Usv Pharmaceutical Corporation v. Weinberger 8212 666, No. 72

CourtUnited States Supreme Court
Writing for the CourtDOUGLAS
Citation37 L.Ed.2d 244,412 U.S. 655,93 S.Ct. 2498
PartiesUSV PHARMACEUTICAL CORPORATION, Petitioner, v. Caspar W. WEINBERGER, Secretary of Health, Education, and Welfare, et al. —666
Docket NumberNo. 72
Decision Date18 June 1973

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, 1973.

Syllabus

Petitioner sells drug products containing citrus bioflavonoid, an extract from fruit skins, as a principal active ingredient. In the 1950's new drug applications (NDA's) were filed and became effective for seven products, and two were sold without any NDA. After the enactment of the 1962 amendments to the Federal Food, Drug, and Cosmetic Act, these products, together with a large number of other bioflavonoid products were examined by the Food and Drug Administration (FDA) for effectiveness. Based upon National Academy of Sciences-National Research Council (NAS—NRC) reports and its own evaluation, FDA gave notice of opportunity for hearing on its proposal to with draw approvals of NDA's for all drugs containing these compounds, alone or in combination with other drugs. Petitioner then brought suit in the District Court, seeking a declaratory judgment that its drugs are exempt from the efficacy requirements under § 107(c)(4), the so-called 'grandfather' clause. FDA refused a stay pending the judicial proceedings and went forward with its administrative action. Petitioner submitted no evidence of 'adequate and well-controlled investigations' as required by § 505(d) to support its claims of effectiveness, and FDA withdrew petitioner's NDA's. Section 107(c)(4) exempts from the effectiveness requirements any drug which on the day preceding the 1962 enactment (1) was commercially used or sold in the United States, (2) was not a 'new drug' as defined in the 1938 Act, and (3) 'was not covered by an effective application' for a new drug under the 1938 Act. The District Court found that two of the products had never been covered by effective NDA's and that, while seven had been covered, their applications had later been withdrawn by petitioner. It concluded that petitioner's drugs were not covered by effective applications, and hence were exempt from the effectiveness criterion. The Court of Appeals reversed on the merits. It held that petitioner's drugs were not entitled to an exemption, that an applicant could not withdraw an NDA once

Page 656

it became effective, that the drugs were 'covered by an effective application,' and that although 'me-too' drugs (similar drugs) of other manufacturers would be exempt, petitioner's 'me-too's' were not exempt. Held:

1. 'Any drug' is used in § 107(c)(4) in the generic sense, which means that the 'me-too's' whether the products of the same or of different manufacturers 'covered' by an 'effective' NDA are not exempt from the efficacy requirement of § 201(p). Pp. 663—665.

2. Prescription drugs on the market are subject to the 1962 efficacy requirements, for if the 1962 amendments are to be comprehensively meaningful, § 107(c)(4) cannot be read so as to provide a loophole to permit the marketing of drugs previously subject to new drug regulation without demonstrating by the new statutory standards that they have the claimed efficacy. Pp. 665 666.

3. The congressional purpose was to exempt only those drugs that never had been subject to the new drug regulation, and therefore any drug for which an NDA had once been effective does not fall within the exempt category. Pp. 666—668.

461 F.2d 223, affirmed.

Opening statement by Daniel M. Friedman, Washington, D.C., for Caspar W. Weinberger, Secretary, HEW, in all five cases.

Andrew L. Frey, Washington, D.C., for respondents.

Joel E. Hoffman, Washington, D.C., for petitioner.

Page 657

Mr. Justice DOUGLAS delivered the opinion of the Court.

Petitioner sells a line of drugs containing as a principal active ingredient, citrus bioflavonoid, which is an extract from fruit skins. The drugs are sold in capsules, syrup, and tablets. In the 1950's new drug applications (NDA's) were filed and became effective for seven of them; two, however, were sold without any NDA. In 1961 the Food and Drug Administration (FDA) advised petitioner that two of the products, when distributed under the existing labels, were not new drugs. These drugs were recommended for a wide variety of ailments from bleeding, to hypertension, to ulcerative colitis. After the 1962 amendments to the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040, as amended, 76 Stat. 780, these products, together with a large number of other bioflavonoid products, were examined by FDA for drug effectiveness. The National Academy of Sciences-National Research Council (NAS—NRC) panels reviewed them. One panel on metabolic disorders concluded that the 'use of these materials as hemostatic agents for capillary fragility is felt to be unjustifiable and not proved.' A panel on hematologic disorders found there was no proof that these products were efficacious for any medical use.

Based upon the NAS—NRC reports and its own evaluation, FDA gave notice of opportunity for hearing on its proposal to withdraw approvals of NDA's for all drugs containing these compounds, alone or in combination with other drugs. Petitioner thereupon brought suit in the District Court, asking for a declaratory judgment that its drugs are exempt from the efficacy requirements under

Page 658

s 107(c)(4). The administrative proceedings went forward, FDA refusing a stay pending the judicial proceedings. Petitioner submitted no evidence of 'adequate and well-controlled investigations' as required by § 505(d) of the Act, 21 U.S.C. § 355(d), to support its claims of effectiveness. The Commissioner made findings and withdrew petitioner's NDA's.

