Abbott Laboratories v. Gardner case summary
387 U.S. 136 (1967)
Constitutional Law
PROCEDURAL HISTORY: Petitioner drug manufacturers appealed a judgment from the United States Court of Appeals for the Third Circuit, which held that pre-enforcement review of rules was precluded under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., and no case or controversy existed such that no relief was available under the Administrative Procedure Act, 5 U.S.C.S. §§ 701-704, or the Declaratory Judgment Act, 28 U.S.C.S § 2201.
FACTS:
-Petitioners appealed a judgment, which dismissed their complaint that challenged regulations issued by the Commissioner of Food and Drugs. Petitioners argued that the Commissioner had exceeded his authority under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.S. § 301 et seq., by requiring labels, advertisements, and other printed matter to designate the established name of a drug every time its trade name was used.
-The dismissal was based on a holding that pre-enforcement review of rules was precluded by the Act, and because no case or controversy existed and no relief was available under the Administrative Procedure Act or the Declaratory Judgment Act.
HOLDING:
-The Supreme Court held there was no explicit statutory preclusion of pre-enforcement review and no persuasive reason to conclude Congress intended to preclude such review.
ANALYSIS:
-The Court held that the controversy was ripe for adjudication where the legal issues presented were fit for judicial resolution and the challenged provisions of the Act imposed an immediate change in petitioners' conduct, with serious penalties for noncompliance. Accordingly, judgment dismissing petitioners' complaint was reversed.
CONCLUSION: The judgment dismissing petitioners' complaint was reversed, and the case was remanded, where there was no explicit statutory preclusion of, and no persuasive reason, to conclude Congress intended to preclude pre-enforcement review, and the controversy was ripe for adjudication.
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387 U.S. 136 (1967)
Constitutional Law
PROCEDURAL HISTORY: Petitioner drug manufacturers appealed a judgment from the United States Court of Appeals for the Third Circuit, which held that pre-enforcement review of rules was precluded under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 301 et seq., and no case or controversy existed such that no relief was available under the Administrative Procedure Act, 5 U.S.C.S. §§ 701-704, or the Declaratory Judgment Act, 28 U.S.C.S § 2201.
FACTS:
-Petitioners appealed a judgment, which dismissed their complaint that challenged regulations issued by the Commissioner of Food and Drugs. Petitioners argued that the Commissioner had exceeded his authority under the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.S. § 301 et seq., by requiring labels, advertisements, and other printed matter to designate the established name of a drug every time its trade name was used.
-The dismissal was based on a holding that pre-enforcement review of rules was precluded by the Act, and because no case or controversy existed and no relief was available under the Administrative Procedure Act or the Declaratory Judgment Act.
HOLDING:
-The Supreme Court held there was no explicit statutory preclusion of pre-enforcement review and no persuasive reason to conclude Congress intended to preclude such review.
ANALYSIS:
-The Court held that the controversy was ripe for adjudication where the legal issues presented were fit for judicial resolution and the challenged provisions of the Act imposed an immediate change in petitioners' conduct, with serious penalties for noncompliance. Accordingly, judgment dismissing petitioners' complaint was reversed.
CONCLUSION: The judgment dismissing petitioners' complaint was reversed, and the case was remanded, where there was no explicit statutory preclusion of, and no persuasive reason, to conclude Congress intended to preclude pre-enforcement review, and the controversy was ripe for adjudication.
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