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

   No. 84-1878

   In the Supreme Court of the United States

   October Term, 1984

   On Writ of Certiorari to the United States Court of Appeals for the
District of Columbia Circuit

   Reply Brief for the Petitioner

   1. Respondents' submission depends almost entirely on a "strong
presumption" favoring judicial review of "all final agency action"
(Resp. Br. 19;  see also id. at 19-40, 65-69) -- perhaps in implicit
recognition of the weakness of their argument that there is "law to
apply" in this case.  /1/ However, respondents have not in any way
refuted our contention (Pet. Br. 15-25) that no such presumption
applies to administrative enforcement decisions and that, if anything,
the presumption is precisely the reverse.  See Allen v. Wright, No.
81-757 (July 3, 1984), slip op. 23 ("The Constitution, after all,
assigns to the Executive Branch, and not to the Judicial Branch, the
duty to 'take Care that the Laws be faithfully executed.' U.S. Const.,
Art. II, Section 3.").

   Respondents' logic would require that even criminal prosecutorial
decisions be reviewed by the courts, and respondents seem to suggest
that such decisions are in fact reviewable to determine whether there
has been an abuse of prosecutorial discretion (see Resp. Br. 23-24 &
n.14).  This is a sharp departure from this Court's precedents (see
Pet. Br. 18).  /2/ Respondents also attempt to distinguish
prosecutorial determinations from administrative enforcement decisions
on the ground that "(c)riminal prosecutorial decisions are made to
protect society as a whole," while administrative enforcement
decisions directly affect classes of "individuals whom the statutes
were enacted to protect" (Resp. Br. 26).  This distinction is
specious.  Administrative enforcement is often designed primarily to
protect the public.  Certainly that is the chief purpose of FDA's
enforcement actions under the FDCA.  And criminal statutes, no less
than statutes calling for administrative enforcement, often have the
effect of protecting particular groups or individuals.  Bank robbery
statutes, for example, protect banks and bank employees;  criminal
statutes in the securities field protect investors.  But it has never
been held that such private parties may obtain judicial review under
the APA of prosecutorial decisions they dislike.

   Respondents cite a plethora of cases in an effort to show that
enforcement decisions are freely reviewable, but respondents cite only
one decision of this Court -- Dunlop v. Bachowski, 421 U.S. 560 (1975)
-- in which the exercise of enforcement discretion was held to be
reviewable under the APA.  In our opening brief (at 23-25), we showed
that Bachowski is easily distinguishable from the present case.
Respondents state (Br. 30) that our characterization of Bachowski is
"flatly wrong," but it is respondents who are in error.  Respondents
suggest (Br. 30-31) that the discussion in this Court's opinion
concerned the question whether the Secretary of Labor's decision in
that case was a matter "committed to agency discretion by law" and
thus exempt from review under 5 U.S.C. 701(a)(2).  Contrary to
respondents' suggestion, this Court's discussion was limited to the
separate question whether the Secretary's decision was exempt from
review under 5 U.S.C. 701(a)(1) on the ground that Title IV of the
Labor-Management Reporting and Disclosure Act of 1959 (LMRDA), 29
U.S.C. 481 et seq., "preclude(s) review" (5 U.S.C. 701(a)(1)).  The
very portions of this Court's opinion that respondents quote (Br.
31-32) show that the discussion was restricted to 5 U.S.C. 701(a)(1).
This Court did not discuss 5 U.S.C. 701(a)(2) but merely expressed
agreement with the court of appeals' treatment of the issue (421 U.S.
at 567 n.7).  And in our opening brief (at 24-25), we demonstrated
that none of the factors found by the court of appeals to support
review in Bachowski is present in this case.  /3/

   Moreover, it is significant that the statutory scheme at issue in
Bachowski, unlike the FDCA, did not grant unfettered enforcement
discretion to the Secretary of Labor.  Under Title IV of the LMRDA,
the Secretary may not bring suit to set aside a union election unless
a union member exhausts his internal union remedies and files a
complaint with the Secretary.  See Local 82 v. Crowley, No. 82-432
(June 12, 1984), slip op. 12.  In that narrow circumstance, the Court
concluded that Congress intended to permit the complaining union
member of the general public -- to bring suit pursuant to the APA to
challenge the Secretary's exercise of discretion.  /4/ Here, by
contrast, the FDA's enforcement discretion is not limited by statute,
and respondents' submission, if accepted, would allow anyone to seek
judicial review of the agency's decision not to bring enforcement
proceedings under any portion of the Act.

