Abbott Laboratories v. Gardner

387 U.S. 136 (1967)

Quick Summary

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Abbott Laboratories and other drug companies (plaintiffs) challenged regulations issued by Gardner, the Health Commissioner (defendant), regarding drug labeling requirements. The dispute centered around whether these regulations exceeded statutory authority by mandating the established name’s use alongside trade names on all drug-related printed materials.

The Supreme Court reviewed whether such regulations could be subject to pre-enforcement judicial review. The Court concluded that judicial review was permissible, as Congress did not intend to exclude such actions from court consideration, and remanded the case for further proceedings.

Facts of the Case

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In 1962, the U.S. Congress updated the Federal Food, Drug, and Cosmetic Act, mandating that prescription drug producers prominently print both the common and trade names on drug packaging. Abbott Laboratories and thirty-seven other drug companies (plaintiffs) took legal action against Gardner (defendant), the Commissioner of Health, Education, and Welfare, asserting that the Commissioner’s regulations overstepped his legal bounds.

The plaintiffs argued that the regulations compelled them to use the established name of a drug every time its trade name appeared on labels and promotional materials, which they believed was not required by the statute.

The plaintiffs were initially successful in obtaining a court order to prevent enforcement of these regulations, but the Court of Appeals overturned this decision. The case eventually escalated to the United States Supreme Court for a definitive resolution.

Procedural Posture and History

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  1. Plaintiffs filed suit alleging overreach by the Commissioner in regulation.
  2. Plaintiffs obtained injunctive and declaratory relief in district court.
  3. Court of Appeals reversed the district court’s decision.
  4. United States Supreme Court granted certiorari to review the case.

I.R.A.C. Format


Issue Icon

Whether the Commissioner of Food and Drugs exceeded his statutory authority by requiring prescription drugs to display the established name every time the trade name is used on labels and promotional materials.

Rule of Law

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Judicial review of a final agency action will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress. The Administrative Procedure Act provides for review of final agency actions unless precluded by statute or committed by law to agency discretion.

Reasoning and Analysis

Reasoning Icon

The Supreme Court considered if Congress intended to forbid pre-enforcement review of regulations such as those promulgated by the Commissioner. The Court found no evidence in the statute or its legislative history indicating an intent to preclude such judicial review. Instead, they determined that specific provisions for review in the Act were meant to supplement rather than replace other forms of legal remedy.

Additionally, the Court analyzed whether the issues were appropriate for judicial resolution at this stage, considering both the fitness of the issues for decision and any hardship deferring court consideration might impose on the parties. The Court found that the purely legal question of statutory interpretation presented by this case was fit for judicial resolution and that immediate compliance with the regulation would impose significant hardship on the plaintiffs.


Conclusion Icon

The Supreme Court held that pre-enforcement review of these regulations was authorized, and no statute precluded such relief. The case was remanded for further proceedings consistent with this opinion.

Key Takeaways

Takeaway Icon
  1. The Supreme Court will allow judicial review of final agency actions unless Congress explicitly indicates otherwise.
  2. Pre-enforcement review of agency regulations is permissible under the Administrative Procedure Act if no statutory prohibition exists and if immediate hardship to parties is demonstrated.
  3. The Supreme Court’s decision affirmed that specific provisions for judicial review in a statute are intended to provide additional remedies rather than to limit or replace existing legal recourse.

Relevant FAQs of this case

What constitutes final agency action for the purposes of judicial review under the Administrative Procedure Act?

Final agency action is a decision by an administrative agency that marks the culmination of the agency’s decision-making process, and by which rights or obligations have been determined, or from which legal consequences will flow. It must be definitive and have a direct impact on the parties.

  • For example: The EPA issuing a compliance order to a manufacturing plant to reduce emissions, after its deliberative process, is considered final agency action.

How does hardship factor into a court's decision to allow pre-enforcement review of an agency's regulations?

Hardship is a consideration for pre-enforcement review when compliance with the regulation would cause significant costs or burdens, potentially irreparable harm, or infringe upon rights requiring immediate judicial intervention.

  • For example: A small business facing immediate closure due to costly compliance with new OSHA regulations could demonstrate sufficient hardship for pre-enforcement review.

What role does statutory interpretation play in determining the validity of an agency's regulations?

Statutory interpretation involves analyzing legislation to understand the powers granted to an agency. Courts assess if regulations align with the intent of Congress as articulated in the statute, verifying that regulations are within the scope of authority provided.

  • For example: If a statute limits data collection by an agency but the agency imposes expansive monitoring regulations, courts would examine if such regulations are supported by the statutory language.


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