Amicus Curiae Brief — Gonzales v. Oregon

IN THE

Supreme Court of the United States

ALBERTO R. GONZALES, ATTORNEY GENERAL, ef ai.,

Petitioners,

Vv.

STATE OF OREGON, ef al.,

Respondents.

On Writ of Certiorari to the

United States Court of Appeals

for the Ninth Circuit

BRIEF AMICUS CURIAE OF

THE THOMAS MORE SOCIETY

IN SUPPORT OF PETITIONERS

Paul Benjamin Linton Thomas Brejcha

Counsel of Record Thomas More Society

921 Keystone Avenue 29 S. La Salle St. Suite 440

Northbrook, Illinois 60062 Chicago, Illinois 60603

(847) 291-3848 (312) 782-1680

May 9, 2005

TABLE OF CONTENTS

er ID od a nce wee teeueueneaen ili

ee. o ccctndncsnadadsasasneuan l

INTRODUCTION AND SUMMARY OF ARGUMENT . 2

ARGUMENT:

L

THE COURT OF APPEALS ERRED IN RELYING

ON THE “PLAIN STATEMENT” RULE OF

GREGORY V. ASHCROFT, 501 U.S. 452 (1991),

TO ENJOIN THE ATTORNEY GENERAL

FROM ENFORCING AN INTERPRETIVE RULE

FORBIDDING THE PRESCRIPTION OF

CONTROLLED SUBSTANCES FOR THE

PURPOSE OF ASSISTING AN INDIVIDUAL

IN COMMITTING SUICIDE ................. 8

ADOPTION OF THE COURT OF APPEALS’

HOLDING WOULD UNDERMINE ENFORCE-

MENT OF THE CONTROLLED SUBSTANCES

ACT AND COMPROMISE THE ATTORNEY

GENERAL’S AUTHORITY TO DETERMINE

THAT CERTAIN USES OF CONTROLLED

SUBSTANCES ARE NOT MEDICALLY

LEGITIMATE, ARE NOT CONSISTENT WITH

THE PUBLIC INTEREST AND SHOULD BE

PROHIBITED, NOTWITHSTANDING

ee gt PPP TTT ere eee 16

Facilitating Religious Expression ............. 17

Enhancing Athletic Performance .............. 19

ND NED oo 0 ndBOT cs cccccsccececcces 22

POOR TIROTOTE o oo 5 ste nner oS cece: 22

Operating Unauthorized Narcotic Drugs

Maintenance Programs .............4.+. 23

Conducting Unregulated Research ............ 24

Oe ieled es Genes ave deekepnen at ens 27

TABLE OF AUTHORITIES

Cases:

Amos v. Maryland Dep't of Public Safety and

Correctional Services, 126 F.3d 589 (4" Cir. 1998),

vacated and remanded on other grounds,

Ss cccadvaudepeusestteuess 15

Associated Builders & Contractors v. Perry,

817 F.Supp. 49 (E.D. Mich. 1992) ............. 15

Atascadero State Hospital v. Scanlon,

ID cca ccsucceouseensd 6,11, 12

Bernal v. Fainter, 467 U.S. 216 (1984) ............... 12

BFP vy. Resolution Trust Corp., 511 U.S. 531 (1994) .... 15

City of Edmonds v. Oxford House, Inc.,

I, Oe oe i ee kha ss 13

Conant v. Walters, 309 F.3d 629 (9 Cir. 2002) ......... 3

Crawford v. Indiana Dep't of Corrections,

DED RSE Ge, TED oo cc cccccncccssess 15

Cushing v. Moore, 783 F.Supp. 727 (N.D.N.Y. 1992),

aff'd as modified, 970 F.2d 1103 (2™ Cir. 1992) .. 24

De Sylva v. Ballentine, 351 U.S. 570 (1956) ............ 3

E.E.O.C. v. Commonwealth of Massachusetts,

og tg eee 14

Fry v. D.E.A., 353 F.2d 1041 (9 Cir. 2003) ........... 26

Gately v. Commonwealth of Massachusetts,

ee Oe Ge SEED oS bc ccivcvocccccens 16

Gooding v. United States, 416 U.S. 430 (1974) .......... 4

Gregory v. Ashcroft, 501 U.S. 452 (1991) ......... passim

Jerome v. United States, 318 U.S. 101 (1943) ......... 4,8

Jin Fuey Moy v. United States, 254 U.S. 189 (1920) ..... 24

League of United Latin American Citizens Council No. 4434

v. Clements, 986 F.2d 728 (5 Cir. 1993) ....... 16

Leary v. United States, 383 F.2d 851 (5" Cir. 1967),

rev'd on other grounds, 395 U.S. 6 (1969) ...... 18

Luna v. Harris, 888 F.2d 949 (2™ Cir. 1989) .......... 23

McBride v. United States, 225 F.2d 249 (5" Cir. 1955)... 24

Mississippi Band of Choctaw Indians v. Holyfield,

Se BOSE ecccccesecececossenss passim

Native American Church of New York v. United States,

468 F.Supp. 1247 (S.D.N.Y. 1979),

aff d mem. op., 633 F.2d 205 (2™ Cir. 1980) .... 18

Nicols v. City of Chicago,

789 F.Supp. 1438 (N.D. Tl. 1992) ............. 15

iV

O Centro Espirita Benficiente Uniao do Vegetal v. Ashcroft,

342 F.3d 1170 (10" Cir. 2003), on reh'g,

389 F.3d 973 (10" Cir. 2004) (en banc),

cert. granted, April 18, 2005, Docket 04-1084 ... 18

O Centro Espirita Benficiente Uniao do ‘/egetal v. Ashcroft,

389 F.3d 973 (10 Cir. 2004) (en banc),

cert. granted, April 18, 2005,

DEE s0ddecoesobndcuctsucesese 18, 19

Olsen v. Drug Enforcement Administration,

878 F.2d 1458 (D.C. Cir. 1989) ............... 18

Oregon v. Ashcroft, 192 F. Supp.2d 1077 (D. Or. 2000) ... 2

Oregon v. Ashcroft, 368 F.3d 1118 (9" Cir. 2004) .. passim

Pennsylvania Dep't of Corrections v. Yeskey,

SP EE s sdetindustetestnesnéees 15

Peyote Way Church of God, Inc. v. Thornburgh,

922 F.2d 1210 (S® Cir. 1991) .............. 17, 18

Sugarman v. Dougall, 413 U.S. 634 (1973) ......... 6, 12

Taylor v. Beckham, 178 U.S. 548 (1900) .............. 11

Torcasio v. Murray, 57 F.3d 1340 (4" Cir. 1995) ....... 15

United States v. Behrman, 258 U.S. 280 (1922) ........ 24

United States v. Boettjer, 569 F.2d 1078 (9" Cir. 1978),

cert. denied, 435 U.S. 976 (1978) ............. 10

v

United States v. Castro,

401 F.Supp. 120 (N.D. Ill. 1975) .............. 22

United States v. Collier, 478 F.2d 268 (5® Cir. 1973) .... 24

United States v. Green, 511 F.2d 1062 (7" Cir. 1975)... 10

United States v. Henry, 727 F.2d 1373 (5® Cir. 1984),

on reh'g, 749 F.2d 203 (5 Cir. 1984) (en banc) . . 22

United States v. Kirk, 584 F.2d 773 (6" Cir. 1978),

cert. denied, 439 U.S. 1048 (1978) ............ 10

United States v. Lot 5, Fox Grove, Alachua County, Florida,

23 F.3d 359 (11 Cir. 1994),

cert. denied, 513 U.S. 1076(1995) .......... 6, 14

United States v. Moore, 423 U.S. 122 (1975) ....... 10, 24

United States v. Norris, 780 F.2d 1207 (5 Cir. 1986) ... 10

United States v. Oakland Cannabis Buyers’ Cooperative,

DPE 6 ccdbedcacceescsedees 10, 26

United States v. Rosenberg, 515 F.2d 190 (9" Cir. 1975),

cert. denied, 423 U.S. 1031 (1975) ............. ]

