Petition for Writ of Certiorari — Gonzales v. Oregon

NOV 9 ~ 2004

No.

In the Supreme Court of the Anited States

JOHN ASHCROFT, ATTORNEY GENERAL, ET AL.,

PETITIONERS

v.

STATE OF OREGON, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

PAUL D. CLEMENT

Acting Solicitor General

Counsel of Record

PETER D. KEISLER

Assistant Attorney General

EDWIN S. KNEEDLER

Deputy Solicitor General

GREGORY G. KATSAS

Deputy Assistant Attorney

General

DOUGLAS HALLWARD-DRIEMEIER

Assistant to the Solicitor

General

MARK B. STERN

JONATHAN H. LEVY

Attorneys

Department of Justice

Washington, D.C. 20530-0001

(202) 514-2217

Yi

QUESTION PRESENTED

Whether the Attorney General has permissibly construed

the Controlled Substances Act, 21 U.S.C. 801 et seq., and its

implementing regulations to prohibit the distribution of fed-

erally controlled substances for the purpose of facilitating an

individual’s suicide, regardless of a state law purporting to

authorize such distribution.

(I)

II

PARTIES TO THE PROCEEDING

Petitioners are John Ashcroft, Attorney General of the

United States; Karen Tandy, Administrator of the Drug En-

forcement Administration; Kenneth W. McGee, Assistant

Special Agent-in-Charge of the Portland Office of the Drug

Enforcement Administration; the United States of America;

the United States Department of Justice; and the Drug En-

forcement Administration.

Respondents are the State of Oregon, Peter A. Ras-

mussen, David Malcolm Hochhalter, Richard Holmes, James

Romney, Melissa Bush, and John Doe #1.

TABLE OF CONTENTS

Page

Opinions below 1

Jurisdiction 1

Statutory provisions involved 2

Statement 2

Reasons for granting the petition 9

I. The Ninth Circuit erred in holding that a single

State’s law rendered invalid the Attorney General's

reasonable interpretation of the Controlled Sub-

stances Act and its implementing regulations to bar

the of controlled substances to facilitate suicide .......... 11

A. The Attorney General's reasonable interpretation

of the comprehensive federal statute must

prevail over he determination by a particular

State that departs radically from long-accepted

legal and ethical norms ll

B. The Ninth Circuit’s reliance on Gregory v.

Ashcroft and related principles to defeat the

application of federal law to the private conduct

of dispensing drugs is fundamentally flawed ......... 20

II. The Court of Appeals’ decision warrants review

because it conflicts with decisions of this Court

and improperly allows states to dictate the content

of federal law 26

Conclusion 28

TABLE OF AUTHORITIES

Cases:

Alliance for Cannabis Therapeutics v. DEA, 15 F.3d

1131 (D.C. Cir. 1994) 16-17

Auer v. Robbins, 519 U.S. 452 (1997) 12

(IID)

Cases—Continued: Page

United States v. Oakland Cannabis Buyers’ Coop.:

190 F.3d 1109 (9th Cir. 1999), rev'd, 582 U.S.

IV

Cases—Continued: Page

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

Inc., 467 U.S. 837 (1984) 11-12

Dickerson v. New Banner Inst., Inc., 460 U.S. 108

(1983) 19

Gately v. Massachusetts, 2 F.3d 1221 (ist Cir.

1993) 21

Gregory v. Ashcroft, 501 U.S. 452 (1991) 10, 20, 21

Hammer v. Dagenhart, 247 U.S. 251 (1918) 22

Jerome v. United States, 318 U.S. 101 (1943) ................... 18

Linder v. United States, 268 U.S. 5 (1925) 20, 22

Minor v. United States, 396 U.S. 87 (1969) 22

Mississippi Band of Choctaw Indians v. Holyfield,

490 U.S. 30 (1989) 8, 18

NLRB v. Natural Gas Util. Dist., 402 U.S. 600

(1971) 20

NLRB v. Randolph Elec. Membership Corp., 343

F.2d 60 (4th Cir. 1965) 20

Raich v. Ashcroft, 352 F.3d 1222 (9th Cir. 2003),

cert. granted, 124 S. Ct. 2909 (2004) 26

Reina v. United States, 364 U.S. 507 (1960) 22

Solid Waste Agency v. United States Army Corps

of Eng’rs, 531 U.S. 159 (2001) x

Thomas Jefferson Univ. v. Shalala, 512 U.S. 504

(1994) 12

United States v. Daniel, 3 F 3d 775 (4th Cir. 1993),

cert. denied, 510 U.S. 1130 (1994) 18

United States v. Darby, 312 U.S. 100 (1941) 22

United States v. Lot 5, Fox Grove, 23 F.3d 359

(11th Cir. 1994), cert. denied, 513 U.S. 1076

(1995) 21

United States v. Moore, 423 U.S. 122 (1975) 3, 4, 9,

14, 17-18, 22, 25

United States v. Norris, 780 F.2d 1207 (5th Cir.

1986) 18

483 (2001) 26

532 U.S. 483 (2001) 6, 10, 15, 16, 22

United States v. Pelzer, 312 U.S. 399 (1941) 19

United States v. Turley, 352 U.S. 407 (1957) 18

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

1986), cert. denied, 479 U.S. 1036 (1987) 18

Washington v. Glucksberg, 521 U.S. 702 (1997) ........ 7, 12, 13

Constitution, statute and regulations:

U.S. Const. Art. I, § 8, Cl. 3 (Commerce Clause) ................ 26

Controlled Substances Act, Pub. L. No. 91-513,

Tit. I1, 84 Stat. 1242 (21 U.S.C. 801 et seq.) 2

21 U.S.C. 801(1) 13, 24

21 U.S.C. 801(2) 23

21 U.S.C. 801(6) 19

21 U.S.C. 802(10) ... 2

21 U.S.C. 802(21) ‘2,14

21 U.S.C. 811 4

21 U.S.C. 811(a) 14, 16

21 U.S.C. 812 4

21 U.S.C. 812(b) 14, 15

21 U.S.C. 812(b)\(1) 16

21 U.S.C. 812(b)(1B) 3, 6, 10, 14

21 U.S.C. 812(b)(2)(5) 14

21 U.S.C. 812(b2XB) 3

21 U.S.C. 812(b3\B) 3

21 U.S.C. 812(b)(4\(B) 3

21 U.S.C. 812(b)(5B) 3

21 U.S.C. 812(¢) 3

21 U.S.C. 821 4

21 U.S.C. 822(a\(2) 2

21 U.S.C. 822(b) 2

21 U.S.C. 823(a\(1) 14, 24

21 U.S.C. 823(f) 2, 3, 8, 14, 24, 25

VI

Statute and regulations: Page

21 U.S.C. 823(f(3) 8-9

21 U.S.C. 823(f\4) 8-9, 25

21 U.S.C. 823(fK5) 9, 2, 25

21 U.S.C. 824aX4) 2

21 U.S.C. 829 3,4, 14

21 U.S.C. 82%a) 14

21 U.S.C. 82%c) 14

21 U.S.C. 830(b3)( Ai) 15

21 U.S.C. 841(aX(1) 2,3

21 U.S.C. 871(b)

21 U.S.C. 877

21 U.S.C. 908

Harrison Act of 1914, ch. 1, 38 Stat. 785

21 U.S.C. 352(j)

21 U.S.C. 355(d)

42 U.S.C. 257a (1970)

42 U.S.C. 290bb-2a

42 U.S.C. 1320a-7(a)

42 U.S.C. 1320a-7(b\6\B)

42 U.S.C. 1320¢-H(a\(1)

42 U.S.C. 1320c-K(b)

42 U.S.C. 1395y(ay(1)(A) (2000 & Supp. I 2001) .................

Cal. Health & Safety Code § 11362.5(b)(1)(A) (West

Supp. 2001)

