abbott laboratories gardner argued january decided may commissioner food drugs exercising authority delegated secretary health education welfare issued regulations requiring labels advertisements prescription drugs bear proprietary names drugs ingredients carry corresponding established name designated secretary every time proprietary trade name used regulations designed implement amendment federal food drug cosmetic act petitioners drug manufacturers manufacturers association challenged regulations ground commissioner exceeded authority statute district granted declaratory injunctive relief sought finding scope statute broad regulations appeals reversed without reaching merits holding review regulations unauthorized beyond jurisdiction district actual case controversy existed held review regulations prohibited federal food drug cosmetic act pp courts restrict access judicial review upon showing clear convincing evidence contrary legislative intent rusk cort pp statutory scheme food drug area exclude judicial review pp provisions act applying regulations embodying technical factual determinations simply intended assure adequate judicial review agency decisions manifest congressional purpose eliminate review kinds agency action saving clause remedies provided subsection shall addition substitution remedies provided law foreclose judicial review read harmony policy favoring judicial review expressed administrative procedure act decisions pp ewing mytinger casselberry concern promulgation regulation distinguished pp case presents controversy ripe judicial resolution pp issue statutory construction purely legal regulations final agency action within administrative procedure act columbia broadcasting system similar cases followed pp impact regulations upon petitioners sufficiently direct immediate render issue appropriate judicial review stage pp challenge nearly prescription drug manufacturers calculated delay impede effective enforcement federal food drug cosmetic act pp gerhard gesell argued cause filed briefs petitioners nathan lewin argued cause respondents brief solicitor general marshall assistant attorney general vinson beatrice rosenberg jerome feit william goodrich justice harlan delivered opinion congress amended federal food drug cosmetic act stat amended drug amendments stat et seq require manufacturers prescription drugs print established name drug prominently type least half large used thereon proprietary name designation drug labels printed material established name one designated secretary health education welfare pursuant act proprietary name usually trade name particular drug marketed underlying purpose amendment bring attention doctors patients fact many drugs sold familiar trade names actually identical drugs sold established less familiar trade names significantly lower prices commissioner food drugs exercising authority delegated secretary fed reg fed reg published proposed regulations designed implement statute fed reg inviting considering comments submitted interested parties commissioner promulgated following regulation efficient enforcement act label labeling prescription drug bears proprietary name designation drug ingredient thereof established name corresponding proprietary name designation shall accompany appearance proprietary name designation cfr present action brought group individual drug manufacturers pharmaceutical manufacturers association petitioner companies members includes manufacturers nation supply prescription drugs challenged regulations ground commissioner exceeded authority statute promulgating order requiring labels advertisements printed matter relating prescription drugs designate established name particular drug involved every time trade name used anywhere material district cross motions summary judgment granted declaratory injunctive relief sought finding statute sweep broadly permit commissioner every time interpretation supp appeals third circuit reversed without reaching merits case held first statutory scheme provided federal food drug cosmetic act review regulations unauthorized therefore beyond jurisdiction district second appeals held actual case controversy existed reason relief administrative procedure act supp ii declaratory judgment act event available general importance question apparent conflict decision appeals second circuit toilet goods assn gardner also review today post granted certiorari given standard wholly unpersuaded statutory scheme food drug area excludes type action government relies explicit statutory authority argument review unavailable insists instead statute includes specific procedure review certain enumerated kinds regulations encompassing kind involved types necessarily meant excluded review issue however readily resolved must go inquire whether context entire legislative scheme existence circumscribed remedy evinces congressional purpose bar agency action within purview judicial review leading authority field noted mere fact acts made reviewable suffice support implication exclusion others right review important excluded slender indeterminate evidence legislative intent jaffe supra case government demonstrated purpose indeed study legislative history shows rather conclusively specific review provisions designed give additional remedy cut traditional channels review time food drug cosmetic act consideration late administrative procedure act yet enacted declaratory judgment act infancy scope judicial review administrative decisions equity power unclear factors led form statute ultimately took evidence members congress meant preclude traditional avenues judicial relief indeed throughout consideration various bills submitted deal issue recognized always appropriate remedy equity cases administrative officer exceeded authority adequate remedy law protection given declaratory judgments act specifically brought attention congress methods fact used food drug area department justice opposing enactment procedures submitted memorandum read floor house stating matter fact entire subsection really unnecessary even without express provision bill review citizen aggrieved order secretary contends