Document: 387 U.S. 136 87 S.Ct. 1507 18 L.Ed.2d 681 ABBOTT LABORATORIES et al., Petitioners,v.John W. GARDNER, Secretary of Health, Education, and Welfare al. No. 39. Argued Jan. 16, 1967. Decided May 22, Gerhard A. Gesell, Washington, D.C., for petitioners. Nathan Lewin, respondents. Mr. Justice HARLAN delivered the opinion Court. 1 In 1962 Congress amended Federal Food, Drug, Cosmetic Act, (52 Stat. 1040, as by Drug Amendments 1962, 76 780, 21 U.S.C. § 301 seq.), to require manufacturers prescription drugs print 'established name' drug 'prominently in type at least half large that used thereon any proprietary name or designation such drug,' on labels other printed material, 502(e)(1)(B), 352(e)(1)(B). The is one designated pursuant 502(e)(2) 352(e)(2); 'proprietary usually a trade under which particular marketed. underlying purpose amendment was bring attention doctors patients fact many sold familiar names are actually identical their 'established' less significantly lower prices. Commissioner Food Drugs, exercising authority delegated him Secretary, 22 Fed.Reg. 1051, 25 8625, published proposed regulations designed implement statute, 28 1448. After inviting considering comments submitted interested parties promulgated following regulation 'efficient enforcement' 701(a), 371(a): 2 'If label labeling bears ingredient thereof, established name, if there be, corresponding designation, shall accompany each appearance designation.' CFR 1.104(g)(1). 3 A similar rule made applicable advertisements drugs, 1.105(b)(1). 4 present action brought group 37 individual Pharmaceutical Manufacturers Association, all petitioner companies members, includes more than 90% Nation's supply drugs. They challenged ground exceeded his statute promulgating an order requiring labels, advertisements, matter relating designate involved every time its anywhere material. 5 District Court, cross motions summary judgment, granted declaratory injunctive relief sought, finding did not sweep so broadly permit Commissioner's 'every time' interpretation. 228 F.Supp. 855. Court Appeals Third Circuit reversed without reaching merits case. 352 F.2d 286. It held first statutory scheme provided Act pre-enforcement1 review these unauthorized therefore beyond jurisdiction Second, no 'actual case controversy' existed and, reason, Administrative Procedure §§ 701—704 (1964 ed., Supp. II), Declaratory Judgment 2201, event available. Because general importance question, apparent conflict with decision Second Toilet Goods Assn. v. Gardner, 360 677, we also today, 158, 1520, 697, certiorari. 383 924, 86 928, 15 844. I. 6 question consider whether intended forbid pre-enforcement this sort Commissioner. phrased terms 'prohibition' rather 'authorization' because survey our cases shows judicial final agency aggrieved person will be cut off unless persuasive reason believe Congress. Board Governors Agnew, 329 441, 67 411, 91 L.Ed. 408; Heikkila Barber, 345 229, 73 603, 97 972 B rownell We Shung, 180, 77 252, 225; Harmon Brucker, 355 579, 78 433, 503; Leedom Kyne, 358 184, 79 210; Rusk Cort, 369 367, 82 787, 7 809. Early entertained, e.g., Shields Utah Idaho Central R. Co., 305 177, 59 160, 83 111; Stark Wickard, 321 288, 64 559, 88 733, have been reinforced enactment embodies basic presumption 'suffering legal wrong action, adversely affected within meaning relevant statute,' 702, long precludes committed law discretion, 701(a). provides specifically only '(a)gency reviewable statute' but 'final adequate remedy court,' 704. legislative material elucidating seminal act manifests congressional intention it cover broad spectrum administrative actions,2 has echoed theme noting Act's 'generous provisions' must given 'hospitable' Shaughnessy Pedreiro, 349 48, 51, 75 591, 594, 99 868; see United States Interstate Commerce Comm'n, 337 426, 433—435, 69 1410, 1414—1415, 93 1451; Brownell supra; supra. Again supra, 379—380, 794, upon showing 'clear convincing evidence' contrary intent should courts restrict access review. See also, Jaffe, Judicial Control Action 336—359 (1965). Given standard, wholly unpersuaded food area excludes action. Government relies explicit argument unavailable, insists instead specific procedure certain enumerated kinds regulations,3 encompassing those kind here, types were necessarily meant excluded from issue, however, readily resolved; go further inquire context entire existence circumscribed evinces bar purview As leading field noted, 'The mere some acts suffice support implication exclusion others. right too important slender indeterminate evidence intent.' 