U.S. Supreme Court Heckler v. Chaney, 470
U.S. 821 (1985) Heckler v. Chaney No. 83-1878 Argued December 3,
1984 Decided March 20,
1985 470
U.S. 821 CERTIORARI TO THE UNITED STATES
COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA
CIRCUIT Syllabus Respondent prison inmates were convicted of capital offenses and
sentenced to death by lethal injection of drugs. They petitioned
the Food and Drug Administration (FDA), alleging that use of the
drugs for such a purpose violated the Federal Food, Drug, and
Cosmetic Act (FDCA), and requesting that the FDA take various
enforcement actions to prevent those violations. The FDA refused
the request. Respondents then brought an action in Federal District
Court against petitioner Secretary of Health and Human Services,
making the same claim and seeking the same enforcement actions. The
District Court granted summary judgment for petitioner, holding
that nothing in the FDCA indicated an intent to circumscribe the
FDA's enforcement discretion or to make it reviewable. The Court of
Appeals reversed. Noting that the Administrative Procedure Act
(APA) only precludes judicial review of federal agency action when
it is precluded by statute, 5 U.S.C. § 701(a)(1), or "committed to
agency discretion by law," § 701(a)(2), the court held that §
701(a)(2)'s exception applies only where the substantive statute
leaves the courts with "no law to apply," that here there was "law
to apply," that therefore the FDA's refusal to take enforcement
action was reviewable, and that, moreover, such refusal was an
abuse of discretion. Held: The FDA's decision not to take the enforcement
actions requested by respondents was not subject to review under
the APA. Pp. 470 U. S.
827 -838.

															(a) Under § 701(a)(2), judicial review of an administrative
agency's decision is not to be had if the statute in question is
drawn so that a court would have no meaningful standard against
which to judge the agency's exercise of discretion. In such a case,
the statute ("law") can be taken to have "committed" the
decisionmaking to the agency's judgment absolutely. An agency's
decision not to take enforcement action is presumed immune from
judicial review under § 701(a)(2). Such a decision has
traditionally been "committed to agency discretion," and it does
not appear that Congress, in enacting the APA, intended to alter
that tradition. Accordingly, such a decision is unreviewable unless
Congress has indicated an intent to circumscribe agency
enforcement Page 470 U. S. 822 discretion, and has provided meaningful standards for defining
the limits of that discretion. Pp. 827- 470 U. S.
835 .

															(b) The presumption that agency decisions not to institute
enforcement proceedings are unreviewable under § 701(a)(2) is not
overcome by the enforcement provisions of the FDCA. Those
provisions commit complete discretion to the Secretary to decide
how and when they should be exercised. The FDCA's prohibition of
"misbranding" of drugs and introduction of "new drugs," absent
agency approval, does not supply this Court with "law to apply."
Nor can the FDA's "policy statement" indicating that the agency
considered itself "obligated" to take certain investigative actions
be plausibly read to override the agency's rule expressly stating
that the FDA Commissioner shall object to judicial review of a
decision to recommend or not to recommend civil or criminal
enforcement action. And the section of the FDCA providing that the
Secretary need not report for prosecution minor violations of the
Act does not give rise to the negative implication that the
Secretary is required to investigate purported, "major" violations
of the Act. Pp. 470 U. S.
835 -837.

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

															REHNQUIST, J., delivered the opinion of the Court, in which
BURGER, C.J., and BRENNAN, WHITE, BLACKMUN, POWELL, STEVENS, and
O'CONNOR, JJ., joined. BRENNAN, J., filed a concurring opinion, post, p. 470 U. S. 838 .
MARSHALL, J., filed an opinion concurring in the judgment, post, p. 470 U. S.
840 . Page 470 U. S. 823 JUSTICE REHNQUIST delivered the opinion of the Court.

