HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES v. CHANEY ET AL.
No. 83-1878
SUPREME COURT OF THE UNITED STATES
Argued December 3, 1984—Decided March 20, 1985
470 U.S. 821
Deputy Solicitor General Geller argued the cause for petitioner. With him on the briefs were Solicitor General Lee, Acting Assistant Attorney General Willard, Samuel A. Alito, Jr., Leonard Schaitman, John M. Rogers, Thomas Scarlett, and Michael P. Peskoe.
Steven M. Kristovich argued the cause for respondents. With him on the brief were David E. Kendall, Julius LeVonne Chambers, James M. Nabrit III, John Charles Boger, James S. Liebman, and Anthony G. Amsterdam.*
*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.
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,
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
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,
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-
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
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 juris-
The APA‘s comprehensive provisions for judicial review of “agency actions” are contained in
This Court has not had occasion to interpret this second exception in
This Court first discussed
“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
To this point our analysis does not differ significantly from that of the Court of Appeals. That court purported to apply
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 in-
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.”
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
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,
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
III
To enforce the various substantive prohibitions contained in the FDCA, the Act provides for injunctions,
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
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.5
“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
The judgment of the Court of Appeals is
Reversed.
JUSTICE BRENNAN, concurring.
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,
On this understanding of the scope of today‘s decision, I join the Court‘s opinion.2
Easy cases at times produce bad law, for in the rush to reach a clearly ordained result, courts may offer up principles, doctrines, and statements that calmer reflection, and a fuller understanding of their implications in concrete settings, would eschew. In my view, the “presumption of unreviewability” announced today is a product of that lack of discipline that easy cases make all too easy. The majority, eager to reverse what it goes out of its way to label as an “implausible result,” ante, at 827, not only does reverse, as I agree it should, but along the way creates out of whole cloth the notion that agency decisions not to take “enforcement action” are unreviewable unless Congress has rather specifically indicated otherwise. Because this “presumption of unreviewability” is fundamentally at odds with rule-of-law principles firmly embedded in our jurisprudence, because it seeks to truncate an emerging line of judicial authority subjecting enforcement discretion to rational and principled constraint, and because, in the end, the presumption may well be indecipherable, one can only hope that it will come to be understood as a relic of a particular factual setting in which the full implications of such a presumption were neither confronted nor understood.
I write separately to argue for a different basis of decision: that refusals to enforce, like other agency actions, are reviewable in the absence of a “clear and convincing” congressional intent to the contrary, but that such refusals warrant deference when, as in this case, there is nothing to suggest
that an agency with enforcement discretion has abused that discretion.I
In response to respondents’ petition, the FDA Commissioner stated that the FDA would not pursue the complaint “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 .... [W]e decline, as a matter of enforcement discretion, to pursue supplies of drugs under State control that will be used for execution by lethal injection.”
The FDA may well have been legally required to provide this statement of basis and purpose for its decision not to take the action requested. Under the
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
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,”
The Court, however, is not content to rest on this ground. Instead, the Court transforms the arguments for deferential review on the merits into the wholly different notion that “enforcement” decisions are presumptively unreviewable
This “presumption of unreviewability” is also a far cry from prior understandings of the
“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. . . . [O]nly 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).
See generally H. R. Rep. No. 1980, 79th Cong., 2d Sess., 41 (1946) (to preclude
Moreover, for at least two reasons it is inappropriate to rely on notions of prosecutorial discretion to hold agency inaction unreviewable. First, since the dictum in Nixon, the Court has made clear that prosecutorial discretion is not as unfettered or unreviewable as the half-sentence in Nixon suggests. As one of the leading commentators in this area has noted, “the case law since 1974 is strongly on the side of reviewability.” 2 K. Davis, Administrative Law § 9:6, p. 240 (1979). In Blackledge v. Perry, 417 U. S. 21, 28 (1974), instead of invoking notions of “absolute” prosecutorial discretion, we held that certain potentially vindictive exercises of prosecutorial discretion were both reviewable and impermissible. The “retaliatory use” of prosecutorial power is no longer tolerated. Thigpen v. Roberts, 468 U. S. 27, 30 (1984). Nor do prosecutors have the discretion to induce guilty pleas through promises that are not kept. Blackledge v. Allison, 431 U. S. 63 (1977); Santobello v. New York, 404 U. S. 257, 262 (1971). And in rejecting on the merits a claim of improper prosecutorial conduct in Bordenkircher v. Hayes, 434 U. S. 357 (1978), we clearly laid to rest any notion that prosecutorial discretion is unreviewable no matter what the basis is upon which it is exercised:
“There is no doubt that the breadth of discretion that our country‘s legal system vests in prosecuting attorneys carries with it the potential for both individual and institutional abuse. And broad though that discretion may
be, there are undoubtedly constitutional limits upon its exercise.” Id., at 365.
