Document: 412 U.S. 655 93 S.Ct. 2498 37 L.Ed.2d 244 USV PHARMACEUTICAL CORPORATION, Petitioner,v.Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. No. 72—666. Argued April 17, 1973. Decided June 18, Syllabus Petitioner sells drug products containing citrus bioflavonoid, an extract from fruit skins, as a principal active ingredient. In the 1950's new applications (NDA's) were filed became effective for seven products, two sold without any NDA. After enactment 1962 amendments to Federal Food, Drug, Cosmetic Act, these together with large number other bioflavonoid examined by Food Drug Administration (FDA) effectiveness. Based upon National Academy Sciences-National Research Council (NAS—NRC) reports its own evaluation, FDA gave notice opportunity hearing on proposal draw approvals NDA's all drugs compounds, alone or in combination drugs. then brought suit District Court, seeking declaratory judgment that are exempt efficacy requirements under § 107(c)(4), so-called 'grandfather' clause. refused stay pending judicial proceedings went forward administrative action. submitted no evidence 'adequate well-controlled investigations' required 505(d) support claims effectiveness, withdrew petitioner's NDA's. Section 107(c)(4) exempts effectiveness which day preceding (1) was commercially used United States, (2) not 'new drug' defined 1938 (3) 'was covered application' Act. The Court found had never been that, while covered, their later withdrawn petitioner. It concluded applications, hence criterion. Appeals reversed merits. held entitled exemption, applicant could withdraw NDA once it effective, 'covered application,' although 'me-too' (similar drugs) manufacturers would be exempt, 'me-too's' exempt. Held: 1. 'Any is generic sense, means whether same different 'covered' 'effective' requirement 201(p). Pp. 663—665. 2. Prescription market subject requirements, if comprehensively meaningful, cannot read so provide loophole permit marketing previously regulation demonstrating statutory standards they have claimed efficacy. 665 666. 3. congressional purpose only those regulation, therefore does fall within category. 666—668. 461 F.2d 223, affirmed. Opening statement Daniel M. Friedman, Washington, D.C., Caspar Weinberger, Secretary, HEW, five cases. Andrew L. Frey, respondents. Joel E. Hoffman, Mr. Justice DOUGLAS delivered opinion Court. 1 line ingredient, skins. capsules, syrup, tablets. them; two, however, 1961 advised petitioner when distributed existing labels, These recommended wide variety ailments bleeding, hypertension, ulcerative colitis. Act 1938, 52 Stat. 1040, amended, 76 780, panels reviewed them. One panel metabolic disorders 'use materials hemostatic agents capillary fragility felt unjustifiable proved.' A hematologic there proof efficacious medical use. 2 NAS—NRC thereupon asking s 107(c)(4). forward, refusing proceedings. 21 U.S.C. 355(d), Commissioner made findings 3 contended reason amendments, provides: 4 'In case which, immediately date, (A) (B) section 201(p) basic force, (C) application 505 this shall apply such intended solely use conditions prescribed, recommended, suggested labeling respect day.' 5 'safe' treating abnormal permeability fragility. drugs, meaning criterion added regulatory provisions §§ 355 321(p). ruling, necessarily determined it, FDA, jurisdiction decide exemption questions. 6 agreed but merits.1 223. none As filed, effective. even generally recognized safe date 107(c)(4)(C) thus amendments. specific NDA, competing bioflavonoids because covering pioneer prepared similar formula labeling. While Government agrees should accorded treatment who NDA's, parties at odds issues.2 7 resolution questions presented turns essentially quoted above. But background problem construction, references 201(p)3 amended redefine one experts both prescribed has material extent time. 505(a) require affirmative approval where provided automatically become unless contrary order issued.4 505(d)5 disapproval 'a lack substantial will effect purports represented have.' 505(e) previous whenever appears information otherwise drug's 8 There remained already market. Without transitional protection drugs—except marketed prior whose changed provision 201(p)—would violation Even outstanding ineffective approved them criteria. 107(c)(2) provides before deemed 'approved.' eliminated necessity review approve every file. 9 107(c)(3) file remains unchanged affected 505(b) refusals insofar concerned, long suspended 505(e). also withdrawal until years after adopted, reasons than whichever came first. seems apparent industry assured continue given minimum submit 'substantial evidence' products. 