Does the Federal Food, Drug, and Cosmetic Act preclude pre-enforcement judicial review of a regulation requiring the established drug name to accompany the proprietary name every time it appears, and is a challenge to that regulation ripe for review under the Administrative Procedure Act and the Declaratory Judgment Act?

In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act to require manufacturers of prescription drugs to print the drug's "established name" prominently, in type at least half as large as the proprietary name, on labels and other printed material. The purpose was to alert doctors and patients that many drugs sold under familiar trade names are identical to lower-priced drugs sold under their established names. The Commissioner of Food and Drugs, acting under authority delegated by the Secretary of Health, Education, and Welfare, promulgated a regulation after notice and comment requiring the established name to accompany the proprietary name every time the proprietary name appears on labels, labeling, and advertisements for prescription drugs. The regulation was effective on publication, and the Government's counsel represented that immediate compliance was expected. Thirty-seven drug manufacturers and the Pharmaceutical Manufacturers Association, whose members make more than 90% of the Nation's prescription drugs, challenged the regulation as exceeding the Commissioner's statutory authority. Compliance would require changing all labels, advertisements, and promotional materials, destroying printed stocks, and investing in new printing. Noncompliance risked criminal and civil penalties for distributing misbranded drugs.

The manufacturers and the association filed a declaratory and injunctive action in the United States District Court for the District of Delaware. On cross motions for summary judgment, the District Court granted the relief sought, finding that the statute did not authorize the Commissioner's "every time" interpretation (228 F. Supp. 855). The Court of Appeals for the Third Circuit reversed without reaching the merits, holding that pre-enforcement review was unauthorized under the statutory scheme, so the District Court lacked jurisdiction, and that no actual case or controversy existed for relief under the Administrative Procedure Act or the Declaratory Judgment Act (352 F. 2d 286). The Supreme Court granted certiorari because of the question's general importance and an apparent conflict with the Second Circuit's decision in Toilet Goods Assn. v. Gardner, 360 F. 2d 677.

(Harlan, J.)

Yes. Nothing in the Act precludes pre-enforcement review, and the challenge is ripe.

Judicial review of final agency action by an aggrieved person is not cut off absent persuasive evidence that Congress intended to bar it. The Administrative Procedure Act, 5 U.S.C. §§ 701-704, embodies a presumption of judicial review, and only "clear and convincing evidence" of contrary legislative intent restricts access. Rusk v. Cort, 369 U.S. 367 (1962). The Government argued that because § 701(f) provides special direct review for certain enumerated regulations, other regulations were impliedly excluded from pre-enforcement review. The mere fact that some actions are made reviewable does not support an implied exclusion of others. The legislative history shows that § 701(f) was meant to supplement traditional equity and declaratory remedies by giving a more generous substantial-evidence review of technical factual determinations and broader venue. Section 701(f)(6) expressly saves other remedies provided by law and must be read at face value. Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950), is inapposite because it involved an interim probable-cause finding, not a promulgated industry-wide regulation.

On ripeness, the Court weighs the fitness of the issues for judicial decision and the hardship to the parties of withholding review. The issue is purely legal, since the parties treat it as a question of congressional intent and the Government made no factual defense of the regulation. The regulation is final agency action: it was promulgated formally, took effect on publication, and compliance was expected. Columbia Broadcasting System v. United States, 316 U.S. 407 (1942); Frozen Food Express v. United States, 351 U.S. 40 (1956); United States v. Storer Broadcasting Co., 351 U.S. 192 (1956). That the Attorney General must authorize enforcement does not change this result.

The hardship is direct and immediate. Petitioners face a dilemma: incur heavy compliance costs or risk serious criminal and civil penalties. Where the legal issue is fit for resolution and a regulation requires an immediate and significant change in conduct under threat of serious penalties, review must be permitted absent a statutory bar. The Government's concern about multiple suits is answered by venue transfer, stays, equitable defenses such as laches, and the fact that suit does not itself stay the regulation. The judgment is reversed and remanded to the Third Circuit to review the merits.