Abbott Laboratories v. Gardner, No. 39

CourtUnited States Supreme Court
Writing for the CourtHARLAN
PartiesABBOTT LABORATORIES et al., Petitioners, v. John W. GARDNER, Secretary of Health, Education, and Welfare et al
Docket NumberNo. 39
Decision Date22 May 1967

387 U.S. 136
87 S.Ct. 1507
18 L.Ed.2d 681
ABBOTT LABORATORIES et al., Petitioners,

v.

John W. GARDNER, Secretary of Health, Education, and Welfare et al.

No. 39.
Argued Jan. 16, 1967.
Decided May 22, 1967.

Page 137

Gerhard A. Gesell, Washington, D.C., for petitioners.

Nathan Lewin, Washington, D.C., for respondents.

Mr. Justice HARLAN delivered the opinion of the Court.

In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act, (52 Stat. 1040, as amended by the Drug Amendments of 1962, 76 Stat. 780, 21 U.S.C. § 301 et seq.), to require manufacturers of prescription drugs to print the 'established name' of the drug 'prominently

Page 138

and in type at least half as large as that used thereon for any proprietary name or designation for such drug,' on labels and other printed material, § 502(e)(1)(B), 21 U.S.C. § 352(e)(1)(B). The 'established name' is one designated by the Secretary of Health, Education, and Welfare pursuant to § 502(e)(2) of the Act, 21 U.S.C. § 352(e)(2); the 'proprietary name' is usually a trade name under which a particular drug is marketed. The underlying purpose of the 1962 amendment was to bring to the attention of doctors and patients the fact that many of the drugs sold under familiar trade names are actually identical to drugs sold under their 'established' or less familiar trade names at significantly lower prices. The Commissioner of Food and Drugs, exercising authority delegated to him by the Secretary, 22 Fed.Reg. 1051, 25 Fed.Reg. 8625, published proposed regulations designed to implement the statute, 28 Fed.Reg. 1448. After inviting and considering comments submitted by interested parties the Commissioner promulgated the following regulation for the 'efficient enforcement' of the Act, § 701(a), 21 U.S.C. § 371(a):

'If the label or labeling of a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding to such proprietary name or designation, shall accompany each appearance of such proprietary name or designation.' 21 CFR § 1.104(g)(1).

A similar rule was made applicable to advertisements for prescription drugs, 21 CFR § 1.105(b)(1).

The present action was brought by a group of 37 individual drug manufacturers and by the Pharmaceutical Manufacturers Association, of which all the petitioner companies are members, and which includes manufacturers of more than 90% of the Nation's supply of pre-

Page 139

scription drugs. They challenged the regulations on the ground that the Commissioner exceeded his authority under the statute by promulgating an order requiring labels, advertisements, and other printed matter relating to prescription drugs to designate the established name of the particular drug involved every time its trade name is used anywhere in such material.

The District Court, on cross motions for summary judgment, granted the declaratory and injunctive relief sought, finding that the statute did not sweep so broadly as to permit the Commissioner's 'every time' interpretation. 228 F.Supp. 855. The Court of Appeals for the Third Circuit reversed without reaching the merits of the case. 352 F.2d 286. It held first that under the statutory scheme provided by the Federal Food, Drug, and Cosmetic Act pre-enforcement1 review of these regulations was unauthorized and therefore beyond the jurisdiction of the District Court. Second, the Court of Appeals held that no 'actual case or controversy' existed and, for that reason, that no relief under the Administrative Procedure Act, 5 U.S.C. §§ 701—704 (1964 ed., Supp. II), or under the Declaratory Judgment Act, 28 U.S.C. § 2201, was in any event available. Because of the general importance of the question, and the apparent conflict with the decision of the Court of Appeals for the Second Circuit in Toilet Goods Assn. v. Gardner, 360 F.2d 677, which we also review today, 387 U.S. 158, 87 S.Ct. 1520, 18 L.Ed.2d 697, we granted certiorari. 383 U.S. 924, 86 S.Ct. 928, 15 L.Ed.2d 844.

I.

The first question we consider is whether Congress by the Federal Food, Drug, and Cosmetic Act intended to forbid pre-enforcement review of this sort of regulation

