# United States Reports/Volume 470/Heckler v. Chaney/Opinion of the Court

​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." 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:
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. 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. §§ 701706. 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 ​discretion 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 (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 (1975), and Citizens to Preserve Overton Park v. Volpe, 401 U. S. 402 (1971), for the view that these exceptions should be narrowly construed, the court held that the "committed to agency discretion by law" exception of § 701(a)(2) should be invoked only where the substantive statute left the courts with "no law to apply." 231 U. S. App. D. C., at 146, 718 F. 2d, at 1184 (citing Citizens to Preserve Overton Park, supra, at 410). The court cited Dunlop as holding that this presumption "applies with no less force to review of ... agency decisions to refrain from enforcement action." 231 U. S. App. D. C., at 146, 718 F. 2d, at 1184.
The court found "law to apply" in the form of a FDA policy statement which indicated that the agency was "obligated" to investigate the unapproved use of an approved drug when such use became "widespread" or "endanger[ed] the public health." Id., at 148, 718 F. 2d, at 1186 (citing 37 Fed. Reg. 16504 (1972)). The court held that this policy statement constituted a "rule" and was considered binding by the FDA. Given the policy statement indicating that the FDA should take enforcement action in this area, and the strong presumption that all agency action is subject to judicial review, the court concluded that review of the agency's refusal was not foreclosed. It then proceeded to assess whether the agency's decision not to act was "arbitrary, capricious, or an abuse of discretion." Citing evidence that the FDA assumed ​jurisdiction over drugs used to put animals to sleep and the unapproved uses of drugs on prisoners in clinical experiments, the court found that the FDA's refusal, for the reasons given, was irrational, and that respondents' evidence that use of the drugs could lead to a cruel and protracted death was entitled to more searching consideration. The court therefore remanded the case to the District Court, to order the FDA "to fulfill its statutory function."
The dissenting judge expressed the view that an agency's decision not to institute enforcement action generally is unreviewable, and that such exercises of "prosecutorial discretion" presumptively fall within the APA's exception for agency actions "committed to agency discretion by law." He noted that traditionally courts have been wary of second-guessing agency decisions not to enforce, given the agency's expertise and better understanding of its enforcement policies and available resources. He likewise concluded that nothing in the FDCA or FDA regulations would provide a basis for a court's review of this agency decision. A divided Court of Appeals denied the petition for rehearing. 233 U. S. App. D. C. 146, 724 F. 2d 1030 (1984). We granted certiorari to review the implausible result that the FDA is required to exercise its enforcement power to ensure that States only use drugs that are "safe and effective" for human execution. 467 U. S. 1251 (1984). We reverse.
II
The Court of Appeals' decision addressed three questions: (1) whether the FDA had jurisdiction to undertake the enforcement actions requested, (2) whether if it did have ​jurisdiction its refusal to take those actions was subject to judicial review, and (3) whether if reviewable its refusal was arbitrary, capricious, or an abuse of discretion. In reaching our conclusion that the Court of Appeals was wrong, however, we need not and do not address the thorny question of the FDA's jurisdiction. For us, this case turns on the important question of the extent to which determinations by the FDA not to exercise its enforcement authority over the use of drugs in interstate commerce may be judicially reviewed. That decision in turn involves the construction of two separate but necessarily interrelated statutes, the APA and the FDCA.
The APA's comprehensive provisions for judicial review of "agency actions" are contained in 5 U. S. C. §§ 701–706. Any person "adversely affected or aggrieved" by agency action, see § 702, including a "failure to act," is entitled to "judicial review thereof," as long as the action is a "final agency action for which there is no other adequate remedy in a court," see § 704. The standards to be applied on review are governed by the provisions of § 706. But before any review at all may be had, a party must first clear the hurdle of § 701(a). That section provides that the chapter on judicial review "applies, according to the provisions thereof, except to the extent that—(1) statutes preclude judicial review; or (2) agency action is committed to agency discretion by law." Petitioner urges that the decision of the FDA to refuse enforcement is an action "committed to agency discretion by law" under § 701(a)(2).
