200 word response 1 response/intext citation
Due 2/2/2025
Sinclair
Explain the relevancy to Administrative Law—ie. why does this case relate to our study of Administrative Law—- why is it important for us to know this particular case precedent in this field of study?
1. The name of the case is Abbott Laboratories v. Gardner. The case was brought to Federal Supreme Court and was decided on May 22, 1967.
2. In 1962 Congress amended the Federal Food, Drug and Cosmetic Act to require prescription drug manufacturers to print the established name” of a drug “prominently and half as big as the proprietary name or designation of the drug (Mathews, 2024). This is so that doctors and consumers are aware of a cheaper alternative to a drug which is often sold by the established name rather than the proprietary name (brand/trade name) (Mathews, 2024). A similar rule was also made applicable to advertisements for prescription drugs.
3. Thirty-seven drug manufacturers sued the FDA Commissioner and Department of Health Secretary before the regulation was enforced stating that this exceeded the Commissioner’s Authority (Mathews, 2024). Initially the District Court ruled in favor of the drug manufacturers then the United States Third Court of Appeals reversed the decision (Quimbee, 2017). Because of this, the case was brought to the United States Supreme Court for decision (Quimbee, 2017).
4. The Supreme Court details that under the Administrative Procedure Act, the Court can review administrative decisions (Quimbee, 2017). In so doing, the Supreme Court reversed the Third Courts ruling (Quimbee, 2017).
5. The Court’s Rational: Type in the court’s reasons for the holdings. The Supreme Court’s rationals were that unless Congress intended to restrict the authority of the agency, the FDA, then judicial review cannot be withheld (Quimbee, 2017). In this case, Congress did not restrict the FDA. Also, based on the doctrine of Ripeness: which prevents courts from prematurely deciding on abstract issues, agency decisions will not be reviewed unless there is a actual case or controversy “ripe” for review (Quimbee, 2017).
The issue was fit for judicial resolution as the commissioner’s authority is a purely legal question and the regulation was a final agency decision. Also, if the judicial review was refused, it would cause hardship to the plaintiffs through potential sanctions if they did not follow the regulation and costs to adhere such as changing labels, advertisements and promotional materials (Quimbee, 2017).