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

et seq. (2003)

§ 127.300

§ 127.300(11)

§ 127.815

§ 127.815(d)

§ 127.820

§ 127.885(1)

» #

ananaaoann & BSSSSRBKKVNVEawe

Vil

Statute and regulations—Continued:

21 C.F.R.:

Section 1306.04

Section 1306.04(a) 4, 15,17

Section 1308.12(e)

28 C.F.R. 0.100(b)

Miscellaneous:

66 Fed. Reg. 56,607 (2001)

H.R. Rep. No. 1444, 91st Cong., 2d Sess. Pt. 1(1970) .........

http://www.dhs.state.or.us/publichealth/chs/pas/ar-tbl-4.

cfm

Letter from Janet Reno, Attorney General of the

United States, to Henry J. Hyde, Chairman, Com-

mittee on the Judiciary, U.S. House of Representatives

(June 5, 1998)

Health & Human Servs., Medicare Benefit Policy

Manual (visited Nov. 5, 2004) <http://www.cms.

hhs.gov/manuals/102__policy/bp102c 16.pdf> ................-

Kevin F. O'Malley et al., Federal Jury Practice and

Instructions (Criminal) (5th ed. 2000)

17

18

In the Supreme Court of the Gnited States

No.

JOHN ASHCROFT, ATTORNEY GENERAL, ET AL.,

PETITIONERS

v.

STATE OF OREGON, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

The Acting Solicitor General, on behalf of the Attorney

General of the United States and the other federal parties,

respectfully petitions for a writ of certiorari to review the

judgment of the United States Court of Appeals for the

Ninth Circuit in this case.

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-63a) is

reported at 368 F.3d 1118. The order of the district court

granting respondents’ motion for a preliminary injunction

(Pet. App. 64a-97a) is reported at 192 F. Supp. 2d 1077.

JURISDICTION

The judgment of the court of appeals was entered on May

26, 2004. A petition for rehearing was denied on August 11,

(1)

2004 (Pet. App. 98a-99a). The jurisdiction of this Court is

invoked under 28 U.S.C. 1254(1).

STATUTORY PROVISIONS INVOLVED

Relevant provisions of the Controlled Substances Act

(CSA or Act), Pub. L. No. 91-513, Tit. II, 84 Stat. 1242 (21

U.S.C. 801 et seq.) and the implementing regulation, 21

C.F.R. 1306.04, are set out in an appendix to this petition.

Pet. App. 149a-161a. The relevant provisions of the Oregon

Death with Dignity Act, Or. Rev. Stat. §§ 127.800 et seq.

(2003), are also set out in the appendix. Pet. App. 162a-165a.

STATEMENT

1. a. The Controlled Substances Act, 21 U.S.C. 801

et seq., establishes a comprehensive federal scheme to regu-

late controlled substances. The CSA makes it unlawful to

“manufacture, distribute, or dispense, or possess with intent

to manufacture, distribute, or dispense” any controlled

substance, “le]xcept as authorized by [21 U.S.C. 801 et seq.].”

21 U.S.C. 841(a)(1). Physicians and other practitioners who

dispense’ controlled substances must “obtain from the

Attorney General a registration.” 21 U.S.C. 822(a)(2). They

may dispense controlled substances only “in the course of

professional practice or research,” 21 U.S.C. 802(21), and

only “to the extent authorized by their registration and in

conformity with the other provisions of [the CSA],” 21

U.S.C. 822(b).

The CSA authorizes the Attorney General to deny or re-

voke the registration of a practitioner “if he determines that

the issuance of such registration would be inconsistent with

the public interest.” 21 U.S.C. 823(f), 824(a)(4). In deter-

mining the “public interest” for registration purposes, the

1 Under the CSA, the term “dispense” includes the issuance of a pre-

scription by a practitioner as well as delivering a controlled substance

directly to a patient. 21 U.S.C. 802(10).

Attorney General considers a number of factors including

the registrant’s compliance with federal, state, and local laws

relating to controlled substances, 21 U.S.C. 823(f)(3) and (4),

and “such other conduct which may threaten the public

health and safety.” 21 U.S.C. 823(f)(5). In addition, a

physician who dispenses controlled substances outside the

“accepted limits” of medical practice is subject to prose-

cution under 21 U.S.C. 841(a)(1). United States v. Moore,

423 U.S. 122, 142 (1975).

Under the CSA, each controlled substance is placed in one

of five schedules, depending on whether the substance has a

currently accepted medical use in treatment in the United

States and the relative abuse potential of the substance. The

Act imposes varying regulatory restrictions on controlled

substances depending on the applicable schedule. Sub-

stances in Schedule I—the most restricted schedule—have

“no currently accepted medical use in treatment in the

United States,” 21 U.S.C. 812(b)(1)(B), and may not be pre-

scribed by a physician. 21 U.S.C. 829. Human consumption

of Schedule I controlled substances is permissible only in a

research setting where the research has been approved by

the Food and Drug Administration and the researcher has

obtained from the Drug Enforcement Administration (DEA)

a registration authorizing the specific research protocol. 21

U.S.C. 823(f). Substances in Schedules II through V have a

“currently accepted medical use in treatment in the United

States,” 21 U.S.C. 812(b)(2)(B), (3)(B), (4)(B) and (5)(B)), and

therefore may be dispensed for medical use. 21 U.S.C. 829.

When the CSA was enacted in 1970, Congress made an

initial assignment of controlled substances to the schedules it

believed appropriate. 21 U.S.C. 812(c). Congress authorized

the Attorney General, in consultation with the Secretary of

Health and Human Services, to add or remove substances or

to transfer substances from one schedule to another based

upon statutory criteria that take into account changes in

medical and scientific understanding and shifts in patterns of

abuse. 21 U.S.C. 811, 812. In addition, Congress provided

the Attorney General with broad authority to promulgate

“rules and regulations * * * relating to the registration and

control of the manufacture, distribution, and dispensing of

controlled substances,” 21 U.S.C. 821, and “any rules, regula-

tions, and procedures which he may deem necessary and ap-

propriate for the efficient execution of his functions” under

the CSA, 21 U.S.C. 871(b). The Attorney General has dele-

gated his functions under the Act to the Administrator of

DEA. 28 C.F.R. 0.100(b).