order invalid may test legality order bringing injunction suit secretary head bureau general equity powers cong rec main issue contention whether methods review satisfactory compare majority minority reports review provisions sess acknowledged traditional judicial remedies available disagreed need additional procedures provisions embodied modified form supported feared power given act executive officials fear voiced many members congress supporters section sought include act primarily method reviewing agency factual determinations example argued level tolerance poisonous sprays apple crops secretary agriculture recently set factual matter reviewable equity absence special statutory review procedure congressmen urged challenge type determination form de novo hearing district act finally passed compromised matter allowing appeal record substantial evidence test affording considerably generous judicial review arbitrary capricious test available traditional injunctive suit second reason special procedure provide broader venue litigants challenging technical agency determinations time suit secretary proper district columbia advantage government sought preserve house bill however originally authorized review district face senate bill allowing review district columbia conference committee reached compromise preserved present statute authorizing review agency actions courts appeals background think quite apparent procedures provided applying regulations embodying technical factual determinations simply intended assure adequate judicial review agency decisions enactment manifest congressional purpose eliminate judicial review kinds agency action conclusion strongly buttressed fact act remedies provided subsection shall addition substitution remedies provided law saving clause passed appeals without discussion view however bears heavily issue taken face value foreclose government main argument case government deals clause arguing read applying review regulations sections specifically enumerated conceivable reading requires considerable straining language common understanding saving clause contains limitations requires artificial statutory construction read general grant right judicial review begrudgingly cut agency actions literal reading cover support legislative background reading clause included house bill whose report provision saved method review regulation placed effect secretary whatever rights exist initiate historical proceeding equity enjoin enforcement regulation whatever rights exist initiate declaratory judgment proceeding senate conferees accepted provision government argues clause included part therefore read apply sections procedure applies difficult think appropriate place put general saving clause congress placed conclusion section setting special procedure use certain specified instances furthermore government reading result anomaly procedure included act order deal problem technical determinations normal equity power deemed insufficient see supra pp seem little reason congress enacted time included clause aimed preserving determinations types review whose supposed inadequacy reason provisions government view indeed difficult ascertain saving clause even come play special provisions apply presumably must used grant injunctive declaratory judgment relief unless appropriate administrative procedure exhausted special procedure apply government deems saving clause likewise inapplicable government sure present rather example considers possible application relief saved merely state reveals weakness government position prefer take saving clause face value read harmony policy favoring judicial review expressed administrative procedure act decisions argument government requiring attention preclusive effect statute ewing mytinger casselberry counsels restrictive view judicial review food drug area case food drug administrator found probable cause drug adulterated misbranded way fraudulent misleading injury damage purchaser consumer multiple seizures ordered libel actions manufacturer drug brought action challenge directly administrator finding probable cause held owner raise constitutional statutory factual claims libel actions mere finding probable cause administrator challenged separate action decision quite clearly correct nothing reasoning holding bearing declaratory judgment action challenging promulgated regulation ewing first noted administrative finding probable cause required merely statutory prerequisite bringing lawsuit issues aired situation bears analogy promulgation formal procedures rule must followed entire industry equate finding probable cause proceeding particular drug manufacturer promulgation regulation immunize nearly agency rulemaking activities coverage administrative procedure act second determination probable cause ewing effect action consequent upon finding give legal life noted like determination grand jury probable cause proceed accused finding vitality proceeding commenced time appropriate challenges made also noted unique type relief sought drug manufacturer inconsistent policy act favoring speedy action goods circulation believed probable cause adulterated also relief specifically granted act provide another type relief form consolidation multiple libel actions convenient venue drug manufacturer ewing quite obviously seeking form relief allowed permitted interference early stages administrative determination specific facts prevented regular operation seizure procedures established act refused permit action hardly authority cutting jurisdiction federal courts hear appropriate cases suits declaratory judgment act administrative procedure act challenging final agency action kind present conclude nothing food drug cosmetic act precludes action ii former factor believe issues presented appropriate judicial resolution time first parties agree issue tendered purely legal one whether statute properly construed commissioner require established name drug used every time proprietary name employed sides moved summary judgment district claim made administrative proceedings contemplated suggested justification rule might vary different circumstances