Document: 394 U.S. 784 89 S.Ct. 1410 22 L.Ed.2d 726 UNITED STATES, Petitioner,v.AN ARTICLE OF DRUG . BACTO-UNIDISK No. 343. Argued Jan. 23, 1969. Decided April 28, Rehearing Denied June 9, See 395 954, 2013. Lawrence G. Wallace, Dept. of Justice, Washington, D.C., for petitioner. Edward Brown Williams, respondent. Mr. Chief Justice WARREN delivered the opinion court. 1 At issue here is scope statutory definition drug contained in Federal Food, Drug, and Cosmetic Act extent Secretary Health, Education, Welfare's regulatory authority under that definition. The specific item involved this definitional controversy a laboratory aid known as an antibiotic sensitivity disc, used screening test help determining proper to administer patients. If article 'drug' within general § 201 (52 Stat. 1040, 21 U.S.C. 321 (1964 ed., Supp. II)), then can subject it pre-market clearance regulations promulgated pursuant 507 (21 357). Section authorizes require batch certification any product which also meets 201. If, on other hand, merely 'device' Act, only misbranding adulteration proscriptions does not have be pretested before marketing; and, course, if disc fall either definition, itself totally inapplicable. 2 When discs were marketed without complying with Secretary, Government condemned them 334 331) assumption drugs thus validly regulation. In action following condemnation, however, United States District Court Eastern Michigan held meaning suggesting that, anything, they devices. It therefore ruled since was required or authorized, seizure improper. Appeals Sixth Circuit affirmed same reasoning. We reverse. I. 3 Some background information about development controlling legislation necessary understanding determinations made by courts below. Various antibiotics, more commonly 'wonder drugs' such familiar names penicillin, aureomycin, terramycin, tetracycline, streptomycin, proved very useful World War II treating numerous infectious dieas s.1 Produced biologically, these tend vary greatly their quality potency unless developed, thereafter tested, carefully controlled conditions. Consequently,2 Congress enacted directing Welfare promulgate establishing standards identity, potency, quality, purity ensure 'safety' 'efficacy' those antibiotics. present, than 30 are listed CFR 145.3) accompanying covering 700 pages Code Regulations §§ 141.1—148z.4). 4 With proliferation various types doctors found need choose use particular infection. A diffusion test, using descs like one question here, soon became widely employed method.3 round paper has been impregnated antibiotic, placed contact sample cultures, isolates, patient's virus, grown special culture medium (agar) from specimen fluid (blood, spinal fluid, sputum, urine, etc.). places infection sensitive, no new isolate will grow, leaving clear area (an 'inhibition zone'); resistant, area. conjunction specimen, work exclusively, never comes part body itself. 5 had some four years when, 1960, determined regulate 507. After notice opportunity public participation, Commissioner Food Drugs, delegated requiring pre-clearance, batch-testing, (25 Fed.Reg. 9369). Commissioner's action, noted, followed 'numerous complaints medical profession, hospitals, technicians' resulting extensive survey discs. That study unreliable statements loss safety efficacy, 'vital protection health' adopt 9370). 6 This case arose May 1962 rem proceeding against interstate shipment number cases discs, manufactured Difco Laboratories, Inc., trade name 'Bacto-Unidisk.' condemning 301 et seq. claimed, inter alia, product, certified nor exempted 357) thereunder misbranded 502 352).4 Secretary's subjecting requirements authorized Act. Since power over depends ultimately Act's 201(g), validity allegedly violated turned coverage definition: 7 'For purposes chapter— 8 '(g) (1) term means (A) articles recognized official Pharmacopoeia, Homoeopathic Pharmacopoeia States, National Formulary, supplement them; (B) intended diagnosis, cure, mitigation, treatment, prevention disease man animals; (C) (other food) affect structure function (D) component specified clauses (A), (B), paragraph; but include devices components, , accessories.' II). 9 'device,' misbranding, adulteration, labeling provisions 501 applied, invalidly promulgated. Although expressly cannot last phrase above, device given almost parallel 201(h): 10 'The * instruments, apparatus, contrivances, including parts, accessories, (2) animals.' 321(h). 