Appendix — Gonzales v. Oregon

| ome “Wy Cou, U.S.

04-623 NOV 9 - 2004

No. OFFICE OF THE C

In the Supreme Court of the Gnited States

JOHN ASHCROFT, ATTORNEY GENERAL, ET AL.,

PETITIONERS

Vv.

OREGON, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIL

APPENDIX TO THE

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 KATSAS

eo gaa Attorney

DOUGLAS HALLWARD-DRIEMEIER

Assistant to the Solicitor

General

MARK B. STERN

JONATHAN H. LEVY

Attorneys

of Justice

Washington, D.C. 20530-0001

(202) 514-2217

TABLE OF CONTENTS

Appendix A (court of appeals opinion, filed May 26,

2004)

Appendix B (district court opinion & order, filed Apr. 17,

2002)

Appendix C (court of appeals rehearing, filed Aug. 11,

2004)

Appendix D (Attorney General’s interpretive ruling dated

Nov. 9, 2001)

Appendix E (Office of Legal Counsel memorandum,

dated June 27, 2001)

Appendix F (federal statutory provisions) ..

Appendix G (federal regulatory provision)

Appendix H (Oregon statutory provisions) .

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Page

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149a

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APPENDIX A

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

No. 02-35587

STATE OF OREGON, PLAINTIFF-APPELLEE

Vv.

JOHN ASHCROFT, ATTORNEY GENERAL, IN HIS

OFFICIAL CAPACITY AS UNITED STATES

ATTORNEY GENERAL; ASA HUTCHINSON, IN HIS

OFFICIAL CAPACITY AS ADMINISTRATOR OF

THE DRUG ENFORCEMENT ADMINISTRATION; KENNETH

W. MAGEE, IN HIS OFFICIAL

CAPACITY AS DIRECTOR OF THE DRUG ENFORCEMENT

ADMINISTRATION, PORTLAND OFFICE; UNITED STATES

OF AMERICA; UNITED STATES DEPARTMENT OF

JUSTICE; UNITED STATES DRUG ENFORCEMENT

ADMINISTRATION, DEFENDANTS-APPELLANTS

V.

PETER A. RASMUSSEN; DAVID MALCOLM

HOCHHALTER; RICHARD HOLMES;

JAMES ROMNEY; MELISSA BUSH; JOHN DOE # 1,

PLAINTIFFS-INTERVENORS-APPELLEES

Argued and Submitted May 7, 2003

Filed May 26, 2004

OPINION

Before: LAY,* WALLACE, and TALLMAN,

Circuit Judges.

* Senior United States Circuit Judge for the Eighth Circuit,

sitting by designation.

(la)

TALLMAN, Circuit Judge.

A doctor, a pharmacist, several terminally ill pa-

tients, and the State of Oregon challenge an interpre-

tive rule issued by Attorney General John Ashcroft

which declares that physician assisted suicide violates

the Controlled Substances Act of 1970 (“CSA”), 21

U.S.C. §§ 801-904. This so-called “Ashcroft Directive,”

published at 66 Fed. Reg. 56,607, criminalizes conduct

specifically authorized by Oregon’s Death With Dignity

Act, Or. Rev. Stat. § 127.800-127.897. We hold that the

Ashcroft Directive is unlawful and unenforceable be-

cause it violates the plain language of the CSA, contra-

venes Congress’ express legislative intent, and over-

steps the bounds of the Attorney General’s statutory

authority. See 5 U.S.C. § 706(2)(C), (D). The petitions

for review are granted.

We have original jurisdiction over “final deter-

minations, findings, and conclusions of the Attorney

General” made under the CSA. 21 U.S.C. § 877.

Because the Attorney General maintains that his

interpretive rule is a “final determination” and because

the Directive orders sanctions for violations of its

provisions, we have original jurisdiction pursuant to

§ 877. See Hemp Indus. Ass’n v. DEA, 333 F.3d 1082,

1085 (9th Cir. 2003) (holding that an interpretive rule

issued by the Attorney General pursuant to the CSA is

a “final determination” for jurisdictional purposes

because the rule “impos[es] obligations and sanctions in

the event of violation [of its provisions]”); see also City

of Auburn v. Qwest, 260 F.3d 1160, 1171-73 (9th Cir.

3a

2001). We consider the matter transferred to us from

the district court pursuant to 28 U.S.C. § 1631.'

This case is ripe for review because, under the

Directive, health care practitioners risk criminal prose-

cution and loss of the privilege to prescribe medication

if they choose to assist in the suicide of terminally ill

patients pursuant to Oregon’s Death With Dignity Act.

See Hemp Indus., 333 F.3d at 1086 (“[I)f . . . the

challenged regulations present[ ] plaintiffs with the

immediate dilemma to choose between complying with

newly imposed, disadvantageous restrictions and risk-

ing serious penalties for violation, the controversy is

ripe.”) (citation omitted). “Because standing overlaps

substantially with ripeness” in these circumstances, the

petitioner health care practitioners have standing to

challenge the Ashcroft Directive. See id. *

' On April 17, 2002, United States District Judge Robert E.

Jones entered a permanent injunction against enforcement of the

Ashcroft Directive. 192 F. Supp. 2d 1077 (D. Or. 2002). Recogniz-

ing that he might lack jurisdiction over the matter, Judge Jones

alternatively ordered the petitions for review transferred to us

under 28 U.S.C. § 1631 (“Whenever a civil action is filed in a court

. . « including a petition for review of administrative action .. .

and that court finds that there is a want of jurisdiction, the court

shall, if it is in the interest of justice, transfer such action or appeal

to any other such court in which the action or appeal could have

been brought at the time it was filed or noticed [.}”). 192 F. Supp.

2d at 1086-87. Although we conclude that the district court did not

have jurisdiction, Judge Jones’ opinion on the merits is well

reasoned, and we ultimately adopt many of his conclusions.

2 We need not decide whether the other plaintiffs also have

standing. See Leonard v. Clark, 12 F.3d 885, 888 (9th Cir. 1993).

However, we do note the argument by the plaintiff patients that

the Ashcroft Directive, if followed, will achieve the in terrorem

effect intended. Doctors will be afraid to write prescriptions

sufficient to painlessly hasten death. Pharmacists will fear filling

4a

The Ashcroft Directive purports to interpret and

implement the CSA, which Congress enacted as Title II

of the Comprehensive Drug Abuse Prevention and

Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236

(1970) (codified at 21 U.S.C. §§ 801-904). The stated

purpose of the CSA is “to provide increased research

into, and prevention of, drug abuse and drug depend-

ence . . . and to strengthen existing law enforcement

authority in the field of drug abuse.” Jd. at 1236

(preamble); see also H.R. Rep. No. 91-1444, reprinted in

1970 U.S.C.C.A.N. 4566, 4567 (“This legislation is de-

signed to deal in comprehensive fashion with the

growing menace of drug abuse in the United States|.]”);

United States v. Moore, 423 U.S. 122, 141, 96 S. Ct. 335,

46 L. Ed. 2d 333 (1975); Raich v. Ashcroft, 352

F.3d 1222, 1228-29 (9th Cir. 2003); United States v.

Rosenberg, 515 F.2d 190, 194 (9th Cir. 1975) (noting that

the purpose of the CSA is to “counter drug abuse”).

Under the CSA, it is unlawful to prescribe or dis-

pense controlled substances without a federal registra-

tion. 21 U.S.C. § 841(a)(1); see also id. §§ 823(f),

822(a)(2). The CSA originally provided automatic

federal registration for state-licensed health-care prac-

titioners. § 303(f), 84 Stat. at 1255. The Attorney

General could revoke a practitioner’s federal registra-

tion only if the practitioner falsified his or her regis-

tration application, was convicted of a felony related to

the prescriptions. Patients will be consigned to continued suf-

fering and, according to the declarations of record, may die slow

and agonizing deaths. Should patients attempt suicide without the

assistance of their doctors and pharmacists, they may fail or leave

loved ones with the trauma of dealing with the aftermath of certain

forms of suicide too unpleasant to describe in this opinion.

5a

a controlled substance, or had his or her state license

suspended or revoked. Jd. § 304(a), 84 Stat. at 1255.

In 1971, pursuant to his authority to issue rules

regulating controlled substances under the CSA, see 21

U.S.C. § 871(b), then Attorney General John Mitchell

promulgated the following regulation:

A prescription for a controlled substance to be effec-

tive must be issued for a legitimate medical purpose

by an individual practitioner acting in the usual

course of his professional practice. . . . An order

purporting to be a prescription issued not in the

usual course of professional treatment . . . is nota

prescription within the meaning and intent of .. .

the Act and the person knowingly filling such a

purported prescription, as well as the person issuing

it, shall be subject to the penalties provided for

violations of the provisions of law relating to con-

trolled substances.

21 C.F.R. § 1306.04 (originally designated as 21 C.F.R.

§ 306.04). This regulation exposec properly licensed

and registered physicians to federal prosecution for

distributing prescription drugs outside “the usual

course of professional practice.” See, e.g., Moore, 423

U.S. at 143, 96 S. Ct. 335 (“In practical effect, [Dr.

Moore] acted as a large-scale ‘pusher’ not as a physi-

cian.”); Rosenberg, 515 F.2d at 193 (“[A] doctor who

acts other than in the course of professional practice

is not a practitioner under the [CSA] and is therefore .

. . . Subject to the criminal provisions of the Act [.]”)

(citations omitted).

In 1984, Congress amended the CSA to give broader

authority to the Attorney General. The Attorney

General is now authorized to revoke a physician’s pre-

6a

scription privileges upon his determination that the

physician has “committed such acts as would render his

registration . . . inconsistent with the public

interest[.]” 21 U.S.C. § 824(a)(4). When determining

which acts are inconsistent with the public interest, the

Attorney General must consider the following factors:

(1) The recommendation of the appropriate State

licensing board or professional disciplinary author-

ity;

(2) The applicant’s expertise in dispensing . . .

controlled substances;

(3) The applicant’s conviction record under Fed-

eral or State laws relating to the manufacture,

distribution, or dispensing of controlled substances;

(4) Compliance with applicable State, Federal, or

local laws relating to controlled substances;

(5) Such other conduct which may threaten the

public health and safety.

21 U.S.C. § 823(f). Although this provision gives the

Attorney General new discretion over the registration

of health care practitioners, Congress explained that

“the amendment would continue to give deference to

the opinions of State licencing authorities, since their

recommendations are the first of the factors to be con-

sidered[.]” S. Rep. No. 98-225, at 267 (1984), reprinted

in 1984 U.S.C.C.A.N. 3182, 3449.

Against this backdrop of federal regulation, in 1994,

the State of Oregon enacted by ballot measure the

country’s first law authorizing physician assisted

suicide. See Or. Rev. Stat. § 127.800-897. Oregon’s

Death With Dignity Act authorizes physicians to pre-

scribe lethal doses of controlled substances to termi-

7a

nally ill Oregon residents according to procedures de-

signed to protect vulnerable patients and ensure that

their decisions are reasoned and voluntary. See id.’

Oregon voters reaffirmed their support for the Death

With Dignity Act on November 4, 1997, by defeating a

ballot measure that sought to repeal the law.

Soon thereafter, several members of Congress, in-

cluding then Senator John Ashcroft, urged then-

Attorney General Janet Reno to declare that physician

assisted suicide violated the CSA. She declined to do

so. Ina letter dated January 5, 1998, Attorney General

Reno explained that the CSA was not “intended to

displace the states as the primary regulators of the

medical profession, or to override a state’s determina-

tion as to what constitutes legitimate medical practice.”

She concluded that “the CSA does not authorize [the

Drug Enforcement Administration (“DEA”)' to prose-

cute, or to revoke DEA registration of, a physician who

has assisted in a suicide in compliance with Oregon

law.’

% Under Oregon’s Death With Dignity Act, only adult Oregon

residents suffering from an incurable disease likely to result in

death within six months are eligible for a lethal prescription. Or.

Rev. Stat. 127.800 § 1.01(12); id. 127.805 § 2.01(1). A >atient’s dia-

gnosis must be confirmed by two independent physicians. /d.

