Document: 412 U.S. 645 93 S.Ct. 2488 37 L.Ed.2d 235 Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al., Petitioners,v.BENTEX PHARMACEUTICALS, INC., al. No. 72—555. Argued April 17, 1973. Decided June 18, Syllabus Respondent drug marketers filed suit for a declaratory judgment that their drugs containing pentylenetetrazol are generally recognized as safe effective thus not 'new drugs' within the meaning § 201(p) Federal Food, Drug Cosmetic Act 1938, amended. They also sought exemption under 107(c)(4), grandfather clause, 1962 amendments to Act. The Food Administration (FDA) Commissioner, based on NAS—NRC panel reports, concluded there was lack substantial evidence were intended uses gave notice his intention initiate proceedings withdraw approval new applications (NDA's). In light FDA's position withdrawal an NDA would operate remove marketing all similar composition, known 'me-too' drugs, whether or expressly covered by NDA, Commissioner invited holders NDA's 'and any interested person who might be adversely affected removal from market' submit 'adequate well-controlled studies' establish effectiveness drugs. Only one holder submitted further evidence, which held did satisfy statutory standard. He intent issue order withdrawing NDA's, only requested hearing but no supporting data. issued orders appeal taken. Respondents here market none NDA. District Court FDA should resolve drug' 'grandfather' issues in administrative proceeding. Appeals reversed remanded with directions determine challenged may lawfully marketed without approved holding has jurisdiction, primary concurrent, decide what is required. Held: Court's referral proper. Pp. 649 654. (a) While denying reviewable 505(h), declaring status Administrative Procedure Court. P. 651 652. (b) reach scientific inquiry both 505(d) same, Weinberger v. Hynson, Westcott Dunning, Inc., 609, 2469, 207 it implicit regulatory scheme jurisdiction finality, subject judicial review, individual classes 652—653. (c) peculiarly suited initial determination its specialized competence expertise. 653—654. 463 F.2d 363, reversed. Opening statement Daniel M. Friedman, Washington, D.C., Weinberger, Secretary, HEW, five cases. petitioners. George F. Townes, Greenville, S.C., respondents. Mr. Justice DOUGLAS delivered opinion 1 this case Bentex some 20 other firms effective, 201(p)(1) Drug, amended, 76 Stat. 781, 21 U.S.C. 321(p) (1). requirements reason 107(c)(4) Act, clause. 2 As part Administration's (FDA's) Efficacy Study Implementation program, three separate National Academy Sciences-National Research Council (NAS—NRC) panels reviewed concerning these each 'ineffective' indicated use. had taken f they NDA.1 Accordingly, pentylenetetrazol, market,' See 505(d), 355(d). thereupon 505(e), 355(e). Again, those given opportunity participate. data support it. (35 Fed.Reg. 14412); This followed. It appears parties 3 although could 'new' 'grandfathered' concurrent entered injunction preserve quo ruled if decline hold issue. NDA's. 363. either proceeding view established two forums regulation drugs: premarketing clearances previously right appeal; and, second, enforcement requirement cleared before providing Government remedies seizure, injunction, criminal prosecution available solely Id., at 371—372. 4 We reverse Appeals. 5 FDA, result study after due notice, faced up problem proposing found lacking effectiveness. One method have 1,000 hearings—perhaps many 3,500, lasting probably weeks. cost time budget enormous. regulations,2 already discussed & 207, defining 'scientific principles characterize adequate clinical investigation,'3 elaborates 'substantial evidence' test. And, we basis regulations laid unless party seeking proffered least nature quality. 6 By May 1972, 102 final effecting 452 been issued; resulted additional 1,473 drugs.4 still troubled because census marketplace authorized. That why Congress enacted Listing 86 559, §§ 331(p), 335(e), 360(e), (f), (c), (d) (1970 ed., Supp. II). requires manufacturers list market, including showing labeling, advertising.5 Senate Report stated:6 7 'The provisions ready availability current inventory just completing thorough review pursuant during period 1938—1962, required Amendments 1962. Application results important related frustrated easily obtained.' 