357. 8 demonstrated purpose; indeed, study history conlu sively provisions give additional down traditional channels At consideration, late 1930's, had yet enacted,4 infancy,5 scope decisions equity power unclear.6 factors led form ultimately took. There members preclude avenues relief. Indeed, throughout consideration various bills deal recognized 'There always appropriate where officer law, * (and that) protection so-called Judgments *.' H.R.Rep. 2755, 74th Cong., 2d Sess., 8. methods area,7 Department Justice, opposing special-review procedures 701, memorandum read floor House stating: 'As fact, subsection really unnecessary, even express provision bill court review, citizen who contends invalid, may test legality bringing injunction suit against head Bureau, powers court.' Cong.Rec. 7892 (1938). 9 main issue contention satisfactory. Compare majority minority reports provisions, H.R.Rep.No.2139, 75th 3d Sess. (1938), both acknowledged remedies available, disagreed need procedures. now embodied modified 701(f) supported feared life-and-death executive officials, fear voiced supporters section sought include primarily method reviewing factual determinations. For example, argued level tolerance poisonous sprays apple crops, Agriculture recently set, matter, absence special procedure.8 Some congressmen urged challenge determination de novo hearing district court, finally passed compromised allowing appeal record 'substantial test, affording considerably generous 'arbitrary capricious' available suit.9 10 second provide broader venue litigants challenging technca l time, proper Columbia, advantage preserve. bill, originally authorized face Senate Conference Committee reached compromise preserved authorizing actions appeals.10 11 Against background think quite 701(f), applying embodying technical determinations,11 simply assure decisions, does manifest eliminate 12 This conclusion strongly buttressed itself, 701(f)(6), states, addition substitution law.' saving clause over discussion. view, heavily taken value would foreclose Government's deals arguing sections 701(e). conceivable reading, requires considerable straining language common understanding. itself contains limitations, artificial construction grant begrudgingly, out literal reading cover. 13 clause. included whose report states '* saved placed effect whatever rights exist initiate historical proceeding enjoin enforcement regulation, judgment proceeding.' 11. conferees accepted provision.12 argues part apply applies. But difficult place put it—at setting use specified instances. Furthermore, result anomaly. 701(e)—(f) problem determinations normal deemed insufficient. See, pp. 142 144. seem little enacted same aimed preserving supposed inadequacy very provisions. 14 Under Goverme nt's ascertain when come into play: apply, presumably they exhausted.13 When deems likewise inapplicable. Government, sure, far-fetched example what considers possible application merely state reveals weakness position.14 prefer take value, harmony policy favoring expressed Court's decisions. preclusive Ewing Mytinger & Casselberry, Inc., 339 70 870, 94 1088, counsels restrictive view area. Administrator found probable cause 'adulterated' misbranded way 'fraudulent' 'misleading injury damage purchaser consumer.' 304(a), 334(a). Multiple seizures ordered through libel actions. manufacturer directly Administrator's cause. owner could raise constitutional, statutory, claims themselves, separate That clearly correct, nothing reasoning holding bearing regulation. 16 noted 'administrative required 304(a) prerequisite lawsuit,' issues aired. U.S., 598, S.Ct., 872. Such situation analogy promulgation, after formal procedures, followed industry. To equate promulgation self-operative industry-wide immunize nearly rulemaking activities coverage Act. 17 'no itself,' 872; consequent life. like grand jury proceed accused, vitality once commenced, challenges can made. unique inconsistent speedy goods circulation believed adulterated. Also, another consolidation multiple convenient venue. 