Page 140

promulgated by the Commissioner. The question is phrased in terms of 'prohibition' rather than 'authorization' because a survey of our cases shows that judicial review of a final agency action by an aggrieved person will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress. Board of Governors v. Agnew, 329 U.S. 441, 67 S.Ct. 411, 91 L.Ed. 408; Heikkila v. Barber, 345 U.S. 229, 73 S.Ct. 603, 97 L.Ed. 972 B rownell v. We Shung, 352 U.S. 180, 77 S.Ct. 252, 1 L.Ed.2d 225; Harmon v. Brucker, 355 U.S. 579, 78 S.Ct. 433, 2 L.Ed.2d 503; Leedom v. Kyne, 358 U.S. 184, 79 S.Ct. 180, 3 L.Ed.2d 210; Rusk v. Cort, 369 U.S. 367, 82 S.Ct. 787, 7 L.Ed.2d 809. Early cases in which this type of judicial review was entertained, e.g., Shields v. Utah Idaho Central R. Co., 305 U.S. 177, 59 S.Ct. 160, 83 L.Ed. 111; Stark v. Wickard, 321 U.S. 288, 64 S.Ct. 559, 88 L.Ed. 733, have been reinforced by the enactment of the Administrative Procedure Act, which embodies the basic presumption of judicial review to one 'suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute,' 5 U.S.C. § 702, so long as no statute precludes such relief or the action is not one committed by law to agency discretion, 5 U.S.C. § 701(a). The Administrative Procedure Act provides specifically not only for review of '(a)gency action made reviewable by statute' but also for review of 'final agency action for which there is no other adequate remedy in a court,' 5 U.S.C. § 704. The legislative material elucidating that seminal act manifests a congressional intention that it cover a broad spectrum of administrative actions,2 and this Court has echoed that theme by noting that the Ad-

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ministrative Procedure Act's 'generous review provisions' must be given a 'hospitable' interpretation. Shaughnessy v. Pedreiro, 349 U.S. 48, 51, 75 S.Ct. 591, 594, 99 L.Ed. 868; see United States v. Interstate Commerce Comm'n, 337 U.S. 426, 433—435, 69 S.Ct. 1410, 1414—1415, 93 L.Ed. 1451; Brownell v. We Shung, supra; Heikkila v. Barber, supra. Again in Rusk v. Cort, supra, 369 U.S. at 379—380, 82 S.Ct. at 794, the Court held that only upon a showing of 'clear and convincing evidence' of a contrary legislative intent should the courts restrict access to judicial review. See also, Jaffe, Judicial Control of Administrative Action 336—359 (1965).

Given this standard, we are wholly unpersuaded that the statutory scheme in the food and drug area excludes this type of action. The Government relies on no explicit statutory authority for its argument that pre-enforcement review is unavailable, but insists instead that because the statute includes a specific procedure for such review of certain enumerated kinds of regulations,3 not encompassing those of the kind involved here, other types were necessarily meant to be excluded from any pre-enforcement review. The issue, however, is not so readily resolved; we must go further and inquire whether in the context of the entire legislative scheme the existence of that circumscribed remedy evinces a congressional purpose to bar agency action not within its purview from judicial review. As a leading authority in this field has noted, 'The mere fact that some acts are made reviewable should not suffice to support an implication of exclusion as to others. The right to review is too important to be excluded on such slender and indeterminate evidence of legislative intent.' Jaffe, supra, at 357.

Page 142

In this case the Government has not demonstrated such a purpose; indeed, a study of the legislative history shows rather conlu sively that the specific review provisions were designed to give an additional remedy and not to cut down more traditional channels of review. At the time the Food, Drug, and Cosmetic Act was under consideration, in the late 1930's, the Administrative Procedure Act had not yet been enacted,4 the Declaratory Judgment Act was in its infancy,5 and the scope of judicial review of administrative decisions under the equity power was unclear.6 It was these factors that led to the form the statute ultimately took. There is no evidence at all that members of Congress meant to preclude traditional avenues of judicial relief. Indeed, throughout the consideration of the various bills submitted to deal with this issue, it was recognized that 'There is always an appropriate remedy in equity in cases where an administrative officer has exceeded his authority and there is no adequate remedy of law, * * * (and that) protection is given by the so-called Declaratory Judgments Act * * *.' H.R.Rep. No. 2755, 74th Cong., 2d Sess., 8. It was specifically brought to the attention of Congress that such methods had in fact been used in the food and drug area,7 and the Department of Justice, in opposing the enactment of the special-review procedures of § 701, submitted a memorandum which was read on the floor of the House

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stating: 'As a matter of fact, the entire subsection is really unnecessary, because even without any express provision in the bill for court review, any citizen aggrieved by any order of the Secretary, who contends that the order is invalid, may test the legality of the order by bringing an injunction suit against the Secretary, or the head of the Bureau, under the general equity powers of the court.' 83 Cong.Rec. 7892 (1938).

The main issue in contention was whether these methods of review were satisfactory. Compare the majority and minority reports on the review provisions, H.R.Rep.No.2139, 75th Cong., 3d Sess. (1938), both of which acknowledged that traditional judicial remedies were available, but disagreed as to the...

