Amicus Curiae Brief — Gonzales v. Oregon

No. 04-623 MAY 11 2005

RK

In The

Supreme Court of the Gnited States

o

ALBERTO R. GONZALES, in his official capacity

as United States Attorney General, et al.,

Petitioners,

v.

State of OREGON, et al.,

Respondents.

.

On Writ Of Certiorari To The

United States Court Of Appeals

For The Ninth Circuit

s

AMICUS CURIAE BRIEF OF SENATORS

RICK SANTORUM, TOM COBURN, M.D., JAMES M.

INHOFE, JIM DEMINT, CHRISTOPHER S. BOND,

LARRY CRAIG, JUDD GREGG, AND SAM

BROWNBACK, AND REPRESENTATIVES STEVE

CHABOT, CHRIS SMITH, JACK KINGSTON,

JOHN SHIMKUS, JOSEPH R. PITTS, HENRY HYDE,

MARK GREEN, TODD AKIN, ROSCOE BARTLETT,

JEFF MILLER, STEVE KING, THOMAS PETRI,

MARK E. SOUDER, PETE KING, PAUL RYAN,

VIRGIL H. GOODE, JR., GENE TAYLOR,

JOHN N. HOSTETTLER, AND RALPH HALL

IN SUPPORT OF PETITIONERS

7

Counsel for Amici

DONALD A. DAUGHERTY, JR.*

JOHN B. TUFFNELL

WHYTE HIRSCHBOECK DUDEK S.C.

555 E. Wells Street, Suite 1900

Milwaukee, WI 53202

(414) 273-2100

*Counsel of Record for Amici

COCKLE LAW BRIEF PRINTING CO (800) 225-6964

OR CALL COLLECT (402) 342-2831

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ...........c:cccccesecesesesesssesseeevees iii

INTEREST OF AMICI CURIAE...........0cccccceccceseseseseeee 1

SUMMARY OF ARGUMENT. ..........ccccccccsssesesseeseeseseeees 2

pS PSIG a POE AN oP a I 3

I. A REVIEW OF THE LEGISLATIVE HISTORY

IS INSTRUCTIVE FOR DISCERNING CON-

GRESSIONAL INTENT BEHIND THE CSA... 5

Il. THE CSAS LEGISLATIVE HISTORY

CLEARLY SHOWS THAT CONGRESS IN-

TENDED THE FEDERAL GOVERNMENT

TO PLAY AN ACTIVE ROLE IN REGULAT-

ING THE PRESCRIPTION AND DISPENS-

ING OF CONTROLLED SUBSTANCES BY

Feel bacesenceveseresensccevesepaseeesssnsesnecenesstenest 6

A. The CSA Enhanced The Federal Govern-

ment’s Long-Standing Role As The Regu-

lator Of Controlled Substances .................. 6

B. The 1974 Amendments Distinguished Be-

tween The Roles Of HHS And The Attor-

ney General With Regard To Treatment

Programs For Narcotics Addicts And Are Ir-

relevant To The Issues Before This Court.... 10

C. The 1984 Amendments Clarified The Fed-

eral Government’s Authority To Act Where

States Ineffectively Regulated Physician

Use Of Controlled Substances..................... 12

D. The Interpretive Rule Is Based Upon A

Reasonable Interpretation Of The CSA’s

I CRED ecccenesserecscnsescsecnenectneseeees 16

ii

TABLE OF CONTENTS - Continued

Page

E. The Federal Government’s Role As Regu-

lator Of Controlled Substances Does Not

Displace The States’ Role As Primary

Regulators Of The Practice Of Medicine.... 18

Ill. THE ATTORNEY GENERAL HAS THE

AUTHORITY TO DETERMINE WHETHER

PHYSICIAN-ASSISTED SUICIDE VIOLATES

THE CSA, NOTWITHSTANDING THE AB-

SENCE OF SPECIFIC REFERENCES TO

THE PRACTICE IN THE LEGISLATIVE HIS-

TABLE OF AUTHORITIES

Page

CASES:

Am. Pharm. Ass’n v. Weinberger, 377 F. Supp. 824

(D. D.C.1974), aff’d, 530 F.2d 1054 (D.C. Cir.

ELL 13

Babbit v. Sweet Home Chapter of Communities for a

Greater Oregon, 515 U.S. 687 (1995) ............ccccccecceeeeeeees 5

Barnhart v. Walton, 535 U.S. 212 (2002) ............ccccccccceceeees 5

Browder v. United States, 312 U.S. 335 (1941)........... 23, 24

Chevron U.S.A., Inc. v. Natural Res. Def. Council,

ET 17

Dep't of Commerce v. United States House of Repre-

sentatives, 525 U.S. 316 (1999) ................cccscesseeeeeersereees 5

Dickerson v. New Banner Institute, Inc., 460 U.S.

a csssssonsooecs 5

H.J. Inc. v. Northwestern Bell Telephone Co., 492

EEE EES EE 22, 24

INS v. Cardoza-Fonseca, 480 U.S. 421 (1987)............c0cc006 5

Lewis v. United States, 523 U.S. 155 (1998) ...............cccc00ee 5

Mississippi Band of Choctaw Indians v. Holyfield,

i sesesserenenee 5

Nationsbank of North Carolina, N.A. v. Variable

Annnuity Life Ins. Co., 513 U.S. 251 (1995) ................. 17

Negonsott v. Samuels, 507 U.S. 99 (1993)..............ccccceeeeeees 5

Oncale v. Sundowner Offshore Servs., Inc., 523 U.S.

ELTA 23, 24

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

cert. granted, 125 S. Ct. 1299 (2005)..................004. passim

iv

TABLE OF AUTHORITiES -— Continued

Page

Rust v. Sullivan, 500 U.S. 173 (1991) ...............cccccseeeeeeeees 24

United States v. Moore, 423 U.S. 122 (1975) ................ 7,10

United States v. Rosenberg, 515 F.2d 190 (9th Cir.

TTT ccenssnscncecenneniestetanaimeaesieathatimastaaiiaeaiatiadeasiatitasaaasaiaselataaaiedaiaidiadl 7

United States v. Southwestern Cable Co., 392 U.S.

ff ESR heen renner 23, 24

United States v. Steinberg, 525 F.2d 1126 (2d Cir.

TTT icscteccncensniniiiindansiansaaeieiadaasediianieiaiiai sneneninennntiniuasiies 7

United States v. Upthegrove, 504 F.2d 682 (6th Cir.

TTITII ccninesicinensdasiesemamsiandeneeesteaeaseaausdiatstaieadiostasitasesiebasimamaieeiiemiamanmtiliaids 7

West v. Gibson, 527 U.S. 212 (1999)............cccccceeseeeeeeeeeeeeees 5

STATUTES AND REGULATIONS:

21 C.F.R.:

QO ee 10, 16, 18

BBE BIO ....cccsninsennccecntenintnniepeniansansentensmiaipiesepmenmminenes 8

66 Fed. Reg. 56,607 (Nov. 9, 2001).............:ccceceeeeees 2, 10, 18

Pub. L. No. 91-513, § 202, 84 Stat. 1236€........................008. 8

Pub. L. No. 91-518, § 201(aX(1), 84 Stat. 1236 (1

AEE, So Gi crccnicsnsicnncnstitestennsiesieiitaninienitinjensiiiemnabntinamsineasiitaiaes 8

Pub. L. No. 98-473, Title II § 501 (1984), 98 Stat.

