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Heckler v. Chaney et al., 105 S. Ct. 1649, 470 U.S. 821 (1985) - Court rejects claim that FDA must regulate drugs used for lethal injections.
 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).
constituted a violation of the Act's prohibitions against "misbranding."*fn1 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.
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.*fn2 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.
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.
jurisdiction over drugs used to put animals to sleep*fn3 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.
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).
"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.
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.
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.
may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers.*fn4 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.
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.)).
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.
 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 "[the] 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' 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.
 "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.
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.
 231 U. S. App. D.C. 136, 718 F.2d 1174, reversed.
 Today the Court holds 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, 5 U. S. C. ?? 701-706. I concur in this decision. This general presumption is based on the view that, in the normal course of events, Congress intends to allow broad discretion for its administrative agencies to make particular enforcement decisions, and there often may not exist readily discernible "law to apply" for courts to conduct judicial review of non-enforcement decisions. See Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 410 (1971).
I also agree that, despite this general presumption, "Congress did not set agencies free to disregard legislative direction in the statutory scheme that the agency administers." Ante, at 833. Thus the Court properly does not decide today that non-enforcement decisions are unreviewable in cases where (1) an agency flatly claims that it has no statutory jurisdiction to reach certain conduct, ante, at 833, n. 4; (2) an agency engages in a pattern of non-enforcement of clear statutory language, as in Adams v. Richardson, 156 U. S. App. D.C. 267, 480 F.2d 1159 (1973) (en banc), ante, at 833, n. 4; (3) an agency has refused to enforce a regulation lawfully promulgated and still in effect, ante, at 836;*fn1 or (4) a non-enforcement decision violates constitutional rights, ante, at 838. It is possible to imagine other non-enforcement decisions made for entirely illegitimate reasons, for example, non-enforcement in return for a bribe, judicial review of which would not be foreclosed by the nonreviewability presumption. It may be presumed that Congress does not intend administrative agencies, agents of Congress' own creation, to ignore clear jurisdictional, regulatory, statutory, or constitutional commands, and in some circumstances including those listed above the statutes or regulations at issue may well provide "law to apply" under 5 U. S. C. ? 701(a)(2). Individual, isolated non-enforcement decisions, however, must be made by hundreds of agencies each day. It is entirely permissible to presume that Congress has not intended courts to review such mundane matters, absent either some indication of congressional intent to the contrary or proof of circumstances such as those set out above.
that an agency with enforcement discretion has abused that discretion.
 "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. . . . [We] decline, as a matter of enforcement discretion, to pursue supplies of drugs under State control that will be used for execution by lethal injection."
basis for holding, on the merits, that the FDA's refusal to grant the relief requested was within its discretion.
 First, respondents on summary judgment neither offered nor attempted to offer any evidence that the reasons for the FDA's refusal to act were other than the reasons stated by the agency. Second, as the Court correctly concludes, the FDCA is not a mandatory statute that requires the FDA to prosecute all violations of the Act. Thus, the FDA clearly has significant discretion to choose which alleged violations of the Act to prosecute. Third, the basis on which the agency chose to exercise this discretion -- that other problems were viewed as more pressing -- generally will be enough to pass muster. Certainly it is enough to do so here, where the number of people currently affected by the alleged misbranding is around 200, and where the drugs are integral elements in a regulatory scheme over which the States exercise pervasive and direct control.
 When a statute does not mandate full enforcement, I agree with the Court that an agency is generally "far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities." Ante, at 831-832. As long as the agency is choosing how to allocate finite enforcement resources, the agency's choice will be entitled to substantial deference, for the choice among valid alternative enforcement policies is precisely the sort of choice over which agencies generally have been left substantial discretion by their enabling statutes. On the merits, then, a decision not to enforce that is based on valid resource-allocation decisions will generally not be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," 5 U. S. C. ? 706(2)(A). The decision in this case is no exception to this principle.
altogether -- unreviewable whether the resource-allocation rationale is a sham, unreviewable whether enforcement is declined out of vindictive or personal motives, and unreviewable whether the agency has simply ignored the request for enforcement. But cf. Logan v. Zimmerman Brush Co., 455 U.S. 422 (1982) (due process and equal protection may prevent agency from ignoring complaint). But surely it is a far cry from asserting that agencies must be given substantial leeway in allocating enforcement resources among valid alternatives to suggesting that agency enforcement decisions are presumptively unreviewable no matter what factor caused the agency to stay its hand.