															This case presents the question of the extent to which a
decision of an administrative agency to exercise its "discretion"
not to undertake certain enforcement actions is subject to judicial
review under the Administrative Procedure Act, 5 U.S.C. § 501 et seq. (APA). Respondents are several prison inmates
convicted of capital offenses and sentenced to death by lethal
injection of drugs. They petitioned the Food and Drug
Administration (FDA), alleging that, under the circumstances, the
use of these drugs for capital punishment violated the Federal
Food, Drug, and Cosmetic Act, 52 Stat. 1040, as amended, 21 U.S.C.
§ 301 et seq. (FDCA), and requesting that the FDA take
various enforcement actions to prevent these violations. The FDA
refused their request. We review here a decision of the Court of
Appeals for the District of Columbia Circuit, which held the FDA's
refusal to take enforcement actions both reviewable and an abuse of
discretion, and remanded the case with directions that the agency
be required "to fulfill its statutory function." 231 U.S.App.D.C.
136, 153, 718 F.2d 1174, 1191 (1983). I Respondents have been sentenced to death by lethal injection of
drugs under the laws of the States of Oklahoma and Texas. Those
States, and several others, have recently adopted this method for
carrying out the capital sentence. Respondents first petitioned the
FDA, claiming that the drugs used by the States for this purpose,
although approved by the FDA for the medical purposes stated on
their labels, were not approved for use in human executions. They
alleged that the drugs had not been tested for the purpose for
which they were to be used, and that, given that the drugs would
likely be administered by untrained personnel, it was also likely
that the drugs would not induce the quick and painless death
intended. They urged that use of these drugs for human execution
was the "unapproved use of an approved drug," and Page 470 U. S. 824 constituted a violation of the Act's prohibitions against
"misbranding." [ Footnote 1 ]
They also suggested that the FDCA's requirements for approval of
"new drugs" applied, since these drugs were now being used for a
new purpose. Accordingly, respondents claimed that the FDA was
required to approve the drugs as "safe and effective" for human
execution before they could be distributed in interstate commerce. See 21 U.S.C. § 355. They therefore requested the FDA to
take various investigatory and enforcement actions to prevent these
perceived violations; they requested the FDA to affix warnings to
the labels of all the drugs stating that they were unapproved and
unsafe for human execution, to send statements to the drug
manufacturers and prison administrators stating that the drugs
should not be so used, and to adopt procedures for seizing the
drugs from state prisons and to recommend the prosecution of all
those in the chain of distribution who knowingly distribute or
purchase the drugs with intent to use them for human execution.

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

															"Were FDA clearly to have jurisdiction in the area, moreover, we
believe we would be authorized to decline to exercise it under our
inherent discretion to decline to pursue certain enforcement
matters. The unapproved use of approved drugs is an area in which
the case law is far from uniform. Generally, enforcement
proceedings in this area are initiated only when there is a
serious Page 470 U. S. 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.
[ Footnote 2 ] Jurisdiction was
grounded in the general federal question jurisdiction statute, 28
U.S.C. § 1331, and review of the agency action was sought under the
judicial review provisions of the APA, 5 U.S.C. §§ 701706. The
District Court granted summary judgment for petitioner. It began
with the proposition that

															"decisions of executive departments and agencies to refrain from instituting investigative and enforcement
proceedings are essentially unreviewable by the courts." Chaney v. Schweiker, Civ. No. 81-2265 (DC, Aug. 30,
1982), App. to Pet. for Cert. 74a (emphasis in original). The court
then cited case law stating that nothing in the FDCA indicated an
intent to circumscribe the FDA's enforcement discretion or to make
it reviewable.

															A divided panel of the Court of Appeals for the District of
Columbia Circuit reversed. The majority began by discussing the
FDA's jurisdiction over the unapproved use of approved drugs for
human execution, and concluded that the FDA did have jurisdiction
over such a use. The court then addressed the Government's
assertion of unreviewable discretion Page 470 U. S. 826 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 , 387 U. S.
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 401 U. S.
410 ). The court cited Dunlop as holding that
this presumption "applies with no less force to review of . . .
agency decisions to refrain from enforcement action." 231
U.S.App.D.C. at 146, 718 F.2d at 1184. The court found "law to
apply" in the form of a FDA policy statement which indicated that
the agency was "obligated" to investigate the unapproved use of an
approved drug when such use became "widespread" or"endanger[ed] the
public health." Id. at 148, 718 F.2d at 1186 (citing 37
Fed.Reg. 16504 (1972)). The court held that this policy statement
constituted a "rule," and was considered binding by the FDA. Given
the policy statement indicating that the FDA should take
enforcement action in this area, and the strong presumption that
all agency action is subject to judicial review, the court
concluded that review of the agency's refusal was not foreclosed.
It then proceeded to assess whether the agency's decision not to
act was "arbitrary, capricious, or an abuse of discretion." Citing
evidence that the FDA assumed Page 470 U. S. 827 jurisdiction over drugs used to put animals to sleep [ Footnote 3 ] and the unapproved uses of
drugs on prisoners in clinical experiments, the court found that
the FDA's refusal, for the reasons given, was irrational, and that
respondents' evidence that use of the drugs could lead to a cruel
and protracted death was entitled to more searching consideration.
The court therefore remanded the case to the District Court, to
order the FDA "to fulfill its statutory function."