127.815 § 3.01; 127.820 § 3.02. Patients must sign a written request

for the prescription in the presence of two witnesses attesting that

the patient is competent and acting voluntarily. Jd. 127.810 § 2.02.

* In response to Attorney General Reno’s letter, members of

Congress introduced bills to amend the CSA to explicitly authorize

the Attorney General to revoke the registration of any practitioner

who “intentionally dispensed or distributed a controlled substance

with a purpose of causing, or assisting in causing, the suicide

or euthanasia of any individual.” H.R. 4006, 105th Cong. (1998)

(“Lethal Drug Abuse Prevention Act of 1998”). The amendments

8a

With a change of administrations came a change of

perspectives. On November 9, 2001, newly appointed

Attorney General John Ashcroft reversed the position

of his predecessor and issued the Directive at issue

here. The Ashcroft Directive proclaims that physician

assisted suicide serves no “legitimate medical purpose”

under 21 C.F.R. § 1306.04 and that specific conduct

authorized by Oregon’s Death With Dignity Act “may

‘render [a practitioner’s] registration . . . inconsistent

with the public interest’ and therefore subject to

possible suspension or revocation.” 66 Fed. Reg. at

56,608 (quoting 21 U.S.C. § 824(a)(4)). The Directive

specifically targets health care practitioners in Oregon

and instructs the DEA to enforce this determination

“regardless of whether state law authorizes or permits

such conduct by practitioners.” Jd.’

failed. In 1999, Congress again declined to enact a similar pro-

posed amendment. See H.R. 2260, 106th Cong. (1999) (“Pain Relief

Promotion Act of 1999”).

5 The dissent argues that the Ashcroft Directive does not ban

physician assisted suicide outright, but only bars the use of con-

trolled substances for assisting suicide. This argument is wrong

for two reasons. First, the Attorney General may revoke physi-

cian prescription privileges for any conduct appropriately deemed

inconsistent with the public interest; such conduct need not involve

controlled substances. See 21 U.S.C. § 824(a)(4). Second, it is clear

to us that controlled substances provide the best and most reliable

means for terminally ill patients to painlessly take their own lives.

See Gerrit K. Kimsma, Euthanasia and Euthanizing Drugs in The

Netherlands, in DRUG USE IN ASSISTED SUICIDE AND

EUTHANASIA 193, 198-204 (Margaret P. Battin and Arthur G.

Lipman eds., 1996); Kathy Farber-Langendoen and Jason H.T.

Karlawish, Should Assisted Suicide Be Only Physician Assisted?,

ANNALS INTERNAL MED., Mar. 21, 2000, at 482-87.

9a

Ill

To be perfectly clear, we take no position on the

merits or morality of physician assisted suicide. We ex-

press no opinion on whether the practice is inconsistent

with the public interest or constitutes illegitimate

medical care. This case is simply about who gets to

decide. All parties agree that the question before us is

whether Congress authorized the Attorney General to

determine that physician assisted suicide violates the

CSA. We hold that the Attorney General lacked Con-

gress’ requisite authorization. The Ashcroft Directive

violates the “clear statement” rule, contradicts the plain

language of the CSA, and contravenes the express

intent of Congress.

A

We begin with instructions from the Supreme Court

that the “earnest and profound debate about the

morality, legality, and practicality of physician-assisted

suicide” belongs among state lawmakers. Washington

v. Glucksberg, 521 U.S. 702, 735, 117 S. Ct. 2258 (1997).

In Glucksberg, Justice O’Connor emphasized that

“[s]tates are presently undertaking extensive and seri-

ous evaluation of physician-assisted suicide. . . . In

such circumstances, the . . . challenging task of

crafting appropriate procedures for safeguarding . . .

liberty interests is entrusted to the ‘laboratory’ of the

States . . . in the first instance.” Jd. at 737, 1175S. Ct.

2258 (O’Connor, J., concurring) (citations and quotation

marks omitted); cf. Cruzan v. Director, 497 U.S. 261,

293, 110 S. Ct. 2841, 111 L. Ed. 2d 224 (Scalia, J., con-

curring) (“[W]hen it is demonstrated . . . thata

patient no longer wishes certain measures to be taken

to preserve his or her life, it is up to the citizens[of the

10a

States] to decide, through their elected representatives,

whether that wish will be honored.”). Here, Oregon

voters have twice declared their support for the

legalization of physician assisted suicide in their state.

We disagree with the dissent’s suggestion that this

court, rather than the Attorney General, is interfering

with the democratic process. See Glucksberg, 521 U.S.

at 735, 117 S. Ct. 2258 (“Our holding permits this debate

[about physician assisted suicide] to continue, as it

should in a democratic society.”).

The principle that state governments bear the pri-

mary responsibility for evaluating physician assisted

suicide follows from our concept of federalism, which

requires that state lawmakers, not the federal govern-

ment, are “the primary regulators of professional

[medical] conduct.” Conant v. Walters, 309 F.3d 629,

639 (9th Cir. 2002); see also Glucksberg, 521 U.S. at

737, 117 S. Ct. 2258 (O’Connor, J., concurring). The

Supreme Court has made the constitutional principle

clear: “Obviously, direct control of medical practice

in the states is beyond the power of the federal govern-

ment.” Linder v. United States, 268 U.S. 5, 18, 45 S. Ct.

446, 69 L. Ed. 819 (1925); see also Barsky v. Bd. of

Regents, 347 U.S. 442, 449, 74 S. Ct. 650, 98 L. Ed. 829

(1954) (“It is elemental that a state has broad power to

establish and enforce standards of conduct within its

borders relative to the health of everyone there. It is a

vital part of a state’s police power.”). The Attorney

General “may not . . . regulate [the doctor-patient]

relationship to advance federal policy.” Conant, 309

F.3d at 647 (Kozinski, J., concurring).”

6 As noted in Younger v. Harris, 401 U.S. 37, 44-45, 91 S. Ct.

746, 27 L. Ed. 2d 669 (1971):

lla

By criminalizing medical practices specifically

authorized under Oregon law, the Ashcroft Directive

interferes with Oregon’s authority to regulate medical

care within its borders and therefore “alter[s] the ‘usual

constitutional balance between the States and the

Federal Government.’” Gregory v. Ashcroft, 501 U.S.

452, 461, 111 S. Ct. 2395, 115 L. Ed. 2d 410 (1991) (quot-

ing Atascadero State Hosp. v. Scanlon, 473 U.S. 234,

242, 105 S. Ct. 3142, 87 L. Ed. 2d 171 (1985)). Under

these circumstances, “[i]t is incumbent on the federal

courts to be certain of Congress’ intent” before finding

that federal authority supercedes state law. Gregory,

501 U.S. at 460, 111 S. Ct. 2395 (quotation marks and

citation omitted).

Unless Congress’ authorization is “unmistakably

clear,” the Attorney General may not exercise control

over an area of law traditionally reserved for state

authority, such as regulation of medical care. Id. at 460-

61, 111 S. Ct. 2395 (quoting Atascadero State Hosp., 473

U.S. at 242, 105 S. Ct. 3142); see also Solid Waste

Agency of N. Cook County v. U.S. Army Corps of

Eng’rs, 531 U.S. 159, 173, 121 S. Ct. 675, 148 L. Ed. 2d

576 (2001) ( “This concern is heightened where an ad-

ministrative interpretation alters the federal-state

The concept [of federalism] does not mean blind deference to

“States’ Rights” any more than it means centralization of

control over every important issue in our National Govern-

ment and its courts. The Framers rejected both these courses.

What the concept does represent is a system in which there

is sensitivity to the legitimate interests of both State and

National Governments, and in which the National Govern-

ment, anxious though it may be to vindicate and protect

federal rights and federal interests, always endeavors to do so

in ways that will not unduly interfere with the legitimate

activities of the States.

12a

framework by permitting federal encroachment upon a

traditional state power.”); United States v. Bass, 404

U.S. 336, 349, 92 S. Ct. 515, 30 L. Ed. 2d 488 (1971)

(“(U]nless Congress conveys its purpose clearly, it

will not be deemed to have significantly changed the

federal-state balance.”). In divining congressional

intent, it is a “cardinal principle” of statutory inter-

pretation that “where an otherwise acceptable con-

struction of a statute would raise serious constitutional

problems, [federal courts shall] construe the statute to

avoid such problems unless such construction is plainly

contrary to the intent of Congress.” Edward J. De-

Bartolo Corp. v. Fla. Gulf Coast Bldg. & Constr.

Trades Council, 485 U.S. 568, 575, 108 S. Ct. 1392, 99 L.

Ed. 2d 645 (1988).

The Ashcroft Directive is invalid because Congress

has provided no indication—much less an “unmistak-

ably clear” indication—that it intended to authorize the

Attorney General to regulate the practice of physician

assisted suicide. By attempting to regulate physician

assisted suicide, the Ashcroft Directive invokes the

outer limits of Congress’ power by encroaching on state

authority to regulate medical practice. See Linder, 268

U.S. at 18, 45 S. Ct. 446; Conant, 309 F.3d at 639.

Because Congress has not clearly authorized such an

intrusion, the Ashcroft Directive violates the clear

statement rule. See Solid Waste Agency, 531 U.S. at

172-73, 121 S. Ct. 675; Yeskey, 524 U.S. at 208-09, 118

S. Ct. 1952. We need not, and therefore do not, decide

whether the Ashcroft Directive actually exceeds Com-

merce Clause boundaries, but only that it “invokes the

outer limits of Congress’ power” without explicit

authority from Congress. Solid Waste Agency, 531 US.

at 172, 121 S. Ct. 675 (citing Edward J. DeBartolo

13a

Corp., 485 U.S. at 575, 108 S. Ct. 1392); see also Pa.

Dep't of Corr. v. Yeskey, 524 U.S. 206, 208-09, 118 S. Ct.

1952, 141 L. Ed. 2d 215 (1998) (“[A]bsent an unmistaka-

bly clear expression of intent to alter the usual constitu-

tional balance between the States and the Federal

Government, we will interpret a statute to preserve

rather than destroy the States’ substantial sovereign

powers.”) (quotation marks and citations omitted).

The Ashcroft Directive not only lacks clear con-

gressional authority, it also violates the plain language

of the CSA. We hold that the Directive exceeds the

scope of federal authority under the CSA, misconstrues

the Attorney General’s role under the statute, and fails

to follow explicit instructions for revoking physician

prescription privileges.

The CSA expressly limits federal authority under the

Act to the “field of drug abuse.” Pub. L. No. 91-513, 84

Stat. 1236; 21 U.S.C. § 801(2)-(6). Contrary to the

Attorney General’s characterization, physician assisted

suicide is not a form of drug “abuse” that Congress

intended the CSA to cover.’

7 The dissent argues that when Congress enacted the CSA it

was not solely concerned with “drug abuse,’ as that term is com-

monly understood. The dissent suggests that a reference in the

legislative record to “suicides and attempted suicides” and “drug-

related deaths” indicates that Congress understood “drug abuse”

to encompass physician assisted suicide. These excerpts are taken

entirely out of context. In the record cited by the dissent, suicide is

distinguished from “abuse,” see H.R. Rep. No. 91-1444 (1970), 1970

U.S.C.C.A.N. at 4602, and statements concerning “drug-related

deaths” clearly refer to overdoses from abuse of pharmaceutical

drugs “diverted from the sick and injured to the black market.”

