Abbott Labs. v. Gardner

Supreme Court of United States
387 U.S. 136 (1967)

ELI5:

Rule of Law:

Pre-enforcement judicial review of a final agency regulation is presumptively available unless there is clear and convincing evidence of a contrary legislative intent. A challenge to such a regulation is ripe for adjudication if it satisfies a two-part test evaluating the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration.

Facts:

In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require that a drug's 'established name' (generic name) be printed on labels and promotional materials in type at least half as large as its 'proprietary name' (brand name).
The Commissioner of Food and Drugs promulgated a regulation to implement this amendment.
The regulation required that the established name accompany the proprietary name 'each appearance' it made on any labels, advertisements, or other printed material.
Abbott Laboratories and a coalition of other drug manufacturers (Petitioners) contended this 'every time' requirement exceeded the authority granted by the statute.
To comply with the regulation, the drug manufacturers would need to immediately change all labels and promotional materials, destroy existing printed stocks, and invest in new supplies, incurring substantial financial costs.
Failure to comply with the regulation would expose the manufacturers to significant civil and criminal penalties for the distribution of 'misbranded' drugs.

Procedural Posture:

Abbott Laboratories and 36 other drug manufacturers (plaintiffs) sued the Commissioner of Food and Drugs in the U.S. District Court for the District of Delaware, seeking a declaratory judgment and an injunction.
The District Court (trial court), ruling on cross-motions for summary judgment, found in favor of the drug manufacturers, holding that the regulation exceeded the Commissioner's statutory authority.
The Commissioner (defendant-appellant) appealed to the U.S. Court of Appeals for the Third Circuit.
The Court of Appeals (intermediate appellate court) reversed, holding that the statutory scheme of the FDCA precluded pre-enforcement review and that the case was not ripe for adjudication.
The drug manufacturers (petitioners) successfully petitioned the U.S. Supreme Court for a writ of certiorari.

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Issue:

Does the Federal Food, Drug, and Cosmetic Act preclude pre-enforcement judicial review of a regulation promulgated by the Commissioner, and if not, is the legal challenge to the regulation ripe for review when compliance would require immediate and costly changes to business practices and non-compliance carries the risk of serious civil and criminal penalties?

Opinions:

Majority - Mr. Justice Harlan

No, the Act does not preclude pre-enforcement review, and yes, the challenge is ripe for judicial review. The Court held there is a strong presumption that final agency action is subject to judicial review, which can only be overcome by clear and convincing evidence of legislative intent to restrict it. The FDCA contains no such intent; its specific review provisions were meant to supplement, not supplant, traditional remedies, as confirmed by the Act's saving clause. The challenge is ripe for review because it satisfies a two-part test. First, the issue is fit for judicial decision because it presents a purely legal question of statutory construction, and the regulation constitutes a 'final agency action.' Second, withholding review would cause significant hardship to the Petitioners, as the regulation places them in a dilemma: either incur the high costs of immediate compliance with a potentially invalid rule or risk serious criminal and civil sanctions for non-compliance. This is the precise type of situation the Declaratory Judgment Act was designed to ameliorate.

Analysis:

This case is a landmark in administrative law as it establishes the modern framework for the ripeness doctrine and strongly affirms the availability of pre-enforcement review of agency regulations. The two-part 'fitness and hardship' test created here provides a clear standard for courts to determine when a challenge to an agency rule is judicially cognizable. The decision empowers regulated parties to challenge the legality of a final agency rule before the government initiates an enforcement action, preventing them from being forced into the difficult choice between costly compliance and the risk of severe penalties for non-compliance. This has had a profound impact on administrative procedure, making agencies more accountable by allowing for more immediate judicial oversight of their rulemaking authority.

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