   Most of the remaining cases cited by respondents -- and certainly
all of the remaining decisions of this Court -- are inapposite.  Many
do not involve enforecement activity at all, /5/ much less an agency's
refusal to take enforcement activity at all, /5/ much less an agency's
refusal to take enforcement action in a particular case, which of
course is what is at issue here.  Still other cases cited by
respondents (Br. 27, 28) involve an agency's refusal to promulgate
regulations.  /6/ But since Congress often specifically intends for
agencies to issue implementing regulations, such cases are easily
distinguishable from cases involving an agency's refusal to take
enforcement action in a particular case -- a matter on which Congress
rarely intends to restrict an agency's discretion.  See also Pet. App.
45a-46a (Scalia, J., dissenting).  Likewise, respondents' reliance on
cases involving an agency's refusal to adjudicate disputes between
private parties is misplaced.  /7/ While there is a stong tradition of
prosecutorial and enforcement discretion, adjudicatory bodies do not
customarily have the same discretion to decline to entertain cases
falling within their jurisdiction.

   2. Respondents acknowledge (Br. 40-41), as they must, that the
FDA's decision in this case is unreviewable if there is "'no law to
apply.'" Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S.
402, 410 (1971), quoting S. Rep. 752, 79th Cong., 1st Sess. 26 (1945).
 Respondents have found no law to apply.

   The bulk of respondents' discussion on this point (Br. 41-48,
58-65) confuses two entirely different concepts:  law explaining what
the FDCA prohibits and law setting forth standards for the exercise of
the FDA's enforcement discretion.  Only the latter has a bearing on
whether the FDA's exercise of enforcement discretion is reviewable
under the APA.  Respondents instead rely on "criteria by which
noncompliance with the (FDCA) can be determined" (Resp. Br. 41-48) and
case law regarding what constitutes a violation of the FDCA (Resp. Br.
58-65).  If respondents were correct, all prosecutorial decisions
would be judicially reviewable.  For example, the bank robbery statute
(18 U.S.C. 2113) provides "criteria by which noncompliance with the
(statute) can be determined," and there is abundant case law regarding
what constitutes a violation of the statute.  But that hardly means
that a prosecutor's decision not to charge under the bank robbery
statute is reviewable.  What is critical is that neither the bank
robbery statute nor the FDCA provides law to apply in the form of
standards restricting the exercise of prosecutorial or administrative
enforcement discretion.  /8/

   Respondents are thus relegated to relying on a few words taken out
of context from a preamble to an unadopted regulation (Resp. Br.
45-58).  This is a slender reed that cannot possibly bear the weight
of respondents' argument.

   In our opening brief, we showed (at 23-31) that the preamble did
not purport to provide standards for the exercise of the FDA's
enforcement discretion.  Respondents have not attempted to answer this
dispositive argument.  We also argued (Pet. Br. 31-35) that the
preamble did not bind the FDA in this case because the preamble is not
a legislative rule and because the FDA's own rules do not regard the
preamble as having binding effect in this context.  Respondents
contend (Br. 57-58 & n.29) that the preamble need not be a legislative
rule in order to provide "law to apply." However, respondents have not
cited any authority that supports this proposition.  /9/ Respondents
also disagree with the FDA's interpretation of its rules regarding
advisory opinions (Resp. Br. 53-57), but respondents' alternative
interpretation -- that advisory opinions always bind the FDA but do
not bind adversely affected third parties -- is not supported by the
language of the rules or by any cited authority.  In any event, the
FDA is the best judge of its own regulations.  /10/

   Respondents have also made virtually no response (see Resp. Br. 66
n.33) to the legislative history of the FDCA, which demonstrates
Congress's understanding that the FDA would have no judicially
cognizable duty to initiate proceedings to enforce the Act.  See Pet.
Br. 39-42.  Contrary to respondents' characterization, the excerpts we
relied on do not refer solely to FDA's "limited 'discretion' under 21
U.S.C. Section 336" (Resp. Br. 66 n.33).  The excerpts speak for
themselves and show that Congress clearly intended for the FDA to have
unreviewable enforcement discretion.

   3. Finally, respondents have failed to show that the FDA abused its
discretion in not investigating the means used by the states in
carrying out capital punishment.  First, the FDA lacks jurisdiction
over the use of approved drugs by state authorities for capital
punishment purposes.  It is a sheer contradiction in terms for
respondents to contend that the FDA has "abandoned" (Resp. Br. 75) and
"jettisoned" (Resp. Br. 76) its original position in this regard,
while at the same time arguing that the FDA's present position is
"identical" to (Resp. Br. 78) and only "couched in slightly different
terms" from (Resp. Br. 76) that original position.  /11/ Respondents'
reliance on the Supremacy Clause (Resp. Br. 80-81) is also an
irrelevant distraction, for while Supremacy Clause provides for the
preemptive effect of federal law (Resp. Br. 80-81), the Clause does
not assist in construing the extent of jurisdiction provided by a
particular federal statute.