 "The legislative material elucidating [the APA] manifests a congressional intention that it cover a broad spectrum of administrative actions, and this Court has echoed that theme by noting that the Administrative Procedure Act's 'generous review provisions' must be given a 'hospitable' interpretation. . . . [Only] upon a showing of 'clear and convincing evidence' of a contrary legislative intent should the courts restrict access to judicial review." Id., at 140-141 (citations omitted; footnote omitted).
give clear and convincing evidence of an intent to withhold it"); cf. Moog Industries, Inc. v. FTC, 355 U.S. 411, 414 (1958) (Federal Trade Commission decisions to prosecute are reviewable and can be overturned when "patent abuse of discretion" demonstrated).2[a] Rather than confront Abbott Laboratories, perhaps the seminal case on judicial review under the APA, the Court chooses simply to ignore it.*fn3 Instead, to support its new-found "presumption of unreviewability," the Court resorts to completely undefined and unsubstantiated references to "tradition," see ante, at 831, and to citation of four cases. See United States v. Batchelder, 442 U.S. 114 (1979); United States v. Nixon, 418 U.S. 683 (1974); Vaca v. Sipes, 386 U.S. 171 (1967); Confiscation Cases, 7 Wall. 454 (1869).*fn4 Because the Court's "tradition" rationale, which flies in the face of Abbott Laboratories, stands as a flat, unsupported ipse dixit, these four cases form the only doctrinal foundation for the majority's presumption of unreviewability.
to attempt to exercise it contrary to validly promulgated regulations. Thus, Nixon actually stands for a very different proposition than the one for which the Court cites it: faced with a specific claim of abuse of prosecutorial discretion, Nixon makes clear that courts are not powerless to intervene. And none of the other prosecutorial discretion cases upon which the Court rests involved a claim that discretion had been abused in some specific way.
be, there are undoubtedly constitutional limits upon its exercise." Id., at 365.
whom Congress has singled out as statutory beneficiaries. The interests at stake in review of administrative enforcement decisions are thus more focused and in many circumstances more pressing than those at stake in criminal prosecutorial decisions. A request that a nuclear plant be operated safely or that protection be provided against unsafe drugs is quite different from a request that an individual be put in jail or his property confiscated as punishment for past violations of the criminal law. Unlike traditional exercises of prosecutorial discretion, "the decision to enforce -- or not to enforce -- may itself result in significant burdens on a . . . statutory beneficiary." Marshall v. Jerrico, Inc., supra, at 249.
 Perhaps most important, the sine qua non of the APA was to alter inherited judicial reluctance to constrain the exercise of discretionary administrative power -- to rationalize and make fairer the exercise of such discretion. Since passage of the APA, the sustained effort of administrative law has been to "continuously [narrow] the category of actions considered to be so discretionary as to be exempted from review." Shapiro, Administrative Discretion: The Next Stage, 92 Yale L. J. 1487, 1489, n. 11 (1983). Discretion may well be necessary to carry out a variety of important administrative functions, but discretion can be a veil for laziness, corruption, incompetency, lack of will, or other motives, and for that reason " the presence of discretion should not bar a court from considering a claim of illegal or arbitrary use of discretion." L. Jaffe, Judicial Control of Administrative Action 375 (1965). Judicial review is available under the APA in the absence of a clear and convincing demonstration that Congress intended to preclude it precisely so that agencies, whether in rulemaking, adjudicating, acting or failing to act, do not become stagnant backwaters of caprice and lawlessness. "Law has reached its finest moments when it has freed man from the unlimited discretion of some ruler, some civil or military official, some bureaucrat." United States v. Wunderlich, 342 U.S. 98, 101 (1951).
to an agency's decision to decline to seek penalties against an individual for past conduct, not to a decision to refuse to investigate or take action on a public health, safety, or welfare problem.
the problem of agency inaction and its concrete effects more regularly than do we, have responded with a variety of solutions to assure administrative fidelity to congressional objectives: a demand that an agency explain its refusal to act, a demand that explanations given be further elaborated, and injunctions that action "unlawfully withheld or unreasonably delayed," 5 U. S. C. ? 706, be taken. See generally Stewart & Sunstein, 95 Harv. L. Rev., at 1279. Whatever the merits of any particular solution, one would have hoped the Court would have acted with greater respect for these efforts by responding with a scalpel rather than a blunderbuss.