United States v. Vamos, 797 F.2d 1146 (2™ Cir. 1986),

cert. denied, 479 U.S. 1036 (1987) ............ 10

United States v. Whitley, 734 F.2d 1129 (6 Cir. 1984) .. 22

Webb v. United States, 249 U.S. 960 (1919) ........... 24

vi

Whyte v. United States, 471 A.2d 1018

SC GED Réddbcesescnceceeesoses 18

Yeskey v. Commonwealth of Pennsylvania

Dep't of Corrections, 118 F.3d 168 (3 Cir. 1997),

aff'd, 524 U.S. 204 (1998) ...........0ceeeees 15

Statutes and Regulations:

Be ie OD GD cv vcccvccecesccecsosess 2

21 U.S.C. § 802(41)(A) (2000) ............ cece eens 19

21 U.S.C. § 812(c), Schedule I (c)(11) (2004) .......... 17

21 U.S.C. § 812(c), Schedule I (c)(12) (2000) .......... 17

21 U.S.C.§ 812(c), Schedule I(a)(4) (2000) ........... 22

21 U.S.C. § 812(c), Schedule M(e) (2000) ............ 19

BP DEED cccnccccesenssecsuacees 5, 9, 25

Be a SUED eviecscdcccoscceccases passim

BO DBE, GEO cbc cccccccccccvccccess 25

21 U.S.C. § 823(g) (Supp. 2005) ..............22445. 23

21 U.S.C. § 823(g)(2)(B) (Supp. 2005) ............... 23

21 U.S.C. § 823(g2\(C) (Supp. 2005) ............... 23

21 U.S.C. § 823(g)(2)(D) (Supp. 2005) ............... 23

Vii

21 U.S.C. § 823(g)(2)(E)(i) (Supp. 2005) ............. 23

28 UBL. § GI GRID cc cccccccvccccccccccecess 25

21 U.S.C. § 824(a)(4) (2000) ......... 0. cee eee 2, 23, 25

Be We BOFE GUD ccccccccccccsvccescssesesoes 3

29 U.S.C. § 621 et seq. (2000)... 0... cee eee eee. 5,11

BP OBE. GSR GRRE ccc cccccccccccccccecosens 1]

BP UBL. GGRSE GRD cc cccccccccccccsveecves 6, 12

FP UB. GG GRD oc ccccccccccccccccccccess 1]

SETURL. 9 TRS GINEED cccccccsccccsccctiosoccves 17

42 U.S.C. § 2000bb et seg. (2000) .......... cece eens 18

PEG EEE. da vccdncosnvecncsedsanacesesseedss 21

of} Br Ue Ff fF BPPPrrrrrer rere 13

PD CEE ncbbcévedeesosescdedaccuecesnsnees 6, 13

DE FOE: se Sekscwerdcdsadntcdssadiediaseueets 13

Be le OF OD bc ctcctbdcccosennsdecwoseveses 17

rife) BE: BR ly | PPPPrrrrrrrrerrrier eee 25

23 CPR. § 1FG0ZS GG) onc cccccccvcccccccsccess 25

21 C.F.R. § 1304.03(c) (2004) ....... 2.2 ce eee eee ees 23

Vill

21 C.F.R. § 1304.03(d) (2004)... 0.6 cece eee 23

21 C.F.R. § 1304.04(f) (2004) 0... ccc eee eee 23

21 C.F.R. § 1304.22(c) (2004)... 0... cece eee eee 25

21 CPR. § 1306.26 (2006) 0. nc rcccvcccccscccccces 23

Be Cram © ERR GED oc ccccccccccsccesssetene 23

21 C.F.R. § 1306.04(a) (2004)... 06. cece eee 2

21 C.F.R. § 1306.07(a) (2004)... 0... cece eee eee ee 23

Be Gre © BPS G ee GED ce cccccctccescovessedees 17

21 C.F.R. § 1308.11(d)(21) (2004) ......... cece eee 17

21 C.F.R. § 1308.11(d)(23) (2004) ......... cece eee 17

21 C.F.R. § 1308.12(b)(4) (2004) 2.0... cee cece eee 22

21 CPR. § 1308.13(f) (2006) 0... cece cc cceccvcens 19

SOU CD TENE cb cccccccccdvecccsnetceceneeces 2

Mo. Const. art. V, § 26 (West 1995) ................. 11

Or. REV. STAT. § 127.800 et seg. (2003) ...........545. 2

ix

Other Authorities:

H.R. 91-1444, 91" Cong, 2 Sess. (1970),

reprinted in 1970 U.S.C.C.A.N. 4566 .......... 13

S.. Rep. No. 98-225 at 267, 98" Cong., 2" Sess. (1984),

reprinted in 1984 U.S.C.C.A.N. 3182 .......... 25

House Committee on Government Reform,

Hearings on Steroid Use in Sports, March 17, 2005

http://reform.house.gov/GovReform/Hearings/

Event Single.aspx?EventID1637 ........... 19-21

Joseph F. Spillane, “The Road to the Harrison Narcotics

Act: Drugs and Their Control, 1875-1918,”

FEDERAL DRUG CONTROL[:]

THE EVOLUTION OF POLICY AND PRACTICE

(Haworth Press 2004) (Jonathon Erlen & Joseph F.

PEED Secaccdeusevessercacesennens 13

Interest of Amicus Curiae’

The Thomas More Society is a non-sectarian

501(c)(3) public charity based in Chicago, Dlinois, and is

incorporated as an [linois not-for-profit corporation.

Founded in 1997, the Thomas More Society was established

to help meet the burgeoning legal needs of the pro-life move-

ment and, in particular, to defend those who face legal battles

as a result of their commitment to the protection of basic civil

rights for the most vulnerable and defenseless members of

our society, innocent prenatal human beings. The Thomas

More Society provides legal advice and assistance to those

who face harassment, employment discrimination, unjust

treatment or prosecution as a result of their pro-life position.

The Thomas More Society approves of appropriate

public policies to protect innocent human life at all stages of

life, from conception to natural death. Consistent wit its

mission and the respect for human life which that mission

implies, the Thomas More Society opposes state-sanctioned

physician-assisted suicide and supports the Attorney Gen-

eral’s rule prohibiting the prescription of contralled sub-

stances to facilitate physician-assisted suicide. A ruling by

this Court affirming the Ninth Circuit would undermine en-

forcement of the Controlled Substances Act and compromise

the authority of the Attorney General to determine that

certain uses of controlled substances, including the prescrip-

tion of such substances for the purpose of assisting an indi-

vidual in committing suicide, are not medically legitimate,

are not consistent with the public interest and should be

prohibited, notwithstanding contrary state law. To assist the

Court in addressing the issues presented, amicus submits this

brief.

” Letters of consent have been filed with the Clerk. None of the

counsel for the parties authored this brief in whole or in part, and no one

other than amicus or its counsel has contributed money or services to the

preparation or submission of this brief.