In the District Court petitioner contended that the drugs were exempt from regulation by reason of § 107(c)(4) of the 1962 amendments, which provides:

'In the case of any drug which, on the day immediately preceding the enactment date, (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force, and (C) was not covered by an effective application under section 505 of that Act, the amendments to section 201(p) made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.'

The District Court found that two of the products had never been covered by effective NDA's and that, while seven had been covered, their applications had later been withdrawn by petitioner. It found that the products were 'safe' for use in treating abnormal capillary permeability and fragility. It therefore concluded that, as of the day the 1962 amendments became effective, petitioner's products were not new drugs, were not covered by effective applications within the meaning of § 107(c)(4), and hence were exempt from the effectiveness criterion added to the regulatory provisions of §§ 505 and 201(p) 21 U.S.C. §§ 355 and 321(p). In so ruling,

Page 659

the District Court necessarily determined that it, and not FDA, had jurisdiction to decide exemption questions.

The Court of Appeals agreed that the District Court alone had jurisdiction but reversed on the merits.1 461 F.2d 223. It held that none of petitioner's bioflavonoid drugs were entitled to exemption under § 107(c)(4). As to the seven for which NDA's had been filed, it held that an applicant could not withdraw an NDA once it became effective. It concluded that even if the drugs were generally recognized as safe on the day preceding the effective date of the 1962 Act, they were 'covered by an effective application' within the meaning of § 107(c)(4)(C) and thus were not exempt from the 1962 amendments. As to the 'me-too' drugs, those specific drugs for which petitioner had not filed an NDA, the Court of Appeals held that although the 'me-too's' of other manufacturers competing with petitioner's bioflavonoids would be exempt, petitioner's 'me-too's' were not exempt because the NDA's covering the pioneer drugs prepared by petitioner covered all of its products similar in formula and labeling. While the Government agrees that peti-

Page 660

tioner's 'me-too' products should be accorded the same treatment as the 'me-too's' of other manufacturers who had never filed NDA's, the parties are at odds on other issues.2

The resolution of the questions presented turns essentially on the meaning of § 107(c)(4), quoted above. But as background for the problem of construction, references should be made to other 1962 amendments. Section 201(p)3 was amended to redefine a 'new drug' as one not generally recognized by experts as both safe and effective for use under the conditions prescribed or one that has not been used to a material extent and for a material time. Section 505(a) was amended to require affirmative approval of FDA, where previously it

Page 661

had provided that an NDA would automatically become effective unless a contrary order were issued.4 Section 505(d)5 was amended to require disapproval of an appli-

Page 662

cation if there is 'a lack of substantial evidence that the drug will have the effect it purports or...

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33 practice notes
  • US v. Premo Pharmaceutical Laboratories, Civ. No. 80-699.
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • January 20, 1981
    ...v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973); USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244 (1973); United States v. Articles of Drug (Lannett), 585 F.2d 575 (3d Cir. 1978); Hoffmann-LaRoche, Inc. v. Weinberger......
  • Cutler v. Kennedy, Civ. A. No. 77-0734.
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 16, 1979
    ...230; Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235; and USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244. For a thorough discussion of the significance of the Drug Amendments of 1962 see Note, Drug Efficacy and the......
  • National Ass'n of Pharmaceutical Mfrs. v. Food and Drug Administration, No. 204
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • January 5, 1981
    ...230; Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235; and USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244. Although Professor Kenneth Culp Davis cites these, along with the passage just quoted from Abbott Laboratori......
  • National Nutritional Foods Ass'n v. Weinberger, No. 228
    • United States
    • U.S. Court of Appeals — Second Circuit
    • February 3, 1975
    ...Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973); USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 Page 697 L.Ed.2d 244 (1973). Those decisions interpreted § 701(a) as giving FDA the power to promulgate substantive regulat......
  • Request a trial to view additional results
31 cases
  • US v. Premo Pharmaceutical Laboratories, Civ. No. 80-699.
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • January 20, 1981
    ...v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973); USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244 (1973); United States v. Articles of Drug (Lannett), 585 F.2d 575 (3d Cir. 1978); Hoffmann-LaRoche, Inc. v. Weinberger......
  • Cutler v. Kennedy, Civ. A. No. 77-0734.
    • United States
    • United States District Courts. United States District Court (Columbia)
    • July 16, 1979
    ...230; Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235; and USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244. For a thorough discussion of the significance of the Drug Amendments of 1962 see Note, Drug Efficacy and the......
  • National Ass'n of Pharmaceutical Mfrs. v. Food and Drug Administration, No. 204
    • United States
    • United States Courts of Appeals. United States Court of Appeals (2nd Circuit)
    • January 5, 1981
    ...230; Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235; and USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed.2d 244. Although Professor Kenneth Culp Davis cites these, along with the passage just quoted from Abbott Laboratori......
  • National Nutritional Foods Ass'n v. Weinberger, No. 228
    • United States
    • U.S. Court of Appeals — Second Circuit
    • February 3, 1975
    ...Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973); USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 Page 697 L.Ed.2d 244 (1973). Those decisions interpreted § 701(a) as giving FDA the power to promulgate substantive regulat......
  • Request a trial to view additional results

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