of statutory "guidelines" precluding such factors as bases of decision, Congress should not be presumed to have departed from principles of rationality and fair process in enacting the APA.*fn11 Moreover, the agency may well narrow its own enforcement discretion through historical practice, from which it should arguably not depart in the absence of explanation, or through regulations and informal action. Traditional principles of rationality and fair process do offer "meaningful standards" and "law to apply" to an agency's decision not to act, and no presumption of unreviewability should be allowed to trump these principles.
abused because the decision was "made without a rational explanation, inexplicably departed from established policies, or rested . . . on other considerations that Congress could not have intended to make relevant." Wong Wing Hang v. INS, 360 F.2d 715, 719 (CA2 1966). In that event, we would not be finding enforcement decisions unreviewable, but rather would be reviewing them on the merits, albeit with due deference, to assure that such decisions did not result from an abuse of discretion.
 That is the basis upon which I would decide this case. Under ? 706(A)(2) and Abbott Laboratories v. Gardner, 387 U.S. 136 (1967), agency action, including the failure to act, is reviewable to assure that it is not "arbitrary, capricious, or an abuse of discretion," unless Congress has manifested a clear and convincing intent to preclude review. Review of enforcement decisions must be suitably deferential in light of the necessary flexibility the agencies must have in this area, but at least when "enforcement" inaction allegedly deprives citizens of statutory benefits or exposes them to harms against which Congress has sought to provide protection, review must be on the merits to ensure that the agency is exercising its discretion within permissible bounds. See Berger, Administrative Arbitrariness: A Synthesis, 78 Yale L. J. 965 (1969); L. Jaffe, Judicial Control of Administrative Action 375 (1965).
cover their eyes and their reasoning power when asked to review an agency's failure to act, but as recognizing that courts must approach the substantive task of reviewing such failures with appropriate deference to an agency's legitimate need to set policy through the allocation of scarce budgetary and enforcement resources. Because the Court's approach, if taken literally, would take the courts out of the role of reviewing agency inaction in far too many cases, I join only the judgment today.
 * A brief of amicus curiae urging reversal was filed for the Washington Legal Foundation by Daniel J. Popeo, Paul D. Kamenar, George C. Smith, and Stephen Weitzman.
 Briefs of amici curiae urging affirmance were filed for the American Society of Law and Medicine et al. by James M. Doyle; and for the Public Citizen by Alan B. Morrison and William B. Schultz.
 *fn1 See 21 U. S. C. ? 352(f): "A drug or device shall be deemed to be misbranded . . . [unless] its labeling bears (1) adequate directions for use. . . ."
 *fn2 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.
 *fn3 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."
 *fn4 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., Adams 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."
 *fn5 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 [on] 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.
 *fn1 Cf. Motor Vehicle Manufacturers Assn. v. State Farm Mutual Ins. Co., 463 U.S. 29, 40-44 (1983) (failure to revoke lawfully a previously promulgated rule is reviewable under the APA).
 *fn2 I adhere to my view that the death penalty is in all circumstances cruel and unusual punishment forbidden by the Eighth and Fourteenth Amendments, see Gregg v. Georgia, 428 U.S. 153, 227 (1976) (BRENNAN, J., dissenting). My concurrence here should not be misread as an expression of approval for the use of lethal injections to effect capital punishment as an independent matter. The Court is correct, however, that "profound differences of opinion over the meaning of the Eighth Amendment" should not influence our consideration of a question purely of statutory administrative law. Ante, at 838.