INTRODUCTION AND SUMMARY OF ARGUMENT

For more than thirty years, Department of Justice

regulations implementing the Controlled Substances Act

(CSA), 21 U.S.C. § 801 et seg. (2000), have provided that a

prescription for drugs covered by the Act is valid only if

issued for a “legitimate medical purpose by an individual

practitioner acting in the usual course of his professional

practice.” 21 C.F.R. § 1306.04(a) (2004). On November 6,

2001, the Attorney General issued an interpretive ruling,

effective November 9, 2001, to clarify that a prescription of a

controlled substance issued for the purpose of assisting an

individual in committing suicide is not one made for a “legit-

imate medical purpose” within the meaning of § 1306.04(a),

and that “prescribing, dispensing, or administering federally

controlled substances to assist suicide violates the CSA.” 66

Fed. Reg. 56,608. “Such conduct by a physician registered to

dispense controlled substances,” the Attorney General

warned, “may ‘render his registration * * * inconsistent with

the public interest’ and therefore subject to possible suspen-

sion or revocation under 21 U.S.C. 824(a)(4).” Jd., quoting

21 U.S.C. § 824(a)(4). The Attorney General specifically

nted that this conclusion applies “regardless of whether state

law authorizes or permits such conduct by practitioners or

others and regardless of the condition of the person whose

suicide is assisted.” Jd.

Respondents, the State of Oregon, which allows

physician assisted suicide, OR. REV. STAT. § 127.800 et seq.

(2003), and others, challenged the interpretive rule in the

United States District Court for the District of Oregon. The

district court held the rule invalid and enjoined petitioners

“from enforcing, applying, or otherwise giving any legal

effect” to the rule. Oregon v. Ashcroft, 192 F.Supp.2d 1077,

1080 (D. Or. 2000). On appeal, the court of appeals held that

2

the district court had lacked jurisdiction over respondents’

action and treated the case as a petition for review under 21

U.S.C. § 877 that had been mistakenly filed in the district

court and transferred to the court of appeals. Oregon v.

Ashcroft, 368 F.3d 1118, 1120-21 (9 Cir. 2004). On the

merits, a divided court granted the petitions for review and

“continued” the district court’s injunction. Jd. at 1131.

rhe majority held that the Attorney General lacked

Statutory authority to issue the rule in question. The inter-

pretive rule “violates the ‘clear statement’ rule, contradicts

the plain language of the CSA, and contravenes the express

intent of Congress.” 368 F.3d at 1123. With respect to the

first reason, which is the subject of this brief, the court noted

that the States, not the federal government, are “‘the primary

regulators of professional [medical] conduct.’” Jd. at 1124,

quoting Conant v. Walters, 309 F.3d 629, 639 (9" Cir. 2002).

Accordingly, “state governments bear the primary responsi-

bility for evaluating physician assisted suicide ....” Jd. The

Attorney General’s interpretive rule, however, “interferes

with Oregon’s authority to regulate medical care within its

borders” by “criminalizing medical practices specifically

authorized under Oregon law [i.e., the use of physician pre-

scribed controlled substances to assist a terminally ill patient

in committing suicide].” Jd. This “interference,” according

to the majority, “‘alter[s] the usual constitutional balance

between the States and the Federal Government.’” Jd., quot-

ing Gregory v. Ashcroft, 501 U.S. 452, 460 (1991) (internal

quotation marks and citation omitted). “Under these circum-

stances,” the court determined, “‘it is incumbent upon the

federal courts to be certain of Congress’ intent’ before find-

ing that federal authority supercedes state law.” Jd. at 1124-

25, quoting Gregory, 501 U.S. at 460 (internal quotation

marks and citation omitted).

The majority held that in the absence of an “‘unmis-

takably clear’” authorization from Congress, “the Attorney

General may not exercise control over an area of law tradi-

tionally reserved for state authority, such as regulation of

medical care.” Jd. at 1125, quoting Gregory, 501 U.S. at 460

(internal quotation marks and citation omitted). The court

found “no indication—much less an ‘unmistakably clear’

indication—that [Congress] intended to authorize the Attorney

General to regulate the practice of physician assisted sui-

cide.” Id. “By attempting to regulate the practice of physi-

cian assisted suicide, the [interpretive rule] invokes the outer

limits of Congress’ power by encroaching on state authority

to regulate medical practice.” Jd. The majority concluded

that the interpretive rule “violates the clear statement rule”

because “Congress has not clearly authorized such an intru-

sion [into the State’s authority to regulate medical practice].”

Id.

Senior Judge Wallace dissented. The majority's

reliance on the “clear statement” rule was misplaced and

ignored controlling Supreme Court precedents, as well as the

text of the Controlled Substances Act itself. 368 F.3d at

1136-37. Although “federal law occasionally incorporates

state-law definitions by reference, id., at 1136, citing De

Sylva v. Ballentine, 351 U.S. 570, 580-82 (1956) (defining

the word “children” in a federal statute according to state

law), “recourse to state law is the exception rather than the

norm.” Jd. “[T}he general assumption [is] that ‘in the ab-

sence of a plain indication to the contrary, . . . Congress when

it enacts a statute [does] not mak[e] the application of the

federal act dependent on state law.’” Mississippi Band of

Choctaw Indians v. Holyfield, 490 U.S. 30, 43 (1989), quot-

ing Jerome v. United States, 318 U.S. 101, 104 (1943).

The dissent noted that there is no language in the

Controlled Substances Act suggesting that Congress intended

4

the Act to be dependent upon state law. “State law may be

relevant to certain provisions of the . . . Act,” 368 F.3d at

1137, citing 21 U.S.C. § 823 (f) (instructing the Attorney

General to consider state-law violations when deciding

whether a physician’s registration would be contrary to the

public interest), “but nothing in the Controlled Substances

Act plainly evinces a congressional intent to define ‘the

public interest’ solely according to state law.” Jd. Section

823 “instructs the Attorney General to identify acts ‘inconsis-

tent with the public interest’ by reference to a variety of

sources, including a physician’s federal conviction record,

compliance with ‘Federal . . . laws relating to controlled

substances,’ and ‘other conduct which may threaten public

health and safety.’” Jd., quoting 21 U.S.C. § 823. Thus,

“(t]he majority’s contention that the Attorney General cannot

suspend or revoke a physician’s registration without state

authorization ignores Mississippi Band’s ‘plain indication’

rule and contravenes Congress’ clearly expressed intent.” Jd.

Amicus curiae concurs with Senior Judge Wallace’s dissent.

1. The majority’s reliance on Gregory v. Ashcroft,

501 U.S. 452 (1991), was clearly misplaced. At issue in

Gregory was whether the Age Discrimination in Employ-

ment Act (ADEA), 29 U.S.C. § 621 et seg. (2000), applied to

State court judges who had been appointed to office by the

Governor of Missouri and who were required to retire by age

70 by a provision of the Missouri Constitution. The Court

noted that the mandatory retirement provision “goes beyond

an area traditionally regulated by the States; it is a decision of

the most fundamental sort for a sovereign entity. Through

the structure of the government, and the character of those

who exercise government authority, the State defines itself as

a sovereign.” 501 U.S. at 460. If Congress intends to alter

the “‘usual constitutional balance between the States and the

Federal Government,’” it must make its intention to do so

5

‘unmistakably clear in the language of the statute.’” /d.,

quoting Atascadero State Hospital v. Scanlon, 473 U.S. 234,

242 (1985). The “plain statement” rule applies to “state

decisions that ‘go to the heart of representative govern-

ment.” Jd. at 461, quoting Sugarman v. Dougall, 413 U.S.

634, 647 (1973). In Gregory, the Court determined that the

ADEA was at least ambiguous whether a state judge is an

“appointee on the policymaking level,” within the meaning of

29 U.S.C. § 630(f), and therefore excluded from the scope of

the Act. Jd. at 467. In the absence of a “plain indication”

that Congress intended to include appointed judges within

the scope of the Act, the Court declined to attribute such an

intent to Congress. /d. at 470.