															The dissenting judge expressed the view that an agency's
decision not to institute enforcement action generally is
unreviewable, and that such exercises of "prosecutorial discretion"
presumptively fall within the APA's exception for agency actions
"committed to agency discretion by law." He noted that
traditionally courts have been wary of second-guessing agency
decisions not to enforce, given the agency's expertise and better
understanding of its enforcement policies and available resources.
He likewise concluded that nothing in the FDCA or FDA regulations
would provide a basis for a court's review of this agency decision.
A divided Court of Appeals denied the petition for rehearing. 233
U.S.App.D.C. 146, 724 F.2d 1030 (1984). We granted certiorari to
review the implausible result that the FDA is required to exercise
its enforcement power to ensure that States only use drugs that are
"safe and effective" for human execution. 467 U.S. 1251 (1984). We
reverse. II The Court of Appeals' decision addressed three questions: (1)
whether the FDA had jurisdiction to undertake the enforcement
actions requested, (2) whether if it did have jurisdiction Page 470 U. S. 828 its refusal to take those actions was subject to judicial
review, and (3) whether, if reviewable, its refusal was arbitrary,
capricious, or an abuse of discretion. In reaching our conclusion
that the Court of Appeals was wrong, however, we need not and do
not address the thorny question of the FDA's jurisdiction. For us,
this case turns on the important question of the extent to which
determinations by the FDA not to exercise its enforcement
authority over the use of drugs in interstate commerce may be
judicially reviewed. That decision in turn involves the
construction of two separate but necessarily interrelated statutes,
the APA and the FDCA.

															The APA's comprehensive provisions for judicial review of
"agency actions" are contained in 5 U.S.C. §§ 701-706. Any person
"adversely affected or aggrieved" by agency action, see §
702, including a "failure to act," is entitled to "judicial review
thereof," as long as the action is a "final agency action for which
there is no other adequate remedy in a court," see § 704.
The standards to be applied on review are governed by the
provisions of § 706. But before any review at all may be had, a
party must first clear the hurdle of § 701(a). That section
provides that the chapter on judicial review

															"applies, according to the provisions thereof, except to the
extent that -- (1) statutes preclude judicial review; or (2) agency
action is committed to agency discretion by law."

															Petitioner urges that the decision of the FDA to refuse
enforcement is an action "committed to agency discretion by law"
under § 701(a)(2).

															This Court has not had occasion to interpret this second
exception in § 701(a) in any great detail. On its face, the section
does not obviously lend itself to any particular construction;
indeed, one might wonder what difference exists between § (a)(1)
and § (a)(2). The former section seems easy in application; it
requires construction of the substantive statute involved to
determine whether Congress intended to preclude judicial review of
certain decisions. That is the approach taken with respect to §
(a)(1) in cases such as Southern Page 470 U. S. 829 R. Co. v. Seaboard Allied Milling Corp, 442 U.
S. 444 (1979), and Dunlop v. Bachowski, 421
U.S. at 421 U. S. 567 .
But one could read the language "committed to agency discretion by law " in § (a)(2) to require a similar inquiry. In
addition, commentators have pointed out that construction of §
(a)(2) is further complicated by the tension between a literal
reading of § (a)(2), which exempts from judicial review those
decisions committed to agency "discretion," and the primary scope
of review prescribed by § 706(2)(A) -- whether the agency's action
was "arbitrary, capricious, or an abuse of discretion. "
How is it, they ask, that an action committed to agency discretion
can be unreviewable and yet courts still can review agency actions
for abuse of that discretion? See 5 K. Davis,
Administrative Law § 28:6 (1984) (hereafter Davis); Berger,
Administrative Arbitrariness and Judicial Review, 65 Colum.L.Rev.
55, 58 (1965). The APA's legislative history provides little help
on this score. Mindful, however, of the common-sense principle of
statutory construction that sections of a statute generally should
be read "to give effect, if possible, to every clause . . . ," see United States v. Menasche, 348 U.
S. 528 , 348 U. S.
538 -539 (1955), we think there is a proper construction
of §(a)(2) which satisfies each of these concerns.