States remain free to enact their own laws relating to con-

trolled substances, such as their own criminal penalties, but

state laws are preempted to the extent of any “positive con-

flict” between a provision of state law and the CSA such that

the two “cannot consistently stand together.” 21 U.S.C. 903.

b. When the CSA became effective in 1971, DEA’s

predecessor (the Bureau of Narcotics and Dangerous Drugs)

issued regulations through notice-and-comment rulemaking

to implement the Act. One of those regulations, now found

at 21 C.F.R. 1306.04(a), requires that a prescription for a

controlled substance “must be issued for a legitimate medical

purpose by an individual practitioner acting in the usual

course of his professional practice.” A purported prescrip-

tion that is not issued “in the usual course of professional

treatment or in legitimate and authorized research” does not

qualify as a “prescription” for purposes of 21 U.S.C. 829 and,

if issued knowingly, will subject the practitioner “to the pen-

alties provided for violations of the provisions of law relating

to controlled substances.” 21 C.F.R. 1306.04(a). As this

Court indicated in Moore, this legitimate medical purpose

requirement is implicit in various provisions of the CSA,

such as 21 U.S.C. 829, but is made explicit by virtue of the

implementing regulation, 21 C.F.R. 1306.04(a). See Moore,

423 U.S. at 137-139 & n.13.

2. In November 1994, Oregon voters passed a ballot ini-

tiative referred to as the Oregon Death with Dignity Act

(DWDA), Or. Rev. Stat. §§ 127.800 et seg. (2003). The

DWDA allows the prescribing and dispensing of “medica-

tion” for the purpose of enabling an individual with a termi-

nal disease to commit suicide. Jd. § 127.800(11). It requires

the physician prescribing or dispensing the lethal substance

to ensure that the patient is a resident of Oregon, is compe-

tent, has a terminal disease, and is making a voluntary and

informed decision to obtain the drugs for the purpose of

ending his or her life. See id. §§ 127.800, 127.815. A second

physician must also verify most of those facts. /d.

§§ 127.815(d), 127.820. The DWDA provides that a physician

who prescribes or dispenses a lethal amount or combination

of drugs in accordance with the DWDA shall not, for that

reason, “be subject to civil or criminal liability or profes-

sional disciplinary action.” Jd. § 127.885(1). Oregon is the

only State in the Union that purports to authorize physician-

assisted suicide.

3. In 2001, the Attorney General sought an opinion from

the Office of Legal Counsel (OLC) in the Department of Jus-

tice on the question whether a prescription for a drug to as-

sist in a person’s suicide, as contemplated in Oregon’s

DWDA, is a valid prescription pursuant to the CSA and its

implementing regulation.2 On June 27, 2001, OLC issued a

memorandum concluding that “assisting in suicide is not a

2 No interpretive rule had previously been issued by the Attorney

General on this subject. The Administrator of the DEA had previously

concluded that assisting suicide in accordance with the DWDA would

violate the CSA, E.R. 17, but then-Attorney General Janet Reno reached

a different conclusion, see Pet. App. 109a (quoting Letter from Janet

Reno, Attorney General of the United States, to Henry J. Hyde, Chair-

man, Committee on the Judiciary, U.S. House of Representatives (June 5,

1998)). Neither of those previous documents was published in the Federal

Register.

‘legitimate medical purpose’ that would justify a physician’s

dispensing controlled substances consistent with the CSA.”

Pet. App. 130a; see id. at 106a-148a.

The OLC memorandum explained that “(t]he CSA

establishes a uniform, nation-wide statutory scheme for

regulating the distribution of controlled substances,” Pet.

App. 130a, and that this Court had held, in United States v.

Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483 (2001),

that a California voter initiative purporting to recognize a

medical use for marijuana could not provide the basis for an

implied “medical necessity” exception or defense in the CSA

in the face of Congress’s placement of marijuana on Schedule

I, which is reserved for substances with “no currently

accepted medical use in treatment in the United States,” 21

U.S.C. 812(b)(1)(B). Pet. App. 131la-133a. The OLC memo-

randum concluded that Oregon’s ballot initiative likewise

could not immunize a physician from prosecution or loss of

registration under the CSA, if the Attorney General deter-

mined, pursuant to the regulatory authority granted to him

in the CSA, that assisting an individual to commit suicide

does not constitute a “legitimate medical purpose” for which

controlled substances may be prescribed. /d. at 133a-134a.

The OLC memorandum also canvassed the views of medi-

cal and nursing associations, federal and state law, and judi-

cial opinions and concluded, based on that review, that de-

spite the Oregon voters’ approval, physician-assisted suicide

is not a “legitimate medical purpose.” The memorandum

noted that “state law and policy, with the sole exception of

Oregon’s, emphatically oppose assisted suicide,” Pet. App.

117a, and that federal law likewise prohibits such conduct in

federal medical facilities and denies federal financial assis-

tance in support of it, id. at 119a-122a. For example, the

memorandum noted that the Health Care Financing Admini-

stration in the Department of Health and Human Services

had determined that physician-assisted suicide is not eligible

for reimbursement under Medicare because it is “not rea-

sonable and necessary to the diagnosis and treatment of dis-

ease or injury.” /d. at 120a-121a (internal quotation marks

omitted).* In addition, the OLC memorandum reviewed the

position of leading organizations of the medical profession,

including the American Medical Association, American

Nurses Association, and American Psychiatric Association,

all of which took the view that physician-assisted suicide was

“fundamentally incompatible with the physician’s role as

healer.” Jd. at 124a (quoting AMA Br. at 5, Washington v.

Glucksberg, 521 U.S. 702 (1997) (No. 96-110)).

On November 9, 2001, the Attorney General published an

interpretive rule in the Federal Register (66 Fed. Reg.

56,607 (2001)), that adopted the analysis of the OLC

Memorandum. Pet. App. 100a-105a. The Attorney General

determined that “assisting suicide is not a ‘legitimate

medical purpose’ within the meaning of 21 CFR

§ 1306.04,” and therefore that “prescribing, dispensing, or

administering federally controlled substances to assist

suicide violates the CSA.” Id. at 102a. The Attorney

General made clear that these conclusions “appl{y] regard-

less of whether state law authorizes or permits such conduct

by practitioners or others.” bid.

4. The State of Oregon and others challenged the inter-

pretive rule in the United States District Court for the Dis-

trict of Oregon. That court held the interpretive rule invalid

and enjoined its application. Pet. App. 64a-97a. The Attor-

ney General and the other federal parties appealed. The

court of appeals first held that the district court had lacked

3 The Health Care Financing Administration is now called the Centers

for Medicare and Medicaid Services (CMS). CMS maintains this policy at

present, and it is currently reflected in the Health & Human Servs.,

Medicare Benefit Policy Manual, ch. 16, § 20 (visited Nov. 5, 2004)

<http://www.cms.hhs.gov/ manuals/102_policy/bp102c16.pdf>.

jurisdiction over respondents’ suit. /d. at 2a-3a & n.1, 56a-

6la. Instead, the court of appeals treated the action as a

petition for review under 21 U.S.C. 877 that had been

mistakenly filed in district court and transferred to the court

of appeals. Pet. App. 2a-3a & n.1. On the merits, a divided

panel granted the petitions for review.

a. The majority concluded that the interpretive rule was

invalid absent an “unmistakably clear” indication of congres-

sional intent to regulate physician-assisted suicide, because,

in the majority’s view, the rule “invokes the outer limits of

Congress’ power” by altering “the usual constitutional bal-

ance between the States and the Federal Government.” Pet.

