Document: 460 U.S. 453 103 S.Ct. 1298 75 L.Ed.2d 198 UNITED STATES, Petitionerv.GENERIX DRUG CORPORATION et al. No. 81-1222. Argued Nov. 3, 1982. Decided March 22, 1983. Syllabus The Federal Food, Drug and Cosmetic Act (Act) prohibits the marketing of a "new drug" without prior approval Food Administration (FDA). Section 201(p) defines as "any drug . [which] is not generally recognized safe effective or which has not, otherwise than in [safety effectiveness] investigations, been used to material extent for time." 201(g)(1) term "drug" as, inter alia, "articles intended use diagnosis, cure, mitigation, treatment, prevention disease man other animals." Government brought an action District Court enjoin respondent Generix Corp. (respondent) from distributing number generic products containing specified active ingredients, alleging that FDA had never approved applications with respect such products. Holding product same ingredients previously pioneer marketed under brand name if there reasonable possibility differences inactive "excipients" between will make less effective, finding established safety effectiveness respondent's might be affected by their those found products, court enjoined question. Appeals vacated injunction remanded instructions dismiss complaint, holding statutory prohibition against sale does apply having product, regardless any "excipients." Held: A within meaning indicated definition § 201(g)(1). That broad enough encompass entire complete ingredients. Accordingly, drug," subject approval, until (and merely its ingredients) no longer falls terms 201(p). Pp. 457-461. 654 F.2d 1114, reversed. Jerrold J. Ganzfried, New York City, petitioner. Robyn Greene, Miami, Fla., respondents. Justice STEVENS delivered opinion Court. 1 question presented whether (FDA) requires have new (NDAs) before it may market In terms, we are required determine relevant sections Drug, (Act), amended, 21 U.S.C. §§ 301 seq., refers only ingredient product. We hold Congress word broader meaning. 2 * most prescription drugs constitute 10% product; (such coatings, binders, capsules) rest. "generic describe contains but necessarily excipients so-called "pioneer name.1 Respondent distributor manufactured firms. 3 initiated this interstate commerce contain eight ingredients.2 It alleged products.3 4 held requiring NDA, effective. 498 F.Supp. 288, 292. clear evidence support general proposition affect Excipients rate at diseased organ. If delivery too fast, patient harmed just he received overdose; slow, treatment ineffective. Id., 291. 5 case, six products.4 defendants further distribution designated 6 Fifth Circuit, now Eleventh Court's complaint. 1114. excipients. based conclusion on view requirement evaluating must normally relate because precise technique formulating finished part information known medical scientific community. Moreover, believed legislative history suggested create product-by-product licensing system. Since issue all necessary concluded was entitled relief all. 7 Because obviously important decided differently circuits,5 granted certiorari. 455 988, 102 1610, 71 847.6 II 8 resolving narrow presented, misread text. 9 time. ."7 did rest decision Generix's effective; rather, rested phrase include ingredient. simply untenable. 10 original Drugs June 30, 1906, 34 Stat. 768, prohibited adulterated misbranded foods drugs. statute plainly completed provided: 11 "That 'drug,' Act, shall medicines preparations United States Pharmacopoeia National Formulary internal external use, substance mixture substances either 769. 12 1938, passed statute, application submitted introduced into commerce. 52 1040, seq. Act's even old one: 13 "[201](g)(1) 'drug' means (A) articles official Pharmacopeia, Homoeopathic States, Formulary, supplement them; (B) animals; (C) (other food) structure function body (D) component article clauses (A), (B), paragraph; devices components, parts, accessories." 1041, 321(g)(1). 14 examining definition, persuaded come subsection (A). F.2d, 1116.8 Unfortunately, analyze definition. done so, would noted both subsections more also they do so unless superfluous. disjunctive, quite Act. 15 natural reading corroborated 501(a) provides deemed "if bears contains, purposes coloring only, color additive unsafe." 1049, 351(a)(4). 502(e) "drug fabricated two ingredients" label includes "whether quantity proportion bromides, ether, chloroform, [etc.]." 1050-1051, 352(e)(1). And 505(b) "a full list components [and] statement composition drug." 1052, 355(b). throughout ingredients.9 16 Neither nor pointed anything text inconsistent our plain language.10 makes arguments upon administrative practice regarding over-the-counter lend need precisely molecular order "drug."11 None arguments, however, warrants 17 case what types significant insignificant statute. argues theory "active ingredient"; argue products—active together—are latter argument would, course, unavailing facts us; questioned bioequivalent products.12 thus reach demonstrably different excipients, some circumstances "drug." 18 summary, Such therefore requirements 505, ingredient) judgment accordingly 19 Reversed. Generic drugs, called "copycat" "me-too" usually relatively low prices manufacturers incur research, development, promotional costs associated creation were: allopurinol, spironolactone, hydrochlorothiazide, furosemide, diethylpropion hydrochloride, chlorothiazide reserpine, amitriptyline perphenazine, prochloreperazine maleate, chlorthalidone. explained each these noting one widely being treat hypertension edema. F.Supp., 289-290. 505(a) 76 784, 355(a), provides: "(a) Necessity "No person introduce deliver introduction drug, filed pursuant (b) section drug. concerning formulations maleate chlorthalidone hearing, 294. Premo Pharmaceutical Laboratories, Inc. v. 629 795 (CA2 1980). argued moot almost store disputed saleable, future intends sell approval. change mind sufficient preclude mootness. See City Mesquite Aladdin's Castle, Inc., 283, 288-289, 1070, 1074, 152 (1982); W.T. Grant Co. 345 629, 632, 73 894, 897, 97 L.Ed. 1303 (1953). 201(p), 1041-1042, 781, 321(p), reads follows: "The 'new drug' means— "(1) Any (except animal feed bearing drug) recognized, among experts qualified training experience evaluate conditions prescribed, recommended, labeling thereof, except time 25, contained representations use; "(2) result investigations conditions, become conditions." But cf. America, Twentieth Revision/The Fifteenth Edition (1980) ("article" item monograph exists; monographs exist "finished, partially preparation [active excipients] formulated patient"). At oral argument, nonsensical understand 502(i) 1051, 352(i), mean product," "an imitation another Tr. Oral Arg. 41-42. prohibit company passing off original; "imitation" understood mind, becomes apparent can should product" 502(i), well. Both referred opposed then 201(p)(2) 1116-1117. (set forth n. 7, supra ) establishes drop out regulation, must—in addition prescribed use—have investigations. appears premise regulatory burden file application. receive public nothing gained deregulation sustained could exempted burden. flawed. Significant record-keeping reporting burdens lifted when status terminates. 505(j) 782-783, 355(j). CFR 310.300-.303 (1982). (1) suggests 1938 rejected system, (2) many pharmacists compounded own pills choice were expected NDA's pill every excipient, (3) 1968 advised certain drugs" require marketed, (4) 1962 Amendments reveal congressional interest promoting availability reduce price consumers, (5) applying Amendments, took position that, purposes, covered copied, (6) since 1972 "monograph" system permit meet standards "suitable" cross-appeal refusal grant chlorthalidone, see ante, occasion pass showing "reasonable possibility" distribution.

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