10 exempted composition unchanged. This applies product safe; application. 11 first question is, copies effecacy itself? Are manufacturer whoever manufactures them? clear 107(c) designed general make applicable two-year grace period. created exception policy. Senator Eastland explained 'transitional provisions,' stating: 'Established go through procedures test clauses concerned.'6 true covers particular names applied personal files it. 505, words, addresses itself individual we agree 'any 'me-too's,' If true, then, said, another holding regulated. That reading discriminatory needlessly so. For avoided taking subsection term. nature works direction. exclude word create hiatus scheme cogent reason. We find persuasive resolve ambiguities favor pre-existing often do equal service escape thrust largely leave pre-1962 unproved untouched perpetuate competitive contest would, course, authority pursue category misbranding slow, cumbersome method utterly unsuited need. decline attribute self-defeating Congress. all, proposes control expert agency lieu more devices, result 'good practice hampered, consumer misled until, perhaps later, gathered necessary sustain burden proving court.'7 12 Petitioner, focusing prescription drugs,8 contends construction urged meaningless. points out, likely come subsequent being some over-the-counter (OTC) known proprietaries, up old, established ingredients. Such coming time between 1962, might regulation. so, Kefauver, main sponsor deplored absence earlier bill failure proprietaries tests He said: 13 'Effectiveness, well safety, proprietary now present requiring them, FOA (sic), I think required. matter can remedied conference legislation.'9 14 inferred subjected requirements. claimed. 15 second 'deactivated' longer effctive stated letter Director New Branch Bureau Medicine '(i)t our recollection C.V.P. class considered . ..' stopped filing supplemental regard NDAs acts sufficient bring exemption. 16 Initially, repeat elgislative history indicates Congress' regulation.10 Quite obviously, 17 Congress rejected approach safe. irrational us construe merely taken formal steps totally unrelated indicate standards. not, though differentiate grounds example, 43 related compounds. believe less another. According Solicitor General, 'state activity, inactivity, withdrawal' varied next inconsistent policy underlying patently unjust, conclude others not. intention and, accordingly, application.' 18 Affirmed. 19 BRENNAN took part consideration decision case. 20 STEWART Unlike situation CIBA Copr. v. 640, 2495, 230, withdrawing final Court's assuming jurisdiction. fact, Columbia Circuit Commissioner's decision, 151 U.S.App.D.C. 284, 466 455, remand Commission. Thus, barred proceeding Dsitrict Cf. Corp. supra. Our today meant concurrent abused discretion action outcome Weinberger Bentex Pharmaceuticals, Inc., 645, 2488, 235. below unnecessary consider failed exhaust remedies. F.2d, 226. lurks unsafe label. question, petition certiorari. 'The term means— '(1) Any (except animal feed bearing drug) recognized, among qualified scientific training experience evaluate safety thereof, except chapter Drugs 30, 1906, contained representations concerning use; '(2) drug, investigations determine conditions, investigations, conditions.' 505(c) 'Within hundred eighty days subsection, additional period may applicant, either— he finds denying specified (d) applies, give approvable. elects accept written request thirty notice, commence ninety expiration agree. thereafter conducted expedited basis Secretary's thereon issued fixed briefs.' 355(c). 'If finds, due accordance (c) giving him hearing, said pursuant (b) ., include adequate methods reasonably show proposed thereof; results conditions; (3 in, facilities controls for, manufacture, processing, packing inadequate preserve identity, strength, quality, purity; (4) application, insufficient (5) evaluated (6) based fair evaluation facts, false misleading particular; issue If, apply, approving (e) consisting including clinical involved, fairly responsibly labelling thereof.' 355(d). 108 Cong.Rec. 17366. H.R.Rep. 2464, 87th Cong., 2d Sess., p. 503(b), 353(b), human habit-forming; 'because toxicity potentiality harmful effect, use, collateral measures supervision practitioner licensed law administer drug'; limited 505. 17368. See S.Rep. 1744, pt. 2, 8; 2526, 22—23; Code Cong. & Admin.News 2884;

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