Heckler v. Chaney

• Citation: 470 U.S. 821,84 L.Ed.2d 714,105 S.Ct. 1649
• Decision Date: 20 March 1985
• Docket Number: No. 83-1878,83-1878
• Parties: Margaret M. HECKLER, Secretary of Health and Human Services, Petitioner v. Larry Leon CHANEY et al
• Court: United States Supreme Court

470 U.S. 821

105 S.Ct. 1649

84 L.Ed.2d 714

Margaret M. HECKLER, Secretary of Health and Human Services, Petitioner

v Larry Leon CHANEY et al.

No. 83-1878.

Argued Dec. 3, 1984.

Decided March 20, 1985.

Syllabus

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

(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, do 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. 835-837.

231 U.S.App.D.C. 136, 718 F.2d 1174 (1983), reversed.

Kenneth S. Geller, Washington, D.C., for petitioner.

Stephen M. Kristovich, Washington, D.C., for respondents.

Justice REHNQUIST delivered the opinion of the Court.

This case presents the question of the extent to which a decision of an administrative agency to exercise its "discretion" not to undertake certain enforcement actions is subject to judicial review under the Administrative Procedure Act, 5 U.S.C. § 501 et seq. (APA). Respondents are several prison inmates convicted of capital offenses and sentenced to death by lethal injection of drugs. They petitioned the Food and Drug Administration (FDA), alleging that under the circumstances the use of these drugs for capital punishment violated the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq. (FDCA), and requesting that the FDA take various enforcement actions to prevent these violations. The FDA refused their request. We review here a decision of the Court of Appeals for the District of Columbia Circuit, which held the FDA's refusal to take enforcement actions both reviewable and an abuse of discretion, and remanded the case with directions that the agency be required "to fulfill its statutory function." 231 U.S.App.D.C. 136, 153, 718 F.2d 1174, 1191 (1983).

I

Respondents have been sentenced to death by lethal injection of drugs under the laws of the States of Oklahoma and Texas. Those States, and several others, have recently adopted this method for carrying out the capital sentence. Respondents first petitioned the FDA, claiming that the drugs used by the States for this purpose, although approved by the FDA for the medical purposes stated on their labels, were not approved for use in human executions. They alleged that the drugs had not been tested for the purpose for which they were to be used, and that, given that the drugs would likely be administered by untrained personnel, it was also likely that the drugs would not induce the quick and painless death intended. They urged that use of these drugs for human execution was the "unapproved use of an approved drug" and constituted a violation of the Act's prohibitions against "misbranding." ¹ They also suggested that the FDCA's requirements for approval of "new drugs" applied, since these drugs were now being used for a new purpose. Accordingly, respondents claimed that the FDA was required to approve the drugs as "safe and effective" for human execution before they could be distributed in interstate commerce. See 21 U.S.C. § 355. They therefore requested the FDA to take various investigatory and enforcement actions to prevent these perceived violations; they requested the FDA to affix warnings to the labels of all the drugs stating that they were unapproved and unsafe for human execution, to send statements to the drug manufacturers and prison administrators stating that the drugs should not be so used, and to adopt procedures for seizing the drugs from state prisons and to recommend the prosecution of all those in the chain of distribution who knowingly distribute or purchase the drugs with intent to use them for human execution.

The FDA Commissioner responded, refusing to take the requested actions. The Commissioner first detailed his disagreement with respondents' understanding of the scope of FDA jurisdiction over the unapproved use of approved drugs for human execution, concluding that FDA jurisdiction in the area was generally unclear but in any event should not be exercised to interfere with this particular aspect of state criminal justice systems. He went on to state:

"Were FDA clearly to have jurisdiction in the area, moreover, we believe we would be authorized to decline to exercise it under our inherent discretion to decline to pursue certain enforcement matters. The unapproved use of approved drugs is an area in which the case law is far from uniform. Generally, enforcement proceedings in this area are initiated only when there is a serious danger to the public health or a blatant scheme to defraud. We cannot conclude that those dangers are present under State lethal injection laws, which are duly authorized statutory enactments in furtherance of proper State functions. . . ."

Respondents then filed the instant suit in the United States District Court for the District of Columbia, claiming the same violations of the FDCA and asking that the FDA be required to take the same enforcement actions requested in the prior petition.² Jurisdiction was grounded in the general federal-question jurisdiction statute, 28 U.S.C. § 1331, and review of the agency action was sought under the judicial review provisions of the APA, 5 U.S.C. §§ 701-706. The District Court granted summary judgment for petitioner. It began with the proposition that "decisions of executive departments and agencies to refrain from instituting investigative and enforcement proceedings are essentially unreviewable by the courts." Chaney v. Schweiker, Civ. No. 81-2265 (DC, Aug. 30, 1982), App. to Pet. for Cert. 74a (emphasis in original). The court then cited case law stating that nothing in the FDCA indicated an intent to circumscribe the FDA's enforcement discretion or to make it reviewable.

A divided panel of the Court of Appeals for the District of Columbia Circuit reversed. The majority began by discussing the FDA's jurisdiction over the unapproved use of approved drugs for human execution, and concluded that the FDA did have jurisdiction over such a use. The court then addressed the Government's assertion of unreviewable dis- cretion to refuse enforcement action. It first discussed this Court's opinions which have held that there is a general presumption that all agency decisions are reviewable under the APA, at least to assess whether the actions were "arbitrary, capricious, or an abuse of discretion." See Abbott Laboratories v. Gardner, 387 U.S. 136, 139-141, 87 S.Ct. 1507, 1510-1511, 18 L.Ed.2d 681 (1967); 5 U.S.C. § 706(2)(A). It noted that the APA, 5 U.S.C. § 701, only precludes judicial review of final agency action—including refusals to act, see 5 U.S.C. § 551(13)—when review is precluded by statute, or "committed to agency discretion by law." Citing this Court's opinions in Dunlop v. Bachowski, 421 U.S. 560, 95 S.Ct. 1851, 44 L.Ed.2d 377 (1975), and Citizens to Preserve Overton Park v. Volpe, ...