The court of appeals gave Gregory an overly broad

reading. The “plain statement” rule, properly understood, “is

limited to federal laws impacting a [S]tate’s self-identifica-

tion as a sovereignty,” not to a State’s “substantive policy

choice[s].” United States v. Lot 5, Fox Grove, Alachua

County, Florida, 23 F.3d 359, 362 (11 Cir. 1994), cert.

denied, 513 U.S. 1076 (1995). Oregon’s decision to legalize

physician-assisted suicide, however, is simply a “substantive

policy choice” on behalf of the State, not part of the State’s

“self-identification as a sovereignty.” The “regulation of

medical care” may be an area “traditionally reserved for state

authority,” 368 F.3d at 1125, but that is not enough to invoke

the “plain statement” rule. In Gregory, the Court stressed that

the mandatory retirement provision in the Missouri Constitu-

tion “goes beyond an area traditionally regulated by the

States, ....” 501 U.S. at 460 (emphasis added). Moreover,

although the regulation of the practice of medicine may be a

matter “traditionally reserved for state authority,” the same

cannot be said of the regulation of controlled substances

which, since adoption of the Harrison Narcotics Act of 1914,

38 Stat. 785, has been a matter of profound federal interest.

6

2. The majority's application of the “plain statement”

rule to the Controlled Substances Act dramatically under-

mines the Attorney General’s authority to enforce the Act

and federal drug control policy. According to the majority,

absent an “unmistakably clear” indication from Congress that

it intended to authorize the Attorney General to regulate the

specific purposes for which controlled substances may be

prescribed (e.g., physician-assisted suicide), each State may

decide for itself the purposes for which such substances may

be prescribed. Thus, under the majority’s holding, a State

could authorize controlled substances to be used for a variety

of purposes—facilitating religious expression, enhancing

athletic performance, inducing euphoria, providing recre-

ation, operating unauthorized narcotic drugs maintenance

programs and conducting unregulated research (with Sched-

ule I substances), as well as assisting suicide—and the Attor-

ney General would be powerless to do anything about it. The

State’s authorization of controlled substances for those pur-

poses would effectively preclude the Attorney General from

taking any action—civil, administrative or criminal—against a

registrant acting in compliance with state law. A holding that

leads to such extraordinary results cannot be reasonable.

Adoption of the majority’s reasoning would inevita-

bly result in the Balkanization of medical practice, in which

each State would be free to decide for itself whether a

controlled substance could be used for a given purpose, no

mater how unethical, unorthodox, untested or unusual.

Under the majority’s holding, conduct that otherwise could

result in suspension or revocation of a physician’s registra-

tion to dispense federal controlled substances, or even crimi-

nal prosecution, would be immune from federal control by

virtue of state law authorizing the specific purposes for

which controlled substances may be prescribed. That is

clearly not what Congress intended in enacting the Con-

trolled Substances Act.

ARGUMENT

I. THE COURT OF APPEALS ERRED IN RELY-

ING ON THE “PLAIN STATEMENT” RULE OF

GREGORY V. ASHCROFT, 501 U.S. 452 (1991),

TO ENJOIN THE ATTORNEY GENERAL

FROM ENFORCING AN INTERPRETIVE

RULE FORBIDDING THE PRESCRIPTION OF

CONTROLLED SUBSTANCES FOR THE PUR-

POSE OF ASSISTING AN INDIVIDUAL IN

COMMITTING SUICIDE.

The court of appeals held that the Attorney General

was powerless to proscribe the prescription of controlled sub-

stances for the purpose of assisting an individual in commit-

ting suicide in the absence of an “unmistakably clear” expres-

sion of Congressional intent authorizing him to so interpret

the Controlled Substances Act. 368 F.3d at 1125. In so

ruling, the majority relied principally on this Court’s decision

in Gregory v. Ashcroft, 501 U.S. 452 (1991). Id. at 1124-25.

That reliance was clearly misplaced.

1. Under well-established precedent, “the general

assumption [is] that ‘in the absence of a plain indication to

the contrary, . .. Congress when it enacts a statute is not

making the application of the federal act dependent on state

law.’” Mississippi Band of Choctaw Indians v. Holyfield, 490

U.S. 30, 43 (1989), quoting Jerome v. United States, 318

U.S. 101, 104 (1943). “One reason for this rule of construc-

tion is that federal stavutes are generally intended to have

uniform nationwide apolication.” /d., citing Jerome. “A

second reason for the presumption against the application of

state law is the danger that ‘the federal program would be

impaired if state law were to control.’” Jd. at 44, quoting

Jerome, 318 U.S. at 104. Both reasons apply here.

First, as Senior Judge Wallace noted in his dissent,

368 F.3d at 1137, there is no language in the Controlled Sub-

stances Act suggesting that Congress intended the Act to be

dependent upon state law. Although “State law may be

relevant to certain provisions of the . . . Act,” e.g., 21 U.S.C.

§ 823(f) (instructing the Attorney General to consider state

law violations when deciding whether a physician’s registra-

tion would be contrary to the public interest), “nothing in the

Controlled Substances Act plainly evinces a congressional

intent to define ‘the public interest’ solely according to state

law.” Id. Section 823 “instructs the Attorney General to

identify acts ‘inconsistent with the public interest’ by refer-

ence to a variety of sources, including a physician’s federal

conviction record, compliance with ‘Federal . . . laws relating

to controlled substances,’ and ‘other conduct which may

threaten public health and safety.’” Jd., quoting 21 U.S.C. §

823. Thus, “[t}he majority’s contention that the Attorney

General cannot suspend or revoke a physician’s registration

without state authorization ignores Mississippi Band's ‘plain

indication’ we and contravenes Congress’ clearly expressed

intent.” Jd.

This Court has recognized that in enacting the Con-

trolled Substances Act, Congress intended to provide “a

comprehensive federal scheme for the control of drug

abuse.” Gooding v. United States, 416 U.S. 430, 449 (1974)

(emphasis added). To be effective, enforceable and uniform,

such a scheme must rely on a general standard of medical

' The majority also ignored its own precedent. See United States

v. Rosenberg, 515 F.2d 190, 198 n.14 (9 Cir. 1975) (rejecting the

argument that a federal prosecution under the Controlled Substances Act

could not proceed unless and until there had been a finding that the

defendant's conduct was unauthorized under state law), cert. denied, 423

U.S. 1031 (1975).

care that exists throughout the United States, not one that

turns on the peculiarities of each State’s law. See United

States v. Moore, 423 U.S. 122, 139 (1975) (approving jury

instruction that, under the Controlled Substances Act, pre-

scriptions must be made “in accordance with a standard of

medical practice generally recognized and accepted in the

United States”).

Second, for the reasons developed in more detail in

the following argument, it is evident that the purposes of the

Controlled Substances Act would be seriously undermined if,

as the majority held, state law were to control what consti-

tutes the permissible uses of substances subject to the Act.

Suffice it to say here that the very concept of a federal

controlled substances act would be compromised if state law

ultimately deterinined the permissible uses of controlled

substances. See United States v. Oakland Cannabis Buyers’

Cooperative, 532 U.S. 483 (2001) (rejecting claim that Cali-

fornians who used marijuana for medical purposes “upon the

recommendation or approval of a physician” in compliance

with California law were exempt from the prohibitions of the

Controlled Substances Act which classifies marijuana as a

Schedule I substance with no recognized medical use).