1 All Members of the Court in Dunlop v. Bachowski, 421 U.S. 560 (1975), agreed that a statement of basis and purpose was required for the denial of the enforcement request at issue there. See id., at 571-575; id., at 594 (REHNQUIST, J., concurring in result in part and dissenting in part). Given the revisionist view the Court takes today of Dunlop, perhaps these statements too are to be limited to the specific facts out of which they emerged. Yet the Court's suggestion that review is proper when the agency asserts a lack of jurisdiction to act, see ante, at 833, n. 4, or some other basis inconsistent with congressional intent, would seem to presuppose the existence of a statement of basis and purpose explaining the basis for denial of enforcement action. 2[a] The Senate Committee Report accompanying the APA stated: "The mere filing of a petition does not require an agency to grant it, or to hold a hearing, or engage in any other public rule making proceedings. The refusal of an agency to grant the petition or to hold rule making proceedings, therefore, would not per se be subject to judicial reversal." S. Doc. No. 248, 79th Cong., 2d Sess., 201 (1946). As Judge McGowan has observed, "this language implies that judicial review would sometimes be available in the circumstances mentioned" in the Report. Natural Resources Defense Council, Inc. v. SEC, 196 U. S. App. D.C. 124, 136, n. 14, 606 F.2d 1031, 1043, n. 14 (1979).
 *fn3 The Court did not ignore Abbott Laboratories in Southern R. Co. v. Seaboard Allied Milling Corp., 442 U.S. 444, 454, 462-463 (1979), a denial of enforcement case that required "clear and convincing evidence" of congressional intent to preclude review of the failure to investigate a complaint.
 *fn4 It is ironic that Vaca v. Sipes and the Confiscation Cases were cited by the Government in its brief in Dunlop when it unsuccessfully pressed the very proposition accepted today: that agency enforcement decisions are presumptively unreviewable. See Brief for Petitioner in Dunlop v. Bachowski, O. T. 1974, No. 74-466, pp. 25-31.
 *fn5 Cf. Southern R. Co. v. Seaboard Allied Milling Corp., supra (concluding, after extensive examination of history and structure of Act, that agency decisions not to investigate under ? 15(8)(a) of the Interstate Commerce Act are unreviewable).
 *fn6 Legal historians have suggested that the notion of prosecutorial discretion developed in England and America largely because private prosecutions were simultaneously available at the time. See Langbein, Controlling Prosecutorial Discretion in Germany, 41 U. Chi. L. Rev. 439, 443-446 (1974). Private enforcement of regulatory statutes, such as the FDCA, is of course largely unavailable.
In addition, scholars have noted that the tradition of unreviewability of prosecutor's decisions developed at a time when virtually all executive action was considered unreviewable. In asking what accounts for this "tradition," one scholar offered the following rhetorical questions: "Is it because the tradition became settled during the nineteenth century when courts were generally assuming that judicial intrusion into any administration would be unfortunate? Is it because the tradition became settled while the Supreme Court was actuated by its 1840 remark that 'The interference of the Courts with the performance of the ordinary duties of the executive departments of the government, would be productive of nothing but mischief.' [citing Decatur v. Paulding, 14 Pet. 497, 516 (1840)]. Is it because the tradition became settled before the courts made the twentieth-century discovery that the courts can interfere with executive action to protect against abuses but at the same time can avoid taking over the executive function? Is it because the tradition became settled before the successes of the modern system of limited judicial review became fully recognized? "On the basis of what the courts know today about leaving administration to administrators but at the same time providing an effective check to protect against abuses, should the courts not take a fresh look at the tradition that prevents them from reviewing the prosecuting function?" K. Davis, Discretionary Justice 211 (1969) (footnote omitted).