This Court has not had occasion to interpret this second exception in § 701(a) in any great detail. On its face, the section does not obviously lend itself to any particular construction; indeed, one might wonder what difference exists between § (a)(1) and § (a)(2). The former section seems easy in application; it requires construction of the substantive statute involved to determine whether Congress intended to preclude judicial review of certain decisions. That is the approach taken with respect to § (a)(1) in cases such as ​Southern R. Co. v. Seaboard Allied Milling Corp, 442 U. S. 444 (1979), and Dunlop v. Bachowski, 421 U. S., at 567. But one could read the language "committed to agency discretion by law" in § (a)(2) to require a similar inquiry. In addition, commentators have pointed out that construction of § (a)(2) is further complicated by the tension between a literal reading of § (a)(2), which exempts from judicial review those decisions committed to agency "discretion," and the primary scope of review prescribed by § 706(2)(A)—whether the agency's action was "arbitrary, capricious, or an abuse of discretion." How is it, they ask, that an action committed to agency discretion can be unreviewable and yet courts still can review agency actions for abuse of that discretion? See 5 K. Davis, Administrative Law § 28:6 (1984) (hereafter Davis); Berger, Administrative Arbitrariness and Judicial Review, 65 Colum. L. Rev. 55, 58 (1965). The APA's legislative history provides little help on this score. Mindful, however, of the common-sense principle of statutory construction that sections of a statute generally should be read "to give effect, if possible, to every clause ...," see United States v. Menasche, 348 U. S. 528, 538–539 (1955), we think there is a proper construction of § (a)(2) which satisfies each of these concerns.
   "In this case, there is no indication that Congress sought to prohibit judicial review and there is most certainly no 'showing of "clear and convincing evidence" of a ... legislative intent' to restrict access to judicial review. Abbott Laboratories v. Gardner, 387 U. S. 136, 141 (1967)....
   "Similarly, the Secretary's decision here does not fall within the exception for action 'committed to agency discretion.' This is a very narrow exception.... The legislative history of the Administrative Procedure Act indicates that it is applicable in those rare instances where 'statutes are drawn in such broad terms that in a given case there is no law to apply.' S. Rep. No. 752, 79th Cong., 1st Sess., 26 (1945)." Overton Park, supra, at 410 (footnote omitted).
The above quote answers several of the questions raised by the language of § 701(a), although it raises others. First, it clearly separates the exception provided by § (a)(1) from the § (a)(2) exception. The former applies when Congress has expressed an intent to preclude judicial review. The latter applies in different circumstances; even where Congress has not affirmatively precluded review, review is not to be had if the statute 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. This construction avoids conflict with the "abuse of discretion" standard of review in § 706—if no judicially manageable standards are available for judging how and when an agency should exercise its discretion, then it is impossible to evaluate agency action for "abuse of discretion." In addition, this construction satisfies the principle of statutory construction mentioned earlier, by identifying a separate class of cases to which § 701(a)(2) applies.
To this point our analysis does not differ significantly from that of the Court of Appeals. That court purported to apply ​the "no law to apply" standard of Overton Park. We disagree, however, with that court's insistence that the "narrow construction" of § (a)(2) required application of a presumption of reviewability even to an agency's decision not to undertake certain enforcement actions. Here we think the Court of Appeals broke with tradition, case law, and sound reasoning.
Overton Park did not involve an agency's refusal to take requested enforcement action. It involved an affirmative act of approval under a statute that set clear guidelines for determining when such approval should be given. Refusals to take enforcement steps generally involve precisely the opposite situation, and in that situation we think the presumption is that judicial review is not available. This Court has recognized on several occasions over many years that an agency's decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency's absolute discretion. See United States v. Batchelder, 442 U. S. 114, 123–124 (1979); United States v. Nixon, 418 U. S. 683, 693 (1974); Vaca v. Sipes, 386 U. S. 171, 182 (1967); Confiscation Cases, 7 Wall. 454 (1869). This recognition of the existence of discretion is attributable in no small part to the general unsuitability for judicial review of agency decisions to refuse enforcement.