* See also United States v. Norris, 780 F.2d 1207, 1209 & n. 2

(5* Cir. 1986) (“a standard medical practice may [not] be based on an

enurely subjective standard” but must be one “recognized and accepted in

the United States”); United States v. Vamos, 797 F.2d 1146, 1153 (2™

Cir. 1986) (“{t]o permut a practitioner to substitute his or her views of

what is good medical practice for standards generally recognized and

accepted in the United States would be to weaken our drug laws in a

critical area”), cert. denied, 479 U.S. 1036 (1987); United States v. Kirk,

584 F.2d 773, 785 (6" Cir. 1978) (relying on “generally acceptable

standards of medical practice for issuing prescriptions”), cert. denied,

439 U.S. 1048 (1978); United States v. Boettjer, 569 F.2d 1078, 1081 (9”

Cir. 1978) (same), cert. denied, 435 U.S. 976 (1978); United States v.

Green, 511 F.2d 1062, 1073 (7” Cir. 1975) (same)

10

2. The majority erred in relying on Gregory v.

Ashcroft to circumvent the “plain indication” rule of Missis-

sippi Band. The issue in Gregory was whether the ADEA,

29 U.S.C. § 621 et seq., which makes it unlawful for an

“employer” “to discharge any individual” who is at least 40

years old “because of such individual’s age,” 29 U.S.C. §§

$23(1), 631(a), applies to state court judges who had been

appointed to office by the Governor of Missouri and who

were subject to mandatory retirement at age 70 by art. V, §

26, of the Missouri Constitution. Mo. CONST. art. V, § 26

(West 1995).

The Court began its analysis of the issue by noting

that art. V, § 26, “goes beyond an area traditionally regulated

by the States; it is a decision of the most fundamental sort for

a sovereign entity. Through the structure of its government,

and the character of those who exercise government author-

ity, a State defines itself as a sovereign.” 501 U.S. at 460.

The States’ power to “‘prescribe the qualifications of their

own officers’” is “‘essential to [their] independence’” and

““should be exclusive and free from external interference,

except so far as plainly provided by the Constitution of the

United States.’” Jd., quoting Taylor v. Beckham, 178 U.S.

548, 570-71 (1900).

The Court observed that “Congressional interference

with [the] decision of the people of Missouri, defining their

constitutional offices, would upset the usual constitutional

balance of federal and state powers.” 501 U.S. at 460. For

that reason, “‘it is incumbent upon the federal courts to be

certain of Congress’ intent before finding that federal law

overrides’ this balance.” /Jd., quoting Atascadero State Hos-

pital v. Scanlon, 473 U.S. 234, 243 (1985). Where Congress

intends to alter the “‘usual constitutional balance between the

States and the Federal Government,’” it must makes its

intention to do so “‘unmistakably clear in the language of the

11

statute.” /d., quoting Atascadero. “This plain statement

rule,” the Court explained, “is nothing more than an

acknowledgment that the States retain substantial powers

under our constitutional scheme, powers with which Con-

gress does not readily interfere.” Jd. at 461.

The Court referred to a recent line of authority in

which it has “acknowledged the unique nature of state deci-

sions that ‘go to the heart of representative government.’”

Gregory, 501 U.S. at 461, quoting Sugarman v. Dougall, 412

U.S. 634, 647 (1973). Under this line of authority, the Court

has considered the authority of state and local governments to

prohibit aliens from public employment and has applied a

lower standard of review than strict scrutiny “when evaluat-

ing the validity of exclusions [from public employment] that

entrust only to citizens important elective and nonelective

positions whose operations ‘go to the heart of representative

government.” Bernal v. Fainter, 467 U.S. 216, 221 (1984),

quoting Sugarman, supra. The “political function” cases

recognize “the authority of the people of the States to deter-

mine the qualifications of their most important government

officials.” Gregory, 501 U.S. at 463.

Turning to the question at hand, the Court noted that

the ADEA excludes from the definition of employee “an

appointee on the policymaking level” chosen by “any person

elected to public office in any State... .” Gregory, 501 U.S.

at 465, quoting 29 U.S.C. § 630(f). After reviewing the

authority of Missouri state court judges, including their

power to interpret and develop the common law, the Court

found that it was “at least ambiguous whether a state judge is

an ‘appointee on the policymaking level,” and thus excluded

from the coverage of the Act. /d. at 467. Because Congress

did not make it clear that judges are included, the Court

concluded that the Act does not cover them. /d. at 470.

12

3. Gregory has no application to the Controlled Sub-

stances Act. First, in Gregory, the Court stressed that the

state constitutional provision at issue “goes beyond an area

traditionally regulated by the States, ....” 501 U.S. at 460

(emphasis added). See City of Edmonds v. Oxford House,

Inc., 514 U.S. 725, 732 n. 5 (1995) (emphasizing this aspect

of Gregory). Thus, the majority's observetion that the “reg-

ulation of medical care” is “an area of law traditionally re-

served for state authority,” 368 F.3d at 1125, does not, in and

of itself, implicate the “plain statement” rule. Second, al-

though regulation of the practice of medicine may be a matter

“traditionally reserved for state authority,” the same certainly

cannot be said of the regulation of controlled substances. For

more than 90 years, from adoption of the Harrison Narcotics

Act of 1914, 38 Stat. 785, through enactment of the Con-

trolled Substances Act of 1970, 84 Stat. 1236, § 100 ef seq.,

the regulation of controlled substances has been a matter of

continuing and uninterrupted federal interest.’

Gregory's “plain statement” rule does not apply

unless “provisions [of federal law] are ambiguous and state

* Indeed, one commentator has pointed out that “[{a]lthough the

Harrison Narcotics Act was certainly an important milestone in the

history of drug control, it hardly represented the first use of the criminal

law in this area, even at the federal level [citing the Pure Food and Drug

Act of 1906, 34 Stat. 768, and various national and international efforts

to ban opium smoking and importation of opium for smoking before

1914].” Joseph F. Spillane, “The Road to the Harrison Narcotics Act:

Drugs and Their Control, 1875-1918,” FEDERAL DRUG CONTROL{:] THE

EVOLUTION OF POLICY AND PRACTICE at 10 (Haworth Press 2004)

(Jonathon Erlen & Joseph F. Spillane, Eds.). See also H.R. 91-1444, 91"

Cong., 2™ Sess. (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4571

(noting that since 1914, “the Congress has enacted more than 50 pieces of

legislation relating to control and diversion, from legitimate channels, of

those drugs referred to as narcotics and dangerous drugs”).

13

sovereignty is at issue,....” E.E.O.C. v. Commonwealth of

Massachusetts, 987 F.2d 64, 69 (1* Cir. 1993) (Gregory did

not prevent the E.E.O.C. from using the ADEA to overturn a

Massachusetts law that required state and local officials and

general employees who are seventy years old or older to take

and pass a medical examination as a condition of continued

employment). For the reasons set forth above, the provisions

of the Controlled Substances Act are not ambiguous and state

sovereignty is not at issue in the regulation of the use of

federally controlled substances.

The Eleventh Circuit has held that “the Gregory plain

Statement rule is limited to federal laws impacting a [S]tate’s

self-.dentification as a sovereignty.” United States v. Loi 5,

Fox Grove, Alachua County, Florida, 23 F.3d 359, 362 (11"

Cir. 1994) (federal civil forfeiture law preempts Fiorida’s

constitutional homestead right). In United States v. Lot 5, the

court of appeals noted that Florida’s homestead protection is

“a substantive policy choice, not a means of sovereign defini-

tion.” Jd. So, too, Oregon's decision to decriminalize the

use of controlled substances for physician assisted suicide

simply represents a “substantive policy choice” of the State

and is not a means of “sovereign definition.”

