US SUPREME COURT DECISIONS

Respondent prison inmates were convicted of capital offenses and sentenced to death by lethal injection of drugs. They petitioned the Food and Drug Administration (FDA), alleging that use of the drugs for such a purpose violated the Federal Food, Drug, and Cosmetic Act (FDCA), and requesting that the FDA take various enforcement actions to prevent those violations. The FDA refused the request. Respondents then brought an action in Federal District Court against petitioner Secretary of Health and Human Services, making the same claim and seeking the same enforcement actions. The District Court granted summary judgment for petitioner, holding that nothing in the FDCA indicated an intent to circumscribe the FDA's enforcement discretion or to make it reviewable. The Court of Appeals reversed. Noting that the Administrative Procedure Act (APA) only precludes judicial review of federal agency action when it is precluded by statute, 5 U.S.C. § 701(a)(1), or "committed to agency discretion by law," § 701(a)(2), the court held that § 701(a)(2)'s exception applies only where the substantive statute leaves the courts with "no law to apply," that here there was "law to apply," that therefore the FDA's refusal to take enforcement action was reviewable, and that, moreover, such refusal was an abuse of discretion.

Held: The FDA's decision not to take the enforcement actions requested by respondents was not subject to review under the APA. Pp. 470 U. S. 827-838.

(a) Under § 701(a)(2), judicial review of an administrative agency's decision is not to be had if the statute in question is drawn so that a court would have no meaningful standard against which to judge the agency's exercise of discretion. In such a case, the statute ("law") can be taken to have "committed" the decisionmaking to the agency's judgment absolutely. An agency's decision not to take enforcement action is presumed immune from judicial review under § 701(a)(2). Such a decision has traditionally been "committed to agency discretion," and it does not appear that Congress, in enacting the APA, intended to alter that tradition. Accordingly, such a decision is unreviewable unless Congress has indicated an intent to circumscribe agency enforcement chanrobles.com-red

Page 470 U. S. 822

discretion, and has provided meaningful standards for defining the limits of that discretion. Pp. 827- 470 U. S. 835.

(b) The presumption that agency decisions not to institute enforcement proceedings are unreviewable under § 701(a)(2) is not overcome by the enforcement provisions of the FDCA. Those provisions commit complete discretion to the Secretary to decide how and when they should be exercised. The FDCA's prohibition of "misbranding" of drugs and introduction of "new drugs," absent agency approval, does not supply this Court with "law to apply." Nor can the FDA's "policy statement" indicating that the agency considered itself "obligated" to take certain investigative actions be plausibly read to override the agency's rule expressly stating that the FDA Commissioner shall object to judicial review of a decision to recommend or not to recommend civil or criminal enforcement action. And the section of the FDCA providing that the Secretary need not report for prosecution minor violations of the Act does not give rise to the negative implication that the Secretary is required to investigate purported, "major" violations of the Act. Pp. 470 U. S. 835-837.

231 U.S.App.D.C. 136, 718 F.2d 1174, reversed.

REHNQUIST, J., delivered the opinion of the Court, in which BURGER, C.J.,and BRENNAN, WHITE, BLACKMUN, POWELL, STEVENS, and O'CONNOR, JJ., joined. BRENNAN, J., filed a concurring opinion, post, p. 470 U. S. 838. MARSHALL, J., filed an opinion concurring in the judgment, post, p. 470 U. S. 840. chanrobles.com-red

Page 470 U. S. 823