   In our opening brief (at 43-37), we argued that the FDA lacked
jurisdiction because the drugs at issue here are not literally "held
for sale" when administered to prisoners and because there is not a
scintilla of evidence that Congress intended for the FDCA to regulate
capital punishment.  We noted (Pet. Br. 44) that respondents' contrary
interpretation would lead to the absurd result of requiring the FDA to
regulate such traditional means of capital punishment as the gas
chamber, electric chair and gallows.  Respondents' argument that
electric chairs and gallows do not fit within the statutory definition
of "device," while the drugs used for lethal injections do fit within
the statutory definition of "drug" (Resp. Br. 93-95 n.46), is based on
a strained reading of the two statutory definitions.  See 21 U.S.C.
321(g)(1), 321(h).  Each definition contains three categories, any one
of which serves to meet the broad statutory requirements:  first,
articles recognized in an official compendium (21 U.S.C. 321(g)(1)(A),
321(h)(1)), second, articles "intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other
animals" (21 U.S.C. 321g(1)(B), 321(h)(2)), and third, articles
"intended to affect the structure or any function of the body of man
or other animals" (21 U.S.C. 321(g)(1)(C), 321(h)(3)).  /12/ It is
absurd for respondents to suggest that means for carrying out capital
punishment are not "intended to affect the structure or any function
of the body of man." Such an argument, in addition to ignoring the
words of the Act, would eviscerate the FDA's ability to regulate
articles that do not fit within the first two categories, thus
frustrating congressional intent in providing a third, separate
category.

   Moreover, apart from what Congress may have intended the FDCA to
mean, the FDA's uncertainty about how the courts would greet any
attempt to assert authority over the state-mandated executions is a
fully adequate basis for an agency with limited resources to decline
proposed enforcement efforts.  See Pet. Br. 47;  Pet. App. 85a.
Respondents rely repeatedly and extensively upon the FDA's actions
regarding drugs used to kill animals (Resp. Br. 61-63, 83, 91,
100-101) and drugs used on human prisoners for research (Resp. Br.
18h, 63-64, 96-97).  In these situations, however, the FDA was on much
sounder jurisdictional footing than it would have been with regard to
the enforcement proceedings sought by respondents.

   In United States v. Beuthanasia-D Regular, (1979 Transfer Binder)
Food Drug Cosm. L. Rep. (CCH Paragraph 38,265 (D. Neb. Aug. 1, 1979),
the FDA did not assert authority over the use of drugs to kill
animals.  That case involved instead a situation in which a
manufacturer was marketing a drug for purposes of animal euthanasia.
Thus the case was of the type in which FDA normally assumes
jurisdiction -- the marketing and promotion by a manufacturer of a
drug for a purpose that has not been subject to premarketing approval.
 /13/

   Similarly, unlike its doubtful authority to regulate drugs used for
administration of the death penalty, the FDA has clear statutory
authority to regulate the use of drugs in a research involving
prisoners.  The FDA has authority over all research investigations,
whether or not involving prisoners, because drugs used in
investigations are manufactured and shipped for that purpose.  To ship
such research drugs without first having obtained FDA approval (21
U.S.C. 351(i)) is a violation of 21 U.S.C. 355(a) and 331(d) because
the FDA has explicit statutory authority to regulate the distribution
of drugs for research.  The regulations referred to by respondents
(Resp. Br. 63-64, 96-97) simply implement Section 355(i) and other
similar FDA statutory authorizations.  See 21 U.S.C. 357(d), (360)(g).

   Finally, respondents (Resp. Br. 89-95) and amici Public Citizen and
American Society of Law and Medicine, et al., argue that the FDA was
legally obligated to intervene because lethal injection is a less
desirable means of capital punishment than other methods.  Whatever
the merits of this argument -- and there is surely much to be said on
the other side /14/ -- it is an argument that should be addressed to
bodies other than the FDA -- to courts, which must review death
sentences and may be called upon to determine whether execution by
lethal injection satisfies Eighth Amendment standards, and to state
legislatures, which in increasing numbers are conducting, after
studying the available evidence, that lethal injection is the least
painful method of execution.  The FDA has no experience or particular
expertise in making a comparative assessment of different methods of
capital punishment, nor does it have a congressional mandate to
venture into this field.  The FDA thus properly declined to intervene.

