Document: 442 U.S. 544 99 S.Ct. 2470 61 L.Ed.2d 68 UNITED STATES et al., Petitioners,v.Glen L. RUTHERFORD al. No. 78-605. Argued April 25, 1979. Decided June 18, 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 interstate shipment sale of Laetrile, a drug not approved for distribution under Federal Food, Drug Cosmetic Act (Act). Section 505 prohibits any "new drug" unless Secretary Health, Education, Welfare approves an application supported by substantial evidence drug's safety effectiveness. 201(p)(1) defines include "any . generally recognized as safe effective use conditions prescribed, recommended, or suggested in labeling." Finding that proper dosages, was nontoxic effective, District Court ordered permit limited purchases one named plaintiffs. While disturbing injunction, Appeals instructed remand case Food Administration (FDA) determination whether Laetrile § 201(p)(1), and, if so, it exempt premarketing approval either Act's two grandfather clauses. After completion administrative hearings, Commissioner FDA found constituted defined fell within neither provision. On review Commissioner's decision, concluded entitled exemption 1962 clause alternatively, had infringed constitutionally protected privacy interests denying access Laetrile. The Appeals, without addressing statutory constitutional rulings Court, held "safety" "effectiveness" standards have "no reasonable application" terminally intravenous injections such individuals. Held: makes no express exception drugs used implied is necessary attain congressional objectives avert unreasonable reading terms "safe" "effective" 201(p)(1). Pp. 551-559. (a) Nothing legislative history suggests Congress intended protection only persons suffering curable diseases. Moreover, implementing scheme, has never exempted ill. construction statute those charged its administration deference particularly where, here, agency's interpretation involves issues considerable public controversy, acted correct misperception objectives. 552-554. (b) erred concluding effectiveness could terminal patients. For purposes does necessarily denote capacity cure; treatment illness, otherwise, fulfills, objective indices, sponsor's claims prolonged life, improved physical condition, reduced pain. Nor concept meaning patients; unsafe ill, anyone else, potential inflicting death injury offset possibility therapeutic benefit. Finally, construing encompass treatments diseases foreclose all resort experimental whom conventional therapy unavailing. That 505(i) explicit provision carefully regulated certain yet demonstrated be reinforces conclusion may judicially implied. 554-559. 582 1234, reversed remanded. Wade H. McCree, Jr., Sol. Gen., Washington, D. C., petitioners. Kenneth Ray Coe, Oklahoma City, Okl., respondents. Mr. Justice MARSHALL delivered opinion Court. 1 question presented Drug, precludes obtaining "safe effective" Act, 52 Stat. 1041, amended, 21 U.S.C. 321(p)(1). 2 * 1052, 355, effectiveness.1 As 321(p)(1), term includes 3 "[a]ny recognized, among experts qualified scientific training experience evaluate drugs, labeling ." Exemptions procedures are available solely investigative use2 qualifying provisions.3 4 In 1975, Act.4 399 F. Supp. 1208, 1215 (WD Okl. 1975).5 appeal Government, Tenth Circuit did disturb injunction. However, 542 1137 (1976). 5 hearings,6 issued his on July 29, 1977. 42 Fed.Reg. 39768 (1977). He determined first uniform definition exists; rather, been generically chemical compounds similar to, consisting at least part of, amygdalin, glucoside present kernels seeds most fruits. Id., 39770-39772. further various forms because prescribed use. See 39775-39787 so ruling, applied criteria delineated Weinberger v. Hynson, Westcott & Dunning, Inc., 412 609, 629-630, 73 2469, 2483, 37 207 (1973), there were adequate well-controlled studies Laetrile's (1977).7 6 Having new drug, proceeded consider 1938 provisions. facts presented, clause. id., 39787-39795. First, showing currently known identical composition distributed before 1938. 321(p)(1); n. 3, supra. conclude submitted that, October 9, 1962, commercially sold United States, safe, labeled same recommended uses marketed drug. 107(c)(4), 76 789; 7 sustained regarded 438 F.Supp. 1287, 1293-1294 1977). court also denial record support findings provision, ruled requirements. 1294-1298. Alternatively, right substance connection personal health, interests. 1298-1300. 8 addressed nor Rather, "the 'safety' 'effectiveness' patients." 