															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 401 U. S. 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: Page 470 U. S. 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 , 387 U. S. 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 401 U. S. 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 Page 470 U. S. 831 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 , 442 U. S.
123 -124 (1979); United States v. Nixon, 418 U. S. 683 , 418 U. S. 693 (1974); Vaca v. Sipes, 386 U. S. 171 , 386 U. S. 182 (1967); Confiscation
Cases , 7 Wall. 454 (1869). This recognition of the
existence of discretion is attributable in no small part to the
general unsuitability for judicial review of agency decisions to
refuse enforcement.

															The reasons for this general unsuitability are many. First, an
agency decision not to enforce often involves a complicated
balancing of a number of factors which are peculiarly within its
expertise. Thus, the agency must not only assess whether a
violation has occurred, but whether agency resources are best spent
on this violation or another, whether the agency is likely to
succeed if it acts, whether the particular enforcement action
requested best fits the agency's overall policies, and, indeed,
whether the agency has enough resources to undertake the action at
all. An agency generally cannot act against each technical
violation of the statute it is charged with enforcing. The agency
is far better equipped than the courts to deal with the many
variables involved Page 470 U. S. 832 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 , 435 U. S. 543 (1978); Train v. Natural Resources Defense Council, Inc., 421 U. S. 60 , 421 U. S. 87 (1975).

															In addition to these administrative concerns, we note that, when
an agency refuses to act, it generally does not exercise its
coercive power over an individual's liberty or property rights, and
thus does not infringe upon areas that courts often are called upon
to protect. Similarly, when an agency does act to enforce,
that action itself provides a focus for judicial review, inasmuch
as the agency must have exercised its power in some manner. The
action at least can be reviewed to determine whether the agency
exceeded its statutory powers. See, e.g., FTC v. Klesner, 280 U. S. 19 (1929). Finally, we recognize that an agency's refusal to institute
proceedings shares to some extent the characteristics of the
decision of a prosecutor in the Executive Branch not to indict -- a
decision which has long been regarded as the special province of
the Executive Branch, inasmuch as it is the Executive who is
charged by the Constitution to "take Care that the Laws be
faithfully executed." U.S.Const., Art. II, § 3.

															We of course only list the above concerns to facilitate
understanding of our conclusion that an agency's decision not to
take enforcement action should be presumed immune from judicial
review under § 701(a)(2). For good reasons, such a decision has
traditionally been "committed to agency discretion," and we believe
that the Congress enacting the APA did not intend to alter that
tradition. Cf. 5 Davis § 28:5 (APA did not significantly
alter the "common law" of judicial review of agency action). In so
stating, we emphasize that the decision is only presumptively
unreviewable; the presumption Page 470 U. S. 833 may be rebutted where the substantive statute has provided
guidelines for the agency to follow in exercising its enforcement
powers. [ Footnote 4 ] Thus, in
establishing this presumption in the APA, Congress did not set
agencies free to disregard legislative direction in the statutory
scheme that the agency administers. Congress may limit an agency's
exercise of enforcement power if it wishes, either by setting
substantive priorities or by otherwise circumscribing an agency's
power to discriminate among issues or cases it will pursue. How to
determine when Congress has done so is the question left open by Overton Park. Dunlop v. Bachowski, 421 U. S. 560 (1975), relied upon heavily by respondents and the majority in the
Court of Appeals, presents an example of statutory language which
supplied sufficient standards to rebut the presumption of
unreviewability. Dunlop involved a suit by a union
employee, under the Labor-Management Reporting and Disclosure Act,
29 U.S.C. § 481 et seq. (LMRDA), asking the Secretary of
Labor to investigate and file suit to set aside a union election.
Section 482 provided that, upon filing of a complaint by a union
member,

															"[t]he Secretary shall investigate such complaint and, if he
finds probable cause to believe that a violation . . . has occurred
. . . he shall . . . bring a civil action. . . ."