130 Cong. Rec. 25,851 (1984) (statement of Rep. Rodino); 98 Cong.

l4a

Physician assisted suicide is an unrelated, general

medical practice to be regulated by state lawmakers in

the first instance. Glucksberg, 521 U.S. at 735, 737, 117

S. Ct. 2258 (O’Connor, J., concurring).

We know that Congress intended to limit federal

authority under the CSA to the field of drug abuse

because the statute’s non-preemption clause provides

that the CSA shall be not be construed to preempt state

law unless there is a “positive conflict” between the

text of the statute and state law. 21 U.S.C. § 903;

see also United States v. Oakland Cannabis Buyers’

Coop., 582 U.S. 483, 502, 121 S. Ct. 1711, 149 L. Ed. 2d

722 (2001) (Stevens, J. concurring) (“[{FJederal courts

[must], whenever possible, . . . avoid or minimize

conflict between federal and state law, particularly in

situations in which the citizens of a state have chosen to

serve as a laboratory in the trial of novel social and

economic experiments without risk to the rest of the

country.”) (citations and quotation marks omitted). No

provision of the CSA directly conflicts with Oregon’s

Death with Dignity Act. However, the Attorney

General’s expansive interpretation of the CSA clearly

conflicts with the Oregon law and therefore cannot be

squared with the CSA’s non-preemption clause. See 21

U.S.C. § 903; see also Cal. Div. of Labor Standards En-

forcement v. Dillingham Constr., N.A., Inc., 519 U.S.

316, 325, 117 S. Ct. 832, 186 L. Ed. 2d 791 (1997) ( “As is

Rec. 365 (1984) (statement of Rep. Waxman). The record is volu-

minous and replete with statements of congressional intent to

combat drug abuse and addiction, and particularly the problem of

doctors who illicitly funnel prescription drugs into the hands of

dealers and addicts. Both the Attorney General and the dissent

expand the scope of the CSA in a manner that contravenes and

distorts Congress’ will.

lda

always the case in our pre-emption jurisprudence,

where federal law is said to bar state action in fields of

traditional state regulation, . . . we have worked on

the assumption that the historic police powers of the

States were not to be superseded by the Federal Act

unless that was the clear and manifest purpose of

Congress.”) (citation and quotation marks omitted).

To the limited extent that the CSA does authorize

federal regulation of medical practice, Congress care-

fully circumscribed the Attorney General’s role. The

Attorney General may not define the scope of legiti-

mate medical practice. See Pub. Law No. 91-513, 84

Stat. at 1241 (now codified at 42 U.S.C. § 290bb-2a).* In

Moore, the Supreme Court held that the CSA “re-

quires” the Secretary of Health and Human Services

“to determine the appropriate methods of professional

practice” under the statute. 423 U.S. at 144, 96 S. Ct.

335 (quoting 42 U.S.C. § 290bb-2a); see also Rosenberg,

515 F.2d at 194-95.

The Attorney General, o. the other hand, is author-

ized to revoke prescription privileges from physicians

for conduct deemed “inconsistent with the public

interest[.]” 21 U.S.C. § 824(a)(4). However, in this case,

the Attorney General improperly invokes this author-

® See also 21 U.S.C. § 811(b) (“The recommendations of the

Secretary to the Attorney General [concerning which substances

shall be covered by the CSA) shall be binding on the Attorney

General as to such scientific and medical matters, and if the Secre-

tary recommends that a drug or other substance not be controlled,

the Attorney General shall not control the drug[.]”); 21 U.S.C.

§ 823(g)2 Hi) (“Nothing in . . . regulations or practice guide-

lines [concerning the treatment of narcotic addicts] may authorize

any Federal official or employee to exercise supervision or control

over the practice of medicine or the manner in which medical

services are provided.”).

l6a

ity. When determining what conduct is inconsistent

with the public interest under the CSA, the Attorney

General is required to consider five factors. See 21

U.S.C. § 823(f). The Attorney General reasons that

physician assisted suicide is inconsistent with the public

interest because the practice threatens public health.

See Memorandum for the Attorney General from the

Office of Legal Counsel, June 27, 2001 (““OLC Memo”),

at 3-18. Although threat to public health is one factor

the Attorney General is to consider when determining

the public interest, in this case he does not consider the

other factors required by the statute. See 21 U.S.C.

§ 823(f).

The Attorney General misreads the CSA when he

concludes that he may evaluate the public interest

“based on any of the five factors identified in the

statute.” OLC Memo at 3 (emphasis added). The CSA

clearly provides that all five public interest factors

“shall be considered.” 21 U.S.C. § 823(f) (emphasis

added). When the Attorney General declares that his

Directive shall apply “regardless of whether state law

authorizes or permits such conduct,” he ignores the

very first factor he is required to consider under

the Act—i.e. “[t]he recommendation of the approp-

riate State licensing board or professional discipli-

nary authority.” 21 U.S.C. § 823(f)(1). The Attorney

General’s categorical prohibition of physician assisted

suicide also fails to consider the second and third public

interest factors required under the CSA. See 21 U.S.C.

§ 823(f)(2), (3) (listing individual practitioner experience

® This memo is attached to the Ashcroft Directive and, accord-

ing to the Attorney General, “sets forth the legal basis for my

decision.” 66 Fed. Reg. at 56,608.

17a

and criminal history as the second and third public

interest factors).

Thus, we see at least three conflicts between the

Ashcroft Directive and the text of the CSA. First, the

Directive purports to regulate medical practices outside

the field of drug abuse and prevention, despite the

statute’s limited scope and Congress’ stated intent.

Second, the Directive makes a unilateral medical deter-

mination that may not be made by the Attorney

General.” Finally, the Directive evaluates public

interest under 21 U.S.C. § 823 without considering all

five factors required by that subsection. See 5 U.S.C.

§ 706(2)(C), (D) (“The reviewing court shall . . . hold

unlawful and set aside agency action, findings, and

conclusions found to be . . . in excess of statutory

jurisdiction, authority, or limitations, or short of

statutory right; [or] without observance of procedure

required by law[.]”).

Cc

The CSA’s legislative record confirms that the

Attorney General has exceeded the scope of his author-

ity. See SEC v. McCarthy, 322 F.3d 650, 655 (9th Cir.

2003) (“When the statute is ambiguous or the statutory

language does not resolve an interpretive issue, our

approach to statutory interpretation is to look to legis-

lative history.”) (citation and quotation marks omitted).

" We do not intend to imply that the Secretary of Health and

Human Services may determine that physician assisted suicide

constitutes an illegitimate medical practice. As noted, by its terms

the CSA is limited to “the field of drug abuse,” which is not so

broad as to include conduct authorized by Oregon’s Death With

a Act. See Pub. L. No. 91-513, 84 Stat. 1236 (preamble)

(1970).

18a

Congress clearly intended to limit the CSA to

problems associated with drug abuse and addiction. See,

e.g., H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N. at 4566;

116 Cong. Rec. 977-78 (Comments of Sen. Dodd, Jan. 23,

1970) (“{I]t cannot be overemphasized that the

[CSA] is designed to crackdown hard on the

narcotics pusher and the illegal diverters of pep pills

and goof balls.”). As we held in Rosenberg, “Congress

was concerned with the diversion of drugs out of

legitimate channels of distribution” when it enacted the

CSA. 515 F.2d at 193. Congress acted to halt “‘the

widespread diversion of [controlled substances] out of

legitimate channels into the illegal market’[.]” /d. at

194 (quoting H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N.

at 4572).

Furthermore, recognizing that this mandate may at

times encroach on a state’s traditional authority to

regulate medical practices, Congress empowered “the

principal health agency of the federal government,” not

the Attorney General, to make medieal decisions under

the Act. See H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N.

at 4581 (“[T]he committee is concerned about the

appropriateness of having federal officials deter-

mine the appropriate method of the practice of

medicine. . . . In view of this situation, this section

will provide guidelines, determined by the principal

health agency of the federal government{[.]”). In Moore,

the Court observed that “Congress pointed out that

criminal prosecutions in the past had turned on the

opinions of federal prosecutors. Under the[CSA], those

physicians who comply with the recommendations

made by the Secretary {of Health and Human Services]

will no longer jeopardize their professional careers|.”

19a

423 U.S. at 144, 96 S. Ct. 335. (emphasis added) (quo-

tation marks and citation omitted).

In 1974, Congress amended the CSA to “cure the

present difficulty in [resolving] . . . the intricate and

nearly impossible burden of establishing what is beyond

the ‘course of professional practice’ for criminal law

purposes.” Moore, 423 U.S. at 140, n. 16, 96 S. Ct. 335

(citation omitted). Although only tangentially related to

this case, the 1974 amendment is noteworthy because it

evinces Congress’s intent to “preserve[ ] the distinc-

tions found in the Controlled Substances Act between

the functions of the Attorney General and the Secre-

tary |of Health and Human Services]. . . . All de-

cisions of a medical nature are to be made by the

Secretary [of Health and Human Services]. Law

enforcement decisions respecting the security of stocks

of narcotic drugs and the maintenance of records on

such drugs are to be made by the Attorney General.”

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

U.S.C.C.A.N. 3029, 3034 (emphasis added).

Congress did not intend to expand the scope or

general purpose of the CSA when it amended the

statute in 1984 to give the Attorney General authority

to revoke the federal registrations of physicians and

pharmacists. See S. Rep. No. 98- 225 at 260, 261-62,

1984 U.S.C.C.A.N. at 3443-44 (“In particular, the

amendments . . . are intended to address the severe

problem of diversion of drugs of legitimate origin into

the illicit market.”). Nor did Congress intend to grant

the Attorney General any broader authority than he

already exercised over the registration of manu-

facturers and distributers of controlled substances. See

id. at 3449 (“The broader considerations for registration

of practitioners set out in{the amendments] . . . are

20a

similar to those applicable under current law to regis-

tration applications on the part of manufacturers and

distributors of controlled substances.”). By enacting

the 1984 amendments, Congress merely intended to

close “loop-holes” in the original legislation by authoriz-

ing the Attorney General to revoke physician registra-

tions without depending on state licencing boards,

which had proven ineffective regulators of physicians

who were diverting drugs into the illicit market. See id.

at 3442- 44.

Finally, the legislative record demonstrates Con-

gress’ clear intent to prevent the Attorney General

from revoking health care practitioners’ DEA registra-

tions on the sole basis of his decision that certain

conduct “may threaten the public health and safety.”

See 21 U.S.C. § 823(f)(5). Congress unmistakably in-

tended the Attorney General to consider all five factors

under § 823(f) before determining whether physician

conduct contravenes public interest. Congress speci-

fically intended that the Attorney General must “con-

tinue to give deference to the opinions of the State

licencing authorities,” as their recommendations “are

the first of the factors to be considered.” S. Rep. No.

98-225 at 267, 1984 U.S.C.C.A.N. at 3449. It is undis-

puted that the Attorney General made no effort to

solicit input from the State of Oregon before issuing his

Directive, notwithstanding an express promise to do so

by his subordinates within the United States Depart-

ment of Justice.

D

The Ashcroft Directive proclaims that physician

assisted suicide constitutes an illegitimate medical prac-

tice under 21 C.F.R. § 1306.04. Just as the Attorney

2la

General's interpretation of the text of the CSA conflicts

with the statute’s plain language and the clear intent of

Congress, so too does his interpretation of this regu-

lation.

The Attorney General’s interpretation of § 1306.04

exceeds the CSA’s limited mandate to combat pre-

scription drug abuse and addiction. See 21 U.S.C.

§ 801(2)-(6); Pub. L. No. 91-513, 84 Stat. 1236 (pre-

amble); S. Rep. No. 98-225 at 260-62, 1984 U.S.C.C.A.N.

at 3442-44; H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N. at

4566; Rosenberg, 515 F.2d at 193-95. To the extent that

the federal regulation of controlled substances impacts

medical care, the Supreme Court in Moore articulated

no role for the Attorney General in determining the

appropriate methods of medical practice under

§ 1306.04. See 423 U.S. at 144, 96 S. Ct. 335. While the

1984 amendments to the CSA do extend the Attorney

General’s authority over federal registration of prac-

ticing physicians, these changes neither impact

§ 1306.04 nor provide the Attorney General the author-

ity to determine the scope of legitimate medical prac-

tice in the manner attempted here.

IV

Given the plain language of the CSA and its legis-

lative record, we are under no obligation to defer to the

Attorney General’s interpretation of his role under the

statute and its implementing regulations. See Chevron

U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837,

842-43, 104 S. Ct. 2778, 81 L. Ed. 2d 694 (1984); see also

Solid Waste Agency, 531 U.S. at 172- 74, 121 S. Ct. 675.