App. 12a-13a (quoting Solid Waste Agency v. United States

Army Corps of Eng’rs, 531 U.S. 159, 172-173 (2001), and

Gregory v. Ashcroft, 501 U.S. 452, 461 (1991) (internal quotes

omitted)). The court also held that the interpretive rule

violated “the plain language of the CSA,” id. at 13a, which,

according to the majority, (1) only addresses “drug abuse,”

id. at 13a-14a, (2) entrusts medical decisions to the Secretary

of Health and Human Services (not the Attorney General),

id. at 15a, and (3) requires the Attorney General to address

all five statutory factors in Section 823(f) that are relevant to

registration of a physician under the CSA, including, in

particular, whether the physician’s conduct complies with

state law, before adopting an interpretive rule such as the

one here at issue, id. at 16a. The panel granted the petitions

for review and “continued” the district court’s injunction. Jd.

at 25a.

b. Senior Judge Wallace dissented. Pet. App. 25a-63a.

He relied upon the presumption that Congress does not

make the application of federal statutes dependent on state

law, id. at 36a (citing Mississippi Band of Choctaw Indians

v. Holyfield, 490 U.S. 30, 43 (1989)), and noted that, while a

physician’s compliance with state law is relevant under the

CSA in determining whether his or her registration would

be consistent with the public interest, id. at 37a (citing 21

U.S.C. 823(f\(3) and (4)), other factors, including whether the

physician’s conduct “may threaten the public health and

safety,” are not dependent on state law, ibid. (citing 21

U.S.C. 823(f)(5)). The dissent further noted that, while the

Secretary of Health and Human Services is specifically

delegated certain functions under the CSA, responsibility

under the Act for determining whether a physician’s regis-

tration serves the public interest is assigned to the Attorney

General alone. /d. at 39a-40a. The dissent also rejected the

majority’s suggestion that application of the CSA to the dis-

pensing of controlled substances to assist suicide is at the

limits of Congress’s power or would alter federal-state rela-

tions, id. at 45a, and pointed out that, to the contrary, Con-

gress’s authority under the Commerce Clause to regulate

the distribution of controlled substances is well-established,

id. at 49a-50a. Finally, the dissent observed that the

Attorney General’s conclusion that physician-assisted suicide

is not a legitimate medical purpose is well supported by an

“overwhelming historical, legal, and medical consensus.” /d.

at 56a.

c. The court of appeals denied the government’s petition

for rehearing or rehearing en banc. Pet. App. 98a-99a

REASONS FOR GRANTING THE PETITION

The Ninth Circuit held in this case that the Attorney Gen-

eral’s ability to administer and enforce the Controlled Sub-

stances Act is subordinate to the views of each of the 50

States regarding the permissible uses of scheduled sub-

stances. That holding is erroneous and stands the proper

relationship between the federal and state governments

under the Constitution on its head. Moreover, the court of

appeals’ ruling conflicts with this Court’s recognition in

United States v. Moore, 423 U.S. 122 (1975), that a

physician's prescription violates the CSA unless made “in

10

the usual course of a professional practice and in accordance

with a standard of medical practice generally recognized and

accepted in the United States,” id. at 139 (emphasis added).

The court of ajypeals’ ruling also conflicts with this Court’s

more recent decision in United States v. Oakland Cannabis

Buyers’ Cooperative, 532 U.S. 483 (2001), which gave effect

to the determination set forth in the CSA that marijuana has

“no currently accepted medical use in treatment in the

United States,” 21 U.S.C. 812(b)(1"3", in the face of a State’s

contrary determination of that disputed medical question,

532 U.S. at 486, 493.

The court of appeals reached this erroneous result only by

misconstruing and dramatically expanding the scope of this

Court’s decision in Gregory v. Ashcroft, 501 U.S. 452 (1991),

and by finding, contrary to this Court’s well-established ju-

risprudence, that federal regulation of the distribution of

controlled substances alters the usual constitutional balance

between the States and the federal government because of

its effect on the practice of medicine. By relying on constitu-

tional avoidance principles to avoid a plainly reasonable in-

terpretation of the CSA by the Attorney General, the court

of appeals’ holding threatens to undermine federal authority

to regulate in numerous other areas that may have an effect

on the practice of medicine. This Court’s review is war-

ranted to correct this serious misconception of the relative

powers of state and federal governments under the Consti-

tution and the CSA.

11

I. THE NINTH CIRCUIT ERRED IN HOLDING

THAT A SINGLE STATE’S LAW RENDERED

INVALID THE ATTORNEY GENERAL’S REASON-

ABLE INTERPRETATION OF THE CONTROLLED

SUBSTANCES ACT AND ITS IMPLEMENTING

REGULATIONS TO BAR THE DISPENSING OF

CONTROLLED SUBSTANCES TO FACILITATE

A. The Attorney General's Reasonable Interpretation

Of The Comprehensive Federal Statute Must Pre-

vail Over The Determination By A Particular State

That Departs Radically From Long-Accepted Legal

And Ethical Norms

The court of appeals acknowledged that the CSA prohibits

practitioners from prescribing or dispensing controlled sub-

stances except for a “legitimate medical purpose” and “in the

usual course of professional treatment.” Pet. App. 5a (quot-

ing 21 C.F.R. 1306.04). Thus, as the court of appeals recog-

nized, the issue presented in this case is “who gets to de-

cide,” id. at 9a, whether a practitioner’s conduct comports

with that federal requirement under the CSA—the Attorney

General, pursuant to a uniform national standard, or each of

the 50 States, according to 50 different views regarding the

proper use of controlled substances. The text and structure

of the CSA, as well as general principles of federalism, com-

pel the conclusion that the CSA, and the Attorney General’s

"ERRNO heneeeeneenpt ta Ry gS

1. In the interpretive ruling under challenge here, the

Attorney General concluded that dispensing drugs to assist

another individual in taking his or her life does not constitute

a “legitimate medical purpose” in the course of medical

“treatment.” 21 C.F.R. 1306.04(a). Because the Attorney

General has primary responsibility for enforcing the CSA,

his interpretation of the Act is entitled to deference under

12

Chevron U.S.A. Inc. v. Natural Resources Defense Council,

Inc., 467 U.S. 837, 843-844 (1984), and his interpretation of

his own regulation is entitled to even greater deference un-

der Auer v. Robbins, 519 U.S. 452, 461 (1997), and Thomas

Jefferson University v. Shalala, 512 U.S. 504, 512 (1994).

The Attorney General clearly acted reasonably in concluding

that dispensing drugs to assist a person to commit suicide is

not for a “legitimate medical purpose” or for “treatment”

within the meaning of the CSA and his implementing

regulation.

Indeed, the Attorney General’s conclusion is the position

maintained by 49 States, the federal government, and

leading associations of the medical profession. As the Court

noted in Washington v. Glucksberg, 521 U.S. 702 (1997), “[iJjn

almost every State—indeed, in almost every western

democracy—it is a crime to assist a suicide.” Jd. at 710.