															After investigating the plaintiff's claims, the Secretary of
Labor declined to file suit, and the plaintiff sought judicial
review under the APA. This Court held that Page 470 U. S. 834 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 421 U. S. 567 ,
n. 7. Our textual references to the "strong presumption" of
reviewability in Dunlop were addressed only to the §
(a)(1) exception; we were content to rely on the Court of Appeals'
opinion to hold that the § (a)(2) exception did not apply. The
Court of Appeals, in turn, had found the "principle of absolute
prosecutorial discretion" inapplicable, because the language of the
LMRDA indicated that the Secretary was required to file suit if
certain "clearly defined" factors were present. The decision
therefore was not " beyond the judicial capacity to supervise.'" Bachowski v. Brennan, 502 F.2d 79, 87-88 (CA3 1974)
(quoting Davis § 28.16, p. 984 (1970 Supp.)). Dunlop is thus consistent with a general presumption of
unreviewability of decisions not to enforce. The statute being
administered quite clearly withdrew discretion from the agency and
provided guidelines for exercise of its enforcement power. Our
decision that review was available was not based on "pragmatic
considerations," such as those cited by the Court of Appeals, see 231 U.S.App.D.C. at 147, 718 F.2d at 1185, that amount
to an assessment of whether the interests at stake are important
enough to justify intervention in the agencies' decisionmaking. The
danger that agencies may not carry out their delegated powers with
sufficient vigor does not necessarily lead to the conclusion that
courts are the most appropriate body to police this aspect of their
performance. That decision is in the first instance for Congress,
and we therefore turn to the FDCA to determine whether in this case
Congress has provided us with "law to apply." If it has indicated
an intent to circumscribe agency enforcement discretion, and has
provided meaningful standards for defining the limits of that
discretion, there is "law to apply" under § 701(a)(2), and
courts Page 470 U. S. 835 may require that the agency follow that law; if it has not, then
an agency refusal to institute proceedings is a decision "committed
to agency discretion by law" within the meaning of that
section. III To enforce the various substantive prohibitions contained in the
FDCA, the Act provides for injunctions, 21 U.S.C. § 332, criminal
sanctions, §§ 333 and 335, and seizure of any offending food, drug,
or cosmetic article, § 334. The Act's general provision for
enforcement, § 372, provides only that "[t]he Secretary is authorized to conduct examinations and investigations . .
." (emphasis added). Unlike the statute at issue in Dunlop, § 332 gives no indication of when an injunction
should be sought, and § 334, providing for seizures, is framed in
the permissive -- the offending food, drug, or cosmetic "shall be
liable to be proceeded against." The section on criminal sanctions
states baldly that any person who violates the Act's substantive
prohibitions "shall be imprisoned . . . or fined." Respondents
argue that this statement mandates criminal prosecution of every
violator of the Act, but they adduce no indication in case law or
legislative history that such was Congress' intention in using this
language, which is commonly found in the criminal provisions of
Title 18 of the United States Code. See, e.g., 18 U.S.C. §
471 (counterfeiting); 18 U.S.C. § 1001 (false statements to
Government officials); 18 U.S.C. § 1341 (mail fraud). We are
unwilling to attribute such a sweeping meaning to this language,
particularly since the Act charges the Secretary only with
recommending prosecution; any criminal prosecutions must be
instituted by the Attorney General. The Act's enforcement
provisions thus commit complete discretion to the Secretary to
decide how and when they should be exercised.

															Respondents nevertheless present three separate authorities that
they claim provide the courts with sufficient indicia of an intent
to circumscribe enforcement discretion. Two of these may be dealt
with summarily. First, we reject Page 470 U. S. 836 respondents' argument that the Act's substantive prohibitions of
"misbranding" and the introduction of "new drugs" absent agency
approval, see 21 U.S.C. §§ 352(f)(1), 355, supply us with
"law to apply." These provisions are simply irrelevant to the
agency's discretion to refuse to initiate proceedings.

															We also find singularly unhelpful the agency "policy statement"
on which the Court of Appeals placed great reliance. We would have
difficulty with this statement's vague language even if it were a
properly adopted agency rule. Although the statement indicates that
the agency considered itself "obligated" to take certain
investigative actions, that language did not arise in the course of
discussing the agency's discretion to exercise its enforcement
power, but rather in the context of describing agency policy with
respect to unapproved uses of approved drugs by physicians. In
addition, if read to circumscribe agency enforcement discretion,
the statement conflicts with the agency rule on judicial review, 21
CFR § 10.45(d)(2) (1984), which states that

															"[t]he Commissioner shall object to judicial review . . . if (i)
[t]he matter is committed by law to the discretion of the
Commissioner, e.g., a decision to recommend or not to
recommend civil or criminal enforcement action. . . ."