1236 (1978). Since patients, definition, would "die regardless what done," realistic against which measure class 1237. therefore Court's injunction permitting certified presumably some toxic when orally administered, see 39786-39787 (1977), relief doctor's supervision. F.2d, addition, directed promulgate regulations "as if" " 'safe' 'effective' Ibid. 9 We granted certiorari, 439 1127, 1042, 59 87 (1979), now reverse. II special treat By terms, requires nn. 2, And supra, 546-547. 11 When scope, must act well-defined constraints. If purpose expressed "plain unambiguous language, duty courts give effect according terms." States Lexington Mill Elevator Co., 232 399, 409, 34 337, 340, 58 L.Ed. 658, 662 (1914). Andrus Sierra Club, 347, 2335, 60 943 (1979). Exceptions clearly statutes will where essential prevent "absurd results" consequences obviously variance policy enactment whole. Helvering Hammel, 311 504, 510-511, 368, 371, 85 303 (1941). TVA Hill, 437 153, 187-188, 98 2279, 2298, 57 117 (1978); Key, 397 322, 324-325, 90 1049, 1051, 25 340 (1970); American Trucking Assns., 310 534, 543-544, 1059, 1063-1064, 84 1345 (1940). instant case, we persuaded consistent implicit A. 12 established safety, Amendments, added current 201(p)(1),8 To contrary, deliberations preceding concern individuals fatal illnesses, cancer, should shielded fraudulent cures. See, e. g., 79 Cong.Rec. 5023 (1935) (remarks Sen. Copeland, sponsor Act); 83 7786-7787, 7789 (1938) Reps. Phillips Lea). Similarly, proponents Amendments including Senator Kefauver, bill's sponsors, indicated understanding "in last stages" ambit statute. 108 17399 (1962) Kefauver); 17401 (comments Eastland). reflected Committee Reports Amendments. Both note FDA's considering passing "life-threatening disease."9 13 made often deference. Board Governors FRS First Lincoln wood Corp., 234, 248, 505, 513, 484 Bayside Enterprises, Inc. NLRB, 429 298, 304, 97 576, 581, 50 494 (1977); Udall Tallman, 380 1, 16, 792, 801, (1965). Such appropriate Red Lion Broadcasting Co. FCC, 395 367, 381, 89 1794, 1801, 23 371 (1969); Zemel Rusk, 381 11-12, 1271, 1278, 14 179 (1965).10 Unless until reluctant longstanding comports plain history, prophylactic Act. B Appeals' view, justified set forth 1236. disagree. Under our framework, federal do sit councils revision, empowered rewrite legislation accord own conceptions prudent policy. Anderson Wilson, 289 20, 27, 53 417, 420, 77 1004 (1933). Only literal yields results manifestly they fairly attributed design language U.S., S.Ct., 2298. Here, however, license depart reasonably shield ineffectual drugs. 15 A general recognition experts, founded evidence, fact produces claimed conditions. 629-634, 93 2483-2485; 7, Contrary apparent assumption, 1236, cure. 39776-39786 16 So too, Few completely sense taken circumstances risk.11 Thus, considers expected gain justifies risk entailed use.12 Indeed, implicitly acknowledged considerations relevance restricting authorized 1237; 551. 17 relationship between context incurable illnesses. An otherwise harmless can dangerous patient produce purported effect. 107 5640 (1961) Kefauver). But individual potentially disease rejects favor demonstrable curative properties, irreversible.13 reason, even incorporated efficacy standard into procedures, considered reviewing illness. 8, practice reflects recognition, amply expert medical testimony impossible identify except retrospect.14 Cancers vary considerably behavior responsiveness different therapy. 39777 (1977).15 Even critically unexpected remissions respond treatment. 39777, 39805. concluded, proved "would lead needless deaths characterized 'terminal' who actually helped legitimate therapy." 18 It bears emphasis although ruling reasoning cannot readily confined. accept proposition deny authority over however ineffectual, guide, market long overlooked. turn century, resourceful entrepreneurs advertised wide variety purportedly simple painless cures liniments turpentine, mustard, oil, eggs, ammonia; peat moss; arrangements colored floodlamps; pastes glycerin limburger cheese; mineral tablets; "Fountain Youth" mixtures spices, suet.16 citing these examples, not, course, intend deprecate sincerity proponents, imply ultimately prove historical suggest why protect less than other vast range self-styled panaceas inventive minds devise. 19 finally 355(i), exempts satisfy preclinical testing criteria.17 clinical National Cancer Institute pending Commissioner. Brief 35 23. Whether, matter, created judgment, judicial inference. 