Heckler v. Chaney Reply Brief for the Petitioner

    No. 83-1878

3tt %  &upr?mp (Umtri uf %  Itnitrii
October Term, 1984

Margaret M. Heckler, Secretary of Health 
and Human Services, petitioner

v.

Larry Leon Chaney, et al.

ON WRIT OF CERTIORARI TO THE 
UNITED STATES COURT OF APPEALS 

FOR THE DISTRICT OF COLUMBIA CIRCUIT

REPLY BRIEF FOR THE PETITIONER

Rex E. Lee 
Solicitor General 
Department of Justice 
Washington, D.C. 20530 
(202) 633-2217

Thomas Scarlett 
Chief Counsel
Food and Drug Adm inistration  
Rockville, M aryland 20857



TABLE OF AUTHORITIES
Cases: Page

Adam s V. Richardson, 480 F.2d 1159_____ ______  3
Allen  V. W right, No. 81-757 (July 3, 1984) 1
Block V. Community N utrition  Institute, (No. 83-

458 (June 4, 1984) ..............       1
British A irw ays Board V. Port A uthority, 564 F.2d

1002 .................................................................. 5
Carpet, Linoleum & Resilient Tile Layers V.

Brown, 656 F'.2d 564 __________ ______ ____ ___
Casivell v. Califano, 583 F.2d 9 ..................... ...............
Citizens to Preserve Overton Park, Inc. V. Volpe,

401 U.S. 402:...................... ................................. .....
Davis V. Romney, 490 F.2d 1360 ________________
Dunlop V. Bachowski, 421 U.S. 560 _____________  2,
Goodman v. United States, 424 F.2;d 9 1 4 ___ _____
Harmon V. Brucker, 355 U.S. 579 ________ _______
Heckler V. Day, No. 82-1371 (May 22, 1984).......
Hotel Employees V. Leedom, 358 U.S. 99 .................
Leedom  v. Kyne, 358 U.S. 1 8 4 ................ ................ ...
Local 82 V. Crowley, No. 82-432 (June 12, 1984)....
Marshall V. Jerrico, Inc., 446 U.S. 238 ............ ........
Medical Committee fo r  H um an R ights  v. SEC, 432

F.2d 659, vacated as moot, 404 U.S. 403 ...............
NRD C  V. E PA , 683 F.2d 752 ................ .....................
N RD C  V. SEC, 606 F.2d 1031 ........... ...... ....................  4-
Office Employees Local No. 11 V. N LR B , 353 U.S.

313 ..................................... ................ ........ .................
Pennsylvania v. National Association of Flood In ­

surers, 520 F.2d 1 1 __________ ______ ______ ___
Rockbridge V. Lincoln, 449 F.2d 567 ___ ____ ____
Safir V. Gibson, 417 F.2d 972, cert, denied, 400 U.S.

850 ............................... ......... ............. ........... ........ .....
Skidmore V. S w ift  & Co., 323 U.S. 134 ........ ........ .
Stark  V. Wickard, 321 U.S, 288 ..... ........................
U AW  V. N LR B , 427 F.2d 1330 .......... ....... ......... ........
United States  V. Beuthanasia-D Regular, [1979 

T ransfer Binder] Food Drug Cosm. L, Rep.
(CCH) H 38 ,265 ............ ........ ....................................  9

(I)



Cases— Continued Page

United States  V. Ew ig Bros., 502 F,2d 715 ......... . 7
W hite v. Mathews, 559 F.2:d 852, cert, denied, 435

U.S. 908 ____ ____________________________ __  5
W W H T, Inc. v. FCC, 656 F.2d 807 ................ ........... . 4

Constitution and s ta tu te s :
U.S, Const.:

Art. VI (Supremacy Clause) _______ ___ ___ 8
Amend. V III ____________       11

Labor-M anagement Reporting and Disclosure Act
of 1959, Tit. IV, 29 U.S.C. 481 et seq. ..................  3