With specific reference to Oregon’s DWDA, the Court made

clear that the Oregon statute was contrary both to

longstanding historical practices and to contemporary trends

in the law. Jd. at 717-718. Thus, contrary to the dominant

theme of the court of appeals’ decision, the Attorney General

did not ignore the laws of the States in interpreting the CSA

to bar the dispensing of controlled substances to facilitate

suicide. His interpretation is consistent with the position of

the overwhelming majority of the States.

Numerous health care experts have agreed that physi-

cian-assisted suicide is not a legitimate medical treatment.

In Glucksberg, the Court noted that New York State’s Task

Force on Life and the Law—a commission composed of doc-

tors, ethicists, lawyers, religious leaders and interested lay-

persons—had unanimously concluded that “[ljegalizing

assisted suicide and euthanasia would pose profound risks to

many individuals who are ill and vulnerable. . . . [T)he

potential dangers of this dramatic change in public policy

would outweigh any benefit that might be achieved.” 521

13

U.S. at 719 (quotation marks and citation omitted).

Likewise, as the OLC memorandum noted, the American

Medical Association, American Nurses Association, and

American Psychiatric Association filed a joint brief in

Glucksberg taking the position that physician-assisted

suicide is “fundamentally incompatible with the physician’s

role as healer.” Pet. App. 124a (quoting AMA Br. at 5,

Washington v. Glucksberg, 521 U.S. 702 (1997) (No. 96-110)).

Within the federal government as well, the Department of

Health and Human Services’ Health Care Financing

Administration similarly has determined that physician-

assisted suicide is not eligible for reimbursement under

Medicare because it is “not reasonable and necessary to the

diagnosis and treatment of disease or injury.” Pet. App.

120a-121a (internal quotes omitted).

There can be no question, then, that the Attorney Gen-

eral’s interpretive ruling is consistent with the prevailing

views regarding medical practice and on that basis is, at the

very least, reasonable and entitled to deference.

2. It is also clear, from the text and structure of the CSA,

that the Attorney General’s responsibility for enforcing the

CSA required him to resolve the question whether the use of

controlled substances to facilitate suicide is a “legitimate

medical purpose” for “treatment.” The principle that con-

trolled substances may be dispensed only for a “legitimate

medical purpose” in “treatment” is central to the CSA and is

reflected throughout its provisions. The starting point of the

Act (indeed, its first provision) is the recognition that

“{mJany of the drugs included within this subchapter have a

useful and legitimate medical purpose and are necessary to

maintain the health and general welfare of the American

people.” 21 U.S.C. 801(1). The federal regulatory scheme is

built upon the dual principles that the dispensing of

controlled substances should be allowed for such “legitimate

14

medical purposes” but that distribution for illegitimate

purposes should be prohibited.

The Attorney General is charged under the CSA, 21

U.S.C. 811(a), with assigning a controlled substance to the

appropriate “schedule” according to whether it has a “cur-

rently accepted medical use in treatment in the United

States,” 21 U.S.C. 812(b), as well as with ensuring that there

is an “adequate * * * supply” of Schedule I and Schedule II

substances “for legitimate medical, scientific, research, and

industrial purposes,” 21 U.S.C. 823(a)(1). Those substances

for which the Attorney General has determined there is “no

currently accepted medical use in treatment in the United

States” are placed in Schedule I, 21 U.S.C. 812(b)(1)(B), and

may not be prescribed or dispensed except pursuant to a re-

search protocol speifically approved by the Attorney Gen-

eral and the Secretary of Health and Human Services with

respect to the medical merits of the proposal and its security

against diverting the substance from “legitimate medical or

scientific use,” 21 U.S.C. 823(f). Substances in other Sched-

ules may be dispensed by practitioners only because they

have “a currently accepted medical use in treatment in

the United States,” 21 U.S.C. 812(b)(2)-(5), and a legitimate

“medical use” in “treatment” therefore is a prerequisite to

such dispensing.

Other provisions of the Act also confine a practitioner’s

latitude in dispensing drugs on Schedules II through V to le-

gitimate medical uses in the course of treatment. See, ¢.g.,

21 U.S.C. 829(c) (“No controlled substance in schedule V

which is a drug may be distributed or dispensed other than

for a medical purpose.”); Moore, 423 U.S. at 137 n.13 (indi-

cating that the same requirement is implicit in 21 U.S.C.

829(a) for Schedule II substances). The Act authorizes the

prescription of controlled substances only by a practitioner

acting “in the course of professional practice or research,” 21

U.S.C. 802(21), and, as a general matter, only by written

15

“prescription,” 21 U.S.C. 829. The Attorney General's

unchallenged regulation clarifies that a prescription, to be

valid, must be “for a legitimate medical purpose” and issued

“in the usual course of professional treatment or in legiti-

mate and authorized research.” 21 C.F.R. 1306.04(a).

Certain reporting requirements imposed by the CSA

similarly define a “valid prescription” as one “issued for a

legitimate medical purpose by an individual practitioner

* * * acting in the usual course of the practitioner’s

professional practice,” 21 U.S.C. 830(b)(3)(A)(ii).

3. a. The centrality of the concepts of “legitimate

medical purpose” and medical “treatment” in the text and

structure of the CSA leaves no doubt that those standards

are to be established and enforced at the federal, rather than

state, level. This Court’s decisions confirm that conclusion.

There is no question, for example, that the determination

whether a drug has a “currently accepted medical use in

treatment in the United States,” for purposes of scheduling

the substance under 21 U.S.C. 812(b), is a federal decision

that is binding on the States, rather than vice-versa. In Oak-

land Cannabis, the voters in California had passed a ballot

initiative that established, for purposes of state law, that

seriously ill Californians could “use marijuana for medical

purposes.” 532 U.S. at 486 (quoting Cal. Health & Safety

Code Ann. § 11362.5(b)(1)(A) (West Supp. 2001)). None-

theless, this Court rejected the marijuana cooperative’s reli-

ance on the state law as supporting a “medical necessity” de-

fense to prosecution under the CSA. The Court held that

such a defense would be inconsistent with Congress’s find-

ing, in classifying marijuana in Schedule I, that it has “no

currently accepted medical use in treatment in the United

States.” Jd. at 492. See id. at 493 (notwithstanding state

law, “Congress has made a determination that marijuana has

no medical benefits worthy of an exception,” and the Court

16

could not “override a legislative determination” to that ef-

fect).

Although Congress, rather than the Attorney General,

made the determination whether marijuana has a generally

accepted medical use in treatment, a determination by the

Attorney General would be no less binding on the States.

The CSA expressly grants the Attorney General authority

to assign substances to the appropriate schedule, and to

move substances—including those originally classified by

Congress—among schedules. 21 U.S.C. 811(a). In fact, in

Oakland Cannabis, the Court specifically recognized

that “[t]he Attorney General can include a drug in schedule I

* * * if the drug ‘has no currently accepted medical use in

treatment in the United States,’” 532 U.S. at 492 (quoting 21

U.S.C. 812(b)(1)), and one issue raised in the case was

whether Congress’s assignment »f marijuana to Schedule I,

without making specific findings a»out its medical useful-

ness, was entitled to as much deference as the Attorney

General's assignment would be. Ibid. The Court specifically

rejected the challenge to Congress’s classification of

marijuana, holding that “the statute consistently treats all

schedule I drugs alike,” whether placed there by Congress

or the Attorney General. Jd. at 492-493.