   For the foregoing reasons and those stated in our opening brief, it
is respectfully submitted that the judgment of the court of appeals
should be reversed.

   REX E. LEE

      Solicitor General

   THOMAS SCARLETT

      Chief Counsel Food and Drug Administration

   NOVEMBER 1984

   /1/ Respondents also err in suggesting that FDA enforcement
decisions are reviewable absent "'clear and convincing' evidence that
Congress intended to prohibit judicial review" (Resp. Br. 65).  See
Block v. Community Nutrition Institute, No. 83-458 (June 4, 1984),
slip op. 10-11.

   /2/ This Court's suggestion (relied upon at Resp. Br. 25-26) in
Marshall v. Jerrico, Inc., 446 U.S. 238, 249-250 (1980), that a
personal financial interest on the part of administrative prosecutors
"may * * * in some contexts" raise due process concerns does not imply
that prosecutorial determinations are presumptively reviewable.
Moreover, respondents' reliance on Jerrico evidences the confusion
that pervades their brief.  Obviously once a law enforcement
proceeding has been instituted, judicial review is available to ensure
compliance with constitutional and statutory requirements.  This case,
of course, involves judicial review of a decision not to bring an
enforcement proceeding.

   /3/ Adams v. Richardson, 480 F.2d 1159 (D.C. Cir. 1973), relied
upon at Resp. Br. 28, 33-35, 73, involved allegations that the
Department of Health, Education, and Welfare had adopted a "general
policy" not to utilize specific statutory enforcement provisions
contained in Title VI of the Civil Rights Act, with the result that
HEW was "actively supplying segregated institutions with federal
funds." 480 F.2d at 1162.  In contrast, the FDA continues to utilize
broadly all of its statutory enforcement provisions:  no statutory
language is nullified by its refusal to apply its enforcement
authority in the particular area of lethal injections.  Moreover, the
FDA is obviously not engaged in affirmative support of activities
contrary to congressional purposes.

   /4/ Indeed, the Court described the Secretary's role as "lawyer for
the complaining union member" (421 U.S. at 572).

   /5/ E.g., Leedom v. Kyne, 358 U.S. 184 (1958) (Resp. Br. 27, 72)
(challenge to NLRB certification of a particular collective bargaining
unit);  Harmon v. Brucker, 355 U.S. 579 (1958) (Resp. Br. 72)
(challenge to less than honorable military discharge);  Stark v.
Wickard, 321 U.S. 288 (1944) (Resp. Br. 72) (challenge to milk
marketing order);  Carpet, Linoleum & Resilient Tile Layers v. Brown,
656 F.2d 564 (10th Cir. 1981) (Resp. Br. 27) (challenge to agency
refusal to comply with Davis-Bacon Act requirement that contractors
pay local prevailing wages);  Pennsylvania v. National Association of
Flood Insurers, 520 F.2d 11 (3d Cir. 1975) (Resp. Br. 28) (challenge
to failure to publicize flood insurance);  Davis v. Romney, 490 F.2d
1360 (3d Cir. 1974) (Resp. Br. 28) (challenge to affirmative action of
HUD in insuring mortgages on plaintiffs' homes);  Goodman v. United
States, 424 F.2d 914 (D.C. Cir. 1970) (Resp. Br. 68) (challenge to
agency refusal to permit withdrawal of employee's resignation).

   /6/ E.g., NRDC v. EPA, 683 F.2d 752 (3d Cir. 1982);  WWHT, Inc. v.
FCC, 656 F.2d 807 (D.C. Cir. 1981);  NRDC v. SEC, 606 F.2d 1031 (D.C.
Cir. 1979);  British Airways Board v. Port Authority, 564 F.2d 1002
(2d Cir. 1977).  Rockbridge v. Lincoln, 449 F.2d 567 (9th Cir. 1971).