This Court has intimated (and lower courts have held)

that “exercising ultimate control over the management of

* Nothing in the Attorney General's interpretive rule affects the

legality of assisted suicide under Oregon law, other than the use of

controlled substances to facilitate suicides. Other means of assisting

suicide, e.g., inhalation of gasses or ingestion of substances not covered

by the Controlled Substances Act, would remain available options, as the

dissent noted. 368 F.3d at 1134-35 (Wallace, Senior Judge, dissenting).

The rule does not prevent “[s}tate legislators [from] authoriz[ing]}

alternative methods for assisting suicide that do not involve the

prescription of controlled substances.” /d. at 1148.

14

state prisons, like establishing the qualifications of state

government officials, is a traditional and essential function

subject to the plain statement rule of Gregory.” Pennsylva-

nia Dep't of Corrections v. Yeskey, 524 U.S. 204, 209

(1998).° The Court has also relied, in part, on Gregory in

holding that States have an “essential sovereign interest in

the security and stability of title to land.” BFP v. Resolution

Trust Corp., 511 U.S. 531, 544 n. 8 (1994). A state law

decriminalizing assisted suicide, however, affects only pri-

vate conduct and does not trench upon the “sovereign

interest(s] of the State.

Gregory's “plain statement” rule has been held not to

apply to federal labor regulation of “the relationship between

a local government employer and its employees,” Nicols v.

City of Chicago, 789 F.Supp. 1438, 1446 (N.D. Ill. 1992), or

to ERISA’s impact on state labor statutes, even though such

matters “traditionally [have been] regulated at the state

level.” Associated Builders & Contractors v. Perry, 817

F.Supp. 49, 53-54 n.3 (E.D. Mich. 1992). In the latter case,

the district court noted that state laws regulating labor

relations “certainly do not rise to the level of ‘the most

fundamental sort for a sovereign entity.’” /d., quoting

Gregory, 501 U.S. at 460. The plain statement rule has also

been held not to apply to a provision of the Voting Rights

Act that “impinges on the authority of [S]tates to employ

certain election practices,” but not on their authority “to set

* See Torcasio v. Murray, 57 F.3d 1340, 1345 (4" Cir. 1995)

(“the management of state prisons is a core state function”); Amos v.

Maryland Dep't of Public Safety and Correctional Services, 126 F.3d

589, 600 (4" Cir. 1998) (adhering to Torcasio), vacated and remanded

on other grounds, 524 U.S. 935 (1998); Crawford v. Indiana Dep't of

Corrections, 115 F.3d 481, 485-86 (7" Cir. 1997) (same); Yeskey v.

Commonwealth of Pennsylvania Dep't of Corrections, 118 F.3d 168, 173

(3 Cir. 1997) (same), aff'd, 524 U.S. 204 (1998).

15

qualifications for their elected officials.” League of United

Latin American Citizens Council No. 4434 v. Clements, 986

F.2d 728, 759 (5" Cir. 1993). See also Gately v. Common-

wealth of Massachusetts, 2 F.3d 1221 (1* Cir. 1993) (declin-

ing to apply Gregory's “plain statement” rule to the ADEA’s

invalidation of state policy mandating retirement of state

police). Oregon’s interest in allowing controlled substances

to be used in facilitating physician-assisted suicide is no

greater than any of tne state interests asserted, but found

wanting, in the foregoing cases.

The court of appeals erred in relying on the “plain

statement” rule of Gregory v. Ashcroft to enjoin the Attorney

General from enforcing his interpretive rule barring the use

of controlled substances for the purpose of assisting an indi-

vidual in committing suicide. Because that error was central

to the court’s analysis, its judgment should be reversed.

Il. ADOPTION OF THE COURT OF APPEALS’

HOLDING WOULD UNDERMINE ENFORCE-

MENT OF THE CONTROLLED SUBSTANCES

ACT AND COMPROMISE THE ATTORNEY

GENERAL’S AUTHORITY TO DETERMINE

THAT CERTAIN USES OF CONTROLLED

SUBSTANCES ARE NOT MEDICALLY

LEGITIMATE, ARE NOT CONSISTENT WITH

THE PUBLIC INTEREST AND SHOULD BE

PROHIBITED, NOTWITHSTANDING

CONTRARY STATE LAW.

The holding of the court of appeals, if adopted by this

Court, would undermine enforcement of the Controlled

Substances Act and compromise the Attorney General’s

authority to determine that certain uses of controlled

substances, including the prescription of such substances for

the purpose of assisting an individual in committing suicide,

16

———oOoOOOeeeee

are not medically legitimate, are not consistent with the

public interest and should be prohibited, notwithstanding

contrary state law. Under the court of appeals’ holding, the

Attorney General may not prohibit the prescription, dispens-

ing or administration of controlled substances for any pur-

poses allowed by state law, in the absence of an “unmistak-

ably clear” indication from Congress authorizing him to do

so. 368 F.3d at 1125.° The possible consequences of such a

holding, if not reversed by this Court, are not difficult to

foresee.

Facilitating Religious Expression

For forty years, first by regulation, 21 C.F.R. §

166.3(c), recodified as 21 C.F.R. § 1307.31 (2004), later by

Statute, 42 U.S.C. § 1996a (2000), federal law has allowed

the traditional religious use of peyote by members of Indian

tribes. The stems of peyote, a variety of cactus, “contain

mescaline which has a hallucinogenic effect when ingested.”

Peyote Way Church of God, Inc. v. Thornburgh, 922 F.2d

1210, 1212 (S® Cir. 1991).’ The exemption in federal law for

the religious use of peyote by members of Indian tribes has

* Respondents fully endorse this holding. See Or. Br. in Op. 15

(“the CSA does not contain a ‘clear statement’ of intent to authorize the

Attorney General to determine what uses state-licensed doctors may make

of substances that concededly have approved medical uses”); Rasmussen

Br. in Op. at 15-18 (same); Patient Br. in Op. 4 (no evidence that

Congress, in enacting the CSA, “‘intended . . .. to override a state’s

determination as to what constitutes legitimate medical practice in the

absence of a federal law prohibiting that practice’’”’) (quoting letter of

June 5, 1998, from Attorney General Reno to Hon. Henry Hyde).

’ Both peyote and mescaline are classified as Schedule I

controlled substances. 21 U.S.C. §§ 812(c), Schedule I (c)(11)

(mescaline); Schedule I (c)(12) (peyote); 21 C.F.R. §§ 1308.11(d)(21)

(mescaline); 1308.11(d)(23) (peyote) (2004).

17

led to a-flurry of lawsuits by other religious groups challeng-

ing, on equal protection and other grounds, the law’s failure

to include exemptions for the religious use of peyote by non-

members of Indiana tribes, see Peyote Way Church of God,

supra, and the religious use of other drugs, particularly mari-

juana. See Olsen v. Drug Enforcement Administration, 878

F.2d 1458, 1461-64 (D.C. Cir. 1989) (Op. of R. Ginsburg, J.)

(Ethiopian Zion Coptic Church), and the cases cited therein);*

O Centro Espirita Benficiente Uniao do Vegetal v. Ashcroft,

342 F.3d 1170, 1186 n.4 (10 Cir. 2003) (rejecting equal

protection claim that religious use of hoasca, a tea containing

dimethyltryptamine, a Schedule I hallucinogen, must be

protected because “the Native American Church’s use of

peyote is protected”), on reh’g, 389 F.3d 973 (10 Cir. 2004)

(en banc), cert. granted, April 18, 2005, Docket 04-1084.’

The foregoing challenges generally have been

rejected.’ Nevertheless, they reflect efforts by some

* See also Whyte v. United States, 471 A.2d 1018 (D.C. Ct. App.