Agency determinations that squarely conflict with gov-

erning statutes are not entitled to deference. Chevron,

467 U.S. at 842-43, 104 S. Ct. 2778. We “must, of course,

22a

set aside [agency] decisions which rest on an erroneous

legal foundation.” NLRB v. Brown, 380 U.S. 278, 291-

92, 85 S. Ct. 980, 13 L. Ed. 2d 839 (1965) (citation and

quotation marks omitted); cf. FDA v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 133, 120

S. Ct. 1291, 146 L. Ed. 2d 121 (2000).

As already explained, the Ashcroft Directive exceeds

the scope of the CSA and ignores the Attorney

General’s limited role. See Pub. L. No. 91-513, 84 Stat.

1236 (preamble); see also S. Rep. No. 98-225 at 260-62,

1984 U.S.C.C.A.N. at 3442-44. The Attorney General

fails to follow the CSA’s clear instructions when he

declares that his assessment of the public interest may

be based on “any” of the five factors required under

§ 823(f) and that his determination shall apply “regard-

less of whether state law authorizes or permits such

conduct.” See 21 U.S.C. § 823(f); see also S. Rep. No.

98-225 at 267, 1984 U.S.C.C.A.N. at 3449.

We also note that the Attorney General has no

specialized expertise in the field of medicine and that he

imposes a sweeping and unpersuasive interpretation of

the CSA—which directly conflicts with that of his

predecessor—without notice or comment. There is no

reason to defer to his interpretation of his authority

under the CSA. See Skidmore v. Swift & Co., 323 U.S.

134, 140, 65 S. Ct. 161, 89 L. Ed. 124 (1994) (holding that

an agency’s interpretation may merit some deference in

a field of its specialized expertise); see also United

States v. Mead Corp., 533 U.S. 218, 234-35, 121 S. Ct.

2164, 150 L. Ed. 2d 292 (2001).

Nor shall we defer to the Attorney General's

interpretation of 21 C.F.R. § 1306.04, which conflicts

with the Supreme Court’s interpretation of the same

regulation in Moore. See 423 U.S. at 144, 96 S. Ct. 335;

23a

see also Alhambra Hosp. v. Thompson, 259 F.3d 1071,

1076 (9th Cir. 2001) (refusing to defer to an agency’s

interpretation of its own regulation when it conflicted

with the “overriding intent” of Congress); Maislin

Indus., U.S., Inc. v. Primary Steel, Inc., 497 U.S. 116,

131, 110 S. Ct. 2759, 111 L. Ed. 2d 94 (1990) (“Once we

have determined a statute’s clear meaning, we adhere

to that determination under the doctrine of stare

decisis, and we judge an agency’s later interpretation of

the statute against our prior determination of the

statute’s meaning.”).

Citing federalism concerns, the Supreme Court

recently refused to defer to an agency’s interpretation

of its own regulations without clear authority from

Congress. See Solid Waste Agency, 531 U.S. at 172-74,

121 S. Ct. 675. As already explained, the Attorney

General’s interpretation of § 1306.04 permits him to

override state regulation of general medical practices

despite Congress’ express intent to limit federal author-

ity under the CSA to the field of drug abuse and

addiction. See Pub. L. No. 91-513, 84 Stat. 1236 (pre-

amble); 21 U.S.C. § 801. Clearly, “our deference does

not extend to agencies’ constructions which conflict

with statutory directives.” Pacific Coast Med. Enter. v.

Harris, 633 F.2d 123, 131 (9th Cir. 1980).”

11 The Supreme Court has also refused to extend deference to

an agency’s interpretation of a regulation when, as here, it conflicts

with the agency’s previous interpretation of the same regulation.

See Norfolk S. Railway Co. v. Shanklin, 529 U.S. 344, 356, 120 S.

Ct. 1467, 146 L. Ed. 2d 374 (2000) (“[NJo . . . deference is appro-

priate [because] [n]ot only is the [agency’s] interpretation incon-

sistent with the text of [the regulation], but it also contradicts the

agency’s own previous construction [.}”) (emphasis added); Solid

Waste Agency, 531 U.S. at 168, 121 S. Ct. 675 (noting that the

24a

V

In sum, the CSA was enacted to combat drug abuse.

To the extent that it authorizes the federal government

to make decisions regarding the practice of medicine,

those decisions are delegated to the Secretary of Heath

and Human Services, not to the Attorney General. The

Attorney General’s unilateral attempt to regulate

general medical practices historically entrusted to state

lawmakers interferes with the democratic debate about

physician assisted suicide and far exceeds the scope of

his authority under federal law. We therefore hold that

the Ashcroft Directive is invalid and may not be en-

forced.

agency’s new interpretation is unsupported by any “evidence that

the [agency] mistook Congress’ intent” the first time); see also

Pc ifie Coast Med. Enter., 633 F.2d at 131 (“The [regulation] must

be reasonably susceptible to the construction placed upon them by

the [agency], both on [its] face and in light of [its] prior inte-

rpretation and application.”) (emphasis added). Nor is deference

due when an agency’s interpretation of a regulation conflicts with

the agency’s intent at the time the regulation was promulgated.

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

114 S. Ct. 2381, 129 L. Ed. 2d 405 (1994) (quoting Gardebring v.

Jenkins, 485 U.S. 415, 430, 108 S. Ct. 1306, 99 L. Ed. 2d 515 (1988)).

Here, the Attorney General asserts that the CSA and its imple-

menting regulations must reflect a uniform federal standard of

practice. But when Attorney General Mitchell promulgated 21

C.F.R. § 1306.04 in 1971, physicians were entitled to distribute

controlled substances—as a matter of right—merely by complying

with state law. See Pub. L. No. 91-513, 84 Stat. 1253, 1255

($$ 303(f), 304(a)). Neither Congress nor Attorney General

Mitchell could have intended § 1306.04 to empower the Attorney

General to enforce a uniform federal standard of medical care, as

contemplated here. when authorization to prescribe drugs under

the CSA turned on the decisions of state licensing and law enforce-

ment authorities. See id.

25a

The petitions for review are GRANTED. The

injunction previously entered by the district court is

ORDERED continued in full force and effect as the

injunction of this court.

WALLACE, Senior Circuit Judge, dissenting:

As my colleagues in the majority suggest, this case is

not about the ethics or public policy implications of

physician-assisted suicide. We need not decide whether

the federal government or the states is better equipped

to regulate physician-assisted suicide. Setting aside the

public policy aspects of physician-assisted suicide that

evoke passionate feelings, this case involves a single

legal question: is the Attorney General’s interpretation

of 21 C.F.R. § 1306.04(a) entitled to deference? Because

our past decisions command deference to the Attorney

General’s interpretive rule, I would deny the petition

for review on the merits.

I.

The Oregon Death with Dignity Act (Oregon Act)

provides that a capable adult who “has been deter-

mined by the attending physician and consulting

physician to be suffering from a terminal disease, and

who has voluntarily expressed his or her wish to die,

may make a written request for medication for the

purpose of ending his or her life in a humane and

dignified manner.” OR. REV. STAT. § 127.805(1).

Once various safeguards have been satisfied, the at-

tending physician may “writ[e] a prescription for

medication to enable a qualified patient to end his or

her life,” id. § 127.815(1)(k), and the attending physi-

cian, the pharmacist, or a third person may dispense the

medication to the patient, id. § 127.815(1)(L). To date,

26a

Oregon is the only state that has passed legislation

expressly legalizing physician-assisted suicide.

By authorizing physicians to prescribe and dispense

controlled substances for the purpose of assisting sui-

cide, the Oregon Act arguably draws Oregon law into

tension with the federal Controlled Substances Act, 21

U.S.C. §§ 801-971. “Except as authorized by [the Con-

trolled Substances Act],” it is unlawful for any person—

including physicians—to “manufacture, distribute, or

dispense” a controlled substance. 21 U.S.C. § 841. The

Controlled Substances Act permits physicians to dis-

pense controlled substances only if they have pre-

viously registered with the Attorney General. /d.

§§ 822(a)(2), 823(f). Even registered physicians may not

distribute controlled substances, however, without first

issuing a “prescription,” id. § 829(a), which, “to be effec-

tive[,] must be issued for a legitimate medical purpose,”

21 C.F.R. § 1306.04(a). The Attorney General may re-

voke or suspend a physician’s registration if the regis-

trant has been convicted of violating the Controlled

Substances Act, 21 U.S.C. § 824(a)(2), or has committed

acts “inconsistent with the public interest,” id. §§ 823(f),

824(a)(4).

Whether physician-assisted suicide is “a legitimate

medical purpose” and “consistent with the public

interest” has been the subject of considerable public

debate. In a letter dated November 5, 1997, Drug

Enforcement Administration (DEA) Administrator

Thomas A. Constantine opined that assisting suicide is

not a “legitimate medical purpose” under the Con-

trolled Substances Act. Letter from Constantine, DEA

Administrator, to Henry J. Hyde, Congressman (Nov.

5, 1997), available at http://www.house.gov/judiciary

/econstantine.htm. Seven months later, however, then-

27a

Attorney General Janet Reno rejected the DEA Ad-

ministrator’s opinion letter, concluding that “the [Con-

trolled Substances Act] does not authorize DEA to

prosecute, or to revoke the DEA registration of, a

physician who has assisted in a suicide in compliance

with Oregon law.” Statement of Attorney General

Reno on Oregon’s Death with Dignity Act (June 5,

1998), available at http://www.usdoj.gov/opa/pr/1998/

June/259ag.htm.html. General Reno’s interpretation of

the Controlled Substances Act prompted a stern letter

from several Senators-including then Missouri Senator

John Ashcroft:

[TJhere is agreement among all three branches of

the Federal government that assisted suicide is not

a legitimate medical practice. The DEA is therefore

on solid ground in concluding that “delivering,

dispensing or prescribing a controlled substance

with the intent of assisting a suicide would not be

under any current definition a ‘legitimate medical

purpose,’” and that such a misuse of drugs warrants

the revocation of a physician’s license to dispense

controlled substances.

Letter from John Ashcroft et al., U.S. Senators, to

Janet Reno, Attorney General (Dec. 19, 1997).

Following his appointment to head the Department

of Justice, General Ashcroft issued an interpretive rule

on November 9, 2001, reversing his predecessor’s

earlier position regarding physician-assisted suicide.

Dispensing of Controlled Substances To Assist Suicide

(Ashcroft Directive), 66 Fed. Reg. 56,607 (Nov. 9, 2001)

(to be codified at 21 C.F.R. pt. 1306). The Ashcroft

Directive states that “assisting suicide is not a ‘legiti-

mate medical purpose’ within the meaning of 21 C.F.R.

28a

§ 1306.04 (2001)” and that a physician who prescribes

controlled substances to assist suicide “may’ render his

registration . . . inconsistent with the public

interest’” and thereby risk suspension or revocation of

his registration under 21 U.S.C. § 824(a)(4). Jd. at

56,608. General Ashcroft directed “the DEA, effective

upon publication of this memorandum in the Federal

Register, to enforce and apply this determination,

notwithstanding anything to the contrary in the June 5,

1998, Attorney General’s letter.” Jd.

Before the Department of Justice took action to

enforce the Ashcroft Directive, a group of physicians,

patients, and the state of Oregon (collectively Peti-

tioners) brought this action in federal district court,

seeking declaratory and injunctive relief. Although the

district court lacked jurisdiction to consider the petition

for review, see Pac. Power & Light Co. v. Bonneville

Power Admin., 795 F.2d 810, 814-16 (9th Cir. 1986);

UMC Indus., Inc. v. Seaborg, 439 F.2d 953, 955 (9th Cir.

1971) (per curiam), this court has jurisdiction pursuant

to 28 U.S.C. § 1631 and 21 U.S.C. § 877.

