MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES,
PETITIONER V. LARRY LEON CHANEY, ET AL.

   No. 83-1878

   In the Supreme Court of the United States

   October Term, 1983

   The Solicitor General, on behalf of the Secretary of Health and
Human Services, petitions for a writ of certiorari to review the
judgment of the United States Court of Appeals for the District of
Columbia Circuit in this case.

   Petition for a Writ of Certiorari to The United States Court of
Appeals for the District of Columbia Circuit

                      PARTIES TO THE PROCEEDINGS

   Margaret M. Heckler, Secretary of Health and Human Services, is the
only petitioner.  In addition to Larry Leon Chaney, the respondents
are Alton Franks, Carl Morgan, Charles W. Davis, Robyn Parks, Doyle
Skillern, Jerry Joe Bird, and Henry Martinez Porter.

            TABLE OF CONTENTS
   Opinions below
   Jurisdiction
   Statutes involved
   Statement
   Reasons for granting the petition
   Conclusion
   Appendix

                            OPINIONS BELOW

   The opinion of the ocurt of appeals (App., infra, 1a-58a) is
reported at 718 F.2d 1174.  The opinion on denial of rehearing (App.,
infra, 59a-62a) is reported at 724 F.2d 1030.  The opinion of the
district court (App., infra, 63a-79a) and the decision of the Food and
Drug Administration (App., infra, 81a-86a) are unreported.

                             JURISDICTION

   The judgment of the court of appeals was entered on October 14,
1983.  A timely petition for rehearing was denied on Januray 17, 1984.
 By order of April 12, 1984, the Chief Justice extended the time
within which to file a petition for a writ of certiorari until May 16,
1984.  The jurisdiction of this Court is invoked under 28 U.S.C.
1254(a).

                           STATUTES INVOLVED

   Relevant provisions of the Administrative Procedure Act, 5 U.S.C.
551 et seq., and the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C.
301 et seq., are reprinted at App., infra, 95a-96a.

                          QUESTIONS PRESENTED

   1. Whether the Administrative Procedure Act, 5 U.S.C. 701-706,
authorizes judicial review of the Food and Drug Administration's
decision not to regulate the states' use, in carrying out capital
punishment by lethal injection, of drugs that have been approved for
other purposes but that have not been found to be "safe and effective"
as a means of causing death.

   2. If the FDA'S decision not to regulate the states' use of drugs
in carrying out capital punishment by lethal injection is subject to
judicial review, whether that decision was properly overturned.

                               STATEMENT

   In recent years, numerous states have enacted statutes prescribing
lethal injection as the method for carrying out the death penalty.
/1/ In this case, prison inmates sentenced to death by lethal
injection in Texas and Oklahoma petitioned the Food and Drug
Administration (FDA) to block their executions on the ground that the
states proposed to employ drugs that had been approved by the FDA as
safe and effective for medical purposes but not for human execution.
Respondents asserted that their execution by this means would violate
the "misbranding" provisions of the Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. 331(k), 352.  They requested the FDA, among other
things, to "(a)dopt a policy and procedure for the seizure and
condemnation from prisons or state departments of corrections of drugs
which are destined or held for use as a means of execution" and to
recommend the criminal prosecution of prison officials and others who
"knowingly buy, possess, (sell) or use drugs for the unapproved use of
lethal injections" (App., infra, 6a).

   The FDA declined to take the requested enforcement actions.  It
concluded (App., infra, 81a-86a) that it lacked jurisdiction under the
FDCA and that, in any event, it would decline to act as a matter of
its enforcement discretion.  The Commissioner of Food and Drugs stated
(id. at 82a, 85a);

         Our conclusion that the use of lethal injection is not
      subject to our jurisdiction is supported by the relevant
      statutory provisions, by our current policy on the use of
      approved drugs for unapproved uses, and by a consideration of
      the proper role of the Federal Government with respect to the
      conduct of State criminal justice systems.