1984) (Rastafarian Church); Leary v. United States, 383 F.2d 851, 861 &

n.11 (5 Cir. 1967) (individual religious use of marijuana), rev’d on other

grounds, 395 U.S. 6 (1969).

* On rehearing, the Tenth Circuit determined that plaintiffs had

shown a probability of success in prevailing on the merits of their claim

that the prohibition of the religious use of hoasca violates the Religious

Freedom Restoration Act, 42 U.S.C. § 2000bb et seg. (2000). 389 F.3d

at 976 (per curiam op.); id. at 1004-1011 (Seymour, J., concurring in part

and dissenting in part); id. at 1018-31 (McConnell, J., concurring).

'© But see Native American Church of New York v. United

States, 468 F.Supp. 1247, 1251 (S.D.N.Y. 1979) (ruling that the

regulatory exemption for peyote would have to be made “equally

available” to “a bona fide religious organization [that] would make use of

peyote for sacramental purposes and regard the drug as a deity”), aff'd

mem. op., 633 F.2d 205 (2™ Cir. 1980).

18

religious groups (and their members) to use the courts to

broaden the circumstances under which controlled substances

may be used for religious purposes. In light of th Ninth

Circuit’s decision in this case, however, those efforts may be

redirected to state legislatures. The States, of course, may

choose to grant religious exemptions to their own controlled

substances laws. What they have not been able to do, until

now, is grant religious exemptions to the Controlled Sub-

stances Act. But that is effectively what the court of appeals

decision permits, possibly with respect to Schedule I con-

trolled substances (for which there is no recognized medical

use), and certainly with respect to controlled substances

classified under Schedules II through V. Allowing state law

to override federal law with respect to the religious use of

controlled substances would undermine “the government’s

interest in the uniform enforcement of the Controlled

Substances Act,” an interest “of the highest order.”” O Centro

Espirita Benficiente Uniao do Vegetal v. Ashcroft, 389 F.3d

at 985 (Murphy, J., concurring in part and dissenting in part).

See also, id., at 1031 (Hartz, J., dissenting) (the Government

has “a compelling interest in uniform application of the

Controlled Substances Act”). Yet that is precisely what the

Ninth Circuit’s decision allows.

Enhancing Athletic Performance

The abuse of anabolic steroids, a Schedule III con-

trolled substance'' that “promotes muscle growth,” 21 U.S.C.

§ 802(41)(A) (defining term “anabolic steroid”), has received

widespread recent attention in Congressional hearings into

the use of steroids in professional sports. See House Com-

mittee on Government Reform, Hearings on Steroid Use in

'' 21 U.S.C. § 812(c), Schedule III(e); 21 C.F.R. § 1308.13(f)

(2004).

19

Sports (ongoing).'* The hearings have disclosed disturbing

details about the extent and seriousness of anabolic steroid

abuse. Although anabolic steroids have appropriate medical

purposes, é.g., “to treat conditions that occur when the body

produces abnormally low amounts of testosterone, such as

delayed puberty and some types of impotence,” and “to treat

body wasting in patients with AIDS and other diseases that

result in loss of lean muscle mass,”’'’ taking steroids for the

purpose of enhancing athletic performance is not one of

them. “Inappropriate use of anabolic steroids can have seri-

ous health consequences,” including, in younger steroid

abusers, “[the] risk of permanently halting their growth,” in

males, ‘a shrinking of their testicles, reduced sperm count,

infertility, baldness, development of breasts, and an increased

risk for prostate cancer,” and in females, “menstrual abnor-

malities, deepening of the voice, shrinkage of breasts, male-

pattern baldness, and an increase in sex drive, acne, body hair

and clitoris size.”'* For both men and women, other conse-

quences include “liver and heart disease, stoke, drug depend-

ence, and increased aggression.”

'? The statements and written testimony of witnesses at the

March 17, 2005, hearing may be found at http://reform.house.gov/

GovReform/Hearings/Event Single.aspx?7EventID1637. The Committee

also heard testimony on April 27, 2005.

'? Statement of Nora D. Volkow, M.D., Consequences of the

Abuse of Anabolic Steroids at 2, Testimony Before the Committee on

Government Reform, U.S. House of Representatives, March 17, 2005.

Dr. Volkow is the Director of the National Institute on Drug Abuse,

National Institutes of Health, United States Department of Health &

Human Services.

4 Id. at 3,9.

'S Id. at 3-4.

20

In one survey conducted in 2003 by the Centers for

Disease Control and Prevention, 6.1% of students in grades 9

through 12 reported illegal use of anabolic steroids at least

once in their lifetime, up from 2.7% in 1991; a somewhat

differently designed study indicated that 79,000 high school

seniors reported having abused anabolic steroids last year

(2004).'° In an attempt to address the problem of steroid

abuse, Congress recently enacted the Anabolic Steroid

Control Act of 2004, 108 Pub. L. 358, 118 Stat. 1661 (2004),

bringing many of the abused substances that previously had

not been illegal (particularly steroid precursors) within the

scope of the Controlled Substances Act.'’ Other medical and

psychiatric testimony underscored the severity of the problem

of anabolic steroid abuse.'*

Under the court of appeals’ holding, however, if a

State decided to authorize the use of anabolic steroids for

purposes which would not generally be regarded as medical

in nature, e.g., enhancing athletic performance, body building

or weight training, the Attorney General would not be able

take any action-civil, administrative or criminal—against

registrants who dispensed drugs for those purposes The

State’s sanctioning of the use of anabolic steroids for such

questionable purposes, no matter how unethical or unusual,

would effectively bar federal enforcement of the Controlled

Substances Act, just as it has with Oregon’s use of controlled

substances in its experiment with physician-assisted suicide.

"© Id. at 7.

"" Id. at 6-7.

'* See Statements of Kirk J. Brower, M.D. and Gary I. Wadler,

M.D., March 17, 2005

21

Inducing Euphoria

There is no generally accepted medical use of con-

trolled substances to induce a state of euphoria."” Yet, under

the Ninth Circuit's holding, if a State decided to authorize

physicians to prescribe cocaine and other stimulants for that

purpose,” the Attorney General would be powerless to take

any action against them. In the majority’s understanding of

the Controlled Substances Act, the States are the ultimate

arbiters of what qualifies as a “legitimate medical purpose.”

Providing Recreation

No State allows controlled substances to be used for

recreational purposes. Any registrant who dispenses con-

trolled substances for such purposes may be prosecuted under

the Controlled Substances Act, see United States v. Henry,

727 F.2d 1373, 1374 (5® Cir. 1984), on reh'g, 749 F.2d 203

(5" Cir. 1984) (en banc), and have his federal registration

suspended or revoked. Yet, if a State decided to authorize

physicians to prescribe controlled substances (e.g., narcotics

or barbiturates) for those purposes, the Attorney General

would be powerless to take any action any against them.

'* By “euphoria,” amicus means “a sense of intense stimulation,

and of psychic and physical well-being.” United States v. Whitley, 734

F.2d 1129, 1140 (6" Cir. 1984).

* Although classified as a narcotic, 21 U.S.C.§ 812(c), Schedule

Il(aX4), 21 C.F.R. § 1308.12(b)(4) (2004), cocaine is a stimulant, not a

depressant. See United States v. Whitley, supra, n. 12, 734 F.2d at 1140;

United States v. Castro, 401 F.Supp. 120, 123 (N.D. Ill. 1975) (noting

that, in the pharmacological sense, cocaine is “universally identified with

amphetamines,” and is “generally considered as an anti-fatigue, anti-

soporific stimulant often used to stimulate alertness or euphoria).