TTD nsceissiarincsinintamctiaastiainiasmtaueitiiaiialiensieinliaeteedieaieiatiieeeatai 15

Assist Suicide Funding Restriction Act, Pub. L.

| eee Cree ee meee eee 25

Comprehensive Drug Abuse Prevention and Control

Act of 1970, Pub. L. No. 91-513, § 100 (amended

1984), reprinted in 1970 U.S.C.C.A.N. 4566.......... passim

v

TABLE OF AUTHORITIES — Continued

Page

Controlled Substances Act:

eS Gee GGG, encnsccecesecsnsntnnctenientnennmnntenmneneden 1

Death With Dignity Act, Or. Rev. Stat. § 127.800,

Ge vercatecnpacenrensttntannemnntscinnineainansiinnininnmeiie 2

Drug-Induced Rape Prevention and Punishment

Act of 1996, Pub. L. No. 104-305, § 1 o0...........cceeeeeeeeeeeee 12

Harrison Act of 1914, ch.1 (codified as amended at

ee ee ND a cncinsstnittcisiisitittiniiiteaiintinininatanssinemen 6,7

Methamphetamine Anti-Proliferation Act of 2000,

Pub. L. No. 106-310, Div. B., Title XXXVI, § 3601........ 12

Narcotic Addict Treatment Act of 1974, Pub. L. No.

es I Bi cvetncncictenscinciinnnudiiniiiiainniiisienidans 10, 12

MISCELLANEOUS:

116 Cong. Rec. 977 (Comments of Sen. Dodd, Jan.

ii SEIU ciccccrteneccnnncccninsiisitecsmunintniaubdidaianaisaiinaiiaiiiasiiniamaniaiias 22

116 Cong. Rec. 18913 (1970) (Sen. McClellan) ................. 22

130 Cong. Rec. H9679 (daily ed. Sept. 18, 1984).............. 14

130 Cong. Rec. H9680 (daily ed. Sept. 18, 1984).............. 14

130 Cong. Rec. H9742 (daily ed. Sept. 18, 1984).............. 15

130 Cong. Rec. S733 (daily ed. Feb 2, 1984)..................... 15

130 Cong. Rec. S758 (daily ed. Feb. 2, 1984).................... 15

130 Cong. Rec. S9681-82 (daily ed. Feb. 2, 1984)............. 17

H.R. Rep. No. 91-1444 (1970), reprinted in 1970

i PS 0 ee 7, 8, 9, 19, 26

H.R. Rep. No. 93-884 (1974), reprinted in 1974

CGC Be. GID cccccccserssencsvessceessssvensnnsesssnacsesssssonsensees 11

vi

TABLE OF AUTHORITIES — Continued

Page

H.R. Rep. No. 98-1030 (1984), reprinted in 1984

EA eee 13, 19, 20

S. Rep. No. 98-225 (1983), nse in 1984

EN Sg EY eenne nena 4

American Medical Association, Code of Medical

enna 25

American Medical Association, Council on Ethical

and Judicial Affairs, Decisions Near the End of

Life, 267 JAMA 2229 (1992)...............secccccssssssssssssreneees 26

American Nursing Association, Position Statement

(available at: http://nursingworld.org/readroom/

position/ethics/etsuic. htm) ...........ccccccccceeereeeeeereeeeeeeenees 26

Dangerous Drug Diversion Control Act of 1984:

Hearing on H.R. 5656 before the Subcomm. on

Health and the Environment of the House Comm.

on Energy and Commerce, 98th Cong., 403-04

(1984) (statement of Gene R. Haislip, Deputy As-

sistant Administrator, Drug Enforcement Admini-

Editorial, Deadly Milestone: 5 years of assisted

suicide, amednews.com, April 21, 2003 (available

at: http://)www.ama-assn.org/amednews/2003/04/

eee 26

Health & Human Servs., Medicare Benefit Policy

Manual, chs. 16 & 20 (available at: http://www.

ems.hhs.gov/manuals/102_policy/bp102c16.pdf)........... 25

Hugh I. Schade, M.D., Denial of Application, 60

Fed. Reg. 56,354 (Nov. 8, 1995) .............ccsssssseeeeeeeeeeeees 24

Jonathan Erlen & Joseph F. Spillane, Federal Drug

Control: The Evolution of Policy and Practice

Vii

TABLE OF AUTHORITIES - Continued

Page

Letter from Hon. Janet Reno, Attorney General of

the United States, to Hon. Henry Hyde, Chair-

man, Committee on the Judiciary United States

House of Representatives (June 5, 1998)................0006. 11

Letter from Hon. Thomas A. Constantine, Adminis-

trator of the Drug Enforcement Administration of

the United States to Hon. Henry J. Hyde, Com-

mittee on the Judiciary, United States House of

Representatives (Nov. 5, 1997) ............ccccccccccceccececeseeeees 24

Memorandum from Deputy Assistant Attorney.

General Sheldon Bradshaw to Hon. John

Ashcroft, “Whether a Physician-Assisted Suicide

Serves a ‘Legitimate Medical Purpose’ Under The

Drug Enforcement Administration Regulations

Implementing the Control Substances Act” (June

ai AEN ctensnsnennnntceniiiianentinciinaniinnindtaiemnimuniiesiasiuiites 18, 20

Oregon Dep't of Human Servs., Off. Of Disease

Prevention and Epidemiology, Seventh Annual

Report on Oregon’s Death with Dignity Act (2005)

(available at: http://egov.oregon.gov/DHS/ph/pas/

a pecnenesecnscmsccensennninnesetinininiamaimgiaisinieenes 8

Press Release, Oregon Dep't of Human Servs.,

Oregon Public Health Servs., Fewer Oregonians

Used Death With Dignity Act in 2001 (Feb. 6,

2002) (available at: http://www.ohd.hr.state.or.us/

newa/2002/0206pas. htm)...............sssssercssssssesssesessseseeses 8

Task Force on the Nurse’s Role in End-of-Life

Decisions, Center for Ethics and Human Rights

GI a cxvcsunnenesnvenensetarnpetonnisesebiunpdensiespenipnieginenstiaadeiimeiaias 26

1

INTEREST OF AMICI CURIAE’

Amici curiae have the honor of serving in the United

States Congress. Amici Craig, Gregg, Hyde, Smith, Petri

and Hall served in Congress at the time of the 1984

amendments to the Controlled Substances Act (“CSA”), 21

U.S.C. § 801, et seg. In addition, several of the amici have

served or are currently serving on relevant committees of

the Senate and House of Representatives, including

Congress’ Judiciary Committees, the Senate Committee on

Health, Education, Labor and Pensions, and Special

Committee on Aging, and the House Energy and Com-

merce Subcommittee on Health. Amicus Hyde has served

as Chair of the House Judiciary Committee. Amici Brown-

back and Hyde have conducted and participated in hear-

ings on the subject of assisted suicide in the United States.