                      * * * * *

      The unapproved use of approved drugs is an area in which the
      case law is far from uniform.  Generally, enforcement
      proceedings in this area are initiated only when there is a
      serious danger to the public health or a blatant scheme to
      defraud.  We cannot conclude that those dangers are present
      under State lethal injection laws, which are duly authorized
      statutory enactments in furtherance of proper state functions.

         Were FDA clearly to have jurisdiction in this area, moreover,
      we believe we would be authorized to decline to exercise it
      under our inherent discretion to decline to pursue certain
      enforcement matters.

   Plaintiffs then brought this suit for injunctive and declaratory
relief in the United States District Court for the District of
Columbia.  The district court dismissed the complaint on the ground
that the enforcement decisions of an agency are not subject to
judicial review.  App., infra, 63a-79a.

   A divided panel of the court of appeals vacated the district
court's judgment and remanded with directions "to order the agency to
fulfill its statutory function" (App., infra, 36a).  The court of
appeals concluded that the FDA has authority under 21 U.S.C. 331(k) to
regulate the use of drugs in administering capital punishment.  That
provision prohibits the "misbranding" of drugs while they are "held
for sale." The court apparently reasoned (App., infra, 14a-15a) that
the states' use of the drugs for an unapproved purpose constitutes
"misbranding" and that the drugs are "held for sale" when they are
injected into the person condemned to death.

   The court of appeals also held that the FDA'S decision not to
initiate enforcement activity was subject to judicial review (App.,
infra, 17a-30a).  In the court's view (id. at 18a-22a), all agency
action, including a decision not to begin enforcement proceedings, is
presumptively reviewable except in those situations "where the
governing statute is 'drawn in such broad terms that in a given case
there is no law to apply.'" The court observed (id. at 24a) that the
"determination of whether there 'is law to apply' turns on such
pragmatic considerations as whether judicial supervision is necessary
to safeguard plaintiff's interests, whether judicial review will
unnecessarily impede the agency in effectively carrying out its
congressionally assigned role, and whether the issues are appropriate
for judicial review.'" In this case, the court found "law to apply" in
the preface to an FDA rule proposed for notice and comment in 1972 but
never promulgated.  /2/ The court concluded (id. at 31a-35a) that the
FDA'S reasons for declining enforcement were irrational in light of
the preface and warned (id. at 37a):  "We must be prepared to compel
FDA to take action with respect to the (plaintiffs') prayer for relief
where an acceptable explanation of (FDA'S) inaction is not promptly
forthcoming." /3/

   Judge Scalia dissented (App., infra, 39a-58a), stating (id. at 39a)
that the majority's decision constituted "a clear intrusion upon
powers that belong to Congress, the Executive Branch, and the states."
He pointed out (id. at 46a) that "far from there being a 'presumption
of reviewability' with regard to enforcement determinations, the well
known presumption is precisely the contrary." Finding no special
circumstances justifying review in this case, Judge Scalia concluded
that review was unavailable.  He noted (id. at 49a-51a) that the
preamble on which the majority relied had never been adopted.  He also
observed (id. at 48a-49a) that even if the preamble had some effect,
it was "full of flexible terms, the precise application of which was
obviously intended to be, and could properly be, left to the
discretion of the agency -- for example whether an unapproved use has
become 'widespread.'"

   Moreover, assuming that the FDA'S decision not to undertake
enforcement action was judicially reviewable, Judge Scalia found
(App., infra, 51a-58a) that the FDA'S actions were not arbitrary and
capricious.  He concluded that the FDA had no statutory authority to
take the requested action because "(u)nder no conceivable
interpretation of the English language could (the drugs used in legal
injections) be deemed 'held for sale'" (id. at 55a).

   By a five-to-five vote, the court of appeals denied the
government's suggestion for rehearing en banc (App., infra, 59a-60a).
/4/ In a statement joined by Judges Wilkey, Bork, and Starr, Judge
Scalia stressed (id. at 60a) the significance of the holding of this
case to "the enforcement authority of all federal agencies."