22

Operating Unauthorized Narcotic Drugs

Maintenance Programs

The Act authorizes practitioners to dispense narcotic

drugs for maintenance treatment. 21 U.S.C. § 823(g) (Supp.

2005). Except in narrowly defined circumstances not involv-

ing Schedule II drugs, however, the statute provides “that

every practitioner who dispenses narcotics for maintenance

treatment must obtain a separate registration, the issuance of

which is conditioned upon standards established by the Sec-

retary of Health and Human Services and the Attorney Gen-

eral of the United States.” Luna v. Harris, 888 F.2d 949, 953

(2™ Cir. 1989). Even with respect to Schedule III, IV and V

narcotic drugs, practitioners who dispense drugs to individu-

als for maintenance treatment must comply with a myriad of

statutory and regulatory requirements. See, e.g., 21 U.S.C. §§

823(g)(2)(B)-(D); 21 C.F.R. §§ 1304.03(c), 1304.03(d),

1304.04(f),1304.24, 1304.25, 1306.07(a)(2004). If a practi-

tioner does not have a separate registration to dispense nar-

cotics for maintenance treatment and dispenses Schedule III,

IV or V narcotic drugs for such treatment in violation of §§

823(g)(2)(B)-(D), the Attorney General may, for purposes of

§ 824(a)(4), “consider the practitioner to have committed an

act that renders the registration of the practitioner pursuant to

subsection (f) of this section [823(f)] to be inconsistent with

the public interest.” 21 U.S.C. § 823(g)(2)(Ei).

Under the court of appeals’ holding, a State could

effectively nullify the elaborate federal regulatory framework

for narcotic drugs maintenance programs by authorizing its

own maintenance program without any of the safeguards

built into the federal structure. The abuse of unregulated (or

inadequately regulated) drug maintenance programs has been

well documented. See Luna, supra, 888 F.2d at 953-54

(noting Congressional concern with the illegal diversion of

23

methadone used in drug maintenance programs); United

States v. Moore, 423 U.S. 122, 126 (1975) (noting physi-

cian’s unorthodox and unapproved method of treating heroin

addicts by “saturat[ing]” them with such large quantities of

methadone that “heroin would have no [physical] effect” on

them and they would develop “a strong psychological desire

for detoxification”). See also Cushing v. Moore, 783 F.Supp.

727, 729 (N.D.N.Y. 1992) (describing regulatory scheme),

aff d as modified, 970 F.2d 1103 (2™ Cir. 1992).

Prior to the court of appeals’ decision in this case, it

was generally understood that “under the guise of treatment a

physician [could not] distribute drugs intended to cater to

cravings of an addict.” United States v. Collier, 478 F.2d

268, 272 (5" Cir. 1973) (methadone), citing, inter alia, Jin

Fuey Moy v. United States, 254 U.S. 189, 193 (1920) (mor-

phine sulfate); Webb v. United States, 249 U.S. 96, 99-100

(1919) (morphine); United States v. Behrman, 258 U.S. 280,

288-89 (1922) (heroin, morphine and cocaine). See also

McBride v. United States, 225 F.2d 249, 253 (5® Cir. 1955)

(codeine). That understanding has been called into question

by the Ninth Circuit's opinion.

Conducting Unregulated Research

The Controlled Substances Act allows practitioners to

conduct research (including dispensing drugs) with Schedule

I controlled substances under strictly defined conditions. The

practitioner must be separately registered under the Act; his

qualifications and competence must be evaluated by the

Secretary of Health and Human Services; and the Secretary

must assess the relative merits of the proposed research

protocol in consultation with the Attorney General regarding

“effective procedures to adequately safeguard against diver-

sion of such controlled substances from legitimate medical or

24

> —

scientific use.” 21 U.S.C. § 823(f). See also 21 C.F.R. §§

1301.18, 1301.22, 1304.22(c) (2004). Even if the Secretary

has deemed the practitioner is qualified to conduct research

with Schedule I controlled substances, the Attorney General

may deny his registration on one of the grounds specified in §

824(a) of the Act. 21 U.S.C. § 823(f).

Section 824(a)(4) authorizes the Attorney General to

suspend or revoke a registration upon a finding that the

registrant “has committed such acts as would render his

registration under section 823 . . . inconsistent with the public

interest as determined under such section.” 21 U.S.C. §

824(a)(4). In determining “the public interest” under § 823,

the Attorney General must consider five factors, the last of

which is “conduct which may threaten the public health and

safety.” 21 U.S.C. § 823(f)(5). The court of appeals, how-

ever, denied that the Attorney General could suspend or

revoke (or deny) “health care practi:.oners’ DEA registra-

tions” solely on this basis. 368 F.2d at 1129.*' In light of the

Ninth Circuit’s exegesis of the legislative history, the Attor-

ney General could not refuse to register a practitioner to

conduct research with Schedule I controlled substances even

if he determinec that registration for that purpose would be

inconsistent with the public interest because of conduct that

might threaten the public health and safety.

** See also Or. Br. in Op. 14 (“the 1984 amendments to the CSA

[which added the cited language) were not intended to broaden the

Attorney General's authority by permitting him to sanction physicians

whose conduct conformed to state laws”) (emphasis added). The

legislative history cited by the majority and Oregon, see S. Rep. No. 98-

225 at 267, 98" Cong., 2™ Sess. (1984), reprinted in 1984 U.S.C_.C_AN.

3182, 3449, does not support this proposition. The requirement that the

Attorney General consider all five factors does not mean that he must find

that all five factors are present in order to deny an application for

registration or suspend or revoke an existing registration.

25

Under current law, Schedule I control: -d substances

may be dispensed only in “federally approved 1..earch pro-

jects.” Fry v. D.E.A., 353 F.2d 1041, 1042 n.1 (9" Cir. 2003-

). See also United States v. Oakland Cannabis Buyers’ Co-

operative, 532 U.S. 483, 490 (2001) (for marijuana and other

Schedule I controlled substances, “there is but one exception,

and it is available only for Government approved research

projects”). The court of appeals’ crabbed reading of the

Attorney General's authority under the Controlled

Substances Act, combined with its inappropriate invocation

of the “plain statement” rule of Gregory v. Ashcroft, effec-

tively overturns the present federal restrictions on research

with Schedule I substances.

The Ninth Circuit’s holding in this case may be fairly

summarized in a single sentence: So long as a controlled

substance has some legitimate medical purpose, which all

substances classified under Schedule II through V do have, a

State may authorize its use for any purpose, no matter how

unethical, unorthodox, untested or unusual, and the Attorney

General would be powerless to take any action under the

Controlled Substances Act against any registrant who had

acted in accord with state law.” As the foregoing examples

show, the court of appeals’ holding would emasculate the

Attorney General’s authority to enforce the Act in a consis-

tent, principled and uniform manner, and subject federal drug

control policy to the vagaries of a patchwork of inconsistent

state laws. Such an extraordinary result cannot be one re-

quired by a proper interpretation of the Act. The judgment of

the court of appeals shOUTd be reversed.

* For the reasons explained above, the court's holding even

affects the Government's authority to regulate research (including

dispensing drugs to human subjects) with Schedule I drugs, for which

there is no recognized legitimate medical purpose.

26

CONCLUSION

For foregoing reasons, amicus curiae, the Thomas

More Society respectfuliy requests that this Honorable Court

reverse the judgment of the Court of Appeals.

Respectfully submitted,

Paul Benjamin Linton Thomas Brejcha

Counsel of Record Thomas More Society

921 Keystone Avenue 29 S. La Salle St. Suite 440

Northbrook, Illinois 60062 Chicago, Illinois 60611

(847) 291-3848 (312) 782-1680

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