The Petitioners do not dispute that the Controlled

Substances Act prohibits physicians from dispensing

and prescribing controlled substances except for legiti-

mate medical purposes. See 21 C.F.R. § 1306.04(a) (“A

prescription for a controlled substance to be effective

must be issued for a legitimate medical purpose. . . .”);

United States v. Moore, 423 U.S. 122, 124, 96 S. Ct. 335,

46 L. Ed. 2d 333 (1975) (holding that physicians violate

the Controlled Substances Act “when their activities

fall outside the usual course of professional practice”);

United States v. Kaplan, 895 F.2d 618, 619 (9th Cir.

29a

1990) (stating that the Controlled Substances Act pro-

hibits “prescribing controlled substances for reasons

other than legitimate medical purposes”); United States

v. Rosenberg, 515 F.2d 190, 193 (9th Cir. 1975) (inter-

preting the Controlled Substances Act “to mean that a

doctor who acts [outside] the course of professional

practice is not a practitioner under the Act and is

therefore not authorized to prescribe controlled sub-

stances”). Instead, they argue that the Ashcroft Direc-

tive is not a valid agency rule—and thus is not entitled

to deference—for the following four reasons: (1) the

Attorney General did not promulgate the Ashcroft

Directive pursuant to the Administrative Procedure

Act’s (APA) notice-and-comment rulemaking pro-

cedures; (2) the Ashcroft Directive violates the Con-

trolled Substances Act’s non-preemption provision; (3)

the Ashcroft Directive exceeds the scope of the

Attorney General’s authority under the Controlled

Substances Act; and (4) the Ashcroft Directive is an

arbitrary and capricious agency action. As will be seen,

none of these creative challenges to the Ashcroft

Directive withstands close scrutiny or justifies the

majority’s departure from our customary canons of

deference to agency action.

A.

Petitioners argue first that deference to the Ashcroft

Directive is not warranted because the Attorney

General did not satisfy the APA’s notice-and-comment

rulemaking procedures. See 5 U.S.C. § 553 (requiring

that agencies give “interested persons” notice of pro-

posed rules and “an opportunity to participate in the

rule making through submission of written data, views,

or arguments with or without opportunity for oral

presentation”). The United States counters that the

30a

APA does not require notice and comment here, be-

cause the Ashcroft Directive is an interpretive rule, not

a legislative rule. See id. § 553(b)(3)(A) (stating the

APA’s notice-and-comment procedures do not ordinar-

ily apply to interpretive rules). If the Ashcroft Direc-

tive is “genuinely an interpretive rule, it is valid despite

the absence of notice and comment procedures.” Hemp

Indus. Ass’n v. DEA, 333 F.3d 1082, 1087 (9th Cir.

2003).

We distinguish interpretive and legislative rules by

asking (1) whether, absent the rule, there would be an

inadequate legislative basis for an enforcement action;

(2) whether the agency “explicitly invoked its general

legislative authority”; and (3) whether “the rule effec-

tively amends a prior legislative rule.” Jd. “If the

answer to any of these questions is affirmative, we have

a legislative, not an interpretive rule.” Sweet v. Shea-

han, 235 F.3d 80, 91 (2d Cir. 2000), quoting Am. Mining

Cong. v. Mine Safety & Health Admin., 995 F.2d 1106,

1112 (D.C. Cir. 1993).

The Ashcroft Directive does not bear any of these

three hallmarks of a legislative rule. First, even absent

the Ashcroft Directive, the Attorney General could

bring an enforcement action because the Controlled

Substances Act itself prohibits distributing a controlled

substance without a prescription, 21 U.S.C. § 82%a),

and preexisting Department of Justice regulations

declare that “[a] prescription for a controlled substance

to be effective must be issued for a legitimate medical

purpose,” 21 C.F.R. § 1306.04(a). Second, the Attorney

General did not expressly invoke his statutory

authority to “promulgate . . . any [legislative rules]

. which he may deem necessary and appropriate for

the efficient execution of his functions under” the

3la

Controlled Substances Act. 21 U.S.C. § 871(b). Third,

although the Ashcroft Directive contradicts former

Attorney General Reno’s 1998 statement, the Ashcroft

Directive is not inconsistent with any legislative rule.

See Chief Prob. Officers of Cal. v. Shalala, 118 F.3d

1327, 1337 (9th Cir. 1997) (holding that an interpretive

rule can amend an interpretive rule); Richard J. Pierce,

Jr., Distinguishing Legislative Rules from Interpreta-

tive Rules, 52 ADMIN. L. REV. 547, 566-73 (2000)

(discussing this principle).

The Ashcroft Directive does not purport to “create

rights, impose obligations, or effect a change in existing

law pursuant to authority delegated by Congress.”

Hemp, 333 F.3d at 1087. Instead, like other interpre-

tive rules, the Ashcroft Directive is “essentially horta-

tory and instructional,” clarifying what the Controlled

Substances Act means when applied to a narrowly

defined situation. Alcaraz v. Block, 746 F.2d 593, 613

(9th Cir. 1984); see also Hemp, 333 F.3d at 1087 (ex-

plaining that interpretive rules “explain, but do not

add to, the substantive law that already exists in the

form of a statute or legislative rule”). Thus, General

Ashcroft’s failure to give Petitioners advance notice

and an opportunity to comment does not invalidate the

Ashcroft Directive.

B.

The Petitioners next contend that the Ashcroft

Directive violates 21 U.S.C. § 903, the Controlled Sub-

stances Act’s non-preemption clause. Section 903

reads:

No provision of this subchapter shall be construed

as indicating an intent on the part of the Congress to

occupy the field in which that provision operates

32a

. . . 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 this subchapter

and that State law so that the two cannot

consistently stand together.

21 U.S.C. § 903. The Petitioners argue that the Ash-

croft Directive construes the Controlled Substances

Act to preempt the Oregon Act and that this result

violates 21 U.S.C. § 903 because there is no “positive

conflict” between the Controlled Substances Act’s text

and the Oregon Act.

Petitioners are wrong; the Ashcroft Directive is

consistent with section 903 because it does not utterly

exclude state regulation of medical practice or even

state regulation of physician-assisted suicide. The Ash-

croft Directive does not effect a “positive conflict” with

state law because it does not make “the federal role

. . . 80 pervasive that no room is left for the states to

supplement it.” Sayles Hydro Assocs. v. Maughan, 985

F.2d 451, 455 (9th Cir. 1993). States may supplement

the Ashcroft Directive by expanding the Controlled

Substances Act’s prohibitions, providing additional civil

or criminal sanctions against physicians who assist

suicide, or permitting conduct that the Ashcroft Direc-

tive does not prohibit.

More relevant for present purposes, the Ashcroft

Directive proscribes only one method of assisting

suicide: prescription, dispensation, and administration

of controlled substances. The majority vastly exag-

gerates the Ashcroft Directive’s scope by intimating

that it “ban{s] physician-assisted suicide outright.” A

closer examination of the Ashcroft Directive’s text re-

veals that “[assisting] suicide is not a ‘legitimate medi-

33a

cal purpose’” only “within the meaning of 21 C.F.R.

§ 1306.04” (prescription of controlled substances). Ash-

croft Directive, 66 Fed. Reg. at 56,608 (emphasis

added). The Ashcroft Directive avoids the sweeping

prohibition claimed by the majority by assiduously

limiting its reach to controlled substances; under its

plain terms, only applications involving controlled

substances may “render [a physician’s) registration

. . . inconsistent with the public interest” and therefore

subject to revocation. Jd., quoting 21 U.S.C. § 824(a)(4).

Oregon physicians may continue to assist suicide by

other means without risking suspension or revocation

of their registration to prescribe controlled substances.

See George J. Annas, The “Right To Die” in America:

Sloganeering from Quinlan and Cruzan to Quill and

Kevorkian, 34 DUQ. L. REV. 875, 891 (1996) (discuss-

ing carbon monoxide as an alternative to controlled

substances); Jeffrey G. Sherman, Mercy Killing and the

Right To Inherit, 61 U. Cin. L. Rev. 803, 834 (1993)

(same). The Ashcroft Directive does not, therefore, “oc-

cupy the field” of physician-assisted suicide in violation

of section 903. See United States v. Leal, 75 F.3d 219,

227 (6th Cir. 1996) (holding that “there is no such

conflict” between 21 C.F.R. § 1306.04 and state law).

Cc.

Petitioners maintain—and the majority agrees—that

the Ashcroft Directive is not entitled to deference be-

cause the Attorney General promulgated it “in excess

of statutory jurisdiction, authority, or limitations, or

short of statutory right.” 5 U.S.C. § 706(2)(C).

1.

The Ashcroft Directive is not entitled to deference,

the majority contends, because “Congress intended to

34a

limit federal authority under the [Controlled Sub-

stances Act] to the field of drug abuse” while pre-

serving states’ discretion to authorize other life-threat-

ening applications of controlled substances. By what

authority? True, the Controlled Substances Act’s pre-

amble arguably manifests Congress’s intent “to

strengthen existing law enforcement authority in the

field of drug abuse,” Comprehensive Drug Abuse Pre-

vention and Control Act of 1970, Pub. L. No. 91-513,

pmbl., 84 Stat. 1236, 1236, but it does not “expressly

limit{ ] federal authority under the Act” to mainstream

drug abuse, as the majority argues. Moreover, there is

simply no textual support for the majority’s conclusory

assertion that “the field of drug abuse,” as discussed in

the Controlled Substances Act, does not encompass

drug-induced, physician-assisted suicide.

The Controlled Substances Act’s text furnishes

ample evidence that Congress was concerned not only

with street-variety drug trafficking and abuse but also

with any other improper drug use that might have a

“detrimental effect on the health and general welfare of

the American people.” 21 U.S.C. § 801(2). The Act

targets all “improper use of controlled substances,” id.,

and gives the Attorney General discretion to decide

whether registering a physician to dispense drugs is

“consistent with the public health and safety,” id.

§ 823(b)(5). Reasonable minds might disagree as to

whether physician-assisted suicide constitutes an

“improper use” of a controlled substance, but nothing in

the Controlled Substances Act’s text precludes its ap-

plication to physician-assisted suicide.

Lacking a textual hook for its position, the majority

attempts to patch the holes in its argument with

inconclusive fragments of legislative history. Discern-

- —E —

35a

ing congressional intent from legislative history is a

speculative enterprise under the best of circumstances,

and the risk of error is compounded in a case such as

this when legislators’ published statements do not

squarely address the question presented-i.e., whether

Congress intended to exclude drug-induced, physician-

assisted suicide from regulation under the Controlled

Substances Act. See Chisom v. Roemer, 501 U.S. 380,

406, 111 S. Ct. 2354, 115 L. Ed. 2d 348 (1991) (Scalia, J.,

dissenting) (“We are here to apply the statute, not

legislative history, and certainly not the absence of

legislative history.”).

The Controlled Substances Act’s legislative history

suggests that some members of Congress envisioned

the physician-registration provisions primarily as a

mechanism to stem the flow of controlled substances

into illicit channels, Moore, 423 U.S. at 135, 96 S. Ct.

335, but the record also specifically identifies “sui-

cides and attempted suicides” as a”[m]isuse of a drug.”

H.R. REP. NO. 91-1444 (1970), reprinted in 1970

U.S.C.C.A.N. 4566, 4572; see also Dangerous Drug

Diversion Control Act of 1984: Hearing on H.R. 5656

Before the House Subcomm. on Health and the Env't,

98th Cong. 365 (1984) (statement of Rep. Henry A.

Waxman, Chairman, House Subcomm. on Health and

the Env’t) (expressing concern that “[dJjrugs legally

manufactured for use in medicine are responsible for a

substantial majority of drug-related deaths”); 130

CONG. REC. 25,851 (statement of Rep. Rodino) (1984)

(reporting that “diversion” of prescription drugs “is

responsible for 70 percent of the deaths and injuries

due to all drug abuse”). Viewed holistically, the record

“does not demonstrate a clear and certain congressional

intent” to preclude physician-assisted suicide from

36a

regulation under sections 823 and 824. Rust v. Sulli-

van, 500 U.S. 173, 190, 111 S. Ct. 1759, 114 L. Ed. 2d 233

(1991). Controlling precedent thus compels the con-

clusion that the Controlled Substances Act’s “legis-

lative history . . . cannot form the basis for enjoining

(the Attorney General’s] regulation| |.” /d.; see also

Student Loan Fund of Idaho, Inc. v. U.S. Dept. of

Educ., 272 F.3d 1155, 1165 (9th Cir. 2001) (applying this

principle in an analogous setting).