                   REASONS FOR GRANTING THE PETITION

   The decision of the court of appeals is in direct conflict with
decisions of two other circuits.  It usurps the traditional
enforcement discretion of the executive branch and diverts the Food
and Drug Administration from the important responsibilities assigned
by Congress;  it unjustifiably interferes with the states' lawful
exercise of their power to enforce their criminal laws;  and it makes
a mockery of the Food, Drug, and Cosmetic Act.  Review by this Court
is clearly warranted.

   1. The decision below squarely conflicts with decisions of the
Fifth and Eighth Circuits.  In O'Bryan v. McKaskle, 729 F.2d 991
(1984) (App., infra, 88a-94a), a Texas prisoner sentenced to death by
lethal injection brought suit against the state authorities, claiming
among other things that execution by lethal injection violated the
Food, Drug, and Cosmetic Act as interpreted by the court of appeals in
the instant case.  Refusing to stay his execution, the Fifth Circuit
expressly disagreed with the court of appeals' decision in this case
(App., infra, 92a-93a):

      On theprobable merits of O'Bryan's claim of a violation of the
      Act, we think that for the reasons set forth in Judge Scalia's
      dissenting opinion in Chaney, O'Bryan's claim is insubstantial
      and he is unlikely to succeed on appeal.

   This Court also refused to enter a stay (O'Bryan v. McKaskle, Nos.
A-786 and A-787 (Mar. 30, 1984)), /5/ and O'Bryan was executed.

   The court of appeals' holding concerning judicial review of FDA
enforcement decisions conflicts with the Eighth Circuit's decision in
National Milk Producers Federation v. Harris, 653 F.2d 339, 340
(1981).  In that case, dairy producers sought to compel the FDA to
initiate "investigative, enforcement, or prosecutorial proceedings"
against persons alleged to be violating the FDCA by selling misbranded
cheese substitutes in interstate commerce.  Affirming the dismissal of
the dairy producers' complaint, the Eighth Circuit stated (653 F.2d at
343) that "(t)he executive branch and its departments enjoy a
discretion in the initiation of * * * enforcement * * * actions
limited only by constitutional strictures and relevant statutory
directives." The court concluded (id. at 344 (footnote omitted)):
"After carefully reviewing the (FDCA) we have found no provision which
narrows or limits the discretion of the FDA to investigate, enforce,
or prosecute alleged violations of the Act or its regulations."

   2. a.  The court of appeals' decision in this case is also plainly
wrong.  First, in holding that the FDA'S exercise of enforcement
discretion was subject to judicial review, the court departed
dramatically from settled principles of adminstrative law.

   The Administrative Procedure Act, 5 U.S.C. 701(a)(2), provides that
final agency action is not subject to judicial review if it is
"committed to agency discretion by law." This bar to judicial review
applies where the governing "'statutes are drawn in such broad terms
that in a given case there is no law to apply.'" Citizens to Preserve
Overton Park v. Volpe, 401 U.S. 402, 410 (1971) (quoting S. Rep. 752,
79th Cong., 1st Sess. 26 (1945)).

   This is a paradigmatic case in which the governing statute provides
"no law to apply." The FDCA does not command the FDA to initiate
investigative or enforcement activity whenever a statutory violation
is alleged or found.  /6/ Indeed, the Act does not even suggest the
standards to be used by the FDA in determining whether and when to
undertake such activity.  Instead, the Act confers upon the
Commissioner of Food and Drugs a "broad discretion -- broad enough
undoubtedly to enable him to perform his duties fairly without wasting
his efforts on what may be no more than technical infractions of the
law." United States v. Sullivan, 332 U.S. 689, 694 (1948).  See also
21 C.F.R. 10.45(d)(2)(i) (initiation of FDA enforcement proceedings
discretionary).  Because most statutes granting enforcement powers to
administrative agencies are cast in similar terms, it is well
established that agency enforcement decisions are not subject to
judicial review, absent special circumstances.  /7/ See, e.g.,
Southern Ry. v. Seaboard Allied Milling Corp;  442 U.S. 444, 455-456
(1979) (ICC);  Vaca v. Sipes, 386 U.S. 171, 182 (1967) (NLRB);  see
also United States v. Batchelder, 442 U.S. 114, 124 (1979) (criminal
prosecution);  Bordenkircher v. Hayes, 434 U.S. 357, 364 (1978)
(same);  Confiscation Cases, 74 U.S. (7 Wall.) 454 (1869) (forfeiture
proceedings).