Finally, amicus Coburn is a practicing family physician.

In these various capacities, amici are directly con-

cerned with the interpretation and enforcement of the

CSA, as well as the relationship between the state and

federal governments. Because of the unique perspective

they offer in discerning Congress’ intent, this brief focuses

on the erroneous conclusion of the United States Court of

Appeals for the Ninth Circuit that the CSA’s legislative

history supported its decision.

>

* Pursuant to Supreme Court Rule 37.6, no person other than

counsel identified on the cover participated in authoring this brief. No

entities other than amici and counsel provided financial support for this

brief. Further, the consent of the parties to the filing of this amicus

curiae brief has been obtained and filed with the Clerk of the Court.

2

SUMMARY OF ARGUMENT

The legislative history to the CSA makes clear that in

enacting and later amending the CSA, Congress was

concerned with, inter alia, the diversion by physicians of

federally-controlled substances to illegitimate uses outside

the usual course of conduct of medical professionals, and

that Congress saw ineffective state regulation as a signifi-

cant factor in that illegitimate activity. The interpretive

rule issued by the Attorney General pursuant to the CSA

on November 9, 2001 (the “Interpretive Rule”) states that

prescribing controlled substances to assist a patient's

suicide is not a “legitimate medical purpose.” The Rule is

entirely consistent with the statute’s legislative history.

The Interpretive Rule was issued largely in response

to the 1994 Oregon Death with Dignity Act (the “DWDA”),

Or. Rev. Stat. § 127.800, et seg., which permits physicians

in that state to prescribe and dispense medications,

including federally-controlled substances, to assist certain

patients in committing suicide. Under the Interpretive

Rule, physicians who prescribed, dispensed or adminis-

tered federally-controlled substances to facilitate a pa-

tient’s suicide would be subject to denial, suspension or

revocation of their registrations with the Drug Enforce-

ment Administration (“DEA”) because such conduct

“render[ed] [the physician’s] registration ... inconsistent

with the public interest.” 66 Fed. Reg. 56,607, 56,608 (Nov.

9, 2001).

As seen from the CSA's legislative history, the Inter-

pretive Rule addresses concerns and advances goals that

were considered and discussed by Congress in enacting

and amending the statute. Further, by issuing the Inter-

pretive Rule, the Attorney General acted in the role that

3

Congress had envisioned for the federal government.

Although the legislative history does not show that Con-

gress contemplated physician-assisted suicide specifically,

this does not detract from the Attorney General’s authority

under the CSA to issue the Interpretive Rule.

The CSA would not apply (and actions taken pursuant

to it by the Attorney General would not be authorized) if a

state decided to permit assisted suicide but ensured that it

would somehow occur without the involvement of DEA-

registered physicians prescribing controlled substances.

However, that is not the case here. Where a state seeks to

permit DEA-registered physicians to assist their patients

in committing suicide by prescribing controlled sub-

stances, the CSA authorizes the Attorney General to speak

to whether this is a legitimate medical purpose. The

Interpretive Rule is consistent with the CSA's legislative

intent and a reasonable response to the DWDA.

S

ARGUMENT

Upholding an injunction against enforcement of the

Interpretive Rule, the Ninth Circuit mistakenly concluded

that the Interpretive Rule conflicted with the CSA’s

legislative history and that the Attorney General had

exceeded his authority by issuing the Rule. Oregon uv.

Ashcroft, 368 F.3d 1118, 1127 (9th Cir. 2004) (“The CSA’s

legislative record confirms that the Attorney General has

exceeded the scope of his authority” under the statute),

cert. granted, 125 S. Ct. 1299 (2005). To reach this conclu-

sion, the Ninth Circuit ignored the importance of amend-

ments made to the CSA in 1984 and focused primarily on

legislative history predating those amendments. Jd. at

4

1128. The Ninth Circuit sought to characterize the 1984

amendments as little more than an effort to tidy up “loop-

holes” in the CSA, but acknowledged that the amendments

“authorize[ed]) the Attorney General to revoke physician

registrations without depending on state licensing boards.”

Id. at 1129 (citing S. Rep. No. 98-225, at 260-62 (1983),

reprinted in 1984 U.S.C.C.A.N. 3182, 3442-44). What the

Ninth Circuit failed to acknowledge was that the Attorney

General issued the Interpretive Rule pursuant to this

independent authority.

The Ninth Circuit tried to buttress its flawed conclu-

sion by exaggerating the significance of legislative history

from 1974 that discussed the role of the Secretary of

Health and Human Services (“HHS”) in registering practi-

tioners who conduct treatment programs for narcotic

addicts, which was entirely unrelated to the issue before

the Court. Completing its erroneous analysis, the Ninth

Circuit asserted that the legislative record supported its

belief that the Attorney General was required not only to

review and consider relevant Oregon law (which he did

do), but also to solicit and obtain specific input from the

state before he could issue the Interpretive Rule; however,

this assertion makes little sense in light of the 1984

amendments, which, as the Ninth Circuit recognized, were

expressly intended to permit the Attorney General to take

action independent of state authorities.

The Ninth Circuit’s reading of the CSA and its rele-

vant legislative history was overly narrow and ultimately,

mistaken. A review of the full legislative history estab-

lishes that it squarely supports the Attorney General’s

interpretation of the CSA and the Interpretive Rule was

fully consistent with congressional intent.

5

I. AREVIEW OF THE LEGISLATIVE HISTORY IS

INSTRUCTIVE FOR DISCERNING CONGRES-

SIONAL INTENT BEHIND THE CSA.

Among the interpretive tools available for determin-

ing the Congressional intent underlying a statute is the

statute’s legislative history. See, e.g., Barnhart v. Walton,

535 U.S. 212, 220 (2002); Dep't of Commerce v. United

States House of Representatives, 525 U.S. 316, 342-43

(1999); Babbitt v. Sweet Home Chapter of Communities for

a Greater Oregon, 515 U.S. 687, 704-07 (1995); Negonsott

v. Samuels, 507 U.S. 99, 104-05 (1993). A review of legisla-

tive history may be especially appropriate where, as here,

the relevant statutory language is broad and susceptible to

more than one meaning. See, e.g., West v. Gibson, 527 U.S.

212, 219-20 (1999); INS v. Cardoza-Fonseca, 480 U.S. 421,

432-35 (1987). Further, this Court has looked to legislative

history in determining whether Congress intended for the

meaning of terms in a federal statute to depend upon state

law, which is also at issue in this case. See, e.g., Lewis v.

United States, 523 U.S. 155, 170-71 (1998); Mississippi

Band of Choctaw Indians v. Holyfield, 490 U.S. 30, 44-45

(1989); Dickerson v. New Banner Institute, Inc., 460 U.S.