															But in any event, the policy statement was attached to a rule
that was never adopted. Whatever force such a statement might have,
and leaving to one side the problem of whether an agency's rules
might under certain circumstances provide courts with adequate
guidelines for informed judicial review of decisions not to
enforce, we do not think the language of the agency's "policy
statement" can plausibly be read to override the agency's express
assertion of unreviewable discretion contained in the above rule.
[ Footnote 5 ] Page 470 U. S. 837 Respondents' third argument, based upon § 306 of the FDCA,
merits only slightly more consideration. That section provides:

															"Nothing in this chapter shall be construed as requiring the
Secretary to report for prosecution, or for the institution of
libel or injunction proceedings, minor violations of this chapter
whenever he believes that the public interest will be adequately
served by a suitable written notice or ruling."

															21 U.S.C. § 336.

															Respondents seek to draw from this section the negative
implication that the Secretary is required to report for
prosecution all "major" violations of the Act, however those might
be defined, and that it therefore supplies the needed indication of
an intent to limit agency enforcement discretion. We think that
this section simply does not give rise to the negative implication
which respondents seek to draw from it. The section is not
addressed to agency proceedings designed to discover the existence
of violations, but applies only to a situation where a violation
has already been established to the satisfaction of the agency. We
do not believe the section speaks to the criteria which shall be
used by the agency for investigating possible violations of the
Act. IV We therefore conclude that the presumption that agency decisions
not to institute proceedings are unreviewable under 5 U.S.C. §
701(a)(2) is not overcome by the enforcement provisions of the
FDCA. The FDA's decision not to take the Page 470 U. S. 838 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 , 415 U. S. 366 (1974); Yick Wo v. Hopkins, 118 U.
S. 356 , 118 U. S.
372 -374 (1886). The fact that the drugs involved in this
case are ultimately to be used in imposing the death penalty must
not lead this Court or other courts to import profound differences
of opinion over the meaning of the Eighth Amendment to the United
States Constitution into the domain of administrative law.

															The judgment of the Court of Appeals is Reversed. [ Footnote 1 ] 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. . . ."

															[ Footnote 2 ]

															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.

															[ Footnote 3 ]

															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."

															[ Footnote 4 ]

															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 (197) (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."

															[ Footnote 5 ]

															Respondents also urge, as did the Court of Appeals, that a
statement by the FDA's lawyers in a footnote to to their
"memorandum in support of dismissal" in the District Court
indicates that the agency considers the "policy statement"
"binding." The footnote said that the "Federal Register notice . .
. sets forth the agency's current position o[n] the legal status of
approved labeling for prescription drugs." The statement from the
memorandum cites no authority, is taken out of context, and, on its
face, does not indicate that the agency considered this position
"binding" in any sense of the word. Moreover, we find it difficult
to believe that statements of agency counsel in litigation against
private individuals can be taken to establish "rules" that bind an
entire agency prospectively. Such would turn orderly process on its
head.

															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, 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
nonenforcement decisions. See Citizens to Preserve Overton Park
v. Volpe, 401 U. S. 402 , 401 U. S. 410 (1971). Page 470 U. S. 839 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 470 U. S. 833 .
Thus, the Court properly does not decide today that nonenforcement
decisions are unreviewable in cases where (1) an agency flatly
claims that it has no statutory jurisdiction to reach certain
conduct, ante at 470 U. S. 833 ,
n. 4; (2) an agency engages in a pattern of nonenforcement 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 470 U. S. 833 ,
n. 4; (3) an agency has refused to enforce a regulation lawfully
promulgated and still in effect, ante at 470 U. S. 836 ;
[ Footnote 2/1 ] or (4) a
nonenforcement decision violates constitutional rights, ante at 470 U. S. 838 .
It is possible to imagine other nonenforcement decisions made for
entirely illegitimate reasons, for example, nonenforcement 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 nonenforcement 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.