   In concluding that the FDA'S decision here was judicially
reviewable, the court of appeals started (App., infra, 18a) from a
presumption of reviewability that stood this case law on its head.
The court then offered the startling suggestion (id. at 24a (emphasis
added)) that whether there is "law to apply" turns on various
"pragmatic considerations," such as the need for judicial supervision
to safeguard the plaintiffs' interests, the impact of review on the
agency's effectiveness, and the appropriateness of the issues raised
for judicial review.  This formulation converts a straightforward
question of statutory interpretation -- whether Congress intended the
courts to review an agency's enforcement decisions -- into an
essentially standardless, legislative decision -- whether, in the
court's judgment, such review would be beneficial.  As Judge Scalia
noted in his dissent from the denial of rehearing en banc (App.,
infra, 61a), this test means that the court is free to intervene
whenever it "think(s) it a good idea."

   The court of appeals found no need to "delve into a detailed
analysis" of "pragmatic considerations" in the present case because it
determined (App., infra, 24a) that the FDA had "made law to govern and
guide its discretion in regulating the unapproved use of approved
drugs." But the "law" upon which the court relied was the preamble to
a rule that was proposed for notice and comment /8/ but was never
adopted by the agency.  This unadopted preamble obviously was never
intended to be a definitive, judicially enforceable statement of how
the agency would exercise its enforcement discretion.  As Judge Scalia
noted in dissent (App., infra, 48a-49a), the preamble was full of
flexible terms that are not susceptible to judicial review.  The
preamble stated (see id. at 24a (emphasis added)), for example, that
"(w)here the unapproved use of an approved new drug becomes widespread
or endangers the public health, the Food and Drug Administration is
obligated to investigate it thoroughly and to take whatever action is
warranted to protect the public health." What is "widespread" use?
What constitutes a sufficient danger to the public health?  And in a
given case, what action is "warranted"?  It is evident that these
questions cannot be answered intelligently without surveying the
potential dangers posed by all the foods and drugs marketed in this
country and all the resources at the FDA'S command.  We do not see how
the courts could perform that function without taking over day-to-day
operation of the agency.

   In sum, the FDA'S decision not to initiate enforcement action in
this case was committed to agency discretion by law and therefore was
not judicially reviewable.  The court of appeals' contrary conclusion,
as Judge Scalia observed, "usurps the authority of the Executive
Branch" and "rests upon a novel interpretation of Supreme Court
precedent" (App., infra, 60a).

   b. Even if the FDA'S decision were reviewable, it nonetheless
should have been upheld.  In those special circumstances in which
judicial review of administrative enforcement decisions is allowed,
the scope of review is limited to determining whether the agency has
stated a rational basis for its decision.  Dunlop v. Bachowski, 421
U.S. 560, 568, 572-t573 (1975).  That standard was easily met here.

   First, the FDA was correct in finding that it lacked authority to
prevent the states from employing the drugs at issue in carrying out
death sentences.  The statutory provision upon which the court of
appeals relied, 21 U.S.C. 331(k), prohibits the "misbranding" of drugs
while they are "held for sale." This provision simply cannot have been
intended by Congress to reach the forcible administration of a lethal
injection to a person lawfully condemned to death.  /9/ See App.,
infra, 54a-58a (Scalia, J., dissenting);  cf. United States v. Evers,
643 F.2d 1043 (5th Cir. 1981).  The peculiar nature of the court of
appeals' statutory construction is highlighted by the fact that
Section 331(k) applies equally to "drug(s)" and "device(s)" and the
fact that the statutory definition of a "device" seems clearly to
encompass many of the paraphernalia traditionally used for executions,
such as the gallows and the electric chair.  21 U.S.C. 321(h).  /10/
Congress may not have contemplated executions by lethal injection when
it enacted the FDCA in 1938, but it certainly was familiar with these
"devices." We are aware of no evidence, and the court below cited
none, indicating that Congress intended to empower the FDA to regulate
the use of such devices.