The reasons for this general unsuitability are many. First, an agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise. Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency's overall policies, and, indeed, whether the agency has enough resources to undertake the action at all. An agency generally cannot act against each technical violation of the statute it is charged with enforcing. The agency is far better equipped than the courts to deal with the many variables ​involved in the proper ordering of its priorities. Similar concerns animate the principles of administrative law that courts generally will defer to an agency's construction of the statute it is charged with implementing, and to the procedures it adopts for implementing that statute. See Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc., 435 U. S. 519, 543 (1978); Train v. Natural Resources Defense Council, Inc., 421 U. S. 60, 87 (1975).
In addition to these administrative concerns, we note that when an agency refuses to act it generally does not exercise its coercive power over an individual's liberty or property rights, and thus does not infringe upon areas that courts often are called upon to protect. Similarly, when an agency does act to enforce, that action itself provides a focus for judicial review, inasmuch as the agency must have exercised its power in some manner. The action at least can be reviewed to determine whether the agency exceeded its statutory powers. See, e. g., FTC v. Klesner, 280 U. S. 19 (1929). Finally, we recognize that an agency's refusal to institute proceedings shares to some extent the characteristics of the decision of a prosecutor in the Executive Branch not to indict—a decision which has long been regarded as the special province of the Executive Branch, inasmuch as it is the Executive who is charged by the Constitution to "take Care that the Laws be faithfully executed." U. S. Const., Art. II, § 3.
We of course only list the above concerns to facilitate understanding of our conclusion that an agency's decision not to take enforcement action should be presumed immune from judicial review under § 701(a)(2). For good reasons, such a decision has traditionally been "committed to agency discretion," and we believe that the Congress enacting the APA did not intend to alter that tradition. Cf. 5 Davis § 28:5 (APA did not significantly alter the "common law" of judicial review of agency action). In so stating, we emphasize that the decision is only presumptively unreviewable; the ​presumption may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers. Thus, in establishing this presumption in the APA, Congress did not set agencies free to disregard legislative direction in the statutory scheme that the agency administers. Congress may limit an agency's exercise of enforcement power if it wishes, either by setting substantive priorities, or by otherwise circumscribing an agency's power to discriminate among issues or cases it will pursue. How to determine when Congress has done so is the question left open by Overton Park.
Dunlop v. Bachowski, 421 U. S. 560 (1975), relied upon heavily by respondents and the majority in the Court of Appeals, presents an example of statutory language which supplied sufficient standards to rebut the presumption of unreviewability. Dunlop involved a suit by a union employee, under the Labor-Management Reporting and Disclosure Act, 29 U. S. C. § 481 et seq. (LMRDA), asking the Secretary of Labor to investigate and file suit to set aside a union election. Section 482 provided that, upon filing of a complaint by a union member, "[t]he Secretary shall investigate such complaint and, if he finds probable cause to believe that a violation ... has occurred ... he shall ... bring a civil action ...." After investigating the plaintiff's claims the Secretary of Labor declined to file suit, and the plaintiff sought judicial review under the APA. This Court held that ​review was available. It rejected the Secretary's argument that the statute precluded judicial review, and in a footnote it stated its agreement with the conclusion of the Court of Appeals that the decision was not "an unreviewable exercise of prosecutorial discretion." 421 U. S., at 567, n. 7. Our textual references to the "strong presumption" of reviewability in Dunlop were addressed only to the § (a)(1) exception; we were content to rely on the Court of Appeals' opinion to hold that the § (a)(2) exception did not apply. The Court of Appeals, in turn, had found the "principle of absolute prosecutorial discretion" inapplicable, because the language of the LMRDA indicated that the Secretary was required to file suit if certain "clearly defined" factors were present. The decision therefore was not "'beyond the judicial capacity to supervise.'" Bachowski v. Brennan, 502 F. 2d 79, 87–88 (CA3 1974) (quoting Davis § 28.16, p. 984 (1970 Supp.)).