103, 119 (1983).

The Ninth Circuit, as well as the district court below,

cited the CSA's legislative history to reach their decisions.

However, read together and in context, statements by the

sponsors and others in Congress at the time the CSA was

enacted in 1970 and amended in 1984, as well as reports

from the House, Senate and conference committees,

provide ample support for the Interpretive Rule.

6

II. THE CSA’S LEGISLATIVE HISTORY CLEARLY

SHOWS THAT CONGRESS INTENDED THE

FEDERAL GOVERNMENT TO PLAY AN ACTIVE

ROLE IN REGULATING THE PRESCRIPTION

AND DISPENSING OF CONTROLLED SUB-

STANCES BY PHYSICIANS.

As seen from the legislative history, Congress viewed

the states as the first line of defense under the CSA

against the misuse of controlled substances. The legisla-

tive history to the CSA also shows that Congress envi-

sioned a central role for the federal government in

establishing and enforcing its own standard as to what

constitutes such misuse. This role necessarily required

that the federal government be able to enforce its standard

when a state could not or would not do so.

A. The CSA Enhanced The Federal Govern-

Ment’s Long-Standing Role As The Regula-

tor Of Controlled Substances.

While states have traditionally regulated the practice

of medicine, the federal government has traditionally

regulated the use of controlled substances. See generally

Jonathon Erlen & Joseph F. Spillane, Federal Drug Con-

trol: The Evolution of Policy and Practice (2004). Since the

1914 Harrison Act, the federal government has played a

significant role in controlling the prescription and dispens-

ing by physicians of toxic, addictive narcotics. Under the

Harrison Act, “every person” who imported, manufactured,

dispensed or in any way distributed opium, coca leaves or

their derivatives, was required to register with the Inter-

nal Revenue Service, and pay taxes on such activity. See

Law of December 7, 1914, ch. 1 (codified as amended at 21

U.S.C. §§ 801-971). Physicians were allowed to dispense or

a

7

distribute the drugs regulated by the Harrison Act pro-

vided that they registered with the IRS, acted “in the

course of [their] professional practice only,” and main-

tained records “of all such drugs dispensed or distributed.”

Id. at ch. 1, § 2(a).

The CSA was Congress’ attempt to collect and ration-

alize the Harrison Act and some 50 other pieces of legisla-

tion that had been enacted over the years for the purpose

of regulating controlled substances. See United States v.

Rosenberg, 515 F.2d 190, 196 (9th Cir. 1975); United States

v. Upthegrove, 504 F.2d 682, 688 n.10 (6th Cir. 1974); see

also H.R. Rep. No. 91-1444, at 4 (1970), reprinted in 1970

U.S.C.C.A.N. 4566, 4571. Further, Congress “intended the

CSA to strengthen rather than to weaken the prior drug

laws.” United States v. Moore, 423 U.S. 122, 139 (1975); see

also United States v. Steinberg, 525 F.2d 1126, 1133 (2d

Cir. 1975).

Congress enacted the CSA as Title II of the Compre-

hensive Drug Abuse Prevention and Control Act of 1970.

Pub. L. No. 91-513, § 100, 84 Stat. 1236, 1242 (amended

1984). Congress “designed [the CSA] to improve the

administration and regulation of the manufacturing,

distribution, and dispensing of controlled substances by

providing for a ‘closed’ system of drug distribution for

legitimate handlers of such drugs.” 1970 U.S.C.C.A.N. at

4589. The CSA created a comprehensive system for federal

regulation of such substances, charging the Attorney

General and the Bureau of Narcotics and Dangerous

Drugs (forerunner to the DEA) with responsibility for

administering the system.

Under the CSA, the differing varieties of controlled

substances were separated into five categories, ranging

8

from Schedule I substances, which had no accepted medi-

cal use and could be used only in limited situations, to

Schedule II, III, IV, and V substances, which had recog-

nized uses and could be manufactured, distributed, and

used, subject to the statute’s limitations. Pub. L. No. 91-

513, § 202 (Schedules I-V), 84 Stat. 1236, 1248-53. Mari-

juana and heroin were Schedule I substances, for example,

while Schedule V included substances such as cough

medicine with codeine.’ Pub. L. No. 91-513, § 202 (Sched-

ules I-IV), 84 Stat. 1236, 1247-1252. The CSA imposed

“tighter controls” on the use of “drugs providing serious

addiction or abuse problems (those listed in schedules I

and II).” H.R. Rep. No. 91-1444, at 4 (1970), reprinted in

1970 U.S.C.C.A.N. 4566, 4569. The CSA authorized the

Attorney General to add, remove or transfer substances to

or between the schedules based on procedures established

by the statute. Pub. L. No. 91-518, § 201(a)(1), 84 Stat.

1236, 1245 (21 U.S.C. § 802(5)).

Discussing the criteria to be used by the Attorney

General in exercising his authority under the CSA to deter-

mine the appropriate schedules for different substances, the

? Schedule II drugs are highly addictive, but have accepted medical

uses. Pub. L. No. 91-513 § 202(b\(2), 84 Stat. 1236, 1247. The two most

commonly-prescribed drugs used to assist suicide under the DWDA are

pentobarbital and secobarbital, see Oregon Dep’t of Human Servs., Off.

of Disease Prevention and Epidemiology, Seventh Annual Report on

Oregon’s Death With Dignity Act 14 (2005) (ava‘lable at: http:/

egov.oregon.gov/DHS/ph/pas/docs/year7.pdf); Press Release, Oregon

Dep’t of Human Servs., Oregon Public Health Servs., Fewer Oregonians

Used Death With Dignity Act in 2001 (Feb. 6, 2002) (available at: www.

ohd_hr.state.or.us/news/2002/0206pas.htm), which fall into Schedule II,

see 21 C.F R. § 1308.12(e). Thus, the DWDA conflicts most directly with

the registration requirements and other controls relating to Schedule II

drugs

House Report noted, “Misuse of a drug in suicides and

attempted suicides, as well as injuries resulting from

unsupervised use, are regarded as indicative of a drug’s

potential for abuse.” 1970 U.S.C.C.A.N. at 4602. Although

this reference in the legislative history was not in the

context of physician-assisted suicide, it establishes that

Congress intended that, in exercising regulatory authority

under the CSA, the Attorney General could consider

whether a controlled substance was being used to commit

suicide.

Besides classifying controlled substances into differ-

ent schedules, the Attorney General’s duties under the

CSA included monitoring the use of controlled substances

through the registration of manufacturers, physicians,

pharmacies, and others. The CSA required ail “legitimate

handlers” (e.g., physicians) to register with the federal

government. Pub. L. No. 91-513, § 302(a), 84 Stat. 1236,

1253. Under the CSA, registration was considered “a

matter of right where the individual ... is engaged in

activities involving these drugs which are authorized or

permitted under State law.” H.R. Rep. No. 91-1444 (1970),

reprinted in 1970 U.S.C.C.A.N. 4566, 4590. The CSA

authorized the Attorney General to deny, suspend or

revoke a physician’s registration for three reasons:

1. falsification of an application to dispense,

distribute, or manufacture a controlled sub-

stance;

2. a felony conviction under state or federal law

relating to a controlled substance; or

3. denial, revocation, or suspension of a state li-

cense or registration.