8 realized impossible apply over-the-counter (OTC) case-by-case basis. There between 100,000 500,000 products, few FDA. 1972 adopted procedure determining particular OTC ineffective, misbranded. 9464. involves establishment independent expert different categories (e.g., antacids, laxatives, analgesic) prepare monographs prescribing manufacturing controls. OTC's conforming monograph will considered misbranded requiring provides panel, comments rebuttal monograph, finally review. 9475. 9 case, like cross-petition Hynson (No. 72 414) raises question authority satisfies noted, ordered withdrawn. Review provided 355(h). Rather, aggrieved Court, detailed. narrow district court. 10 Appeals, 505(h); see make exclusive one. Certainly does deny declares status. supra, 627, 2481. bolstering conclusion note passing Abbott Laboratories Gardner, 387 136, 144, 87 1507, 1513, 18 681, said stated do manifest 'a congressional purpose eliminate kinds agency action.' 505(h) appear obtaining covering instant apparently oppose taking action, presents objection exercise courts case. does, however, strenuously conclusions reached 11 court, drug, never presented when application manufacturer filed. Parties, course, cannot confer jurisdiction; can so. line drawn action hand, other. discern such jurisdictional stated, where drug's effectiveness, based, outlined, investigation experts. But definition encompasses 'not recognized, among experts qualified training experience evaluate safety use.' Whether drug,' depends knowledge scientists controlled experimentation backed literature. function peculiar expertise, types cases overlap strongly suggest desired determination. Even made arises court proceedings, commonplace await appropriate declaration acted. Myers Bethlehem Shipbuilding Corp., 303 41, 50 51, 58 459, 463—464, 82 L.Ed. 638; F.P.C. Louisiana Power Light Co., 406 621, 647, 92 1827, 1842, 32 369. may, true general recognition efficacious kind necessary obtain But, indicate 631, 2484, precisely same. 12 think scheme, spelled out haec verba, provided, deluge litigation follow receive de novo hearings inure interests merchants public anxious protect amendments, well told incapable handling caseload more than perhaps 15 year. Clearly, litigate, basis, now marketed, severely undermined, totally destroyed. Moreover, approach inherently unfair compliance while competitors remain free violate much clouded doubts one, 'in absence compelling Congress' . prohibit imperative achievement agency's ultimate purposes.' Permian Basin Area Rate Cases, 390 747, 780, 88 1344, 1367, 312. And Ricci Chicago Mercantile Exchange, 409 289, 304—306, 573, 581—583, 34 525. 13 conclude appropriate, said: 'Evaluation conflicting reports reputation field matter left chemical medical background.' necessarily implicates complex pharmacological considerations. Threshold questions expertise appropriately routed agency, stays hand. Far Eastern Conference United States, 342 570, 574—575, 492, 494, 96 576: '(I)n raising fact conventional judges discretion, agencies created regulating passed over. so even though facts appraised serve premise legal consequences judicially defined. Uniformity consistency business entrusted secured, limited functions judiciary rationally exercised, preliminary resort ascertaining interpreting circumstances underlying better equipped specialization, insight gained through experience, flexible procedure.' Port Boston Marine Terminal Assn. Rederiaktiebolaget Transatlantic, 400 62, 68, 91 203, 208, 27 203; 581—583. 14 Reversed. BRENNAN took consideration decision 16 STEWART Volume 23187, adding 130.40 CFR, defines 'identical, related, used include 'other brands, potencies, dosage forms, salts, esters same moiety structure properties.' persons interest proposed basic drug. A order, directing evaluation reproduced 26623—26624. 35 3073, 7250. Appendix 634, S.Ct., 2485. Hearings Present Status Competition Pharmaceutical Industry Subcommittee Monopoly Select Committee Small Business, 92d Cong., 2d Sess., pt. 22, p. 8525. Filings 26432. S.Rep.No.92—924, 2, U.S.Code Cong. Admin.News 2963.

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