   /7/ E.g., Hotel Employees v. Leedom, 358 U.S. 99 (1958) (Resp. Br.
35-36, 72) (review of refusal to adjudicate labor disputes in hotel
industry);  Office Employees Local No. 11 v. NLRB, 353 U.S. 313 (1957)
(Resp. Br. 18g, 27, 70-72, 73) (review of refusal to resolve dispute
between labor union and its employees);  Medical Committee for Human
Rights v. SEC, 432 F.2d 659 (D.C. Cir. 1970), vacated as moot, 404
U.S. 403 (1972) (Resp. Br. 25, 28 68) (review of informal decision not
to resolve proxy dispute between management and shareholder);  UAW v.
NLRB, 427 F.2d 1330 (6th Cir. 1970) (Resp. Br. 28, 72) (review of
refusal to decide particular dispute between labor and management).
See also Safir v. Gibson, 417 F.2d 972, 977 & n.6 (2d Cir. 1969),
cert. denied, 400 U.S. 850 (1979) (Resp. Br. 72).  Respondents also
rely upon cases permitting review of agency delays in making
quasi-judicial determinations.  Caswell v. Califano, 583 F.2d 9 (1st
Cir. 1978) (Resp. Br. 27, 37);  White v. Mathews, 559 F.2d 852 (2d
Cir. 1977), cert. denied, 435 U.S. 908 (1978) (Resp. Br. 27, 73).
(These decisions, of course, are no longer good law.  Heckler v. Day,
No. 82-1371 (May 22, 1984).) Such review obviously does not implicate
separation of powers concerns.

   /8/ To the extent that respondents also rely upon statutory
provisions that are not merely substantive requirements of the FDCA --
i.e., statutory language that violators "shall" receive specified
penalties (Resp. Br. 43-44) and the provision of the FDCA regarding
nonreporting of minor violations (21 U.S.C. 336) (Resp. Br. 45-48) --
we have already demonstrated that such reliance is frivolous (see
Gov't Br. 26-27 & n.16).

   /9/ In Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944), on which
respondents rely (Br. 58 n.29), the Court did not hold that an
informal agency pronouncement furnishes law to apply under the APA
(this was of course a pre-APA case) or that such a statement binds the
agency in any other way.  The Court merely took note of the Wage and
Hour Administration's interpretive bulletins in deciding a question of
statutory construction under the Fair Labor Standards Act.

   /10/ United States v. Ewig Bros., 502 F.2d 715, 725 n.34 (7th Cir.
1974), an action brought by the government to enjoin distribution of
fish contaiminated by DDT, is inapposite.  There, an FDA press release
purporting to set tolerance limits for DDT in food was regarded as a
legislative rule because the language of the press release suggested
that it was intended to have such an effect and because the government
had apparently prosecuted the case at trial and on appeal on the
theory that the press release was binding.  See id. at 724-725 &
nn.31-34.  No similar circumstances are present here.

   /11/ Contrary to respondents' assertion (Resp. Br. 18c, 43 n.21),
the government does not agree that drugs used for lethal injections
are necessarily misbranded.  See Pet. Br. 46.

   /12/ The definition of a drug also contains a fourth category that
extends the definition to components of articles specified in the
other three categories (21 U.S.C. 321(g)(1)(D)).

   /13/ Even were this not the case, the agency would still have
clearer statutory authority to intervene in a situation involving the
unapproved use of animal as opposed to human drugs.  21 U.S.C.
360b(a)(1) specifically provides that without approval a new animal
drug "with respect to any particular use or intended use" (emphasis
added) is "unsafe" and therefore "adulterated" as a matter of law
under 21 U.S.C. 351(a)(5).  No comparable provision exists with
respect to human drugs.  Under 21 U.S.C. 331(k), "adulteration" serves
as an alternative to "misbrand(ing)."

   /14/ For contrary expert opinion, see Kemperman, Medical
Involvement in Capital Punishment, The Lancet, Feb. 5, 1983, at
301-302;  Death Row and the Medical Model, Hastings Center Rep., Oct.
1979, at 5;  Nichols, Lethal Injection Rarely Used Execution Method,
Chi. Daily L. Bull., Mar. 19, 1984, at 3;  Note, Criminal Procedure --
Capital Punishment -- Texas Statutes Amended to Provide for Executions
by Intravenous Injection of a Lethal Substance, 9 St. Mary's L.J. 359,
364-365 (1977).

   Respondents argue (Br. 10-11) that since doctors are ethically
barred from administering lethal injections the chances that something
will go wrong are increased.  But as the British Royal Commission on
Capital Punishment observed more than 30 years ago (1949-1953 Report
of the Royal Commission on Capital Punishment 259 (1953)), "it is not
only within the profession that the necessary skill is to be found.
There are many outside it who are fully competent either to give
injections themselves or to train others to do it." See also Bolsen,
Strange Bedfellows:  Death Penalty and Medicine, 248 J.A.M.A. 518,
518-519 (1982);  see Malone, More Humane?  First Execution by
Injection, 69 A.B.A. J. 143 (1983);  N.J. Stat. Ann. Section 2C:  49-2
(West 1984) (specifies use of "execution technicians").