10

Pub. L. No. 91-513, §§ 303(f) & 304(a), 84 Stat. 1236, 1255.

Two of these grounds depended in whole or in part on state

enforcement and, in 1984, Congress acted to repair “leaks”

in the closed system that resulted from this overreliance

on state law.

Nonetheless, even before the 1984 amendments, the

CSA (and its original implementing regulations’) provided

clear authority for the Attorney General to regulate

physician conduct in prescribing controlled substances.

“(T]he scheme of the [CSA], viewed against the back-

ground of the legislative history, reveals an intent to limit

a registered physician's dispensing authority to the course

of his ‘professional practice’ .... [In addition,] [o)ther

provisions throughout the Act reflect the intent of Con-

gress to confine authorized medical practice within ac-

cepted limits.” Moore, 423 U.S. at 140-42.

B. The 1974 Amendments Distinguished Between

The Roles Of HHS And The Attorney General

With Regard To Treatment Programs For Nar-

cotics Addicts And Are Irrelevant To The Is-

sue Before This Court.

In the Narcotic Addict Treatment Act of 1974, Pub. L.

No. 93-281, 88 Stat. 124, Congress amended the CSA “to

provide for the registration of practitioners conducting

* In 1971, the Bureau of Narcotics and Dangerous Drugs promul-

gated the initial regulations under the CSA. The regulations included

standards for prescribing controlled substances: “A prescription for a

controlled substance to be effective must be 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) (emphasis added).

The Interpretive Rule was based on the Attorney General's interpreta-

tion of this regulation. See 66 Fed. Reg. at 56,608.

11

narcotic treatment programs.” H.R. Rep. No. 93-884, at 1

(1974), reprinted in 1974 U.S.C.C.A.N. 3029, 3029. The

Narcotic Addict Treatment Act created, inter alia, a regis-

tration process for the use of controlled substances in

treating addicted persons through, for example, metha-

done maintenance and detoxification programs, that was

separate and in addition to the customary registration

under the CSA. 1974 U.S.C.C.A.N. at 3029-3030; see also

21 U.S.C. § 823(g). The Narcotic Addict Treatment Act is

irrelevant to the issue currently before this Court, which

concerns the customary registration process under the

CSA. Thus, not surprisingly, the Ninth Circuit’s conclusion

from the legislative history to the 1974 amendments that

the Secretary of HHS had ultimate authority to make

“‘lajll decisions of a medical nature’” under the CSA,

Oregon, 368 F.3d at 1128 (citing 1974 U.S.C.C.A.N. at

3034), conflicts with the language of the statute, see, e.g.,

21 U.S.C. § 823(f) (“The Attorney General may deny an

application for ... registration if he determines that the

issuance ... would be inconsistent with the public inter-

est.”) (emphasis added).*

* Under the Ninth Circuit’s reasoning, the 1974 legislative history

would similarly cast doubt on former Attorney General Janet Reno’s

conclusion that dispensing drugs to assist suicides is a legitimate

medical practice under the CSA. See Letter from Hon. Janet Reno,

Attorney General of the United States, to Hon. Henry Hyde, Chairman,

Committee on the Judiciary, United States House of Representatives, at

1 (June 5, 1998) (“Adverse action against a physician who has assisted

in a suicide in full compliance with the [DWDA] would not be author-

ized by the [(CSA].”).

12

C. The 1984 Amendments Clarified The Federal

Government’s Authority To Act Where States

Ineffectively Regulated Physician Use Of

Controlled Substances.

Although the CSA has been amended many times

since 1970, e.g., Narcotic Addict Treatment Act; Drug-

Induced Rape Prevention and Punishment Act of 1996

(Pub. L. No. 104-305, § 1, 110 Stat. 3807); Methampheta-

mine Anti-Proliferation Act of 2000 (Pub. L. No. 06-310,

Div. B, Title XXXVI, § 3601, 114 Stat. 1227), the most

significant amendments occurred in 1984. The legislative

history to the 1984 amendments makes clear that at that

time, Congress had become concerned that states were not

effectively handling the distribution of controlled sub-

stances by physicians and that state law alone was insuffi-

cient to prevent the diversion of controlled substances

from legitimate medical uses.

Thus, Congress amended the CSA to give the Attorney

General additional, independent authority to deny, sus-

pend or revoke a physician’s federal registration where he

determined that the registration was “inconsistent with

the public interest.” See 21 U.S.C. §§ 823(f) & 824(a\(4),

Pub. L. No. 91-513, §§ 303(f) & 304(a)(4), 84 Stat. 1236,

1254. The amendments identified five specific criteria in

section 823(f) (and, by reference, section 824(a)) to be used

by the Attorney General in determining whether a physi-

cian’s registration was consistent with the “public inter-

est.” Although state law remained an important factor, the

Attorney General was also required to consider two

criteria wholly independent of state law: namely, “the

[physician’s} experience in dispensing ... controlled

substances” and “[s)uch other conduct which may threaten

the public health and safety,” 21 U.S.C. § 823(f)(2) & (5).

13

Notably, since the enactment of the CSA in 1970, the

Attorney General has had discretion to determine whether

the registration of a manufacturer or distributor of con-

trolled substances was “inconsistent with the public

interest.” See 21 U.S.C. §§ 823(a), (b), (d) & (e); see also

Am. Pharm. Ass’n v. Weinberger, 377 F. Supp. 824, 829-30

(D. D.C. 1974), aff’d, 530 F.2d 1054 (D.C. Cir. 1976). The

1984 amendments gave the Attorney General the same

authority with regard to “practitioners,” and registration

was no longer “a matter of right” where a physician’s

conduct complied with state law.

The theme of needing to better control the distribution

of controlled substances through physicians by shoring up

weaknesses at the state level pervades the legislative

history. For example, the House Report accompanying the

amendments stated,

Unfortunately, experience under the [CSA]

over the past decade has demonstrated that the

same strong regulatory authority to maintain a

‘closed’ distribution chain does not exist at the

practitioner level.... Under current law, the

grounds for denial or revocation of the registra-

tion of a practitioner are very limited. Indeed,

the Attorney General must presently grant a

practitioner’s registration application unless his

State license has been revoked or he has been

convicted of a felony drug offense, even though

such action may clecrly be contrary to the public

interest.

H.R. Rep. No. 98-1030, at 261-62 (1984), reprinted in 1984

U.S.C.C.A.N. 3182, 3443-44 (emphasis added). Similarly,

Representative Hamilton Fish, a sponsor of the 1984

amendments, stated, “The most serious diversion problem

today exists at the retail level. States have primary

14

responsibility for the licensing of physicians and pharma-

cists. State policing of these activities, as well as peer

review within the profession, have not been adequate

control measures. State laws regarding the dispensing of

controlled substances are also inadequate.” 130 Cong. Rec.

