Legal Opinion
Pharmaceutical Manufacturers Ass'n v. Food & Drug Administration
Court of Appeals for the Third Circuit
Decided November 5, 1980No. 80-1455PublishedCited by 2 opinions
1Opinion of the Court
OPINION OF THE COURT
2Per curiam
In this appeal, the National Association of Chain Drug Stores, Inc. challenges the Food and Drug Administration’s authority to promulgate 21 C.F.R. § 310.515 (1980).1 The challenged regulation requires that patient package insert be provided to *108every patient receiving certain estrogen drugs. In a thorough and well-reasoned opinion, Judge Stapleton, of the District of Delaware, set forth the statutory grounds for the FDA’s regulation.2 We affirm the judgment of the district court.
Responding to the recent studies linking postmenopausal use of estrogens with endometrial…
3Cases cited3 opinions
- Mourning v. Family Publications Service, Inc.Supreme Court of the United States · 1973
- United States v. Nova Scotia Food Products Corp., David Sklar and Emanuel Sklar, and National Fisheries Institute, Intervenor-AppellantCourt of Appeals for the Second Circuit · 1977
- Pharmaceutical Manufacturers Ass'n v. Food & Drug AdministrationDistrict Court, D. Delaware · 1980
4Cited by2 opinions
- Feldman v. Lederle LaboratoriesSupreme Court of New Jersey · 1984
- Pharmaceutical Manufacturers Association v. Food And Drug AdministrationCourt of Appeals for the Third Circuit · 1980