Abbott Laboratories v. Gardner
United States Supreme Court
387 U.S. 136 (1967)
- Written by Jamie Milne, JD
Facts
In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require prescription-drug manufacturers to print the common or “established” name of their drugs in large letters along with the “proprietary” or trade name on labels and other printed materials. To implement that provision, the commissioner of food and drugs adopted regulations that required manufacturers to state a drug’s established name each time the drug’s proprietary name appeared on labels, advertisements, and printed materials. Abbott Laboratories and other prescription-drug manufacturers (the manufacturers) (plaintiffs) sued John Gardner (defendant), the secretary of health, education, and welfare, alleging that the commissioner exceeded his authority by adopting regulations expanding the FDCA’s requirements. The district court granted summary judgment in favor of the manufacturers, ordering both injunctive and declaratory relief. The court of appeals reversed, finding that the FDCA prohibited judicial review of the regulations until they had been enforced and that there was no actual controversy ripe for judicial review. The United States Supreme Court granted certiorari.
Rule of Law
Issue
Holding and Reasoning (Harlan, J.)
Dissent (Fortas, J.)
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