2.

The majority asserts that the Attorney General lacks

authority to decide whether physician-assisted suicide

is consistent with “the public interest” and a “legitimate

medical practice” under the Controlled Substances Act

and its implementing regulations because Congress

intended to preserve the states’ traditional authority to

make these determinations. This argument ignores the

Controlled Substances Act’s text and controlling

Supreme Court decisions.

It is axiomatic that the meaning of federal law is a

federal question. See Reconstr. Fin. Corp. v. Beaver

County, 328 U.S. 204, 208, 66 S. Ct. 992, 90 L. Ed. 1172

(1946) (“What meaning Congress intended is a federal

question we must determine.”). Although federal law

occasionally incorporates state-law definitions by refer-

ence, see, e.g., De Sylva v. Ballentine, 351 U.S. 570, 580-

82, 76 S. Ct. 974, 100 L. Ed. 1415 (1956) (defining the

word “children” in a federal statute according to state

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

the norm. “{I)n the absence of a plain indication to the

contrary, . . . Congress when it enacts a statute [does]

not mak[e] the application of the federal act dependent

on state law.” Miss. Band of Choctaw Indians v.

37a

Holyfield, 490 U.S. 30, 43, 109 S. Ct. 1597, 104 L. Ed. 2d

29 (1989) (quoting Jerome v. United States, 318 U.S.

101, 104, 63 S. Ct. 483, 87 L. Ed. 640 (1943)); Kahn v.

INS, 36 F.3d 1412, 1414 (9th Cir. 1994) (per curiam)

(same).

State law may be relevant to certain provisions of the

Controlled Substances Act, see, e.g., 21 U.S.C. § 823(

(instructing the Attorney General to consider state-law

violations when deciding whether a physician’s regis-

tration would be contrary to the public interest), but

nothing in the Controlled Substances Act plainly

evinces a congressional intent to define “the public

interest” solely according to state law. On the contrary,

section 823 instructs the Attorney General to identify

acts “inconsistent with the public interest” by reference

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

conviction record, compliance with “Federal . . . laws

relating to controlled substances,” and “other conduct

which may threaten public health and safety.” Jd. The

majority’s contention that the Attorney General cannot

suspend or revoke a physician’s registration without

state authorization ignores Mississippi Band’s “plain

indication” rule and contravenes Congress’s clearly

expressed intent.

The majority also cites Washington v. Glucksberg,

521 U.S. 702, 735, 737, 117 S. Ct. 2258, 1388 L. Ed. 2d 772

(1997) (O’Connor, J., concurring), for the position that

the Attorney General must defer to the Oregon Act

because “[p]hysician-assisted suicide is an unrelated,

general medical practice to be regulated by the States

in the first instance.” Glucksberg, however, addressed

states’ authority to prohibit physician-assisted suicide

in the absence of federal regulation; the case did not

answer the question whether Congress may exercise its

38a

Commerce Clause power to deny physicians access to

controlled substances for physician-assisted suicide.

Rather than place federalism limitations on the federal

government’s authority to restrict physician-assisted

suicide, Justice O’Connor’s concurring opinion stressed

that “[t]here is no reason to think the democratic

process will not strike the proper balance between the

interests of terminally ill . . . individuals . . . and the

State’s interests in protecting those who might seek to

end life mistakenly or under pressure.” /d. at 737, 117

S. Ct. 2258. Simply put, courts should defer to the

political process instead of interposing hasty consti-

tutional constraints.

Glucksberg does not require the Attorney General to

interpret the Controlled Substances Act and its imple-

menting regulations according to state standards of

professional conduct. Rather, the Supreme Court’s

decision stands for the broader proposition that federal

courts generally should keep their distance, allowing

the political process to decide whether and how to

regulate physician-assisted suicide. The majority’s

shortsighted decision to declare the Ashcroft Directive

invalid has precisely the opposite effect.

3.

As an alternative, the majority contends that the

Secretary of Health and Human Services (Secretary )—

not the Attorney General—should decide whether

medical practices are “legitimate” and consistent with

the “public interest” under the Controlled Substances

Act and its implementing regulations. The Controlled

Substances Act’s text directly contradicts this argu-

ment: “The Attorney General may deny an application

for . . . registration [of a practitioner to dispense

39a

drugs] if he determines that the issuance of such regis-

tration would be inconsistent with the public interest.”

21 U.S.C. § 823(f) (emphasis added). Congress could

not have stated more plainly that the Attorney General,

not the Secretary, has authority to determine whether

a physician’s registration is consistent with the public

interest.

The majority’s reading of section 823 is a particularly

astonishing exercise in statutory construction because

the Controlled Substances Act specifically provides for

the Secretary’s participation in other discretionary

judgments. See, e.g., 21 U.S.C. § 811(b) (providing that

the Secretary’s determination with respect to the

classification of controlled substances “shall be binding

on the Attorney General”); id. § 823(f) (authorizing the

Secretary to evaluate a practitioner’s “qualifications

and competency” to perform “research with controlled

substances”); id. (stating that the Secretary “shall con-

sult with the Attorney General as to effective pro-

cedures to adequately safeguard against diversion of

. . « controlled substances from legitimate medical or

scientific use”); id. § 823(g)(2)(H)(i) (empowering the

Secretary to “issue regulations . . . or issue practice

guidelines” for the approval of “additional credentialing

bodies”). When Congress wished to entrust a discre-

tionary judgment to the Secretary it said so explicitly.

The Controlled Substances Act conspicuously omits any

reference to the Secretary, however, when discussing

the Attorney General’s authority to assess “the public

interest” for purposes of ordinary physician registra-

tions. Jd. § 823(f). The explanation for this omission is

perfectly clear: section 823 authorizes the Attorney

General—not the Secretary—to decide whether a

40a

physician’s registration is consistent with the public

interest.

The majority asserts that under the Controlled

Substance Act all standards of legitimate professional

conduct are set by the Secretary, not by the Attorney

General. The majority’s argument relies on a section of

the Act entitled “Medical Treatment of Narcotic Addic-

tion,” which is located in a different title of the legis-

lation. This section provides that the Secretary, “after

consultation with the Attorney General . . ., shall

determine the appropriate methods of professional

practice in the medical treatment of . . . narcotic

addiction.” 42 U.S.C. § 290bb 2a (emphasis added).

Obviously, this is irrelevant to the issue before us. Yet

from this narrow provision, the majority draws the

sweeping, untenable conclusion that the Attorney

General cannot enforce the Controlled Substances Act

against a physician unless the Secretary first concludes

that the prescription did not issue for a “legitimate

medical purpose.”

The Supreme Court rejected a similar challenge to

the Attorney General’s interpretive authority in Moore.

The Court explained that Congress designed subsection

290bb 2a to function oniy as a limited safe-harbor for

physicians who prescribe controlled substances to drug

addicts; as long as physicians employ the treatment

methods outlined in the Secretary’s published stan-

dards of professional practice, the Attorney General

may not prosecute them under the Controlled Sub-

stances Act. Moore, 423 U.S. at 144, 96 S. Ct. 335. The

Court recognized, however, that “[t]he negative

implication [of this provision] is that physicians who go

beyond approved practice remain subject to serious

criminal penalties.” Jd. In other words, section 290bb-

4la

2a prevents the Attorney General from enforcing the

Controlled Substances Act and its implementing regu-

lations only when the Secretary declares that a specific

narcotic addiction treatment serves.a “legitimate

medical purpose.”

We confirmed Moore’s reading of subsection 290bb 2a

in Rosenberg, holding that the Attorney General may

enforce the Controlled Substances Act against physi-

cians whose practices do not qualify for protection

under the Secretary’s specific safe-harbor guidelines.

We explained that the Secretary’s authority to

determine the appropriate method of professional

practice in the medical treatment of narcotic

addiction . . . was adopted in light of Congress’

awareness that there had been criminal prosecution

of physicians whose methods of prescribing narcotic

drugs have not conformed to the opinions of Federal

prosecutors. The committee evidenced no intention

to restrict such prosecutions. Indeed|[,] they seemed

to think [these prosecutions] would continue, but

that some standards of professional practice should

be established so that . . . physicians who comply

with the recommendations made by the Secretary

will no longer jeopardize their professional careers

by accepting narcotic addicts as patients.

515 F.2d at 194-95 (emphasis added) (internal quota-

tions omitted), citing H.R. REP. NO. 91-1444, reprinted

in 1970 U.S.C.C.A.N. at 4581 (observing that “for the

last 50 years” federal officials have “determine[d] the

appropriate method of the practice of medicine . . .

through . . . criminal prosecution[s]” and suggesting

that these prosecutions should continue subject to the

Secretary’s limited guidelines for treatment of narcotic

42a

addiction); see also H.R. REP. NO. 93-884 (1974),

reprinted in 1974 U.S.C.C.A.N. 3029, 3034 (recognizing

that “[t]he registration required under [the section of

the Controlled Substances governing treatment of nar-

eotic addiction] is separate and distinct from regular

registration under the Controlled Substances Act,”

which is administered by the Attorney General (em-

phasis added)).

Here the Petitioners have not shown and do not con-

tend that the Secretary’s guidelines approve physician-

assisted suicide as an “appropriate method[ ] of pro-

fessional practice in the medical treatment ae

narcotic addiction.” 42 U.S.C. § 290bb 2a (emphasis

added). As such, subsection 290bb 2a’s safe-harbor rule

does not apply, and the Attorney General was not

required to consult the Secretary prior to issuing his

determination that physician-assisted suicide does not

constitute a “legitimate medical purpose” under 21

C.F.R. § 1306.04(a).

4.

The majority maintains that even if the Controlled

Substances Act authorizes the Attorney General to

ascertain whether physician-assisted suicide is “incon-

sistent with the public interest,” General Ashcroft

abused his discretion in this case by failing to consider

all five factors outlined in 21 U.S.C. § 823(f). Subsection

(f) provides in part that “[iJn determining the public

interest, the following factors shall be considered”:

(1) The recommendation of the appropriate

State licensing board or professional disciplinary

authority.

43a

(2) The applicant’s experience in dispensing, or

conducting research with respect to controlled

substances.

(3) The applicant’s conviction record under

Federal or State laws relating to the manufacture,

distribution, or dispensing of controlled substances.

(4) Compliance with applicable State, Federal,

or local laws relating to controlled substances.

(5) Such other conduct which may threaten the

public health and safety.

28 U.S.C. § 823(f). The Ashcroft Directive is invalid,

the majority argues, because General Ashcroft “made

no effort to solicit input from the State of Oregon before

issuing” the interpretive rule.

Contrary to the majority’s assertion, the Ashcroft

Directive does not sidestep subsection 823(f)’s five-

factor inquiry. The Justice Department has yet to

initiate an enforcement action against any individual

physician pursuant to section 824, so the hour has not

arrived for the Attorney General to consider sub-

sections 823(f)(1)-(4) (i.e., the state licensing board’s

recommendation and physicians’ relevant experience

and criminal record). The Ashcroft Directive merely

cautions that a physician who prescribes controlled

substances to assist suicide “may ‘render his regis-

tration . . . inconsistent with the public interest,’”

Ashcroft Directive, 66 Fed. Reg. at 56,608 (emphasis

added); it does not declare that assisting suicide shall

render a physician’s registration inconsistent with the

public interest. This word choice is significant, because

it conclusively refutes the majority’s contention that

assisting suicide automatically renders a physician's

registration “inconsistent with the public interest”

44a

under the Ashcroft Directive. Even if “assisting suicide

is not a ‘legitimate medical purpose’ within the meaning

of 21 C.F.R. § 1306.04 (2001),” the Attorney General

remains free to consult all of section 823’s five

factors—including the recommendation of Oregon’s

licensing board or disciplinary authority—before

making a final decision whether to suspend or revoke a

particular physician’s registration.