602, 874. 19 obviously seeking unheard-of which, allowed, permitted interference early stages facts, prevented regular operation seizure refused hardly cutting well-established federal hear, cases, suits here. 20 conclude II. inquiry must, discretionary, traditionally reluctant them arise controversy 'ripe' resolution. Without undertaking intricacies ripeness doctrine15 fair say rationale prevent courts, avoidance premature adjudication, entangling themselves abstract disagreements policies, protect agencies until formalized effects felt concrete parties. best seen twofold aspect, us evaluate fitness hardship withholding consideration. former factor, presented resolution time. First, agree tendered purely one: properly construed employed.16 Both sides moved claim here proceedings contemplated. suggested justification might vary different circumstances, expertise passing validity course true, suggestion overlooks approached intent, effort justify terms. 23 find action' 704, An 'agency 'rule,' defined 'an statement applicability future implement, interpret, prescribe policy,' 2(c), 2(g), 551(4), 551(13). dealing interpreted 'finality' element pragmatic way. Thus Columbia Broadcasting System States, 316 407, 62 1194, 1563, Urgent Deficiencies 38 219, Comu nications Commission forth proscribed contractual arrangements between chain broadcasters local stations. FCC direct regulate contracts, asserted license stations maintained contracts networks. Although denied revoked, characterized intentions, 'Such force before sanctions invoked well after. expected conformity causes cognizable equity, appropriately subject attack 418—419, 1201. 24 Two recent similarly flexible finality. Frozen Express 351 40, 569, 100 910, specifying commodities fall class 'agricultural commodities.' Vehicles carrying exempt ICC supervision. carrier claimed transporting commodities, dissenting except notice how carrier, 'judicial intervention (should) withheld complete development,' 45, 572, reviewable. Again, Storer 192, 763, 1081, announcing television applicant already owning five licenses, though Commission. stated: process complete. 'aggrieved." 198, 768. 26 fortiori precedents. manner announcement Register parties17 definitive. hint informal, Helco Products Co. McNutt, U.S.App.D.C. 71, 137 681, 149 A.L.R. 345, ruling subordinate official, Swift Wickham, 230 398, 409, aff'd, Cir., 364 241, tentative. effective publication, Assistant General Counsel Drugs stated compliance expected. 27 argues, distinguished instances directly, while Attorney authorize criminal violations statute. case, do persuasive. These advise General, purport Thus, authority, status carry heavy civil sanctions. representation Attorny disagree area; defending suit. adherence technicality credence contention. Moreover, enforce applications clearance new 505, 355, certification antibiotics, 507, impact petitioners sufficiently immediate render stage. authoritative interpretation day-to-day business companies; puts dilemma ameliorate.18 basis uncontested allegations, 'Either comply requirement incur costs changing promotional follow risk prosecution.' 855, 861. clear-cut, immediately publication; earlier agency's counsel represented If wish change materials; destroy stocks matter; invest printing supplies. alternative compliance—continued good faith meets requirements, meet Commissioner—may costly. serious penalties unlawful distribution 'misbranded' drugs.19 29 juncture recognize sensitive industry, public confidence products especially important. defense harm severely unnecessarily. Where fit resolution, significant plaintiffs' conduct affairs attached noncompliance, permitted, absent unusual circumstance, neither appears 30 dispute real 'mere financial expense' true standing loss sufficient interest sustain governmental Frothingham Mellon, 262 447, 43 597, 1078; Perkins Lukens Steel 310 113, 60 869, 84 1108. plaintiffs: directed particular; requirs make changes everyday practices; fail observe exposed imposition strong 1563; Davis, Law Treatise, c. (1958). is, therefore, remote Mellon cases. 