5 U.S.C. 701(a) (1) ________ ___ _____ __________  3
5 U.S.C. 701 (a) (2) _________ _____ ____ _________  3
18 U.S.C. 2113 ___ _______ ____ _________________  6
21 U.S,C. 321(g) (1) _____________ ____ ___ ____  8
21 U.S.C. 321 (g) (1) (A) ............ ............................ . 9
21 U.S.C. 3 2 1 (g )(1 )(B )  ________ _______ _______  9
21U.S.C. 321(g) (1) (C) ____ _____ _____________  9
21 U.S.C. 3 2 1 (g )(1 )(D ) ________________     9
21 U.S.C. 3211(h) ____________ ________________  8
21 U.S.C. 321 (h) (1) ___________________ _____ 9
21 U.S.C. 321 (h) (2) ____ ____________ ____ _____  9
21 U.S.C, 321 (h) (3)   __ _______ ____ 9
21 U.S.C. 331 (d) ......... ....................... ..........................  10
2:1 U.S.C. 331 (k) __________ ________ __________  10
21 U.S.C. 336 _______ ___ ___ ___ ____ ______ ____  6
21 U.S.C. 351 (a) (5) ______ ___________________  10
21 U.S.C. 355(a) __ ____ ________ ____ _____ __ _ 10
21 U.S.C. 355 (i) ............. ............... ........... ...................  10
21 U.S.C. 357(d) ............. .................... ....... ......... ........  10
21 U.S.C, 360 (b) (a) (1) ______________ ___ ___ _ 10
21 U.S.C. 360(g) ................. ......... .............. ................  10
N.J. Stat. Ann. § 2C:49-2: (W est 1984) ..... ..............  11

M iscellaneous:
Bolsen, Strange Bedfellows: Dealth Penalty and

Medicine, 248 J.A.M.A. 518 (1982) .......... ........ . 11
Kemperman, Medical Involvem ent In  Capital Pun­

ishment, The Lancet, Feb. 5, 1983 ......................... 10

IX



in

Miscellaneous—Continued: Page
Malone', Death Roiv and the Medical Model, Hast­

ings Center Rep., Oct. 1979 ...............................  10
More H um ane? F irst Execution by Injection, 69

A.B.A. J. 143 (1983) ............. ... ............. ......... 11
Nichols, Lethal Injection Rarely Used Execution

Method, Chi. Daily L. Bull., Mar. 19, 1984___  10
Note, Criminal Procedure— Capital Punishment—

Texas Statutes Amended to Provide fo r Execu­
tion by Intravenous Injection of a  Lethal Sub­
stance, 9 St. Mary’s L.J. 359 (1977) ..... ............  10-11

194,9-1953 Report of the Royal Commission on
Capital Punishm ent (1953) ..............................  11

S. Rep. 752, 79th Cong., 1st Sess. (1945) ____ __ 5



Jin %  Bntjmmu? (ta rt nf %  lutti>h §tatps
October Term, 1984

No. 8#1878
Margaret M. Heckler, Secretary of Health 

and Human Services, petitioner

v.
Larry Leon Chaney, et al.

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. Rr. 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 presump­
tion 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, § 3.” ).

1 Respondents also err in suggesting that FDA enforcement de­
cisions 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.

(1)



2

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 prece­
dents (see Pet. Br. 18).2 Respondents also attempt to dis­
tinguish prosecutorial determinations from administrative 
enforcement decisions on the ground that “ [cjriminal 
prosecutorial decisions are made to protect society as a 
whole,” while administrative enforcement decisions di­
rectly 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 call­
ing for administrative enforcement, often have the effect 
of protecting particular groups or individuals. Bank rob­
bery statutes, for example, protect banks and bank em­
ployees; 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—Dun­
lop v. BachowsJci, 421 U.S. 560 (1975)—in which the ex­
ercise of enforcement discretion was held to be reviewable

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 review- 
able. Moreover, respondents’ reliance on Jerrico evidences the con­
fusion 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

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 char­
acterization of Bachowski is “flatly wrong,” but it is re­
spondents who are in error. Respondents suggest (Br.
30- 31) that the discussion in this Court’s opinion con­
cerned the question whether the Secretary of Labor’s de­
cision 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 ques­
tion 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., “pre- 
clude[s] review” (5 U.S.C. 701(a)(1)). The very por­
tions 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 demon­
strated that none of the factors found by the court of 
appeals to support review in Bachotvski is present in this 
case.8

Moreover, it is significant that the statutory scheme at 
issue in Bachowski, unlike the FDCA, did not grant un­
fettered enforcement discretion to the Secretary of Labor. 
Under Title IV of the LMRDA, the Secretary may not 3 * * *

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 De­
partment of Health, Education, and Welfare had adopted a “gen­
eral 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
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—not any mem­
ber 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 ac­
cepted, 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 enforcement ac­
tivity at all,5 6 * much less an agency’s refusal to take en­
forcement action in a particular case, which of course is 
what is at issue here. Still other cases cited by respond­
ents (Br. 27, 28) involve an agency’s refusal to promul­
gate regulations.8 But since Congress often specifically in­

4 Indeed, the Court described the Secretary’s role as “lawyer
for the complaining union member” (421 U.S. at 572).

6 E.g., Leedom v. Kyne, 358 U.S. 184 (1958) (Resp. Br. 27, 72) 
(challenge to NLRB certification of a particular collective bargain­
ing 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. Na­
tional 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).

e 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



5

tends for agencies to issue implementing regulations, such 
cases are easily distinguishable from cases involving an 
agency’s refusal to take enforcement action in a particu­
lar 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’ re­
liance on cases involving an agency’s refusal to adjudicate 
disputes between private parties is misplaced.* 7 While 
there is a strong tradition of prosecutorial and enforce­
ment discretion, adjudicatory bodies do not customarily 
have the same discretion to decline to entertain cases fall­
ing 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 Over- 
ton Park, Inc. v. Volpe, 401 U.S. 402, 410 (1971), quot­
ing S. Rep. 752, 79th Cong., 1st Sess. 26 (1945). Re­
spondents have found no law to apply.