Significantly, the Ashcroft Directive’s warning that

assisting suicide could prom»t Controlled Substances

Act enforcement actions comports with fundamental

administrative law principles:

When a governmental official is given the power to

make discretionary decisions under a broad statu-

tory standard [e.g., “the public interest”), case-by-

case decisionmaking may not be the best way to

assure fairness. Here the [Attorney General] . . .

sought to define the statutory standard . . . by the

use of his rulemaking authority. The decision to use

objective rules in this case provides [physicians]

with more precise notice of what conduct will be

sanctioned and promotes equality of treatment

among similarly situated [individuals].

Dixon v. Love, 431 U.S. 105, 115, 97 S. Ct. 1723, 52 L.

Ed. 2d 172 (1977). The Controlled Substances Act

facilitates adherence to these principles by expressly

authorizing the Attorney General to “promulgate and

enforce any rules, regulations, and procedures which he

may deem necessary and appropriate for the efficient

execution of his functions under this subchapter.” 21

U.S.C. § 871. Thus, General Ashcroft acted well within

the scope of his statutory authority in declaring that

assisting suicide does not serve a “legitimate medical

45a

purpose” vnder 21 C.F.R. § 1306.04(a) and that this

practice “may ‘render [a physician’s] registration .. .

inconsistent with the public interest’ and therefore

subject to possible suspension or revocation under

[section] 824.” Ashcroft Directive, 66 Fed. Reg. at

56,608.

Finally, the majority argues that the Ashcroft Direc-

tive exceeds the Attorney General’s statutory author-

ity because Congress has not clearly authorized the

Attorney General to upset the delicate balance between

federal regulation of centrolled substances and state

control of medical practices. As support for this con-

clusion, the majority invokes the Supreme Court’s

recent analysis in Solid Waste Agency of Northern

Cook County v. U.S. Army Corps of Engineers, 531

U.S. 159, 121 S. Ct. 675, 148 L. Ed. 2d 576 (2001):

Where an administrative interpretation of a statute

invokes the outer limits of Congress’ power, we

expect a clear indication that Congress intended

that result. This requirement stems from «ur pru-

dential desire not to needlessly reach constitutional

issues and our assumption that Congress does not

casually authorize administrative agencies to inter-

pret a statute to push the limit of congressional

authority. This concern is heightened where the

administrative interpretation alters the federal-

state framework by permitting federal encroach-

ment upon a traditional state power.

Id. at 172-73, 121 S. Ct. 675 (internal citations omitted),

citing Edward J. DeBartalo Corp. v. Fla. Gulf Coast

Bldg. & Constr. Trades Council, 485 U.S. 568, 575, 108

S. Ct. 1392, 99 L. Ed. 2d 645 (1988). See generally id. at

46a

172-74, 108 S. Ct. 1392 (refusing to afford deference to

an agency regulation that raised a serious constitutional

issue where there was no indication in the statute that

Congress intended to encroach on traditional state

powers over land and water use). Although the Court

addressed the validity of “an administrative inter-

pretation of a statute,” id. at 172, 121 S. Ct. 675 (em-

phasis added), its reasoning should apply equally to an

administrative interpretation of an agency regulation.

Solid Waste’s clear statement rule is based upon

understandable and significant federalism concerns, the

importance of which I do not doubt. The question we

must ask ourselves, however, is whether this canon of

statutory interpretation applies to the case before us.

Not every colorable constitutional question triggers

Solid Waste’s clear statement rule. Our past decisions

dictate that we must “scrutinize constitutional objec-

tions to[the] agency interpretation skeptically. Only if

the agency’s proffered interpretation raises serious

constitutional concerns may [we] refuse to defer. . . .”

Williams v. Babbitt, 115 F.3d 657, 662 (9th Cir. 1997),

citing Republican Nat'l Comm.v. Fed. Election

Comm’n, 76 F.3d 400, 409 (D.C. Cir. 1996). As such, the

proper approach here is to proceed directly to the

merits of Petitioners’ constitutional challenge, deciding

whether the agency interpretation “raise[s] the sort of

grave and doubtful constitutional questions” that could

lead us to “invalidate the regulations in order to save

the statute from unconstitutionality.” Rust, 500 U.S. at

191, 111 S. Ct. 1759 (internal quotation marks omitted);

see also United States v. Deaton, 332 F.3d 698, 704-08

(4th Cir. 2003) (construing the Solid Waste canon in

light of Rust and deciding the disputed constitutional

question to determine if it is serious enough to warrant

47a

requiring a clear statement). Only if the Attorney

General’s proposed interpretation would likely render

the statute unconstitutional do we apply Solid Waste’s

clear statement canon. See Williams, 115 F.3d at 663

(“Rust . . . limits this intrusion on agency power to

situations where it’s absolutely necessary.”). Applying

these principles, we should not require a clear state-

ment in this case because controlling precedent compels

the conclusion that the Attorney General’s interpreta-

tion did not invoke “the outer limits” of Congress’s

Commerce Clause power. Solid Waste, 531 U.S. at 172,

121 S. Ct. 675; see also Republican Nat'l Comm., 76

F.3d at 409 (“Because we can easily resolve the [consti-

tutional] challenges through the application of con-

trolling precedent . . ., we do not face the sort of

serious constitutional questions ‘that would lead us to

assume Congress did not intend to authorize the [regu-

lation’s] issuance.’” (quoting Rust, 500 U.S. at 191, 111

S. Ct. 1759)).

The Commerce Clause empowers Congress to regu-

late (1) “the use of the channels of interstate com-

merce”; (2) “the instrumentalities of interstate com-

merce, or persons or things in interstate commerce”;

and (3) “those activities that substantially affect inter-

state commerce.” United States v. Lopez, 514 U.S. 549,

558-59, 115 S. Ct. 1624, 131 L. Ed. 2d 626 (1995). Our

court has long recognized that “the Commerce Clause

empowers the federal government to regulate prescrip-

tion drugs,” Jn re Grand Jury Proceedings, 801 F.2d

1164, 1169 (9th Cir. 1986) (per curiam); accord Rosen-

berg, 515 F.2d at 198. We have steadfastly upheld the

Controlled Substances Act against Commerce Clause

challenges, even in cases involving wholly intrastate

activity. See, e.g., United States v. Tisor, 96 F.3d 370,

48a

975 (9th Cir. 1996); United States v. Kim, 94 F.3d 1247,

1250 (9th Cir. 1996). But see Raich v. Ashcroft, 352

F.3d 1222, 1227-28 (9th Cir. 2003) (stating that the Con-

trolled Substances Act, as applied to “the intrastate,

noncommercial cultivation and possession of cannabis

for personal medical purposes as recommended by a

patient’s physician pursuant to a valid California state

law,” likely exceeded Congress’s Commerce Clause

power).

Turning to the specific issue raised here—whether

the prescription or dispensation of controlled

substances to assist suicide substantially affects

interstate commerce—we base our assessment on four

factors:

1) whether the statute in question regulates com-

merce or any sort of economic enterprise, 2)

whether the statute contains any express Juris-

dictional element which might limit its reach to a

discrete set of cases; 3) whether the statute or its

legislative history contains express congressional

findings that the regulated activity affects inter-

state commerce; and 4) whether the link between

the regulated activity and a substantial effect on

interstate commerce is attenuated.

United States v. McCoy, 323 F.3d 1114, 1119 (9th Cir.

2003) (internal quotation marks omitted). Of these four

factors, the first and last are most important. Id.

The Ashcroft Directive clearly satisfies McCoy ’s first

and the last criteria. The Ashcroft Directive regulates

economic transactions: physicians generally prescribe

and dispense controlled substances for a fee. There is

no indication here, as there was in Raich with regards

to medicinal marijuana, that drug-induced physician-

49a

assisted suicide “does not involve [the] sale, exchange,

or distribution” of controlled substances. Raich, 352

F.3d at 1229. The link between these transactions and

their effect on interstate commerce is not attenuated

simply because relatively few Oregonians use con-

trolled substances for assisted suicide. We evaluate

whether an activity’s link to interstate commerce is

attenuated by assessing whether its effect on interstate

commerce is sufficiently direct, Solid Waste, 531 U.S. at

195, 121 S. Ct. 675; McCoy, 323 F.3d at 1123-24, and we

assess individual provisions as “part(s] of a wider

regulatory scheme” (i.e., the Controlled Substances

Act), which regulates a field of drug-related activity

that has “a ‘substantial affect’ on interstate commerce,”

Tisor, 96 F.3d at 375. Here Congress naturally and

directly reduces the amount of a controlled substance

that flows through the interstate channels when it

prohibits the substance’s distribution for a particular

use. Thus, the link between drug prescriptions and

interstate commerce is sufficiently direct and sub-

stantial even if the drugs ultimately are used in

intrastate activities such as physician-assisted suicide

and the activities’ disaggregated effect on interstate

commerce is small.

Because the Ashcroft Directive satisfies McCoy’s

first and last factors, we need not consider whether it

meets the other, less important ones. See McCoy, 323

F.3d at 1119 (explaining that the second and third

factors may “aid” the court’s analysis, but “are ordinar-

ily not, in themselves, dispositive”); id. at 1126-27

(observing that legislative history is “neither necessary

nor conclusive” in Commerce Clause analysis). Under

McCoy, Congress’ Commerce Clause power to prohibit

physicians from prescribing controlled substances to

50a

assist suicide is not open to serious question. That ends

the matter in this circuit and, of course, for this case.

The majority cannot have it otherwise. Their argu-

ment that “direct control of medical practice in the

states is beyond the power of the federal government”

misses the point. Linder v. United States, 268 US. 5,

18, 45 S. Ct. 446, 69 L. Ed. 819 (1925) (emphasis added).

Unless and unti! the Supreme Court directs us dif-

ferently, our opinions and other binding precedent

compel the conclusion that Congress acts comfortably

withiu its Commerce Clause power when it regulates

the prescription and dispensation of controlled sub-

stances. See Minor v. United States, 396 U.S. 87, 98 n.

13, 90 S. Ct. 284, 24 L. Ed. 2d 283 (1969) (stating that “a

flat ban on certain [drug transactions] . . . is

sustainable under the powers granted Congress” by the

Commerce Clause); Reina v. United States,-364 U.S.

507, 511, 81 S. Ct. 260, 5 L. Ed. 2d 249 (1960) (referring

to Congress’s “undoubted power to enact the narcotics

laws”); Tisor, 96 F.3d at 375 (“(D]rug trafficking is a

commercial activity which substantially affects inter-

state commerce.”); Kim, 94 F.3d at 1250 n. 4 (recogniz-

ing that Congress may regulate controlled substances

pursuant to the Commerce Clause even when legis-

lation “intrudes into an area traditionally regulated

by states”); Rosenberg, 515 F.2d at 198 (dubbing an

analogous constitutional challenge “singularly unper-

suasive”). General Ashcroft’s interpretation of 21

C.F.R. § 1306.04(a) does not, therefore, “invoke[ | the

outer limits of Congress’ power,” Solid Waste, 531 U.S.

at 172, 121 S. Ct. 675, the clear statement rule does not

apply, and we must evaluate the Ashcroft Directive

according to ordinary standards of deference.

5la

D.

The Petitioners contend that the Ashcroft Directive

constitutes an arbitrary and capricious interpretation

of section 1306.04(a)’s “legitimate medical practice”

requirement. General Ashcroft’s determination is arbi-

trary and capricious, they argue, because he failed to

examine the “wealth” of substantive data documenting

the Oregon Act’s effect on public health and safety.

They point to a collection of studies which indicate tiuat

the Oregon Act’s procedures have not been used dis-

proportionately by the poor, uneducated, or uninsured.

Normally, an agency rule would be arbitrary and

capricious if the agency . . . entirely failed to consider

an important aspect of the problem.” Motor Vehicle

Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S.

29, 43, 103 S. Ct. 2856, 77 L. Ed. 2d 443 (1983).