															On this understanding of the scope of today's decision, I join
the Court's opinion. [ Footnote
2/2 ] Page 470 U. S. 840 [ Footnote 2/1 ] Cf. Motor Vehicle Manufacturers Assn. v. State Farm Mutual
Ins. Co., 463 U. S. 29 , 463 U. S. 40 -44
(1983) (failure to revoke lawfully a previously promulgated rule is
reviewable under the APA).

															[ Footnote 2/2 ]

															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 , 428 U. S. 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 470 U. S.
838 .

															JUSTICE MARSHALL, concurring in the judgment.

															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 470 U. S. 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 Page 470 U. S. 841 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 Administrative Procedure Act, such a
statement is required when an agency denies a "written application,
petition, or other request of an interested person made in
connection with any agency proceedings." [ Footnote 3/1 ] 5 U.S.C. § 555(e). Whether this written
explanation was legally required or not, however, it does provide a
sufficient Page 470 U. S. 842 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 470 U. S.
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.

															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 Page 470 U. S. 843 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. This "presumption of unreviewability" is also a far cry from
prior understandings of the Administrative Procedure Act. As the
Court acknowledges, the APA presumptively entitles any person
"adversely affected or aggrieved by agency action," 5 U.S.C. § 702
-- which is defined to include the "failure to act," 5 U.S.C. §
551(13) -- to judicial review of that action. That presumption can
be defeated if the substantive statute precludes review, §
701(a)(1), or if the action is committed to agency discretion by law, § 701(a)(2), but, as Justice Harlan's opinion in Abbott Laboratories v. Gardner, 387 U.
S. 136 (1967), made clear in interpreting the APA's
judicial review provisions:

															"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 387 U. S.
140 -141 (citations omitted; footnote omitted). See
generally H.R.Rep. No.1980, 79th Cong., 2d Sess., 41 (1946)
(to preclude APA review, a statute "must, upon its face, Page 470 U. S. 844 give clear and convincing evidence of an intent to withhold
it"); cf. Moog Industries, Inc. v. FTC, 355 U.
S. 411 , 355 U. S. 414 (1958) (Federal Trade Commission decisions to prosecute are
reviewable and can be overturned when "patent abuse of discretion"
demonstrated). [ Footnote 3/2 ]
Rather than confront Abbott Laboratories, perhaps the
seminal case on judicial review under the APA, the Court chooses
simply to ignore it. [ Footnote 3/3 ]
Instead, to support its new-found "presumption of unreviewability,"
the Court resorts to completely undefined and unsubstantiated
references to "tradition," see ante at 470 U. S. 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). [ Footnote 3/4 ] 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. Page 470 U. S. 845 Yet these cases hardly support such a broad presumption with
respect to agency refusal to take enforcement action. The only one
of these cases to involve administrative action, Vaca v.
Sipes, suggests, in dictum, that the General Counsel of the
National Labor Relations Board has unreviewable discretion to
refuse to initiate an unfair labor practice complaint. To the
extent this dictum is sound, later cases indicate that
unreviewability results from the particular structure of the
National Labor Relations Act and the explicit statutory intent to
withdraw review found in 29 U.S.C. § 153(d), rather than from some
general "presumption of unreviewability" of enforcement decisions. See NLRB v. Sears, Roebuck & Co., 421 U.
S. 132 , 421 U. S. 138 (1975). [ Footnote 3/5 ] Neither Vaca nor Sears, Roebuck discusses the APA. The
other three cases -- Batchelder, Nixon, and the Confiscation Cases -- all involve prosecutorial discretion
to enforce the criminal law. Batchelder does not maintain
that such discretion is unreviewable, but only that the mere
existence of prosecutorial discretion does not violate the
Constitution. The Confiscation Cases, involving suits to
confiscate property used in aid of rebellion, hold that, where the
United States brings a criminal action that is "wholly for the
benefit of the United States," 7 Wall. at 74 U. S. 455 , a
person who provides information leading to the action has no
"vested" or absolute right to demand, "so far as the interests of
the United States are concerned," id. at 74 U. S. 458 ,
that the action be maintained. The half-sentence cited from Nixon, which states that the Executive has "absolute
discretion to decide whether to prosecute a case," 418 U.S. at 418 U. S. 693 ,
is the only apparent support the Court actually offers for even the
limited notion that prosecutorial discretion in the criminal area
is unreviewable. But that half-sentence is, of course, misleading,
for Nixon held it an abuse of that discretion Page 470 U. S. 846 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.