 *fn7 See, e. g., Bargmann v. Helms, 230 U. S. App. D.C. 164, 715 F.2d 638 (1983); Natural Resources Defense Council, Inc. v. EPA, 683 F.2d 752, 753, 767-768 (CA3 1982); WWHT, Inc. v. FCC, 211 U. S. App. D.C. 218, 656 F.2d 807 (1981); Carpet, Linoleum & Resilient Tile Layers, Local Union No. 419 v. Brown, 656 F.2d 564 (CA10 1981); Natural Resources Defense Council, Inc. v. SEC, 196 U. S. App. D.C. 124, 606 F.2d 1031 (1979); British Airways Board v. Port Authority of New York, 564 F.2d 1002, 1012-1013 (CA2 1977); Pennsylvania v. National Assn. of Flood Insurers, 520 F.2d 11 (CA3 1975); REA Express, Inc. v. CAB, 507 F.2d 42 (CA2 1974); Davis v. Romney, 490 F.2d 1360 (CA3 1974); Adams v. Richardson, 156 U. S. App. D.C. 267, 480 F.2d 1159 (1973) (en banc); International Harvester Co. v. Ruckelshaus, 155 U. S. App. D.C. 411, 478 F.2d 615 (1973); Rockbridge v. Lincoln, 449 F.2d 567 (CA9 1971); Environmental Defense Fund, Inc. v. Ruckelshaus, 142 U. S. App. D.C. 74, 439 F.2d 584 (1971); Environmental Defense Fund, Inc. v. Hardin, 138 U. S. App. D.C. 391, 428 F.2d 1093 (1970); Medical Committee for Human Rights v. SEC, 139 U. S. App. D.C. 226, 432 F.2d 659 (1970), vacated as moot, 404 U.S. 403 (1972); Trailways of New England, Inc. v. CAB, 412 F.2d 926 (CA1 1969); International Union, United Auto., Aero. & Agric. Implement Workers v. NLRB, 427 F.2d 1330 (CA6 1970); Public Citizen Health Research Group v. Auchter, 554 F.Supp. 242 (DC 1983), rev'd in part, 226 U. S. App. D.C. 413, 702 F.2d 1150 (1983); Sierra Club v. Gorsuch, 551 F.Supp. 785 (ND Cal. 1982); Hoffmann-LaRoche, Inc. v. Weinberger, 425 F.Supp. 890 (DC 1975); NAACP v. Levi, 418 F.Supp. 1109 (DC 1976); Guerrero v. Garza, 418 F.Supp. 182 (WD Wis. 1976); Souder v. Brennan, 367 F.Supp. 808, 811 (DC 1973); City-Wide Coalition Against Childhood Lead Paint Poisoning v. Philadelphia Housing Auth., 356 F.Supp. 123 (ED Pa. 1973); American Public Health Assn. v. Veneman, 349 F.Supp. 1311 (DC 1972).
To be sure, some of these cases involved the refusal to initiate rulemaking proceedings, and the majority expressly disavows any claim that its presumption of unreviewability applies to such refusals. See ante, at 825, n. 2. But the majority offers no explanation of how an enforcement request that seeks protection of the public or statutory beneficiaries from present and future concrete harms, or from loss of deserved benefits, implicates considerations substantially different from those at stake in judicial review of the refusal to initiate rulemaking proceedings.
"'[Negative] order' and 'affirmative order' are not appropriate terms of art. . . . 'Negative' has really been an obfuscating adjective in that it implied a search for a distinction -- non-action as against action -- which does not involve the real considerations on which rest, as we have seen, the reviewability of Commission orders within the framework of its discretionary authority and within the general criteria of justiciability. 'Negative' and 'affirmative,' in the context of these problems, is as unilluminating and mischief-making a distinction as the outmoded line between 'nonfeasance' and 'misfeasance.' ". . . An order of the Commission dismissing a complaint on the merits and maintaining the status quo is an exercise of administrative function, no more and no less, than an order directing some change in status. . . . In the application of relevant canons of judicial review an order of the Commission directing the adoption of a practice might raise considerations absent from a situation where the Commission merely allowed such a practice to continue. But this bears on the disposition of a case and should not control jurisdiction." 307 U.S., at 140-142 (emphasis added; footnotes omitted).
 *fn9 The Court cites 5 K. Davis, Administrative Law ? 28:5 (1984), for the proposition that the APA did not alter the "common law" of judicial review of agency action; Davis' correct statement ought to make clear that traditional principles of fair and rational decisionmaking were incorporated into, rather than obliterated by, the APA, and that judicial review is available to assure that agency action, including inaction, is consistent with these principles. See also Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Curran, 456 U.S. 353, 378 (1982) ("[We] must examine Congress' perception of the law that it was shaping or reshaping").
 *fn10 "A scheme injecting a personal interest, financial or otherwise, into the enforcement process may bring irrelevant or impermissible factors into the prosecutorial decision and in some contexts raise serious constitutional questions." Marshall v. Jerrico, Inc., 446 U.S. 238, 249-250 (1980).
 *fn11 Indeed, "[the] more general and powerful the background understanding, the less likely it is to have been stated explicitly by the legislature, even if the legislature in fact shares that understanding." Stewart & Sunstein, Public Programs and Private Rights, 95 Harv. L. Rev. 1195, 1231 (1982).
 *fn12 When an agency asserts that a refusal to enforce is based on enforcement priorities, it may be that, to survive summary judgment, a plaintiff must be able to offer some basis for calling this assertion into question or for justifying his inability to do so.

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