11 Finally, established at trial definitions operative ones 201(g)(1)(B) provision 201(h)(1) definition;5 essential underlying regulations, then, whether Bacto-Unidisks 'articles 12 resolving negative holding invalid, noted memorandum opinion6 concept limited sense administered externally internally, 'evidence affords basis conclusion extend beyond science, encompass disks.' pointed out although 'literal reading' 'clearly application libeled herein,' enforcing would 'ridiculous contrary common sense.' court Bacto-Unidisk did purview reason medically drug, suggested, deciding, appropriately classified 'devices' 13 On appeal, affirmed, accepting Court's conclusions intend broader one. 392 F.2d 21, 23. physicians determination what treatment furnishing information, apply 'intended (or) treatment' indirect manner. 22. granted Government's petition certiorari because interpretation raised issues importance administration (393 911, 236, 197 (1968)). II. 14 there testimony below debating precise health dangers posed declined substitute judgment Drugs his really protect purely viewpoint. Rather, quite properly confined inquiry examination even unwise, wer specifically, 'drug.' Despite renewed effort relitigate issue, we agree decision implicitly base resolution for, wisdom of, premarket enough us expert agency charged enforcement remedial regulation desirable health, hardly qualified second-guess judgment. Our sole concern statute's contested here; while lower courts' conception reasons outlined below, reverse disposition it. 15 Respondent's primary contention cover so indirectly 'cure, (and) disease. Respondent uses two-step analysis relied below: write broadly internally externally. Alternatively, respondent argues, use' language must clearly view legislative history discussed broad, purpose itself, hesitate give critical narrow, restrictive reading absence congressional direction do so, reject For basic reasons, furthermore argument once come coverage, specifically drugs. 16 stop parse found, parties disagree literal words application' Bacto-Unidisk. again urges 'treat' patient way terms personal application, plays least role selection appropriate drug. Thus, our broad its allow. Viewing structure, history, nature think plain define far profession. separate, parallel, is, shows, relevant intent. helpful consider both initial drug-device dichotomy time. III. 17 outset, word art encompassing strict word. limit one, could stated explicitly, simply reference (or Formulary), first three subsections 201(g)(1), let rest there. historical expansion furthermore, points Congress' intention going usage. 1906 Drug instance, defined rather 'all medicines preparations Formulary internal external use, substance mixture substances 34 768, 769. As subsequent indicates, original enlarged. 18 enactment 1938 illustrates One changes contemplated S. 2800, early version Act,7 19 '(1) all supplements thereto; substances, preparations, (3) food, body.' (See S.Rep. 493, 73d Cong., 2d Sess. (1934).) (Emphasis added.) 20 Senator Copeland New York, who sponsored remarked inclusion prepared statement introducing 2800 follows: present law defines mixtures narrow permits escape legal control therapeutic curative electric belts, example. alter body, as, example, reduce excessive weight. There many worthless dangerous falling classifications. contains ample them.' (78 Cong.Rec. 8960 revised 5, 74th 1st (1935), diagnostic purposes, well (S. 201(b), 361, (1935)).8 'diagnosis' came Senate consideration, developed floor, aimed 'devices,' Senate, 'diagnosis.' 79 4841—4845 (1935).9 Clark contended classify drugs, make bathroom scale drug: 23 '(I)f ought outlawed, I objection that; maintain mechanical treated logic lexicography palpable absurdity, my opinion.' Id., 4841. 24 answer Clark's remark comment: 25 'Mr. President, desire state effect amendment. market certain electrical takes hold handles machine, indicator spins around. 26 stops 'appendicitis,' 'meningitis' *. Such manifestly fraud pon society. amendment designed deal with.' 4842. 27 Copeland's proffered explanation, continued criticism during debates (79 4905 4920, 5215—5234)10 ground lead incongruous result calling items 'drugs': shoulder braces (id., 4841), radium belts (ibid.), 4842), weight scales hospital air conditioning apparatus 5231).11 opposition finally settled 'crutches' 4913)12 signify ultimate absurdity definition's coverage. 28 proposed add included13 when bill returned Committee Commerce later agreed debate. (Id., 8351—8355.14) amendments, still time, goal originally set achieve. Congressman Chapman Kentucky explained House after passed time hundreds contrivances being sold gullible people. Suffice say fake contraption cure consumption just serious menace disease.' 80 10236 (1936).15 According Administration, providing separate devices, instead avoid 'the incongruity classifying belt, lamps, forth, *.' (Testimony hearings subcommittee Interstate Foreign Commerce, (1935).16) Because 'pointed consideration bill,' explained, '(t) hey felt provide independent 'devices." two provided semantic only; provisions. No practical significance distinction between until provisions, similar antibiotics 1945, added tragedy 1937.17 3073, 75th Sess.) excepting clause stating device, 3d Sess., H.R.Rep. 2139). 