H9680 (daily ed. Sept. 18, 1984).

During discussion in the House, Representative

Benjamin Gilman stated that the amendments would

“make it easier for the Drug Enforcement Administration

to suspend or revoke the authority of physicians and

pharmacists who write or dispense prescriptions in a way

that is threatening to the public health or safety.” Id. at

H9681. Similarly, Representative Hughes (also a House

sponsor) stated that the amended CSA “gives to DEA

greater latitude to suspend or revoke the registration of a

practitioner [who] dispenses drugs in a manner that

threatens the public health and safety.” Jd. at H9679.

At a hearing before a House subcommittee considering

the amendments, the DEA testified that the expanded

federal authority to revoke a physician’s registration was

“one of the most important sections of the bill,” not only

because of inadequate state enforcement but also because

“many controlled drug violations . . . are not felonies under

state law and therefore cannot be used in a DEA revoca-

tion action.” Dangerous Drug Diversion Control Act of

1984: Hearing on H.R. 5656 before the Subcomm. on

Health and the Environment of the House Comm. on

Energy and Commerce, 98th Cong., 403-04 (1984) (state-

ment of Gene R. Haislip, Deputy Assistant Administrator,

Drug Enforcement Administration).

In the Senate, sponsor Strom Thurmond noted that,

as originally enacted, the CSA

15

provides necessary regulation of manufacturers

and distributions, but it does not adequately

cover the practitioner level of the distribution

chain, the level at which 80 to 90 percent of cur-

rent diversion of drugs into illicit markets takes

place.... [The 1984 amendments] expand/] the

standards for practitioner registration beyond the

current exclusive reliance upon authorization by

the practitioner’s own jurisdiction.

130 Cong. Rec. S758 (daily ed. Feb. 2, 1984) (emphasis added).

These amendments expanding federal authority received

bipartisan support in Congress. See, e.g., 130 Cong. Rec.

H9680-81 (daily ed. Sept. 18, 1984) (statements of Reps.

Hughes and Sawyer). The amendments were approved by

wide margins, passing in the Senate on February 2, 1984 on a

vote of 91 to 1, see 130 Cong. Rec. S733, 741, and in the House

on September 18, 1984 on a vote of 392 to 1, see 130 Cong.

Rec. H9742-9743 (daily ed. Sept. 18, 1984). The President

signed the legislation, and it became law on October 12, 1984.

See Pub. L. 98-473, Title II § 501 (1984), 98 Stat. 2068.

The legislative history to the 1984 amendments, along

with the amendments themselves, make clear that the

“public interest” standard was intended as a requirement

independent of and in addition to state felony law and

state medical licensing regulations, and that the Attorney

General was to determine whether it was in the public

interest for a physician to be registered to prescribe

controlled substances. The “public interest” provision

clarified, if not increased greatly, the Attorney General's

existing authority to take action even where a practitioner

was in compliance with state law. As the Ninth Circuit

was forced to acknowledge, “the 1984 amendments to the

CSA ... extend the Attorney General’s authority over

16

federal registration of practicing physicians ... ” Oregon,

368 F.3d at 1129. In issuing the Interpretive Rule, the

Attorney General properly exercised this extended author-

ity.

D. The Interpretive Rule Is Based Upon A

Reasonable Interpretation Of The CSA’s

Legislative History.

In light of the legislative intent behind the CSA shown

by these congressional reports and comments, it seems

difficult to conclude that the Attorney General lacked

authority to issue the Interpretive Rule, or that the Rule is

somehow contrary to the statute’s purpose. In fact, both

the 1984 amendments and the Interpretive Rule were

federal responses to leaks in the closed system at the state

level that allowed physicians to divert controlled sub-

stances to improper ends: the 1984 amendments re-

sponded to the problem in the states generally, while the

Interpretive Rule responded to the problem in a specific

state.

Since the 1984 amendments, the following standards

have been among those with which a physician must

comply to prescribe federally-controlled substances:

1. Any prescription must be issued for a “le-

gitimate medical purpose” and while the

physician is acting within the “usual course

of his [or her] professional practice,” 21

C.F.R. § 1306.04(a); and

2. The physician must not commit acts that

cause his or her registration to be inconsis-

tent with the “public interest,” 21 U.S.C.

§§ 823(f) & 824(a)(4).

17

With the broad phrases “legitimate medical purpose,”

“usual course of professional practice,” and “public health

and safety,” the CSA and its implementing regulations

leave room for further definition before these provisions

can be enforced as a practical matter.

Gaps and ambiguities created by such broad terms

can be filled in by the Attorney General based on a rea-

sonable interpretation of their meaning. See Nationsbank

of North Carolina, N.A. v. Variable Annuity Life Ins. Co.,

513 U.S. 251, 257 (1995) (citing Chevron U.S.A., Inc. v.

Natural Res. Def. Council, Inc. 467 U.S. 837, 843-44

(1984)). To fill in gaps in the CSA and its regulations, the

Attorney General can look to the statute’s legislative

history as one tool for discerning Congress’ intent. See

Chevron, 467 U.S. at 851-53.

Here, in concluding that physicians who prescribe

controlled substances to terminate a person’s life are not

acting for a legitimate medical purpose or in the usual

course of their professional practice, and that it is not in

the public interest for such physicians to be able to con-

tinue to issue prescriptions, the Interpretive Rule fits

comfortably within the congressional intent reflected by

the relevant legislative history. Besides the statements

described in Sections II(A) and (C) above, the legislative

history also contains numerous references to the diversion

of narcotic and depressant substances out of the legitimate

system, the public danger caused by drugs prescribed by

physicians for improper reasons, and the large numbers of

deaths annually due to overdoses of prescription drugs.

See, e.g., 130 Cong. Rec. S9681-82 (daily ed. Feb. 2, 1984).

Notwithstanding the broader public debate regarding

the practice of physician-assisted suicide generally, the

18

dispositive legal question before the Ninth Court was a

fairly pedestrian issue of administrative law: “is the

Attorney General’s interpretation of 21 C.F.R. § 1306.04(a)

entitled to deference?” Oregon, 368 F.3d at 1131 (Wallace,

J., dissenting). Based on legislative history (as well as the

statutory language and other sources, see generally Memo-

randum from Deputy Assistant Attorney General Sheldon

Bradshaw to Hon. John Ashcroft, “Whether Physician-

Assisted Suicide Serves a ‘Legitimate Medical Purpose’

Under the Drug Enforcement Administration’s Regula-

tions Implementing the Controlled Substances Act” (June

27, 2001) (‘DAAG Memorandum”)’), the Attorney Gen-

eral’s issuance of the Interpretive Rule was fully within

his authority under the CSA and it was entirely reason-

able for him to exclude physician-assisted suicide from

permissible practices under the CSA and _ section

1306.04(a). Thus, the Ninth Circuit should have deferred

to the Attorney General’s interpretation.