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5235 practice notes
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    • United States District Courts. United States District Court (Columbia)
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    ...and convincing evidence’ necessary to overcome the presumption of judicial review." See id. at 291 (quoting Abbott Labs. v. Gardner , 387 U.S. 136, 141, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967) ). It thus held that the FRA does not "preclude judicial review of the adequacy of [an agency's] reco......
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    ...of American Medical Colleges v. United States , 217 F.3d 770, 780 (9th Cir. 2000). For example, in Abbott Laboratories v. Gardner , 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), the Supreme Court concluded that an interpretive rule was final agency action based on "direct effect on th......
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    ...Administrative Procedure Act's 'generous review provisions' must be given a 'hospitable' interpretation." Abbott Laboratories v. Gardner, 387 U.S. 136, 140-141, 87 S.Ct. 1507, 1511, 18 L.Ed.2d 681 (1967) (footnote omitted). A restrictive interpretation of § 704 would unquestionably, in the ......
  • City of New York v. US Dept. of Commerce, No. 88 CV 3474.
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    ...sense." Continental Air Lines, Inc. v. CAB, 522 F.2d 107, 124 (D.C.Cir.1974) (en banc) (citing Abbott Laboratories, Inc. v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967)). More specifically, however, a two-part test governs the issue because "ripeness turns on `the fitness of ......
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5226 cases
  • Citizens for Responsibility & Ethics in Wash. v. U.S. Dep't of Homeland Sec., Civil Action No. 18-2473 (RC)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • November 30, 2020
    ...and convincing evidence’ necessary to overcome the presumption of judicial review." See id. at 291 (quoting Abbott Labs. v. Gardner , 387 U.S. 136, 141, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967) ). It thus held that the FRA does not "preclude judicial review of the adequacy of [an agency's] reco......
  • Inst. for Fisheries Res. v. Hahn, Case No. 16-cv-01574-VC
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • December 19, 2019
    ...of American Medical Colleges v. United States , 217 F.3d 770, 780 (9th Cir. 2000). For example, in Abbott Laboratories v. Gardner , 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), the Supreme Court concluded that an interpretive rule was final agency action based on "direct effect on th......
  • Bowen v. Massachusetts Massachusetts v. Bowen, Nos. 87-712
    • United States
    • United States Supreme Court
    • June 29, 1988
    ...Administrative Procedure Act's 'generous review provisions' must be given a 'hospitable' interpretation." Abbott Laboratories v. Gardner, 387 U.S. 136, 140-141, 87 S.Ct. 1507, 1511, 18 L.Ed.2d 681 (1967) (footnote omitted). A restrictive interpretation of § 704 would unquestionably, in the ......
  • City of New York v. US Dept. of Commerce, No. 88 CV 3474.
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • June 7, 1990
    ...sense." Continental Air Lines, Inc. v. CAB, 522 F.2d 107, 124 (D.C.Cir.1974) (en banc) (citing Abbott Laboratories, Inc. v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967)). More specifically, however, a two-part test governs the issue because "ripeness turns on `the fitness of ......
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9 books & journal articles
  • Table of authorities
    • United States
    • Introduction to environmental law: cases and materials on water pollution control - 2d Edition
    • July 23, 2017
    ...OF FEDERAL AND STATE CASES FEDERAL CASES Abbott Labs. v. Gardner, 387 U.S. 136 (1967) ....................................................132, 151 In re Acushnet River & New Bedford Harbor: Proceedings re Alleged PCB Pollution, 712 F. Supp. 1010, 19 ELR 21206 (D. Mass. 1989) .....................
  • International Climate Action Without Congress: Does §115 of the Clean Air Act Provide Sufficient Authority?
    • United States
    • Environmental Law Reporter Nbr. 44-7, July 2014
    • July 1, 2014
    ...159. Her Majesty the Queen , supra note 147, 912 F.2d at 1530-31. 160. Id. at 1531. 161. Id. at 1532-33 (citing Abbot Labs. v. Gardner, 387 U.S. 136, 149 (1967)). 162. Id. at 1533. 163. 467 U.S. 837, 14 ELR 20507 (1984). 164. Her Majesty the Queen , supra note 147, 912 F.2d at 1533 (citing ......
  • Introduction to the CWA and the administrative process
    • United States
    • Introduction to environmental law: cases and materials on water pollution control - 2d Edition
    • July 23, 2017
    ...See Block v. Community 132 Water Pollution Control, 2d Edition Nutrition Inst. , 467 U.S. 340 (1984); see also Abbott Labs. v. Gardner , 387 U.S. 136 (1967). Enabling statutes may also limit the timing of review. In addition to statutory limitations on a court’s power to review agency decis......
  • Permits and state permit programs
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    ...are not inal actions subject to judicial review under the doctrine of administrative inality discussed in Abbott Laboratories v. Gardner , 387 U.S. 136 (1967). he efect of the two sections of the Act, 33 U.S.C. §§ 1342(d)(4) and 1369(b), is to place Champion out of court for either of two r......
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