29 creation show, think, fully indicates—and equally clearly, might otherwise Strong indications thought 'ridiculous' should satisfy erred refusing written. But convinced intent well-accepted principle liberal construction consistent overriding 507's products serve 'safety.' Cf. v. Sullivan, 332 689, 693—695, 68 331, 334—335, 92 L.Ed. 297 (1948); Dotterweich, 320 277, 283—284, 64 134, 137—138, 88 48 (1943). IV. alternative contention, plainly necessarily 'drug,' rejected, believe, light foregoing analysis. conceded statute little assistance precisely differentiates 'device': mitigation disease, former 'article' latter includes 'instruments,' 'apparatus,' 'contrivances.' obvious areas overlap entirely guidance propriety overall goals history. 31 More previously analogous situation where seemed insufficiently precise, 'natural way' draw line 'is purpose' (SEC Ralston Purina Co., 346 119, 124 125, 73 981, 984—985, 97 1494 (1953)).18 derive less benefit perhaps harm if, though batch-tested, reasonable determine serve, similarly pre-clearance An opposite undercut value testing themselves, useless exercise wrong administered, partially disc. 32 Furthermore, read purpose, directs classification broadly, confine exception nearly possible suggested debates,19 quack scales, braces, units, crutches. upholding deciding contours classification, point created primarily avoiding contraptions aids routine operation hospital—items characterized fact composed complex chemical compounds biological substances. supported uphold FDA's thereof knowledge may usage believe.20 33 unmindful warning '(i)n anxiety effectuate protecting public, take care exend indicated stop.' 62 Cases Jam 340 593, 600, 71 515, 520, 95 566 (1951). involves corollary principle, short extend. Reversed. 35 DOUGLAS, any, patient, 201(h)* affirm generally L. Goodman & A. Gilman, Pharmacological Basis Therapeutics (3d 1965). 702, 79th (1945). 507, forth 357, reads '(a) Education Welfare, him, shall batches wholly partly kind chlortetracycline, chloramphenicol, bacitracin, derivative thereof. characteristics identity strength, purity, prescribes adequately insure efficacy certified. Prior effective date lieu certification, release which, judgment, released risk use. prescribe expiration conditions cease portions section 352(l) title, 'antibiotic drug' containing quantity produced microorganism capacity inhibit destroy microorganisms dilute solution (including chemically synthesized equivalent substance). '(b) certifications contain carry section, prescribing purity; tests methods assay compliance standards; periods certificates, thereof; (4) procedure; (5) fees, provide, equip, adequate service. rejection shortest section.' Bauer, Kirby, Sherris, Turck, Antibiotic Susceptibility Testing Standardized Single Disk Method, 45 American Journal Clinical Pathology 493 (1966); Petersdorf Methods Significance Vitro Bacterial Sensitivity 39 Medicine 766 (1965); Gould, Laboratory Control Therapy, Chemotherapia 477 (1961); Second Report Expert Antibiotics, Standardization Conducting Microbis Tests, Health Organization Technical Series 210, pp. 12—17 (1961). 502, 352, reads, part, 'A deemed misbranded— '(l) purports be, represented thereof, respect certificate issued 357 Provided, subsection class 357(c) (d) title.' witnesses portion 201(g)(1)(A). unreported; pertinent findings quoted Appeals, 22—23 (1968). earliest versions 1944, (1933), 2000, (1934). succeeded (1935). died House, (1937), eventually into law, supplemented H.R. 9341, (1938). Most reprinted C. Dunn, supra, n. 7, 214, 237, 239. 286—296. 348—385, 429—476. 429 (remarks Clark). 369. Bailey North Carolina remarked: 'I President tolerate moment piece described crutches 'drugs' advertising 'adulteration,' carrying English far.' committee report that: paralleling consumer protected multiplicity abuses law.' (S.Rep.No.646, (1935).) 477. 495—496. 571. 1235, 1247. 'Elixir-Sulfanilamide' September-October, 1937, 100 persons consuming untested o Agriculture Deaths Due Elixir Sulfanilamide-Massengill (submitted response Res. 194 November 16, 1937), 1316—1327. Cawley 272 443, 445 (C.A.2d Cir. 1959): '(U) nless explicitly forbid it, best chosen.' AMP Inc. Gardner, 389 825, 830 Cir.), cert. denied sub nom., Cohen, 393 86, (1968), rehearing pending. W. Dorland's Illustrated Medical Dictionary 449 (24th 1965), as: 'Any compound non-infections substance, properties, patients, human animal, abnormal condition, relief pain suffering, improve physiological pathological condition.' diagnosis indeed difficult clearer description

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