Just as California’s ballot initiative purporting to recog-

nize a “use [for] marijuana for medical purposes,” Cal.

Health & Safety Code § 11362.5(b)(1)(A) (West Supp. 2001),

did not compel recognition in Oakland Cannabis of an

exception to the currently applicable rule under the CSA

that a Schedule I substance has no “currently accepted

medical use in treatment in the United States,” neither

would the state law be binding on the Attorney General for

purposes of compelling him to reclassify marijuana to a

different schedule under the CSA. Rather, such a determi-

nation must be based upon an independent federal assess-

ment of the medical and scientific evidence and, if supported

17

by substantial evidence, is binding upon the entire Nation

for purposes of the CSA. See Alliance for Cannabis Thera-

peutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) (upholding

DEA’s refusal to reschedule marijuana as supported by sub-

stantial evidence). As the D.C. Circuit held in Alliance for

Cannabis, “only rigorous scientific proof can satisfy the

CSA’s ‘currently accepted medical use’ requirement.” Jd. at

1137. There is no basis in the CSA for substituting a ballot

initiative, such as California voters’ approval of medical

marijuana or Oregon voters’ endorsement of physician-

assisted suicide, for the requisite “rigorous scientific proof”

regarding a substance’s “accepted medical use.”

Nor is there any reason to conclude, as the Ninth Circuit

in this case did, that the Attorney General’s determination

whether a particular use of a controlled substance consti-

tutes a “legitimate medical use” “in the usual course of pro-

fessional treatment,” 21 C.F.R. 1306.04(a), is any less binding

in the States for purposes of the CSA than his determination

whether a substance has any accepted medical use. If, as is

evident from Oakland Cannabis, the Attorney General

could reclassify the Schedule II substances used by Oregon

physicians to assist suicide* to Schedule I if the medical and

scientific evidence warranted—despite the passage of the

assisted suicide initiative in Oregon—then he likewise can

determine that, while those Schedule II substances have

other generally accepted medical uses in treatment,

deliberately assisting a person to commit suicide is not one.

This Court’s dec’sion in Moore strongly supports that con-

clusion. Moore involved the prosecution of a physician who

4 According to the Oregon Department of Human Services, the three

drugs dispensed pursuant to the DWDA are secobarbital, pentobar-

bital, and amobarbital, all of which are Schedule II depressants. See

http://www.dhs.state.or.us/publichealth/chs/pas/ar-tbl-4.cfm; 21 C.F.R.

1308.12(e).

18

prescribed large quantities of methadone tablets with little

or no medical assessment or supervision. See 423 U.S. at

126. He was convicted under the CSA for prescribing con-

trolled substances outside the usual course of his profes-

sional practice. This Court held that the CSA was intended

to limit a physician’s distribution of controlled substances to

actions “as a physician” and in the course of “professional

practice.” 423 U.S. at 140, 141. The Court made clear that

Moore’s conviction, which it affirmed, was based on a uni-

form nationwide standard for deciding whether the

prescriptions were valid and permissible under the CSA:

whether they were “in accordance with a standard of medical

practice generally recognized and accepted in the United

States.” Id. at 139 (quoting jury instructions) (emphasis

added).”

b. The conclusion evident from the text and structure of

the CSA—that Congress intended the Act to be applied in a

uniform manner across the Nation—is further confirmed by

the well-established principle of statutory construction that,

“in the absence of a plain indication to the contrary, . . .

Congress when it enacts a statute is not making the applica-

tion of the federal act dependent on state law.” Mississippi

Band of Choctaw Indians v. Holyfield, 490 U.S. 30, 43, 47

(1989) (quoting Jerome v. United States, 318 U.S. 101, 104

(1943), and holding that the word “domicile” used in a federal

law should have a uniform meaning and is not defined by

® With the exception of the decision below, the courts of appeals have

followed Moore and applied a national standard for professional practice

under the CSA. See United States v. Vamos, 797 F.2d 1146, 1151 (2d Cir.

1986) (standard of professional practice “generally recognized and

accepted in the United States”), cert. denied, 479 U.S. 1036 (1987); United

States v. Norris, 780 F.2d 1207, 1209 & n.2 (5th Cir. 1986) (same); United

States v. Daniel, 3 F.3d 775, 778 (4th Cir. 1993) (same), cert. denied, 510

U.S. 1130 (1994); Kevin F. O’Malley et al., Federal Jury Practice and

Instructions (Criminal) § 64.16, at 423 (5th ed. 2000) (same).

19

state law). See United States v. Turley, 352 U.S. 407 (1957)

(word “stolen,” used in federal criminal statute, has a uni-

form nationwide meaning and is not defined by state law);

United States v. Pelzer, 312 U.S. 399 (1941) (same for phrase

“future interests” in federal tax statute). Nothing in either

the CSA or its implementing regulation makes the definition

of “legitimate medical purpose” depend upon state law. To

the contrary, there are strong indications, as Moore and

Oakland Cannabis recognize, that Congress did not intend

the concepts of legitimate medical purpose, medical treat-

ment, or public health and safety to be determined solely by

reference to state law.

The Mississippi Band presumption is particularly appro-

priate with respect to the CSA. Congress made clear that it

intended the CSA to establish a national, comprehensive,

and uniform law governing the use of controlled substances

in this country. The need for national control was so great

that Congress specifically found it necessary to regulate

purely intrastate conduct relating to controlled substances.

See 21 U.S.C. 801(6) (finding that “[flederal control of the

intrastate incidents of the traffic in controlled substances is

essential to the effective control of the interstate incidents of

such traffic”). Thus, as in Mississippi Band, the application

of federal law must not (and does not) depend on state law

because “the application of federal legislation is nationwide

and at times the federal program would be impaired if state

law were to control.” Dickerson v. New Banner Inst., Inc.,

460 U.S. 103, 119-120 (1983). If, for example, one State’s vot-

ers were of the view that marijuana has a medical use in

treating mild depression, and that view was binding on the

Attorney General for purposes of scheduling and ensuring

adequate supplies for legitimate medical uses, the federal

scheme to control the lines of distribution of that

drug—including in other States that did not share the mav-

erick view—would be severely undermined. The CSA’s

20

scheme to control all manufacturing, possession, and distri-

bution of any scheduled drug unquestionably constitutes

“federal legislation, administered by a national agency, in-

tended to solve a national problem on a national scale,” the

success of which cannot depend upon the vagaries of state

law. NLRB v. Naturai Gas Util. Dist., 402 U.S. 600, 603-604

(1971) (quoting NLRB v. Randolph Elec. Membership Corp.,

343 F.2d 60, 63 (4th Cir. 1965)).

B. The Ninth Circuit’s Reliance On Gregory v. Ashcroft

And Related Principles To Defeat The Application Of

The CSA To Private Conduct In Dispensing Drugs Is

Fundamentally Flawed

1. The court of appeals failed to follow Oakland Canna-

bis, Moore, and Mississippi Band, and instead concluded

that this Court’s decision in Gregory v. Ashcroft, 501 U.S.