															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 , 417 U. S. 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 , 468 U. S. 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 , 404 U. S. 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 Page 470 U. S. 847 be, there are undoubtedly constitutional limits upon its
exercise." Id. at 434 U. S. 365 . See also Wayte v. United States, ante at 470 U. S. 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 , 446 U. S. 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 , 410 U. S. 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. 470 U. S. 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 Page 470 U. S. 848 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 446 U. S.
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 narro[w] 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 , 342 U. S. 101 (1951). Page 470 U. S. 849 For these and other reasons, [ Footnote 3/6 ] reliance on prosecutorial discretion,
itself a fading talisman, to justify the unreviewabilty of agency
inaction is inappropriate. See generally Stewart &
Sunstein, Public Programs and Private Rights, 95 Harv.L.Rev. 1195,
1285-1286, n. 386 (1982) (discussing differences between agency
inaction and prosecutorial discretion); Note, Judicial Review of
Administrative Inaction, 83 Colum.L.Rev. 627, 658-661 (1983)
(same). To the extent arguments about traditional notions of
prosecutorial discretion have any force at all in this context,
they ought to apply only Page 470 U. S. 850 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. 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. [ Footnote 3/7 ] This case
law recognizes that attempting to Page 470 U. S. 851 draw a line for purposes of judicial review between affirmative
exercises of coercive agency power and negative agency refusals to
act, see ante at 470 U. S. 832 ,
is simply untenable; one of the very purposes fueling the birth of
administrative agencies was the reality that governmental refusal
to act could have just as devastating an effect upon life, liberty,
and the pursuit of happiness as coercive governmental action. As
Justice Frankfurter, a careful and experienced student of
administrative law, wrote for this Court,

															"any distinction, as such, between 'negative' and 'affirmative'
orders, as a touchstone of jurisdiction to review [agency action]
serves no useful purpose." Rochester Telephone Corp. v. United States, 307 U. S. 125 , 307 U. S. 143 (1939). [ Footnote 3/8 ] The lower
courts, facing Page 470 U. S. 852 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.

															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 470 U. S.
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 APA was enacted and which Congress hardly could be
thought to have intended to displace in the APA. [ Footnote 3/9 ] For example, a refusal to enforce
that stems from a conflict of interest, that is the result of a
bribe, vindictiveness or retaliation, or that traces to personal or
other corrupt motives ought to be judicially remediable. [ Footnote 3/10 ] Even in the absence Page 470 U. S. 853 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.
[ Footnote 3/11 ] 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.

															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.
[ Footnote 3/12 ] 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 Page 470 U. S. 854 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). 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 Page 470 U. S. 855 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.

															[ Footnote 3/1 ]

															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 421 U. S.
571 -575; id. at 421 U. S. 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 470 U. S. 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.

															[ Footnote 3/2 ]

															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).

															[ Footnote 3/3 ]

															The Court did not ignore Abbott Laboratories in Southern R. Co. v. Seaboard Allied Milling Corp., 442 U. S. 444 , 442 U. S. 454 , 442 U. S.
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.

															[ Footnote 3/4 ]

															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.

															[ Footnote 3/5 ] 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).

															[ Footnote 3/6 ]

															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, 39 U. S.
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).

															[ Footnote 3/7 ] 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 470 U. S. 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.

															[ Footnote 3/8 ]

															Justice Frankfurter went to some length in Rochester
Telephone to expose the fallacy of any purported distinction
between agency action and inaction:

															"'[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 307 U. S.
140 -142 (emphasis added; footnotes omitted).

															[ Footnote 3/9 ]

															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 , 456 U. S. 378 (1982) ("[W]e must examine Congress' perception of the law that it
was shaping or reshaping").

															[ Footnote 3/10 ]

															"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 , 446 U. S.
249 -250 (1980).

															[ Footnote 3/11 ]

															Indeed,

															"[t]he 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).

															[ Footnote 3/12 ]

															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.

Summary: The Supreme Court ruled that the Food and Drug Administration's (FDA) decision not to take enforcement action against the use of certain drugs for lethal injection in capital punishment cases is not subject to judicial review under the Administrative Procedure Act (APA). The Court found that agency decisions not to enforce are presumed immune from judicial review and that the Federal Food, Drug, and Cosmetic Act (FDCA) does not provide meaningful standards for defining the limits of the FDA's discretion in this case.