31 threat noncompliance judicially untested unrealistic; Solicitor becomes necessary, 'the civilly condemnation.' cannot accept answer petitioners' petition. inception subsequent defeat it. 32 Finally, urges resort delay impede fully served assuring prompt unimpeded administration Pure convincing. calculated speed enforcement. prevails, industry bound decree; loses, quickly revise 33 contends, allows consolidated suit, then multiplicity jurisdictions regulations. short equipped eventualities. transfer provision, 1404(a), consolidate Or, stayed pending proceeding. American Life Ins. Stewart, 300 203, 215—216, 57 377, 380, 81 605, 111 1268. discretion dismiss litigation elsewhere. Maryland Cas. Consumers Finance Service, 101 514; Carbide Carbon Chemicals Corp. Chemicals, 140 47; Note, Availability Another Suit Is Pending, 51 Yale L.J. 511 (1942). plaintiff intervene Automotive Equip., Inc. Trico Prods. Corp., 292; Allstate Thompson, 121 696. 34 Further, equitable nature, defenses interposed. undertaken harass enforcement, alone. Truly Wanzer, How. 141, 142, 88; cf. Brillhart Excess 491, 495, 1173, 1175, 1620. laches prejudiced delay, Southern Pac. Bogert, 250 483, 488—490, 39 533, 535—536, 63 1099; Pomeroy's Equity Jurisprudence 419c—d (5th ed. Symons, 1941). And refuse nonjoinder not, technically speaking, indispensable. Cf. Samuel Goldwyn, Artists 113 703; 6A Moore, Practice 57.25 (2d 1966). 35 safeguards fears, note institution stay effectiveness indicate 705. believes interest, postpone oppose motion Ibid. scarcely doubted date show, detrimental health safety. Associated Securities SEC, 283 773, 775, (had) sustained burden establishing requested stays harmful *'; Eastern Air Lines CAB, 261 830; Scripps-Howard Radio FCC, 4, 10—11, 875, 880, 1229; 36 Lastly, although presses reach entertained better practice remand Commissioner.20 Reversed remanded. BRENNAN took attempted him. 1980, 79th 41 (1946), U.S.Code Cong.Serv. 1946, p. 1195: 'To clear withhold failure specially certainly review.' S.Rep. 752, 1st (1945). Embodied 701(e), (f), 371(e), discussed hereafter. Section 701(e) issuance sections. establishes appeals 237. 1934, 48 955. discussion Representatives during debate 7891—7896 7783 (remarks Representative Leavy) (1938); Statement Professor David F. Cavers Subcommittee S. 1944, 73d (1933), reprinted Dunn, Its Legislative Record 1110 7772—7773, 7781—7784, 7893—7899 conference report, 9096—9098 7772, 7892, 9092—9093 683, relate subjects chemical properties formulation safety standards protecting health; naturally matters benefit views evidentiary it.' H.R.Conf.Rep. 2716, 8731—8738 (1938) (Senate agreement report). Notes Advisory Rule Civil 57, U.S.C.App., 6136: 'A declaration rendered adjudication 57.08(3) apparently falling opportunity file objections request hearing. alone, asserts, followed.' Brief, 28. (1958); Action, While framed compulsion, essentially character authorization requirement. Express, 41—42, 570, Storer, 193—194, 765. conformed prescribed 1003. 1005, 2—3 (1934); Borchard, Challenging 'Penal' Statutes 52 445, 454 (1943). 502(e)(1)(B) declares complying 'misbranded.' 301, 331, designates 'prohibited acts' misbranding interstate commerce. prohibited injunction, 302, 332, penalties, 303, 333, seizure, totally raised petition certiorari briefs concerns dismissal complaint plaintiffs improper them. All Delaware incorporated 1391(e)(4), government official resides contended 1391(e)(4) incorporate definition 'residence' set 1391(c): corporation sued licensed doing business, regarded residence purposes.' 1391(c) defining corporate defendant, either (1) adopted (2) 'resides' 1391(e)(4). one, farreaching effects, writ two reasons. affirming explicitly endorse court's only: 'We prejudicial error 524, 525. Review left dealt appeals. dismissed considered adequately protected participation, participation remaining interests complaints dismissed. Mishkin State New York, 502, 512—514, 958, 965—966, 56. open seek amicus curiae status.

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