expertise commissioner relevant passing upon validity regulation course true suggestion overlooks fact sides approached case one purely congressional intent government made effort justify regulation factual terms second regulations issue find final agency action within meaning administrative procedure act construed judicial decisions agency action includes rule defined act agency statement general particular applicability future effect designed implement interpret prescribe law policy cases dealing judicial review administrative actions interpreted finality element pragmatic way thus columbia broadcasting system suit urgent deficiencies act stat held reviewable regulation federal communications commission setting forth certain proscribed contractual arrangements chain broadcasters local stations fcc direct authority regulate contracts rule asserted license stations maintained contracts networks although license fact denied revoked fcc regulation properly characterized statement intentions held regulations force law sanctions invoked well promulgated order commission expected conformity causes injury cognizable equity appropriately subject attack two recent cases taken similarly flexible view finality frozen food express issue interstate commerce commission order specifying commodities deemed fall within statutory class agricultural commodities vehicles carrying commodities exempt icc supervision action brought carrier claimed transporting exempt commodities icc order included terms although dissenting opinion noted icc order authority except give notice commission interpreted act effect particular action brought particular carrier argued judicial intervention withheld administrative action reached complete development held order reviewable storer broadcasting held final agency action within meaning administrative procedure act fcc regulation announcing commission policy issue television license applicant already owning five licenses even though specific application commission stated process rulemaking complete final agency action storer claimed aggrieved find decision present case following fortiori precedents regulation challenged promulgated formal manner announcement federal register consideration comments interested parties quite clearly definitive hint regulation informal see helco products mcnutt app ruling subordinate official see swift wickham supp aff tentative made effective upon publication assistant general counsel food drugs stated district compliance expected government argues however present case distinguished cases like frozen food express ground instances agency involved implement policy directly attorney general must authorize criminal seizure actions violations statute context case find argument persuasive regulations meant advise attorney general purport directly authorized statute thus within commissioner authority status law violations carry heavy criminal civil sanctions also representation attorney general commissioner disagree area justice department defending suit adherence mere technicality give credence contention moreover agency direct authority enforce regulation context passing upon applications clearance new drugs certification certain antibiotics also case impact regulations upon petitioners sufficiently direct immediate render issue appropriate judicial review stage regulations purport give authoritative interpretation statutory provision direct effect business prescription drug companies promulgation puts petitioners dilemma purpose declaratory judgment act ameliorate district found basis uncontested allegations either must comply every time requirement incur costs changing promotional material labeling must follow present course risk prosecution supp regulations made effective immediately upon publication noted earlier agency counsel represented district immediate compliance terms expected petitioners wish comply must change labels advertisements promotional materials must destroy stocks printed matter must invest heavily new printing type new supplies alternative compliance continued use material believe good faith meets statutory requirements clearly meet regulation commissioner may even costly course risk serious criminal civil penalties unlawful distribution misbranded drugs relevant juncture recognize petitioners deal sensitive industry public confidence drug products especially important require challenge regulations defense action brought government might harm severely unnecessarily legal issue presented fit judicial resolution regulation requires immediate significant change plaintiffs conduct affairs serious penalties attached noncompliance access courts administrative procedure act declaratory judgment act must permitted absent statutory bar unusual circumstance neither appears government dispute real dilemma petitioners placed regulation contends mere financial expense justification judicial review course true cases dealing standing particular parties bring action held possible financial loss sufficient interest sustain judicial challenge governmental action frothingham mellon perkins lukens steel question present case petitioners sufficient standing plaintiffs regulation directed particular requires make significant changes everyday business practices fail observe commissioner rule quite clearly exposed imposition strong sanctions compare columbia broadcasting system davis administrative law treatise case therefore remote mellon perkins cases government contends threat criminal sanctions noncompliance judicially untested regulation unrealistic solicitor general represented enforcement becomes necessary department justice proceed civilly injunction condemnation accept argument sufficient answer petitioners petition action inception properly brought subsequent representation department justice suffice defeat finally government urges permit resort courts type case may delay impede effective enforcement act fully recognize important public interest served assuring prompt unimpeded administration pure food drug cosmetic act find government argument convincing first particular case challenge nearly prescription drug