E. The Federal Government’s Role As Regulator

Of Controlled Substances Does Not Displace

The States’ Role As Primary Regulators Of

The Practice Of Medicine.

Congress knew when it enacted the CSA that en-

forcement of the statute would result in federal regulation

of certain aspects of the practice of medicine, which as a

general matter had always been considered primarily a

state responsibility. Discussing the CSA in 1970, a House

Report acknowledged the problem, but concluded that it

* The Attorney General relied on the DAAG Memorandum in

issuing the Interpretive Rule, and the Rule incorporates it by reference.

See 66 Fed. Reg. at 56,608.

19

could not be avoided: “Although the Committee is con-

cerned about the appropriateness of having federal offi-

cials determine the appropriate method of the practice of

medicine, it is necessary to recognize that for the last fifty

years this is precisely what has happened, through crimi-

nal prosecution of physicians whose methods of prescrib-

ing narcotic drugs have not conformed to the opinion of

federal prosecutors of what constitutes appropriate meth-

ods of professional practice.” H.R. Rep. No. 91-1444, Part

1, at 51 (1970), reprinted in 1970 U.S.C.C.A.N. 4566, 4581.

However, Congress never intended to displace the

states as primary regulators of physicians, and the CSA

was never intended to result in a wholesale nationalizing

of the practice of medicine. For example, since its enact-

ment in 1970, the CSA has provided that it does not

“occupy the field ... to the exclusion of any State law on

the same subject matter which would otherwise be within

the authority of the State, unless there is a positive

conflict between that provision [of the CSA] and that State

law so that the two cannot consistently stand together.” 21

U.S.C. § 903. Even after the 1984 amendments, Congress

intended that the DEA “would continue to give deference

to the opinions of State licensing authorities, since their

recommendations are the first of the factors to be consid-

ered with respect to practitioner applications.” H.R. Rep.

No. 98-1030 pt. B, at 267 (1984), reprinted in 1984

U.S.C.C.A.N. 3182, 3449; see also 21 U.S.C. § 823(f)(1).

Further, “[rjegistration of a physician under the [CSA] is a

matter entirely separate from a physician’s State license to

practice medicine. Therefore, revocation [of] registration

only precludes a physician from dispensing substances

controlled under the [CSA] and does not preclude his

dispensing other prescription drugs or his continued

20

practice of medicine.” H.R. Rep. No. 98-1030, at 267 n.40

(1984), reprinted in 1984 U.S.C.C.A.N. 3182, 3449 n.40.

Thus, for purposes other than the CSA (and leaving

aside the issue of whether other federal laws would be

implicated), states may have a right to decide whether

physician-assisted suicide is a legitimate medical practice.

Nonetheless, with regard to prescribing and dispensing

federally-regulated substances, the CSA leaves final

determination of what constitutes a “legitimate medical

purpose” to the Attorney General. Congress realized that

not only would federal regulation be concurrent with state

regulation but that, in some situations, it would necessar-

ily supersede state law. The result here is that the DWDA

must yield to the Interpretive Rule and, like all other

DEA-registered physicians in the United States, DEA-

registered physicians in Oregon cannot requisition feder-

ally-controlled substances to facilitate their patients’

deaths.

In determining whether physician-assisted suicide is

“inconsistent with the public interest,” the Attorney

General satisfied the requirement of section 823(f) that he

review and consider, inter alia, Oregon law. See DAAG

Memorandum, at 1-2, 6, 14, 20 (reviewing DWDA and its

history, legal opinion of Oregon Deputy Attorney General,

and effect of proposed interpretation on Oregon physi-

cians). Contrary to the Ninth Circuit’s conclusion, the CSA

does not require that he “solicit input” from Oregon before

issuing the Interpretive Rule, Oregon, 368 F.3d at 1129,

and, at bottom, the Ninth Circuit merely complains that

21

the manner in which the Rule was issued was impolitic.*

Whether this complaint is accurate or not is irrelevant as

a legal matter.

Finally, a decision by this Court to affirm the Ninth

Circuit’s decision will not result in a clean demarcation

between the authority of Oregon and the federal govern-

ment, respectively, to define what constitutes a legitimate

medical practice. Instead, Oregon will merely have carved

out of the CSA a specific purpose for controlled substances

(i.e., assisting suicides) that is governed solely by state

law. In enforcing the CSA in Oregon, the federal govern-

ment will be placed in the position of having to differenti-

ate between “legitimate” and “illegitimate” deaths caused

by physicians prescribing controlled substances in the

state. Moreover, effective regulation of controlled sub-

stances on a national basis will become more difficult if

individual states can opt out of the CSA where they

disagree with the federal government about proper uses

for the substances.

Ill. THE ATTORNEY GENERAL HAS THE AUTHOR-

ITY TO DETERMINE WHETHER PHYSICIAN-

ASSISTED SUICIDE VIOLATES THE CSA,

NOTWITHSTANDING THE ABSENCE OF SPE-

CIFIC REFERENCES TO THE PRACTICE IN

THE LEGISLATIVE HISTORY.

As noted by the Ninth Circuit, much of the legislative

history from the CSA’s initial enactment reflects a specific

* As noted by the dissent, specific input would be appropriate if

and when a particular physician’s registration was being reviewed in

light of the Interpretive Rule, which is not the situation here. See

Oregon, 368 F.3d at 1139-40 (Wallace, J., dissenting).

22

concern with “crack{ing] down hard on the narcotics

pusher and the illegal diverters of pep pills and goof balls.”

Oregon, 368 F.3d at 1128 (quoting 116 Cong. Rec. 977-78

(Comments of Sen. Dodd, Jan. 23, 1970)). Further, al-

though Congress identified “suicides and attempted

suicides” as improper uses of controlled substances, see

1970 U.S.C.C.A.N. at 4602, nothing in the history to the

1970 enactment or the 1984 amendments establishes that

Congress ever had in mind the specific “practice” of physi-

cian-assisted suicide. Nonetheless, these aspects of the

legislative history do not support the Ninth Circuit's

conclusion that the Interpretive Rule is contrary to the

CSA and outside the Attorney General’s authority under

the CSA.

The application of a statute to circumstances beyond

those specifically contemplated by Congress at the time of

enactment is not unusual or improper. For example, in

H.J. Inc. v. Northwestern Bell Telephone Co., 492 U.S. 229,

245-8 (1989), the Supreme Court acknowledged that

Congress’ target in enacting the RICO statute “was the

perceived need to combat organized crime. But Congress

for cogent reasons chose to enact a more general statute,

one which, although it had organized crime as its focus,

was not limited in application to organized crime.” Jd. at

248. As one congressman noted during debate on the

statute, ““‘Whatever the limited occasion for the identifica-

tion of a problem, the Congress has the duty of enacting a

principled solution to the entire problem. Comprehensive

solutions to identified problems must be translated into

well integrated legislative programs.” Id. at 246-47

(quoting 116 Cong. Rec. 18913-18914 (1970) (Sen.

McClellan)).