Dunlop is thus consistent with a general presumption of unreviewability of decisions not to enforce. The statute being administered quite clearly withdrew discretion from the agency and provided guidelines for exercise of its enforcement power. Our decision that review was available was not based on "pragmatic considerations," such as those cited by the Court of Appeals, see 231 U. S. App. D. C., at 147, 718 F. 2d, at 1185, that amount to an assessment of whether the interests at stake are important enough to justify intervention in the agencies' decisionmaking. The danger that agencies may not carry out their delegated powers with sufficient vigor does not necessarily lead to the conclusion that courts are the most appropriate body to police this aspect of their performance. That decision is in the first instance for Congress, and we therefore turn to the FDCA to determine whether in this case Congress has provided us with "law to apply." If it 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 § 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.
III
To enforce the various substantive prohibitions contained in the FDCA, the Act provides for injunctions, 21 U. S. C. § 332, criminal sanctions, §§ 333 and 335, and seizure of any offending food, drug, or cosmetic article, § 334. The Act's general provision for enforcement, § 372, provides only that "[t]he Secretary is authorized to conduct examinations and investigations ..." (emphasis added). Unlike the statute at issue in Dunlop, § 332 gives no indication of when an injunction should be sought, and § 334, providing for seizures, is framed in the permissive—the offending food, drug, or cosmetic "shall be liable to be proceeded against." The section on criminal sanctions states baldly that any person who violates the Act's substantive prohibitions "shall be imprisoned ... or fined." Respondents argue that this statement mandates criminal prosecution of every violator of the Act but they adduce no indication in case law or legislative history that such was Congress' intention in using this language, which is commonly found in the criminal provisions of Title 18 of the United States Code. See, e. g., 18 U. S. C. § 471 (counterfeiting); 18 U. S. C. § 1001 (false statements to Government officials); 18 U. S. C. § 1341 (mail fraud). We are unwilling to attribute such a sweeping meaning to this language, particularly since the Act charges the Secretary only with recommending prosecution; any criminal prosecutions must be instituted by the Attorney General. The Act's enforcement provisions thus commit complete discretion to the Secretary to decide how and when they should be exercised.
Respondents nevertheless present three separate authorities that they claim provide the courts with sufficient indicia of an intent to circumscribe enforcement discretion. Two of these may be dealt with summarily. First, we reject ​respondents' argument that the Act's substantive prohibitions of "misbranding" and the introduction of "new drugs" absent agency approval, see 21 U. S. C. §§ 352(f)(1), 355, supply us with "law to apply." These provisions are simply irrelevant to the agency's discretion to refuse to initiate proceedings.
We also find singularly unhelpful the agency "policy statement" on which the Court of Appeals placed great reliance. We would have difficulty with this statement's vague language even if it were a properly adopted agency rule. Although the statement indicates that the agency considered itself "obligated" to take certain investigative actions, that language did not arise in the course of discussing the agency's discretion to exercise its enforcement power, but rather in the context of describing agency policy with respect to unapproved uses of approved drugs by physicians. In addition, if read to circumscribe agency enforcement discretion, the statement conflicts with the agency rule on judicial review, 21 CFR § 10.45(d)(2) (1984), which states that "[t]he Commissioner shall object to judicial review ... if (i) [t]he matter is committed by law to the discretion of the Commissioner, e. g., a decision to recommend or not to recommend civil or criminal enforcement action ...." But in any event the policy statement was attached to a rule that was never adopted. Whatever force such a statement might have, and leaving to one side the problem of whether an agency's rules might under certain circumstances provide courts with adequate guidelines for informed judicial review of decisions not to enforce, we do not think the language of the agency's "policy statement" can plausibly be read to override the agency's express assertion of unreviewable discretion contained in the above rule.
​Respondents' third argument, based upon § 306 of the FDCA, merits only slightly more consideration. That section provides:
   "Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or ruling." 21 U. S. C. § 336.