See also Wayte v. United States, ante, at 608. Thus, even in the area of criminal prosecutions, prosecutorial discretion is not subject to a “presumption of unreviewability.” See generally Vorenberg, Decent Restraint of Prosecutorial Power, 94 Harv. L. Rev. 1521, 1537-1543 (1981). If a plaintiff makes a sufficient threshold showing that a prosecutor‘s discretion has been exercised for impermissible reasons, judicial review is available.
Second, arguments about prosecutorial discretion do not necessarily translate into the context of agency refusals to act. “In appropriate circumstances the Court has made clear that traditions of prosecutorial discretion do not immunize from judicial scrutiny cases in which the enforcement decisions of an administrator were motivated by improper factors or were otherwise contrary to law.” Marshall v. Jerrico, Inc., 446 U. S. 238, 249 (1980) (citations omitted). Criminal prosecutorial decisions vindicate only intangible interests, common to society as a whole, in the enforcement of the criminal law. The conduct at issue has already occurred; all that remains is society‘s general interest in assuring that the guilty are punished. See Linda R. S. v. Richard D., 410 U. S. 614, 619 (1973) (“[A] private citizen lacks a judicially cognizable interest in the prosecution or nonprosecution of another“). In contrast, requests for administrative enforcement typically seek to prevent concrete and future injuries that Congress has made cognizable—injuries that result, for example, from misbranded drugs, such as alleged in this case, or unsafe nuclear powerplants, see, e. g., Florida Power & Light Co. v. Lorion, ante, p. 729—or to obtain palpable benefits that Congress has intended to bestow—such as labor union elections free of corruption, see Dunlop v. Bachowski, 421 U. S. 560 (1975). Entitlements to receive these benefits or to be free of these injuries often run to specific classes of individuals
Perhaps most important, the sine qua non of the
II
The “tradition” of unreviewability upon which the majority relies is refuted most powerfully by a firmly entrenched body of lower court case law that holds reviewable various agency refusals to act.7 This case law recognizes that attempting to
To be sure, the Court no doubt takes solace in the view that it has created only a “presumption” of unreviewability, and that this “presumption may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers.” Ante, at 832-833. But this statement implies far too narrow a reliance on positive law, either statutory or constitutional, see ibid., as the sole source of limitations on agency discretion not to enforce. In my view, enforcement discretion is also channelled by traditional background understandings against which the
Perhaps the Court‘s reference to guidance from the “substantive statute” is meant to encompass such concerns and to allow the “common law” of judicial review of agency action to provide standards by which inaction can be reviewed. But in that case I cannot fathom what content the Court‘s “presumption of unreviewability” might have. If inaction can be reviewed to assure that it does not result from improper abnegation of jurisdiction, from complete abdication of statutory responsibilities, from violation of constitutional rights, or from factors that offend principles of rational and fair administrative process, it would seem that a court must always inquire into the reasons for the agency‘s action before deciding whether the presumption applies.12 As Judge Friendly said many years ago, review of even a decision over which substantial administrative discretion exists would then be available to determine whether that discretion had been
That is the basis upon which I would decide this case. Under
III
The problem of agency refusal to act is one of the pressing problems of the modern administrative state, given the enormous powers, for both good and ill, that agency inaction, like agency action, holds over citizens. As Dunlop v. Bachowski, 421 U. S. 560 (1975), recognized, the problems and dangers of agency inaction are too important, too prevalent, and too multifaceted to admit of a single facile solution under which “enforcement” decisions are “presumptively unreviewable.” Over time, I believe the approach announced today will come to be understood, not as mandating that courts
Notes
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).
To be sure, some of these cases involved the refusal to initiate rulemaking proceedings, and the majority expressly disavows any claim that
“‘[N]egative 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).
