470 U.S. 821, 105 S. Ct. 1649, 84 L. Ed. 2d 714 (1985)
In 1981 several prison inmates convicted of capital offenses and sentenced to death by lethal injection under the laws of Oklahoma and Texas petitioned the Food and Drug Administration.1 They alleged that the drugs approved by the FDA for medical uses on their labels were being used for executions without approval or testing for that purpose.2 Administration by untrained personnel would likely cause a cruel and protracted death.3 The inmates requested that the FDA affix warnings to the labels of all such drugs stating they were unapproved and unsafe for human execution, send statements to manufacturers and prison administrators that the drugs should not be so used, adopt procedures for seizing the drugs from state prisons, and recommend prosecution of those in the chain of distribution who knowingly supplied them for executions.4
The FDA Commissioner responded in writing and declined to take any of the requested actions.5 He explained that FDA jurisdiction over the unapproved use of approved drugs for human execution was generally unclear. Even if jurisdiction existed, the agency would decline to pursue enforcement matters in this area under its inherent discretion. There was no serious danger to the public health or blatant scheme to defraud, and the uses occurred under duly authorized state lethal injection laws.6
The inmates then filed suit in the United States District Court for the District of Columbia.7 They grounded jurisdiction in 28 U.S.C. § 1331 and sought review of the agency action under the judicial review provisions of the Administrative Procedure Act, 5 U.S.C. §§ 701-706, asking that the FDA be required to take the same enforcement actions requested in the administrative petition.8 The district court granted summary judgment for the Secretary of Health and Human Services.9
A divided panel of the Court of Appeals for the District of Columbia Circuit reversed.10 The majority held that the FDA had jurisdiction, that the refusal to act was subject to judicial review, and that the refusal was arbitrary, capricious, or an abuse of discretion; it remanded with directions that the agency be required to fulfill its statutory function.11 The Court of Appeals denied rehearing en banc by a divided vote, and the Supreme Court granted certiorari.12
Whether the Food and Drug Administration's refusal to take enforcement actions requested by respondents is subject to judicial review under the Administrative Procedure Act?13
The Administrative Procedure Act provides for judicial review of agency actions under 5 U.S.C. §§ 701-706, but section 701(a)(2) creates an exception when agency action is committed to agency discretion by law.14 This exception applies when the governing statute is drawn in such broad terms that a court would have no meaningful standard against which to judge the agency's exercise of discretion.15 Agency decisions not to institute enforcement proceedings are presumptively unreviewable under this provision because they typically involve a complicated balancing of factors peculiarly within the agency's expertise, including resource allocation, likelihood of success, and consistency with overall enforcement policies.16 The presumption may be rebutted only where the substantive statute provides guidelines for the agency to follow in exercising its enforcement powers, as the Court recognized in distinguishing Dunlop v. Bachowski.17
No. The FDCA enforcement provisions commit complete discretion to the Secretary, using permissive language such as the Secretary is authorized to conduct examinations and investigations under 21 U.S.C. § 372 and framing seizure authority in permissive terms.18
The Commissioner's written response declining enforcement on grounds of inherent discretion and absence of public health danger falls squarely within the category of decisions traditionally committed to agency discretion by law.19 The FDCA supplies no guidelines that rebut the presumption of unreviewability.20
The Food and Drug Administration's refusal to take the requested enforcement actions is not subject to judicial review under the Administrative Procedure Act.21
Related opinions on this issue
Justice Brennan filed a concurring opinion agreeing that individual decisions of the Food and Drug Administration not to take enforcement action in response to citizen requests are presumptively not reviewable under the Administrative Procedure Act.22 He emphasized that this general presumption rests on the view that Congress intends to allow broad discretion for administrative agencies to make particular enforcement decisions.23 Readily discernible law to apply often does not exist for courts to review nonenforcement decisions.24 Brennan stressed that the decision leaves open review in cases where an agency claims it has no statutory jurisdiction, engages in a pattern of nonenforcement of clear statutory language, refuses to enforce a lawfully promulgated regulation still in effect, or violates constitutional rights.25
He joined the Court's opinion on the understanding that individual isolated nonenforcement decisions must be made by hundreds of agencies each day and that Congress has not intended courts to review such mundane matters absent special circumstances.26
Justice Marshall filed an opinion concurring in the judgment but rejected the majority's creation of a presumption of unreviewability for agency enforcement decisions.27 He argued that refusals to enforce, like other agency actions, are reviewable in the absence of clear and convincing congressional intent to the contrary under the APA's generous review provisions.28 Such refusals warrant deference on the merits when nothing suggests the agency abused its discretion, as occurred here where the FDA's resource-allocation rationale provided a sufficient basis.29 Marshall contended that the majority's presumption is fundamentally at odds with rule-of-law principles and prior case law such as Abbott Laboratories v. Gardner.30 Traditions of prosecutorial discretion do not justify immunizing agency inaction from scrutiny when enforcement decisions may result in significant burdens on statutory beneficiaries.31
He would have decided the case by reviewing the agency's choice among valid enforcement policies with substantial deference rather than announcing a broad presumption against reviewability.32