Document: 412 U.S. 640 93 S.Ct. 2495 37 L.Ed.2d 230 CIBA CORPORATION, Petitioner,v.Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. No. 72—528. Argued April 17, 1973. Decided June 18, Syllabus Petitioner manufactures a drug called Ritonic Capsules, for which it filed new application (NDA) that became effective in 1959, on the basis drug's safety. After enactment 1962 amendments to Federal Food, Drug, Cosmetic Act, Food Drug Administration (FDA) withdrew approval NDA ground there was no substantial evidence as claimed, under § 505 Act. sought review withdrawal order Court Appeals Second Circuit, provided 505(h), court affirmed order. Prior issuance order, petitioner declaratory injunctive relief District New Jersey, granted Government's motion dismiss complaint lack jurisdiction. The Third Circuit affirmed, holding FDA authorized decide jurisdictional question an incident its power approve or withdraw NDAs, decision reviewable direct appeal by appeals, since had ruled against appeal, issue could not be relitigated separate suit judgment. Held: 1. has jurisdiction administrative proceeding determine whether produce is 'new drug' within meaning 201(p) Weinberger v. Bentex Pharmaceuticals Inc., 645, 2488, 235. Pp. 644—644. 2. While Act provides with sanctions, such civil injunction proceedings, criminal penalties, rem seizure condemnation, enforce prohibition sale commerce any article violation 505, does create dual system, one other judicial. P. 644. 3. Where opportunity litigate before raise may relitigate another proceeding. 463 F.2d 225, affirmed. Opening statement Daniel M. Friedman, Washington, D.C., Caspar Weinberger, Secretary, HEW, all five cases. respondents. Clyde A. Szuch, Newark, N.J., petitioner. Mr. Justice DOUGLAS delivered opinion Court. 1 Capsules* 1959. Under then force, required manufacturer submit adequate proof This particular As we have noted companion cases, 1938, 52 Stat. 1040, amended, 76 780, directed NDA's prior time if, after notice hearing, found 'substantial evidence' involved claimed labeling. And, noted, used §§ 505(d) 505(e)(3), 21 U.S.C. 355(d) 355(e)(3), means 'adequate well-controlled investigations' from experts conclude will effect. 2 A panel National Academy Sciences-National Research Council (NAS—NRC) reviewed claims made Capsules 'ineffective' each claims. concluded efficacy gave intent NDA, offering kind data bearing stating would cause effect, thereby making future sales unlawful. 3 responded, submitting maintained purposes amended. petitioner's insufficient establish effectiveness hearing NDA. contested FDA's authority proceed further, product It reserved right position judicial both. more support position; accordingly claimed. 355(h). CIBA-Geigy Corp. Richardson, Cir., 446 466. 4 Meanwhile, brought Jersey seeking relief. On NDA's, We affirm Appeals. 5 stated Pharmaceuticals, 235, our reasons concluding 321(p). lacks own proceedings coverage administers, subject course review, seriously impair ability discharge responsibilities placed Congress. said Hynson, Westcott & Dunning, 609, 207, case, supra, definition 201(p)(1) involves determination technical scientific questions experts. agency therefore appropriately arm Government make threshold coverage. Cf. Oklahoma Press Publishing Co. Walling, 327 186, 210—211, n. 47, 66 494, 506—507, 90 L.Ed. 614. 6 is, course, true gives second line defense—civil condemnation. See 302(a), 303, 304, 332(a), 333, 334. Those are sanctions 505. But system control—one administrative, Cases arise where been formal issue, being first tendered district court. Even then, however, might well stay hand, awaiting appropriate question. supra. determination, explicit implicit tactic 'reserving' (the issue) later tolerable. There ruling. petitioner, having Yakus United States, 321 414, 444—446, 64 660, 677—678, 88 834. 7 Affirmed. 8 BRENNAN took part consideration this case. 9 STEWART * prescription recommended 'for patients who losing their drive, alertness, vitality zest living because natural degenerative changes advancing years'; 'debilitated depressed chronic illness, overwork, etc., those recuperating illness surgery.'

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