manufacturers calculated speed enforcement government prevails large part industry bound decree government loses quickly revise regulation government contends however allows consolidated suit nothing prevent multiplicity suits various jurisdictions challenging regulations short answer contention courts well equipped deal eventualities venue transfer provision may invoked government consolidate separate actions actions one jurisdiction might stayed pending conclusion one proceeding see american life ins stewart may even discretion dismiss declaratory judgment injunctive suit issue pending litigation elsewhere maryland cas consumers finance service carbide carbon chemicals note availability declaratory judgment another suit pending yale least one suit declaratory judgment relief denied suggestion plaintiff intervene pending action elsewhere automotive trico prods supp see allstate ins thompson supp declaratory judgment injunctive remedies equitable nature equitable defenses may interposed multiplicity suits undertaken order harass government delay enforcement relief denied ground alone truly wanzer cf brillhart excess ins defense laches asserted government prejudiced delay southern pac bogert pomeroy equity jurisprudence ed symons courts may even refuse declaratory relief nonjoinder interested parties technically speaking indispensable cf samuel goldwyn artists moore federal practice ed addition safeguards government fears important note institution type action stay effectiveness challenged regulation nothing record indicate petitioners sought stay enforcement every time regulation pending judicial review see agency believes suit type significantly impede enforcement harm public interest need postpone enforcement regulation may oppose motion judicial stay part challenging regulation ibid scarcely doubted refuse postpone effective date agency action government show made effort delay detrimental public health safety see associated securities sec stay denied petitioners sustained burden establishing requested stays harmful public interest see eastern air lines cab cf radio fcc lastly although government presses us reach merits challenge regulation event find district properly entertained action believe better practice remand case appeals third circuit review district decision regulation beyond power commissioner reversed remanded dissenting opinions justice fortas justice clark see post pp respectively footnotes see preclude judicial review bill statute specific withholding review must upon face give clear convincing evidence intent withhold mere failure provide specially statute judicial review certainly evidence intent withhold review see also embodied discussed hereafter section provides procedure issuance regulations certain specifically enumerated statutory sections section establishes procedure direct review appeals regulation promulgated administrative procedure act enacted stat declaratory judgment act enacted stat see discussion judicial review equity power house representatives debate provisions cong rec see cong rec remarks representative leavy statement professor david cavers subcommittee senate committee commerce sess reprinted dunn federal food drug cosmetic act statement legislative record see cong rec see discussion conference report cong rec see cong rec see toilet goods assn gardner noted agency determinations specifically reviewable relate technical subjects chemical properties particular products formulation application safety standards protecting public health congress naturally wish courts consider matters without benefit agency views evidentiary hearing conf cong rec senate agreement conference report see notes advisory committee federal rule civil procedure reprinted declaration may rendered special statutory proceeding provided adjudication special type case see also moore federal practice ed government apparently views clause applying regulations falling within procedure promulgated without affording required public notice opportunity file objections request public hearing case alone government asserts equity proceeding declaratory judgment action might entertained ground statutory procedures followed brief see davis administrative law treatise jaffe judicial control administrative action every time issue framed parties terms statutory compulsion think essentially legal character different framed terms statutory authorization requirement compare similar procedures followed frozen food express supra storer supra procedure conformed prescribed administrative procedure act see borchard challenging penal statutes declaratory action yale section declares drug complying labeling requirement misbranded section designates prohibited acts misbranding drugs interstate commerce prohibited acts subject injunction criminal penalties seizure totally separate issue raised petition certiorari argued parties briefs concerns dismissal complaint certain plaintiffs ground venue improper petitioners asserted venue proper delaware incorporated also allowing action government official judicial district plaintiff resides contended must read incorporate definition residence set corporation may sued judicial district incorporated licensed business business judicial district shall regarded residence corporation venue purposes issue construction whether read defining corporate venue corporation defendant whether either adopted corporate residence cases corporation plaintiff least definition resides used question difficult one effects think appropriate dismiss writ certiorari question following two reasons first appeals affirming district issue explicitly endorse lower ruling held find prejudicial error dismissal complaint plaintiffs review issue importance best left case fully dealt appeals second one plaintiffs whose complaint dismissed pharmaceutical manufacturers association corporate petitioners members think considered adequately protected suit participation well participation remaining drug companies whose interests identical petitioners whose complaints dismissed cf mishkin new york moreover course litigation open dismissed plaintiffs seek amicus curiae status