Respondents seek to draw from this section the negative implication that the Secretary is required to report for prosecution all "major" violations of the Act, however those might be defined, and that it therefore supplies the needed indication of an intent to limit agency enforcement discretion. We think that this section simply does not give rise to the negative implication which respondents seek to draw from it. The section is not addressed to agency proceedings designed to discover the existence of violations, but applies only to a situation where a violation has already been established to the satisfaction of the agency. We do not believe the section speaks to the criteria which shall be used by the agency for investigating possible violations of the Act.
IV
We therefore conclude that the presumption that agency decisions not to institute proceedings are unreviewable under 5 U. S. C. § 701(a)(2) is not overcome by the enforcement provisions of the FDCA. The FDA's decision not to take the ​enforcement actions requested by respondents is therefore not subject to judicial review under the APA. The general exception to reviewability provided by § 701(a)(2) for action "committed to agency discretion" remains a narrow one, see Citizens to Preserve Overton Park v. Volpe, 401 U. S. 402 (1971), but within that exception are included agency refusals to institute investigative or enforcement proceedings, unless Congress has indicated otherwise. In so holding, we essentially leave to Congress, and not to the courts, the decision as to whether an agency's refusal to institute proceedings should be judicially reviewable. No colorable claim is made in this case that the agency's refusal to institute proceedings violated any constitutional rights of respondents, and we do not address the issue that would be raised in such a case. Cf. Johnson v. Robison, 415 U. S. 361, 366 (1974); Yick Wo v. Hopkins, 118 U. S. 356, 372–374 (1886). The fact that the drugs involved in this case are ultimately to be used in imposing the death penalty must not lead this Court or other courts to import profound differences of opinion over the meaning of the Eighth Amendment to the United States Constitution into the domain of administrative law.
The judgment of the Court of Appeals is
Reversed.
* ↑ See 21 U. S. C. § 352(f): "A drug or device shall be deemed to be misbranded ... [u]nless its labeling bears (1) adequate directions for use ...."
* ↑ Although respondents also requested an evidentiary hearing, the District Court regarded this hearing as having "no purpose apart from serving as a prelude to the pursuit of the very enforcement steps that plaintiffs demanded in their administrative petition." Chaney v. Schweiker, Civ. No. 81–2265 (DC, Aug. 30, 1982), App. to Pet. for Cert. 77a, n. 15. Respondents have not challenged the statement that all they sought were certain enforcement actions, and this case therefore does not involve the question of agency discretion not to invoke rulemaking proceedings.
* ↑ In response to respondents' petition, the Commissioner had explained that the FDA had assumed jurisdiction in these cases because, unlike the drugs used for human execution, these drugs were "new drugs" intended by the manufacturer to be used for this purpose, and thus fell squarely within the FDA's approval jurisdiction. The Court of Appeals did not explain why this distinction was not "rational."
* ↑ We do not have in this case a refusal by the agency to institute proceedings based solely on the belief that it lacks jurisdiction. Nor do we have a situation where it could justifiably be found that the agency has "consciously and expressly adopted a general policy" that is so extreme as to amount to an abdication of its statutory responsibilities. See, e. g., Adam v. Richardson, 156 U. S. App. D. C. 267, 480 F. 2d 1159 (1973) (en banc). Although we express no opinion on whether such decisions would be unreviewable under § 701(a)(2), we note that in those situations the statute conferring authority on the agency might indicate that such decisions were not "committed to agency discretion."
* ↑ Respondents also urge, as did the Court of Appeals, that a statement by the FDA's lawyers in a footnote to to their "memorandum in support of dismissal" in the District Court indicates that the agency considers the "policy statement" "binding." The footnote said that the "Federal Register notice ... sets forth the agency's current position o[n] the legal status of approved labeling for prescription drugs." The statement from the memorandum cites no authority, is taken out of context, and on its face does not indicate that the agency considered this position "binding" in any sense of the word. Moreover, we find it difficult to believe that statements of agency counsel in litigation against private individuals can be taken to establish "rules" that bind an entire agency prospectively. Such would turn orderly process on its head.