   Second, even if the FDCA could somehow be stretched to reach the
adminstration of lethal injections for purposes of capital punishment,
the FDA had sound reasons for declining to intervene.  Regulating the
method of capital punishment used by the states, whether or not
technically within the scope of the FDCA, is far removed from the
FDA'S central responsibilities.  Surely the FDA acted reasonably in
conserving its limited enforcement resources for matters more closely
related to its principal mission.

   The FDA'S decision also was based upon a proper consideration for
the principles of federalism.  The FDA justifiedly expressed
reluctance to interfere with the states' administration of lethal
injection laws, "which are duly authorized statutory enactments in
furtherance of proper State functions" (App., infra, 85a).  Enacting
laws to prevent and punish crime is among the most important powers of
the states, and in prescribing lethal injection as the method of
execution, the states, acted within federal constitutional limits.
The FDA was reasonable in deferring to the states' authority in this
field.

   Finally, the FDA concluded (App., infra, 85a) that state lethal
injection laws did not pose a "serious danger to the public health."
The court of appeals disagreed (id. at 5a), asserting that there was
"a substantial threat of torturous pain to persons being executed."
However, not only is the factual basis for the court's conclusion
dubious (see id at 51a-52a and n.5), but the court appears entirely to
have missed the point.  The proper inquiry is not whether death by
lethal injection involves pain but whether it involves more pain than
death by alternative methods of execution, such as the electric chair,
the firing squad, or the gas chamber.  As Judge Scalia put it (id. at
51a), "it is not a matter of pain versus no pain, but rather pain of
one sort substituted for pain of another -- and in all likelihood
substitution of a lesser pain, since that is the principal purpose of
the lethal injection statutes." Such comparisons were made by the
legislatures that enacted the lethal injection statutes.  The FDA
acted responsibly in declining to review their determinations on this
unique subject.

   3. a. If not reversed, the court of appeals' decision will have
extremely harmful practical consequences.  The FDA will be compelled
to intervene in a highly controversial area far removed from its
proper responsibilities, at the expense of performing its intended
mission of protecting the consuming public from dangerous and
misbranded drugs.

   Furthermore, the decision below is likely to interfere with state
enforcement of capital punishment statutes that satisfy Eighth
Amendment standards.  As noted, the court of appeals held that the
"misbranding" provision of the FDCA (21 U.S.C. 331(k)) prohibits the
use, in carrying out capital punishment, of drugs that have been
approved for other purposes but not for the purpose of causing death.
The court also effectively held that the FDA must take action to
prevent this statutory "violation." /11/ Consequently, at a minimum,
the decision below will prevent executions by lethal injection until a
manufacturer or other party seeks FDA approval for use of the drugs in
executions and demonstrates to the FDA that they are "safe and
effective" in causing death (21 U.S.C. 355(a)).  Moreover, it is
doubtful whether any manufacturer or other firm will seek such
approval in view of the expense involved, the organized opposition to
capital punishment, and the very small quantities of drugs that would
be sold for this new use.  Thus, the practical effect of the court of
appeals' decision might well be to prevent executions by lethal
injection altogether.

   In the long run, the court of appeals' decision may have an ironic
effect.  States have recently enacted statutes prescribing lethal
injection as the method of carrying out death sentences precisely
because that is thought to be the least painful method available.  If
the court of appeals' decision is allowed to stand, it may compel the
states to resort to older and potentially more painful methods.

   b. The court of appeals' holding concerning judicial review of
administrative enforcement decisions threatens judicial interference
with one of the executive branch's core responsibilities.  The
effective functioning of administrative agencies would be seriously
impaired if courts could freely second-guess such decisions.  In
deciding how to employ their limited enforcement resources, agenices
generally concentrate on those efforts that are most needed and offer
the greatest chances of success.  Such choices are necessarily based
in large measure on policy considerations and discretion.  Thus,
judicial review in this area will almost certainly result in the
substitution of the preferences of the judicial branch for those of
the executive.  See App., infra, 39a (Scalia, J., dissenting).  This
alteration of the separation of powers deserves review by this Court.