23

Similarly, in Browder v. United States, 312 U.S. 335,

339-40 (1941), the Supreme Court upheld a criminal

conviction where the defendant used a fraudulently-

obtained passport to re-enter the United States. The

defendant argued that at the time the statute was en-

acted, passports were not customarily used by citizens to

assure easy re-entry and thus, Congress did not intend to

punish the conduct for which he was convicted. The Court

stated,

There is nothing in the legislative history to indi-

cate that Congress considered the question of use

lof passports] by returning citizens. Old crimes,

however, may be committed under new condi-

tions. Old laws apply to changed situations. The

reach of the act is not sustained or opposed by

the fact that it is sought to bring new situations

under its terms. While a statute speaks from its

enactment, even a criminal statute embraces

everything which subsequently falls within its

scope.

312 U.S. at 339-40 (footnote omitted); see also Oncale v.

Sundowner Offshore Servs., Inc., 523 U.S. 75, 79 (1998)

(“male-on-male sexual harassment in the workplace was

assuredly not the principal evil Congress was concerned

with when it enacted Title VII {of the Civil Rights Act of

1964] but statutory prohibitions often go beyond the

principal evil to cover reasonably comparable evils”);

United States v. Southwestern Cable Co., 392 U.S. 157,

172-73 (1968) (FCC has jurisdiction to regulate community

antenna television systems even though when statute

creating FCC was enacted in 1934, Congress could not

envision development of such systems).

24

Like the federal statutes in H.J. Inc., Browder, Oncale

and Southwestern Cables, Congress drafted the CSA with

sufficient breadth such that its language permits reason-

able applications not specifically contemplated by Con-

gress. The mere absence of a specific reference to

physician-assisted suicide in the legislative history cannot

preclude the Attorney General from determining whether

it is a legitimate medical practice under the CSA. De-

manding proof from the legislative history that Congress

envisioned the precise conduct permitted by the DWDA is

unreasonable and the purported lack of such “proof” is not

a proper ground for enjoining the Interpretive Rule. See

Rust v. Sullivan, 500 U.S. 173, 189-90 (1991).

If anything, the absence of specific discussions of

physician-assisted suicide likely reflects the simple fact

that both when the CSA was passed and later amended,

such a practice was beyond what Congress contemplated

as a reasonable possibility. The 1970 House Report's

reference to “misuse of a drug in suicides and attempted

suicides” presumes that such use would be a “misuse.” In

fact, it seems that until former Attorney General Janet

Reno issued her written opinion on June 5, 1998 creating

an exception from the CSA for Oregon, the general under-

standing in Congress was that assisted suicide could not

be considered a legitimate medical practice.’

* Certainly the DEA thought so. See Letter from Hon. Thomas A.

Constantine, Administrator of the Drug Enforcement Administration of

the United States To Hon. Henry J. Hyde, Committee on the Judiciary,

United States House of Representatives (Nov. 5, 1997) (concluding that

prescribing a controlled substance with the intent to assist suicide was

not a legitimate medical purpose and would violate the CSA), see also

Hugh |. Schade, M_D., Denial of Application, 60 Fed. Reg. 56,354 (Nov.

8, 1995) (denying registration on ground of “public health and safety”

(Continued on following page)

25

For example, in 1997 Congress passed the Assisted

Suicide Funding Restriction Act, which President Clinton

signed into law on April 30 of that year. Pub. L. 105-12,

111 Stat. 23. The Assisted Suicide Funding Restriction Act

directly prohibits the use of federal funds for the purpose

of causing or assisting in causing the death of any individ-

ual. Jd. § 3(a)(1). In passing the Act, Congress stated that

its purpose was “to continue current federal policy by

providing explicitly that federal funds may not be used to

pay for items and services (including assistance) the

purpose of which is to cause (or assist in causing) the

suicide, euthanasia, or mercy killing of any individual.”

Pub. L. No. 105-12, § 2(b), 111 Stat. 23 (emphasis added).

And this remains federal policy today. See Health &

Human Servs., Medicare Benefit Policy Manual, ch. 16,

§ 20 (“A health care item or service for the purpose of

causing, or assisting to cause, the death of any individual

(assisted suicide) is not covered” by the Medicare program.)

(available at: http://www.cms.hhs.gov/manuals/102_policy/

bp102c16.pdf). Thus, it seems clear that, apart from the

June 5, 1998 opinion, the position of the federal govern-

ment has consistently been that it will not facilitate

suicide.

This reasonable federal policy is consistent with the

clear ethical consensus of the medical profession from

enactment of the CSA through today. The positions of the

American Medical Association and other medical organiza-

tions have reflected nearly uniformly the view that physi-

cian-assisted suicide is not an acceptable or legitimate

medical practice. See, e.g., Am. Med. Ass’n, Code of Medical

where physician had prescribed lethal amounts of Darvocet to de-

pressed patient who used them to commit suicide).

26

Ethics § 2.211 (2005) (“[pjhysician-assisted suicide is

fundamentally incompatible with the physician’s role as

healer, would be difficult or impossible to control, and

would pose serious societal risks” and “[i)nstead of partici-

pating in assisted suicide, physicians must aggressively

respond to the needs of patients at the end of life”); Edito-

rial, Deadly milestone: 5 years of assisted suicide, amed-

news.com, Apr. 21, 2003 (available at: http://www.ama-

assn.org/amednews/2003/04/2 l/edsb0421.htm); Council on

Ethical and Judicial Affairs, Decisions Near the End of

Life, 267 JAMA 2229, 2233 (1992) (“Physicians must not

... participate in assisted suicide[]” and “({p)hysician

assisted suicide ... is contrary to the traditional prohibi-

tion against using the tools of medicine to cause a patient’s

death” and includes the “potential for coercive financial

and societal pressures on patients to choose suicide.”);

ANA Position Statement (available at: nursingworld.org/

readroom/position/ethics/etsuic_ htm); Task Force on the

Nurse’s Role in End-of-Life Decisions, Center for Ethics

and Human Rights (1994) (“[s)uch an act is in violation of

the Code for nurses ... and the ethical traditions of the

profession”). Notably, when the CSA was enacted, it was

recommended to Congress by a Presidential Commission

that under the CSA's regulations, “the definition of legiti-

mate medical use of narcotic drugs [be] primarily ...

determined by the medical profession.” H.R. Rep. No. 91-

1444, at 21, reprinted in 1970 U.S.C.C.A.N. 4566, 4586. In

the Interpretive Rule, the Attorney General properly

exercised his authority under the CSA by reasonably

concurring with the medical profession that physician-

assisted suicide is not a legitimate medical practice.

+

27

CONCLUSION

For the foregoing reasons, Amici Curiae respectfully

request that the judgment of the Ninth Circuit be re-

versed.

Respectfully submitted,

DONALD A. DAUGHERTY, JR.

Counsel of Record

JOHN B. TUFFNELL

WHYTE HIRSCHBOECK DUDEK S.C.

555 E. Wells Street, Suite 1900

Milwaukee, WI 53202

(414) 273-2100

Counsel for Congressional Amici

May 11, 2005