If Congress has indicated an intent to circumscribe agency enforcement discretion, and has provided meaningful standards for defining the limits of that discretion, there is "law to apply" under 5 U.S.C.S. § 701(a)(2), and courts may require that the agency follow that law; if it has not, then an agency refusal to institute proceedings is a decision "committed to agency discretion by law" within the meaning of that section.
The inmates had been sentenced to death by lethal injection and petitioned the FDA to take enforcement actions to prevent the use of drugs for capital punishment in alleged violation of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C.S. § 301 et seq. The FDA refused. Seeking review under the Administrative Procedure Act (APA), 5 U.S.C.S. §§ 701-706, the inmates filed suit against the Secretary in district court asking that the FDA be required to take the requested enforcement actions. The district court granted summary judgment for the Secretary. The court of appeals reversed, holding the FDA's refusal to take enforcement actions was both reviewable and an abuse of discretion, and remanded the case with directions that the FDA be required "to fulfill its statutory function."
Does the FDA's refusal to take enforcement action in preventing the use of drugs for capital punishment constitute an abuse of discretion, which is reviewable by the Courts?
The Court held that an agency's decision not to take enforcement action should be presumed immune from judicial review under the APA, 5 U.S.C.S. § 701(a)(2). The Court therefore reversed, finding that the discretionary enforcement provisions of the FDCA did not overcome the presumption of non-reviewability under the Administrative Procedure Act, 5 U.S.C.S. §§ 701-706.