                              CONCLUSION

   The petition for a writ of certiorari should be granted.

   Respectfully submitted.

   REX E. LEE

      Solicitor General

   RICHARD K. WILLARD

      Acting Assistant Attorney General

   KENNETH S. GELLER

      Deputy Solicitor General

   SAMUEL A. ALITO, JR.

      Assistant to the Solicitor General

   LEONARD SCHAITMAN

   JOHN M. ROGERS

      Attorneys

   THOMAS SCARLETT

      Chief Counsel

   MICHAEL P. PESKOE

      Associate Chief Counsel for Drugs Food and Drug Administration

   MAY 1984

   /1/ These statutes include:  Ark. Stat. Ann. Section 41-1352 (Supp.
1983);  Idaho Code Section 19-2716 (Supp. 1983);  Ill. Rev. Stat. ch.
38, Section 119-5 (Supp. 1984);  Mont. Code Ann. Section 46-19-103(3)
(1983) (prisoner given choice of hanging or lethal injection);  Nev.
Rev. Stat. Section 176.355 (1979);  1983 N.J. Laws 245;  N.M. Stat.
Ann. Section 31-14-11 (Supp. 1983);  N.C. Gen. Stat. Section 15-187
(1983) (choice of lethal gas or lethal injection);  Okla. Stat. Ann.
tit. 22, Section 1014 (Supp. 1983);  Tex. Crim. Proc. Code Ann.
Section 43.14 (Vernon Supp. 1984);  Utah Code Ann. Section 77-18-5.5
(1983) (choice of firing squad or lethal injection);  Wash. Rev. Code
Section 10.95.180 (Supp. 1984) (choice of hanging or lethal
injection).

   /2/ The preface stated (App., infra, 24a):

   Where the unapproved use of an approved new drug becomes widespread
or endangers the public health, the (FDA) is obligated to investigate
it thoroughly and to take whatever action is warranted to protect the
public * * * .  When necessary the (FDA) will not hesitate to take
whatever action is warranted to protect the public.

   /3/ Although the court of appeals acknowledged that "the state may
take the life of a person as punishment" and that the "FDA is not
responsible for the execution of these prisoners," the court observed
that the "FDA'S impermissible refusal to exercise enforcement
discretion over the use of drugs for lethal injection * * * may also
implicate the Eighth Amdnement's prohibition of cruel and unusual
punishment." App., infra, 37a, 38a.

   /4/ Judges Wilkey, Ginsburg, Bork, Scalia, and Starr voted to grant
rehearing en banc.  Judges Wright, Tamm, Wald, Mikva, and Robinson
voted against rehearing en banc.  Judge Edwards abstained.

   /5/ In addition, the Court refused O'Bryan's request for an order
requiring the FDA to seize the drugs intended for use in his execution
(O'Bryan v. Heckler, No. A-791 (Mar. 30, 1984)).  Earlier that day,
the United States District Court for the District of Columbia had
entered such an order (Civ. No. 84-996), but the court of appeals had
vacated it (No. 84-996) in light of the stay entered by the Chief
Justice in this case (No. A-761) (Mar. 21, 1984).

   /6/ The court of appeals suggested (App., infra, 26a n.29), that
Congress intended for the courts to review the FDA'S enforcement
decisions because the "FDCA'S prohibitions are phrased in mandatory
terms.  See, e.g., 21 U.S.C. 333(a) (any person who violates Section
331 'shall' be imprisoned or fined) * * * ." However, virtually every
law prescribing the penalty for a federal crime is couched in
precisely the same language.  See, e.g., 18 U.S.C. 371 (anyone
convicted of conspiracy "shall" be imprisoned not more than five years
or fined not more than $10,000).  By the court of appeals' reasoning,
Congress must have intended to empower the courts to review federal
prosecutors' decisions concerning the bringing of charges under all of
these statutes.  But see United States v. Nixon, 418 U.S. 683, 693
(1974).

