387 U.S. 136 (1967), 39, Abbott Laboratories v. Gardner

Docket Nº:No. 39
Citation:387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681
Party Name:Abbott Laboratories v. Gardner
Case Date:May 22, 1967
Court:United States Supreme Court
 
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Page 136

387 U.S. 136 (1967)

87 S.Ct. 1507, 18 L.Ed.2d 681

Abbott Laboratories

v.

Gardner

No. 39

United States Supreme Court

May 22, 1967

Argued January 16, 1967

CERTIORARI TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

Syllabus

The Commissioner of Food and Drugs, exercising authority delegated to him by the Secretary of Health, Education, and Welfare, issued regulations requiring that labels and advertisements for prescription drugs which bear proprietary names for the drugs or the ingredients carry the corresponding "established name" (designated by the Secretary) every time the proprietary or trade name is used. These regulations were designed to implement the 1962 amendment to § 502(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Petitioners, drug manufacturers and a manufacturers' association, challenged the regulations on the ground that the Commissioner exceeded his authority under the statute. The District Court granted the declaratory and injunctive relief sought, finding that the scope of the statute was not as broad as that of the regulations. The Court of Appeals reversed without reaching the merits, holding that pre-enforcement review of the regulations was unauthorized and beyond the jurisdiction of the District Court, and that no "actual case or controversy" existed.

Held:

1. Preenforcement review of these regulations is not prohibited by the Federal Food, Drug, and Cosmetic Act. Pp. 139-148.

(a) The courts should restrict access to judicial review only upon a showing of "clear and convincing evidence" of a contrary legislative intent. Rusk v. Cort, 369 U.S. 367, 379-380. Pp. 139-141.

(b) The statutory scheme in the food and drug area does not exclude pre-enforcement judicial review. Pp. 141-144.

(c) The special review provisions of § 701(f) of the Act, applying to regulations embodying technical factual determinations, were simply intended to assure adequate judicial review of such agency decisions, and manifest no congressional purpose to eliminate review of other kinds of agency action. P. 144.

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(d) The saving clause of § 701(f)(6), which states that the "remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law," does not foreclose pre-enforcement judicial review, and should be read in harmony with the policy favoring judicial review expressed in the Administrative Procedure Act and court decisions. Pp. 144-146.

(e) Ewing v. Mytinger & Casselberry Inc., 339 U.S. 594, which did not concern the promulgation of a self-operative industry-wide regulation, distinguished. Pp. 146-148.

2. This case presents a controversy "ripe" for judicial resolution. Pp. 148-156.

(a) The issue of statutory construction is purely legal, and the regulations are "final agency action" within § 10 of the Administrative Procedure Act. Columbia Broadcasting System v. United States, 316 U.S. 407, and similar cases followed. Pp. 149-152.

(b) The impact of the regulations upon petitioners is sufficiently direct and immediate as to render the issue appropriate for judicial review at this stage. Pp. 152-154.

(c) Here, the pre-enforcement challenge by nearly all prescription drug manufacturers is not calculated to delay or impede effective enforcement of the Federal Food, Drug, and Cosmetic Act. Pp. 154-155.

352 F.2d 286, reversed and remanded.

HARLAN, J., lead opinion

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

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and in type at least half as large as that used thereon for any proprietary name or designation for such [87 S.Ct. 1510] 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 prescription

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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, post, p. 158, we granted certiorari. 383 U.S. 924.

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

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promulgated by the Commissioner. The question is phrased in terms of "prohibition", rather than "authorization," [87 S.Ct. 1511] 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; Heikkila v. Barber, 345 U.S. 229; Brownell v. Tom We Shung, 352 U.S. 180; Harmon v. Brucker, 355 U.S. 579; Leedom v. Kyne, 358 U.S. 184; Rusk v. Cort, 369 U.S. 367. Early cases in which this type of judicial review was entertained, e.g., Shields v. Utah Idaho Central R. Co., 305 U.S. 177; Stark v. Wickard, 321 U.S. 288, 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 Administrative

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Procedure Act's "generous review provisions" must be given a "hospitable" interpretation. Shaughnessy v. Pedreiro, 349 U.S. 48, 51; see United States v. Interstate Commerce Comm'n, 337 U.S. 426, 433-435; Brownell v. Tom We Shung, supra; Heikkila v. Barber, supra. Again in Rusk v. Cort, supra, at 379-380, 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...

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