452 (1991), compelled a holding that state law controls the

question whether a physician’s conduct is for a legitimate

medical purpose under the CSA. The court of appeals even

went so far as to conclude that the Attorney General’s

interpretive ruling that dispensing a federally controlled

substance to assist a person to commit suicide is not

permitted under the CSA “invokes the outer limits of

Congress’s power by encroaching on state authority to

regulate medical practice.” Pet. App. 12a (citing Linder v.

United States, 268 U.S. 5, 18 (1925)). Because, in the court of

appeals’ view, the effect of the CSA on Oregon law “alter[s]

the usual constitutional balance between the States and the

Federal Government” by exercising control over “an area of

law traditionally reserved for state authority,” id. at lla

(quoting Gregory, 501 U.S. at 461 (additional internal quotes

omitted)), the court required that the CSA make

“unmistakably clear” the Attorney General’s authority to

adopt the interpretive rule, ibid.

21

The court of appeals’ conclusion that federal regulation of

the distribution of controlled substances “alter[s] the usual

constitutional balance between the States and the Federal

Government” in a manner that requires an “unmistakably

clear” statement by Congress fundamentally misunder-

stands the constitutional rule. The decision in Gregory

turned on the fact that the federal statute at issue threat-

ened to intrude upon a State’s determination of the qualifica-

tions of its own judges, which this Court characterized as a

constitutionally protected “decision of the most fundamental

sort for a sovereign entity.” 501 U.S. at 460. As the courts

of appeals have recognized, Gregory must be limited to such

basic threats to state sovereignty. See United States v. Lot

5, Fox Grove, 23 F.3d 359, 362 (11th Cir. 1994) (noting that

“the Gregory plain statement preemption rule is limited to

federal laws impacting a state’s self-identification as a

sovereignty”), cert. denied, 513 U.S. 1076 (1995); Gately v.

Massachusetts, 2 F.3d 1221, 1230 (1st Cir. 1993) (noting that

Gregory is limited to protecting “a core function going to the

‘heart of representative government”). The Gregory

principle does not apply to the effect an Act of Congress may

have on a State’s views about private conduct that is

otherwise within the scope of Congress’s power to regulate.

Furthermore, there is no merit to the court of appeals’

notion that the application of the CSA here encroaches on

“an area of law traditionally reserved for state authority,”

Pet. App. lla, because, as Glucksberg, makes clear, there is

no tradition of States authorizing physician-assisted suicide,

521 U.S. at 710.

The court of appeals’ suggestion that Congress’s regula-

tion of the distribution of controlled substances in these cir-

cumstances raises significant constitutional problems also

flies in the face of history and this Court’s precedent. Con-

gress has regulated prescriptions for controlled substances

nationwide for almost a century under the CSA and its pre-

22

decessor, the Harrison Act of 1914, ch. 1, 38 Stat. 785. The

court of appeals cited Linder as authority for the proposition

that “direct control of medical practice in the states is

beyond the power of the federal government,” Pet. App. 10a,

and for the further conclusion that the Attorney General’s

interpretive ruling “invokes the outer limits of Congress’

power by encroaching on sta‘ » authority to regulate medical

practice,” id. at 12a. Notaviy, the Court’s Lochner-era

decision in Linder relied upon the then-prevailing view, ar-

ticulated in such cases as Hammer v. Dagenhart, 247 U.S.

251 (1918), that Congress could not employ its enumerated

powers to accomplish more general purposes relating to

health and welfare that were believed to be the exclusive

province of the States. Linder, 268 U.S. at 17 (citing

Hammer, among others, for the proposition that “an act of

Congress ostensibly enacted under power granted by the

Constitution, not naturally and reasonably adapted to the

effective exercise of such power but solely to the achieve-

ment of something plainly within power reserved to the

States, is invalid and cannot be enforced”). That holding of

Hammer was expressly overruled in United States v. Darby,

312 U.S. 100, 115-117 (1941), which upheld the authority of

Congress to regulate interstate commerce for the purpose of

improving the working conditions of laborers, id. at 115.

Moreover, this Court’s subsequent decisions establish that

Linder’s suggestion that the federal government could not

supplant wholesale the States’ “control of medical practice”

does not preclude federal regulation of interstate commerce

in controlled substances despite the effects such regulation

may have on unorthodox practices by physicians. See Oak-

land Cannabis, 532 U.S. at 492-493 (upholding CSA deter-

mination that marijuana lacked an acceptable medical use);

Moore, 423 U.S. at 143 (affirming federal criminal conviction

of physician engaged in unauthorized “experiment(al] * * *

theory of detoxification”); Minor v. United States, 396 U.S.

23

87, 98 n.13 (1969) (ban on sale of narcotics is within Con-

gress’s constitutional power); Reina v. United States, 364

U.S. 507, 511 (1960) (Congress had “undoubted power to en-

act the narcotics laws”).

Thus the court of appeals erred in concluding that the At-

torney General’s adoption of a national rule regarding the

distribution of controlled substances to facilitate suicide up-

set the usual balance between the state and federal govern-

ments.

2. The other reasons the court of appeals gave in support

of its holding are likewise flawed and are, to a significant de-

gree, infected with the court of appeals’ erroneous view that

Gregory's clear statement rule provided the applicable stan-

dard. Under the appropriate framework of affording Chev-

ron deference to the Attorney General’s construction of the

CSA, rather than Gregory’s reverse presumption, none of

the court of appeals’ other points undermines the reason-

ableness of the Attorney General’s interpretive ruling.

a. The court of appeals erred, for example, in relying on

the notion that Congress intended “to limit federal authority

under the CSA to the field of drug abuse,” Pet. App. 14a, and

that the CSA’s “legitimate medical purpose” requirement

must be construed to address that concern alone. In the first

place, the taking of drugs to commit suicide is “drug abuse,”

and prohibiting the dispensing of a drug to facilitate suicide

therefore falls within the purposes of the Act even as the

court of appeals understood them. Moreover, Congress ex-

pressly stated broad goals in enacting the CSA, which was

designed to combat “illegal importation, manufacture, distri-

bution, and possession and improper use of controlled sub-

stances.” 21 U.S.C. 801(2) (emphasis added). There is no

doubt that Congress viewed the use of controlled substances

to commit suicide to be a form of improper use. Congress

specifically referred to the “[mlJisuse of a drug in suicides and

attempted suicides,” and noted that “injuries resulting from

24

unsupervised use are regarded ~s indicative of a drug’s

potential for abuse.” H.R. Rep. No. 1444, 91st Cong., 2d

Sess. Pt. 1., at 35 (1970). See id. at 34 (potential for abuse

indicated by “evidence that individuals are taking the drug

* * * in amounts sufficient to create a hazard to their

health”); 21 U.S.C. 801(1) (noting congressional purpose “to

maintain the health and general welfare of the American

people”); 21 U.S.C. 823(f)(5) (requiring the Attorney General

to consider threats to “the public health and safety” in

issuing and revoking registrations to physicians to distribute

controlled substances).

b. The court of appeals also cited the role of the Secre-

tary of Health and Human Services as a reason why the At-

torney General was not ihe appropriate officer within the

federal government to make determinations under the CSA

that affect the practice of medicine. Pet. App. 15a. While it

is true that the CSA assigns certain functions with respect

to its implementation to the Secretary, the Attorney General

shares a role in many of those functions. E.g., 21 U.S.C.