   We note in this regard that nothing in the court of appeals'
decision limits the court's holding to administrative -- as opposed to
criminal -- enforcement decisions.  Indeed, plaintiffs in this case
sought the initiation of criminal proceedings against state
correctional officials and others (see App., infra, 6a).

   /7/ Dunlop v. Bachowski, 421 U.S. 560 (1975), upon which the court
of appeals relied extensively (App., infra, 18a and n.22, 21a-23a and
nn. 25-26), involved such special circumstances.  In that case, a
defeated candidate for union office sought to compel the Secretary of
Labor to bring suit under provisions of the Labor-Management Reporting
and Disclosure Act (LMRDA), 29 U.S.C. 482(a) and (b), to have the
election set aside.  In holding that the Secretary's refusal to bring
suit was reviewable, this Court did not discuss the Secretary's
contention that the decision was an unreviewable exercise of
prosecutorial discretion, but instead merely expressed agreement (421
U.S. at 567 n.7) with the court of appeals' treatment of the issue.
See Bachowski v. Brennan, 502 F.2d 79 (3d Cir. 1974).  The court of
appeals noted that the exercise of enforcement discretion is generally
unreviewable (see 502 F.2d at 86-87), but distinguished the case on
three gounds.  First, the court concluded (id at 87), based on the
legislative history of the LMRDA, that in empowering the Secretary to
bring suit to set aside an election, Congress intended the Secretary
to act on behalf of aggrieved union members rather than merely on
behalf of the public.  Second, it noted (id. at 87-88) that union
members have no remedy if the Secretary does not act.  And third, the
court observed (id. at 88) that the Secretary's discretion was
restricted by statute because he was required to bring suit whenever
there was probable cause to believe that there had been a violation
affecting the outcome of the election and no settlement was reached.

   None of these factors applies here.  FDA enforcement is intended to
protect the general public, not to redress individual wrongs;  persons
such as plaintiffs in this case can challenge their sentences in a
variety of other ways;  and under the FDCA, the FDA has the
traditional broad scope of enforcement discretion.

   /8/ Legal Status of Approved Labeling for Prescription Drugs:
Prescribing for Uses Unapproved by the Food and Drug Administration,
37 Fed. Reg. 16503 (1972).

   /9/ In concluding that the FDA possessed the authority to grant
respondents' requested relief, the court of appeals repeatedly
referred to the FDA'S actions regarding drugs used to destroy animals
and drugs administered to prisoners participating in research
projects.  App., infra, 11a-12a, 31a, 32a.  These situations, however,
are clearly distinguishable.

   In United States v. Beuthanasia-D Regular, (1979 Transfer Binder)
Food, Drug, Cosm. L. Rep. (CCH) Paragraph 38,265 (D. Neb.), upon which
the court of appeals relied (App., infra, 12a), the FDA did not assert
authority over the use of drugs to destroy animals.  That case instead
involved the marketing of such drugs.  Thus, the case was of the type
in which FDA normally assumes jurisdiction -- the marketing and
promoting by a manufacturer of a drug for a purpose that has not been
subject to pre-marketing approval.  Moreover, the FDA'S statutory
authority with respect to animal drugs differs from its authority with
respect to human drugs. See 21 U.S.C. 360b(a)(1).

   The FDA also has special statutory authority to regulate the use of
drugs in research projects (see 21 U.S.C. 355(i), 357(d), 360j(g),
participation in which in any event is voluntary.  The regulations to
which the court of appeals referred (App., infra, 12a n.17) implement
such special statutory provisions and therefore have no relevance
here.

   /10/ 21 U.S.C. 321(h) defines a "device" to include

   (A)n instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, which is -- ***

   (3) intended to affect the structure or any function of the body of
man or other animals, and which does not achieve any of its principal
intended purposes through chemical action within or on the body of man
or other animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.

   /11/ The court of appeals remanded for the district court to
determine whether the FDA'S reasons for refusing to initiate
enforcement action were sufficient (see App., infra, 31a).  However,
the court of appeals' opinion left no doubt that in its view all of
the FDA'S proferred justifications were unsound (id. at 30a-35a).

   APPENDIX