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 re­
solve 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 per­
mitting review of agency delays in making quasi-judicial deter­
minations. 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.



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 de­
termined” (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 de­
cisions 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 de­
termined,” 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 re­
stricting 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 un­
adopted 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 ex­
ercise 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

8 To the extent that respondents also rely upon statutory pro­
visions that are not merely substantive requirements of the FDCA— 
i.e., statutory language that violators “shall” receive specified penal­
ties (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).

6



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 interpreta­
tion 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. Con­
trary to respondents’ characterization, the excerpts we re­
lied on do not refer solely to FDA’s “limited ‘discretion’ 
under 21 U.S.C. § 336” (Resp. Br. 66 n.33). The ex­
cerpts speak for themselves and show that Congress clearly

9 In Skidmore V. Sw ift & Co., 323 U.S. 134, 140 (1944), on which 
respondents rely (Br. 58 n.29), the Court did not hold that an in­
formal 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 Stand­
ards 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 contaminated 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 re­
lease suggested that it was intended to have such an effect and be­
cause 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.



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 ap­
proved drugs by state authorities for capital punishment 
purposes. It is a sheer contradiction in terms for respond­
ents to contend that the FDA has “abandoned” (Resp. 
Br. 75) and “jettisoned” (Resp. Br. 76) its original posi­
tion 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’ re­
liance on the Supremacy Clause (Resp. Br. 80-81) is 
also an irrelevant distraction, for while the Supremacy 
Clause provides for the preemptive effect of federal law 
(Resp. Br. 80-81), the Clause does not assist in constru­
ing 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 statu­
tory definitions. See 21 U.S.C. 321(g) (1), 321(h). Each 
definition contains three categories, any one of which

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.

8



9
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(l) (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)).112 It is absurd for respondents to suggest that 
means for carrying out capital punishment are not “in­
tended 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 cate­
gories, thus frustrating congressional intent in providing 
a third, separate category.

Moreover, apart from what Congress may have in­
tended the FDCA to mean, the FDA’s uncertainty about 
how the courts would greet any attempt to assert au­
thority over state-mandated executions is a fully ade­
quate basis for an agency with limited resources to de­
cline 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. 18, 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 
1T 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 12

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 )).



10
assumes jurisdiction—the marketing and promotion by a 
manufacturer of a drug for a purpose that has not been 
subject to premarketing approval.18

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. 851 ( i ) ) is a violation of 21 U.S.C. 
355(a) and 331(d) because the FDA has explicit statu­
tory 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 Pub­
lic Citizen and American Society of Law and Medicine, 
et al., argue that the FDA was legally obligated to inter­
vene 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 13 14—it is an argument that should

13 Even were this not the case, the agency would still have clearer 
statutory authority to intervene in a situation involving the un­
approved 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 Involve­
ment in Capital Punishment, The Lancet, Feb. 5, 1983, at 301-302; 
Death Row and the Medical Model, Hastings Center Rep., Oct. 1979, 
a t 5; Nichols, Lethal Injection Rarely Used Execution Method, Chi. 
Daily L. Bull., Mar. 19, 1984, a t 3; Note, Criminal Procedure— 
Capital Punishment— Texas Statutes Amended to Provide for Exe-



11

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 s^ate legis­
latures, which in increasing numbers are coneteSfeng, after 
studying the available evidence, that lethal injection is the 
least painful method of execution. The FDA has no ex­
perience 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 judg­
ment of the court of appeals should be reversed.

Rex E. Lee
Solicitor General

Thomas Scarlett
Chief Counsel
Food and Drug Adm inistration  

N ovember 1984

cutions 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 some­
thing will go wrong are increased. But as the British Royal Com­
mission on Capital Punishment observed more than 30 years ago 
{19U9-1953 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 com­
petent either to give injections themselves or to train others to do 
it.” See also Bolsen, Strange Bedfellows: Death Penalty and Medi­
cine, 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. §2C: 49-2 (West 1984) (specifies use of “execution tech­
nicians”) .

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