823(f) (assigning to both the Secretary and Attorney General

roles in assessing proposed research projects relating to

Schedule I drugs). Many other responsibilities under the

CSA that require making determinations respecting the le-

gitimate medical use of substances are assigned to the At-

torney General alone. E.g., 21 U.S.C. 823(a)(1) (Attorney

General to ensure adequate supply of Schedule II substances

for “legitimate medical * * * purposes”); 21 U.S.C. 823(f)(5)

(listing “the public health and safety” among factors the At-

torney General may consider in determining whether to re-

voke a practitioner’s registration under the CSA). In any

event, the determination whether dispensing drugs to facili-

tate suicide constitutes a “legitimate medical purpose” turns

on an interpretation of the CSA and a regulation of the

Attorney General, and does not require an assessment of

25

medical or scientific evidence of the sort that the CSA has

assigned to the Secretary.*

c. The court of appeals’ conclusion that the Attorney

General violated 21 U.S.C. 823(f) by failing to consider all of

the factors addressed in that section is also flawed. As an

initial matter, Section 823(f) applies, by its terms, only to ac-

tions by the Attorney General to deny or revoke a CSA reg-

istration. The Attorney General’s ruling at issue here is not

such a denial or revocation. It is, rather, an interpretation of

the substantive provisions of the Act, violation of which may

in turn lead to a revocation of registration. In any event,

Section 823(f) requires the Attorney General to consider a

number of factors, including not only compliance with state

laws, 21 U.S.C. 823(f)(4), but others, such as “{clompliance

with applicable * * * Federal * * * laws relating to

controlled substances,” 21 U.S.C. 823(f)(4), and any threat to

“the public health and safety,” 21 U.S.C. 823(f)(5), that

plainly call for an independent determination by the

Attorney General. The court of appeals’ ruling would

preclude the Attorney General from exercising his statutory

responsibility to ascertain whether a physician’s registration

is consistent with the public interest by making one

factor—compliance with state law—determinative of that

question. Indeed the court of appeals would make state law

determinative of the question whether dispensing drugs to

facilitate suicide even violates the CSA to begin with. There

® The court of appeals cited (Pet. App. 15a) this Court’s reference in

Moore to the Secretary’s function in determining “the appropriate

methods of professional practice in the medical treatment of . . . narcotic

addiction.” 423 U.S. at 144 (quoting 42 U.S.C. 257a (1970) (auventiy 42

U.S.C. 290bb-2a)). That provision is not directly at issue here, and the fact

that certain health-related determinations are assigned to the Secretary

does not negate the Attorney General's independent responsibilities under

the CSA to ensure that controlled substances are prescribed only for a

“legitimate medical purpose.”

26

is no support in the statute’s text for those extraordinary

conclusions.

Il. THE COURT OF APPEALS’ DECISION WAR-

RANTS REVIEW BECAUSE IT CONFLICTS WITH

DECISIONS OF THIS COURT AND IMPROPERLY

ALLOWS STATES TO DICTATE THE CONTENT

OF FEDERAL LAW.

The court of appeals’ decision warrants review by this

Court. The holding below is yet another in a series of deci-

sions in which the Ninth Circuit has undermined the federal

government’s ability to enforce the comprehensive federal

law to control dangerous substances by subordinating fed-

eral authority to that of the States. In Oakland Cannabis,

the Ninth Circuit held that in light of California’s medical

marijuana initiative, the United States could not enforce the

CSA against individuals who purport to use marijuana for

medical purposes, despite the federal determination in the

CSA itself that no generally accepted medical use exists for

marijuana. United States v. Oakland Cannabis Buyers’

Coop., 190 F.3d 1109, 1111, 1114 (9th Cir. 1999), rev'd, 532

U.S. 483 (2001). More recently, in Raich v. Ashcroft, 352

F.3d 1222 (2003), cert. granted, 124 S. Ct. 2909 (2004), the

Ninth Circuit held that Congress could not, pursuant to the

Commerce Clause (U.S. Const. Art. 1, § 8, Cl. 3), regulate

“the intrastate, noncommercial cultivation and possession of

cannabis for personal medical purposes as recommended by

a patient’s physician pursuant to valid California state law,”

because, in the court’s view, that sub-class of activity did not

have a sufficient impact on interstate commerce. 352 F.3d at

1228, 1231.

The Ninth Circuit’s decision in this case is equally dismis-

sive of the comprehensive federal regulatory scheme. It

makes that scheme for controlling substances depend not on

a uniform national standard, but on the vagaries of each

State’s notions of what constitutes a “legit‘mate medical

27

purpose” or “treatment,” no matter how far outside the

mainstream of accepted medical practice a particular State’s

views may be.

Moreover, the reasoning by which the court of appeals

reached that conclusion is dramatic in its potential seope—as

evidenced by its reliance on a Lochner-era case as defining

the limits on Congress’s authority to regulate matters that

may indirectly affect the practice of medicine. The court of

appeals’ failure to apply this Court’s presumption of national

uniformity established in Mississippi Band and its

invocation, instead, of the Gregory v. Ashcroft clear state-

ment rule based on the mere fact that the practice of

medicine is implicated could have far-reaching consequences

if applied to other federal statutory schemes. E.g., 21 U.S.C.

355(d) (requiring FDA to deny application for new drug if

not safe and effective for its intended purpose); 21 U.S.C.

352(j) (drug is “misbranded” if “it is dangerous to health

when used in the dosage or manner, or with the frequency or

duration prescribed, recommended, or suggested in the la-

beling thereof”); 42 U.S.C. 1320a-7(a) and (b)(6)(B) (author-

izing Secretary to exclude from participation in “any Federal

health care program” a doctor (or anyone else) who furnishes

services “substantially in excess of the needs of * * * pa-

tients,” regardless of whether those patients were eligible

for or participated in any federal programs); 42 U.S.C. 1320c-

5(a)(1) and (b) (requiring any “health care practitioner” par-

ticipating in Medicare to provide only “medically necessary”

services to Medicare beneficiaries, and allowing the Secre-

tary to bar violators from participating in the Medicare pro-

gram); 42 U.S.C. 1395y(a)(1)(A) (2000 & Supp. I 2001)

(authorizing Medicare to reimburse only “reasonable and

necessary” medical services).

In short, Congress often attaches consequences under

federal statutes to a determination by a federal official re-

garding what constitutes proper, necessary, safe, or effective

28

medical care. The uniform application of such statutory

schemes is cast into doubt by the court of appeals’ decision in

this case.

CONCLUSION

The petition for a writ of certiorari should be granted.

Respectfully submitted.

PAUL D. CLEMENT

Acting Solicitor General

PETER D. KEISLER

Assistant Attorney General

EDWIN S. KNEEDLER

Deputy Solicitor General

GREGORY G. KATSAS

Deputy Assistant Attorney

General

DOUGLAS HALLWARD-DRIEMEIER

Assistant to the Solicitor

General

MARK B. STERN

JONATHAN H. LEVY

Attorneys

NOVEMBER 2004