recognized as effective or safe for their intended use. § 201(p)(1), 21 U.S.C. 321(p)(1). See supra, at 546-547,551. In addition, the Amendments provided that no new drug application may be approved absent substantial evidence that the drug is effective as well as safe under prescribed conditions. § 505(d), 21 U.S.C. 355(d). See n. 1, supra.
To be sure, it may not always be realistic to infer approval of a judicial or administrative interpretation from congressional silence alone. See, e. g., Helvering v. Hallock, 309 U.S. 106, 119-121, 60 S.Ct. 444, 451-452, 84 L.Ed. 604 (1940); Toucey v. New York Life Ins. Co., 314 U.S. 118, 140-141, 62 S.Ct. 139, 147, 86 L.Ed. 100 (1941). But once an agency's statutory construction has been "fully brought to the attention of the public and the Congress," and the latter has not sought to alter that interpretation although it has amended the statute in other respects, then presumably the legislative intent has been correctly discerned. Apex Hosiery Co. v. Leader, 310 U.S. 469, 487-489, 60 S.Ct. 982, 988-989, 84 L.Ed. 1311 (1940). See United States v. Bergh, 352 U.S. 40, 46-47, 77 S.Ct. 106, 109-110, 1 L.Ed.2d 102 (1956). See, e. g., Pub.L. 94-295, 90 Stat. 575; Pub.L. 94-278, 90 Stat. 411; and Pub.L. 91-513, 84 Stat. 1281 (amending § 201 of the Act, 21 U.S.C. 321).