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

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U.S. Supreme Court

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

Abbott Laboratories v. Gardner

No. 39

Argued January 16, 1967

Decided May 22, 1967

387 U.S. 136


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.


1. Preenforcement review of these regulations is not prohibited by the Federal Food, Drug, and Cosmetic Act. Pp. 387 U. S. 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, 369 U. S. 379-380. Pp. 387 U. S. 139-141.

(b) The statutory scheme in the food and drug area does not exclude pre-enforcement judicial review. Pp. 387 U. S. 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. 387 U. S. 144.

Page 387 U. S. 137

(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. 387 U. S. 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. 387 U. S. 146-148.

2. This case presents a controversy "ripe" for judicial resolution. Pp. 387 U. S. 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. 387 U. S. 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. 387 U. S. 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. 387 U. S. 154-155.

352 F.2d 286, reversed and remanded.

Primary Holding

The ripeness doctrine permits judicial review of a regulation if there is a purely legal issue involved and a direct, immediate impact on the party seeking to challenge the regulation.


An amendment to the Food, Drug, and Cosmetic Act required manufacturers to list the established, government-issued names of drugs on their labels. Formerly, manufacturers had used their proprietary names to market the drugs. The amendment was intended to make prescribing doctors aware that the same drugs that were being marketed under proprietary names were also available under established names for a lower cost. The drug manufacturers and their trade association argued that the FDA Commissioner had exceeded his statutory authority in making these regulations. They sought declaratory relief to that effect and an injunction against the enforcement of the regulations.



  • John Marshall Harlan II (Author)
  • Earl Warren
  • Hugo Lafayette Black
  • William Orville Douglas
  • Tom C. Clark
  • William Joseph Brennan, Jr.
  • Potter Stewart
  • Byron Raymond White
  • Abe Fortas

The central issue in the case is whether the Commissioner properly interpreted the law giving rise to the regulations, which is a purely legal issue. Since the regulations provide an authoritative interpretation of a law that has a substantial effect on the regular business of the manufacturers, there is a direct and immediate impact. The courts should be allowed to resolve the dispute so that the manufacturers are not faced with choosing between the cost of compliance and the risk of criminal prosecution for violating the regulations.

Case Commentary

The manufacturers succeeded in framing their issue in such a way that it was concrete enough for an Article III court to rule on it. They focused on whether the Commissioner had overreached his statutory authority rather than a more specific challenge.

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