20 judgment reversed, remanded proceedings opinion.18 ordered. provides part: "(a) No person shall introduce deliver introduction commerce filed pursuant subsection section respect "(b) Any file re- spect subject provisions section. submit (1) full reports investigations show "(d) finds required tests methods applicable proposed thereof; (2) conditions; (4) he insufficient information determine (5) lack purports represented (6) based fair evaluation material facts, false misleading particular; issue order refusing approve application. ., 'substantial evidence' means investigations, involved, basis responsibly thereof. "(i) exempting operation foregoing subsections investigational investigate delegated Administration. CFR 5.1(a)(1) requirements 355(i). 1938, Pure 1906, ch. 3915, 768, retained representations concerning prior This contained codified second clause, provides: "In which, day immediately date [October 10, 1962], (A) (B) 201(p) basic then force, (C) covered [new drug] amendments apply day." 789. suit originally instituted patient, Juanita Stowe, her husband, Jimmie Stowe. Ms. Stowe's death, Glen Rutherford Phyllis S. Schneider, Schneider's amended complaint behalf composed responsible costs entered 1977, 506 Okl.). seek order. subsequently orders affidavits averring membership App. 1-6. initiated announcement Register seeking comment. 10066-10069 Notice afforded 39785-39786. define constitutes structure 2483-2485, interpreted require "expert consensus" upon "substantial evidence" 505(d) 355(d). 1041. Pub.L. 87-781, 789, redefined 546-547,551. provided absent well 505(d), Senate Report states: "The requires, determining 'new drug' offered life-threatening disease, appears occasionally serious lethal effects usefulness justify risks involved cases, is, light provisions, inseparable consideration bill way affect existing Department safety." S.Rep.No.1744, 87th Cong., 2d Sess., pt. p. (1962), U.S.Code Cong. Admin.News pp. 2884, 2891. H.R.Rep.No.2464, (1962). amplified HEW Ribicoff became Amendments: "If progressive diseases, cases effectiveness." Hearings 1552 Subcommittee Antitrust Monopoly Judiciary, 1st 2588 (1961). sure, always infer silence alone. Hallock, 309 106, 119-121, 444, 451-452, 604 (1940); Toucey New York Life Ins. 314 118, 140-141, 62 139, 147, 86 100 once "fully attention Congress," latter sought alter respects, intent correctly discerned. Apex Hosiery Leader, 469, 487-489, 982, 988-989, 1311 Bergh, 352 40, 46-47, 109-110, 102 (1956). 94-295, 575; 94-278, 411; 91-513, 1281 (amending 201 321). plainly escaped notice. Whether freely accessible frequent political debate. Seventeen legalized prescription borders, defeated States. CCH F.D.Cosm.L.Rep. ¶ 42,292 Comment, Laetrile: Statutory Constitutional Limitations Regulation Ineffective Drugs, 127 U.Pa.L.Rev. 233, 234 aware evident hearings 1977 ruling. Hearing Health Scientific Research Human Resources, 95th Sess. Goodman Gilman, Pharmacological Basis Therapeutics 325-339 (5th ed. 1975). statement Dr. Theodore Klumpp, Chief, Division, FDA, 23, 1941, 71,053.59 13, infra. 39768, 39787 (1977) (statement Carl Leventhal, Deputy Director Bureau Assistant Professor Neurology Pathology Georgetown University) ("The human depends, large measure, particular ineffective inexorably patient's death"); ibid. George J. Hill II, Chairman Surgery Marshall University School Medicine, W. Va.) (Ineffectual delay accepted modes deaths; thus, "[i]n absence effectiveness, treating safe"). 39805 Peter Wiernik, Chief Clinical Oncology Branch Institute's Baltimore Center) ("[N]o prospectively accuracy. said dies. Many modern management cancer"); Joseph Ross, California Medicine Los Angeles) ("[T]he distinction 'non-terminal' reliably assumption given ['terminal'] impunity deprive measures help them"). noted patterns account anecdotal Users spontaneous delayed responses abandonment ascribe improvement attribution. Daniel Martin, researcher immunology chemotherapy); 39800 Emil Frereich, Division Texas Medical Houston); Melvin Krant, Project Massachusetts Center). Particularly since chemotherapy radiation painful side effects, subjectively perceive substituting erroneously believe condition arrested ameliorated. 39799-39800. Fed.F.D.Cosm.L.Admin.Reps., 1907-1949, 745 (1951); 1408; 1170-1171, 1298-1299; 224; Ann.Reps., 1950-1974, 309, 464; 45; 412. At present, 300 institutions. 23; Institute, Extramural Trial Programs Treatment, General Overview Scope Contract-Supported Activities During 90,000 participated programs auspices Veterans' Respondents urge questions alternative bases sustaining below. issue, respondents' claims. Vermont Yankee Nuclear Power Corp. Resources Defense Council, 435 519, 549, 1197, 55 460 Arlington Heights Metropolitan Housing Dev. 252, 271, 555, 566, 450

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