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Administrative Law Keyed to Mawshaw
Heckler v. Chaney
Citation:
470 U.S. 821, 105 S. Ct. 1649, 84 L. Ed. 2d 714 (1985)Facts
Several prison inmates sentenced to death by lethal injection petitioned the FDA, claiming that the drugs used for executions violated the Federal Food, Drug, and Cosmetic Act because they were not approved for this purpose and constituted “misbranding.” They requested the FDA to take various enforcement actions, including requiring warning labels, sending notices to manufacturers and prison administrators, seizing the drugs, and recommending prosecution of those in the distribution chain. The FDA Commissioner refused, stating that even if the FDA had jurisdiction, the agency had discretion to decline enforcement in this area, as enforcement proceedings were generally initiated only when there was a serious danger to public health or blatant fraud, which the Commissioner did not find present in state lethal injection laws. The inmates sued, and while the District Court granted summary judgment for the FDA, the Court of Appeals reversed, finding the FDA’s refusal reviewable and an abuse of discretion.
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