DocketNumber: 83-1878
Judges: Rehnquist, Burger, Brennan, White, Blackmun, Powell, Stevens, O'Connor, Marshall
Filed Date: 3/20/1985
Status: Precedential
Modified Date: 10/19/2024
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, arid 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 — H
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*825 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.
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 “endangered] 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 un-reviewable, 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.
I — H I — I
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 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 South
This Court first discussed § (a)(2) in Citizens to Preserve Overton Park v. Volpe, 401 U. S. 402 (1971). That case dealt with the Secretary of Transportation’s approval of the building of an interstate highway through a park in Memphis, Tennessee. The relevant federal statute provided that the Secretary “shall not approve” any program or project using public parkland unless the Secretary first determined that no feasible alternatives were available. Id., at 411. Interested citizens challenged the Secretary’s approval under the APA, arguing that he had not satisfied the substantive statute’s requirements. This Court first addressed the “threshold question” of whether the agency’s action was at all reviewable. After setting out the language of § 701(a), the Court stated:
*830 “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
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.” 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 pre
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 un-reviewability. 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
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
Ill
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
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.
“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
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., Adams v. Richardson, 156 U. S. App. D. C. 267, 480 F. 2d 1159 (1973) (en bane). 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 Regis