. Although these empirical studies might be socially

important, their findings were not an “important aspect

of the problem” confronted by the Attorney General.

General Ashcroft had before him a single question:

whether physician-assisted suicide is a “legitimate

medical purpose” as defined in existing case law,

federal policy, general state law, and medical opinion.

Evidence that Oregon physicians used the Oregon Act’s

procedures disproportionally against the poor, unedu-

cated, or uninsured could have strengthened his con-

clusion that physician-assisted suicide is not a “legiti-

mate medical purpose,” but it does not follow that the

absence of such evidence means physician-assisted

suicide is a “legitimate medical practice.” Thus,

whether the Oregon Act provided adequate safeguards

for vulnerable groups was not a sufficiently important

aspect of the Attorney General's inquiry to render the

52a

Ashcroft Directive an arbitrary and capricious agency

action.

Furthermore, Petitioners’ assertion that General

Ashcroft “entirely failed to consider” Oregon’s position

on the social benefits of physician-assisted suicide is

plainly false. The Attorney General based his decision

on a memorandum from the Office of Legal Counsel,

which considered, but rejected, Oregon’s position in

favor of existing case law, federal policies and practices,

the majority state position, and the dominant views

of the American medical and nursing professions. See

Memorandum from Shelden Bradshaw, Deputy Assis-

tant Attorney General, and Robert J. Delahunty,

Special Counsel, Memorandum for the Attorney

General: Whether Physician-Assisted Suicide Serves a

“Legitimate Medical Purpose” Under the Drug

Enforcement Administration’s Regulations Imple-

menting ihe Controlled Substances Act (Memorandum)

5-14 (June 27, 2001). Thus, Petitioners have not shown

that General Ashcroft’s decision to reject the Oregon

Act’s permissive approach to physician-assisted suicide

was “arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law.” 5 U.S.C.

§ 706(2)(a).

Ill.

Having demonstrated the fallacies of the foregoing

challenges to the Ashcroft Directive, I now consider

what standard of review this court should apply when

assessing the Ashcroft Directive's validity. The degree

of deference we accord an interpretive rule depends

upon whether the rule construes a statute or an agency

regulation.

53a

If the Ashcroft Directive represents a statutory

interpretation, it enjoys deference as defined in

Skidmore v. Swift & Co., 323 U.S. 134, 65 S. Ct. 161, 89

L. Ed. 124 (1944). Omohundro v. United States, 300

F.3d 1065, 1067-68 (9th Cir. 2002). Under Skidmore,

“(t]he weight of such a judgment in a particular case

will depend upon the thoroughness evident in its con-

sideration, the validity of its reasoning, its consistency

with earlier and later pronouncements, and all those

factors which give it power to persuade, if lacking

power to control.” Skidmore, 323 U.S. at 140, 65 S. Ct.

161. Especially relevant under Skidmore is the fact

that the Ashcroft Directive reverses the agency’s

earlier interpretation. See Cmty. Hosp. of the Monterey

Peninsula v. Thompson, 323 F.3d 782, 792 (9th Cir.

2003) (“An agency interpretation . . . which conflicts

with the agency’s earlier interpretation is entitled to

considerably less deference than a consistently held

agency view.” (internal brackets, quotation marks, and

citation omitted)). The agency “is not disqualified from

changing its mind,” however, “and when it does, the

courts still sit in review of the administrative decision

and should not approach the statutory construction

issue de novo and without regard to the administrative

understanding of the statutes.” NLRB v. Local Union

No. 103, Int'l Ass’n of Bridge, Structural & Orna-

mental Iron Workers, 434 U.S. 335, 351, 98 S. Ct. 651,

54 L. Ed. 2d 586 (1978).

If the Ashcroft Directive interprets an agency regu-

lation, rather than the Controlled Substances Act itself,

we must accord it “substantial deference.” Thomas

Jefferson Univ. v. Shalala, 512 U.S. 504, 512, 114 S. Ct.

2381, 129 L. Ed. 2d 405 (1994). Under this highly defer-

ential standard,

54a

folur task is not to decide which among several

competing interpretations best serves the regula-

tory purpose. Rather, the agency’s interpretation

must be given controlling weight unless it is plainly

erroneous or inconsistent with the regulation. In

other words, we must defer to the Secretary’s

interpretation unless an alternative reading is

compelled by the regulation’s plain language or by

other indications of the Secretary’s intent at the

time of the regulation’s promulgation.

Id. (internal citations and quotation marks omitted).

Agency interpretations of regulations enjoy substantial

deference even if they are inconsistent with the

agency’s prior interpretations. As the Supreme Court

explained in Thomas Jefferson, an agency “is not

estopped from changing a view[it] believes to have

been grounded upon a mistaken legal interpretation.”

Id. at 517, 114 S. Ct. 2381 (internal quotation marks and

citation omitted). “[WJhere the agency’s interpretation

of [its regulation] is at least as plausible as competing

ones, there is little, if any, reason not to defer to its

construction.” Jd. (internal quotation marks and cita-

tion omitted) (second brackets in original).

In my view, the Ashcroft Directive constitutes an

interpretation of a regulation rather than a statutory

interpretation. The Ashcroft Directive’s single inter-

pretive act is to “determine that assisting suicide is not

a ‘legitimate medical purpose’ within the meaning of 21

C.F.R. § 1306.04 (2001).” Ashcroft Directive, 66 Fed.

Reg. at 56,608. The Petitioners point to General Ash-

croft’s warning that prescribing a controlled substance

to assist suicide may render a physician’s registration

subject to suspension or revocation under section

824(a)(4). This statement was not an interpretation of

55a

the Controlled Substances Act, however, but an ex-

planation of the logical consequences flowing from

General Ashcroft’s interpretation of 21 C.F.R.

§ 1306.04. If assisting suicide is not a “leyitimate medi-

cal purpose,” the direct result is that a physician cannot

prescribe controlled substances for this purpose with-

out violating Controlled Substances Act section 829 and

thereby risking suspension or revocation of their

registration under sections 823 and 824. See 21 U.S.C.

§ 823(f)(4) (stating that a physician’s violation of federal

law is relevant to determine if his registration is incon-

sistent with the public interest); id. § 824(a)(4) (pro-

viding that a physician’s registration may be revoked

for acts inconsistent with the public interest under

section 823). Petitioners’ contention that General

Ashcroft was interpreting the word “practitioner”

under 21 U.S.C. § 829 is likewise wrong. Nothing in the

Ashcroft Directive turns upon the definition of “practi-

tioner.” Thus, the Ashcroft Directive qualifies for

Thomas Jefferson’s highly deferential standard of re-

view.

Applying the Thomas Jefferson standard, I have no

trouble upholding the Ashcroft Directive from Peti-

ve a attack. As the Office of Legal Counsel con-

cluded:

[T]he overwhelming weight of authority in judicial

decisions, the past and present policies of nearly all

of the States and of the Federal Government, and

the clear, firm and unequivocal views of the leading

associations within the American media! and nurs-

ing professions, establish that assisting in suicide is

not an activity undertaken in the course of pro-

fessional medical practice and is not a legitimate

medical purpose. Indeed, we think it fair to say that

56a

physician-assisted suicide should not be considered a

medical procedure at all. . . . It is plainly a fallacy

to assume that a procedure must be “medical”

because it is performed by a physician rather than,

say, by a family member, or because it involves the

use of a drug that a physician has prescribed.

Memorandum at 13-14; see also Ashcroft Directive,

66 Fed. Reg. at 56,608 (stating that the Memorandum

“sets forth the legal basis for my decision”). In Glucks-

berg, the Supreme Court offered a similar assessment:

“opposition to and eendemnation of suicide—and,

therefore, of assisting suicide—are consistent and

enduring themes of our philosophical, legal, and cultural

heritages. More specifically, for over 700 years, the

Anglo American common-law tradition has punished or

otherwise disapproved of both suicide and assisting

suicide.” Glucksberg, 521 U.S. at 711, 117 S. Ct. 2258

(internal citations omitted). Given this overwhelming

historical, legal, and medical consensus that physician-

assisted suicide is not a legitimate medical purpose, the

Ashcroft Directive clearly satisfies Thomas Jefferson.

Therefore, I would defer to the Ashcroft Directive’s

conclusion that physician-assisted suicide is not a

“legitimate medical practice” under 21 C.F.R.

§ 1306.04(a).

IV.

Although I concur with the majority’s brief dis-

cussion on justiciability and its conclusion as to our

jurisdiction, I write separately to address the latter, as

it is contested by the parties and resolved improperly

by the district court, yet given scant attention by the

majority. The majority suggests that Hemp Industries

Association v. DEA, 333 F.3d 1082 (9th Cir. 2003), is

57a

dispositive, but Hemp Industries declined to answer

the precise question at issue here; that is, we left open

“whether we would have original jurisdiction over an

interpretive rule.” Jd. at 1085. A more thorough

analysis is therefore needed to determine whether the

Ashcroft Directive, which by its terms is an inter-

pretive rule, is a “final determination” within the

meaning of 21 U.S.C. § 877 over which we would have

jurisdiction.

Section 877 provides that “[{a]ll final determinations,

findings, and conclusions of the Attorney General under

this subchapte* shall be final and conclusive decisions of

the matters involved.” 21 U.S.C. § 871. The section

provides us original jurisdiction where “any person

aggrieved by a final decision of the Attorney General”

seeks “review of the decision.” Jd. Significantly, the

Ashcroft Directive echoes the language of this pro-

vision by “advis[ing] . . . that the original DEA deter-

mination is reinstated and should be implemented.”

Ashcroft Directive, 66 Fed. Reg. 56,608 (emphasis

added); see also, e.g., id. (“I hereby determine that

assisting suicide is not a ‘legitimate medical purpose’

within the meaning of 21 C.F.R. § 1306.04 (2001). . . .”

(emphasis added)); id. (“I hereby direct the DEA . . .

to enforce and apply this determination. . . .”

(emphasis added)). Although helpful, the Attorne

General’s choice of words does not necessarily mean his

“determination” is “final.”

The district court held that the Ashcroft Directive is

not “final” because General Ashcroft kept his own

counsel, gave no notice or opportunity for comment,

took no evidence, and did not produce an administrative

record. As the district court observed, there is a

paucity of appellate court decisions analyzing section

58a

877’s requirements for review. In order to respond to

the district court’s argument, therefore, | must reason

by analogy and look to general principles of admini-

strative law formulated under the APA. See U.S. West

Communications, Inc. v. Hamilton, 224 F.3d 1049,

1054-55 (9th Cir. 2000) (using the APA’s definition of

“final” to interpret “final orders” under the Hobbs Act).

For an agency action to be final under the APA, the

agency need not obtain outside advice. It need not give

notice and an opportunity to comment. Guadamuz v.

Bowen, 859 F.2d 762, 771 (9th Cir. 1988). Absent a con-

trary command under the governing statute, the

agency need not produce an administrative record,

especially for review of purely legal questions such as

those in the case before us.

As the Supreme Court held in Bennett v. Spear, 520

U.S. 154, 117 S. Ct. 1154, 187 L. Ed. 2d 281 (1997), an

agency action is “final” under the APA if it satisfies two

criteria: (1) “the action must mark the consummation of

the agency’s decision making process—it must not be of

a merely tentative or interlocutory nature”; and (2) “the

action must be one by which rights or obligations have

been determined, or from which legal consequences will

flow.” Id. at 177-78, 117 S. Ct. 1154 (internal citations

and quotation marks omitted). In evaluating whether

an agency action meets these conditions, relevant con-

siderations include: (a) whether the action is a “defini-

tive statement of an agency’s position,” (b) whether it

has a “direct and immediate effect on the complaining

parties,” (c) whether it “has the status of law,” and (d)

whether it “requires immediate compliance.” Assn. of

Am. Med. Colls. v. United States, 217 F.3d 770, 780 (9th

Cir. 2000).

59a

As an interpretive rule, the Ashcroft Directive does

not have the “force of law.” Hemp Indus. Ass’n, 333

F.3d at 1087. Nevertheless, this does not necessarily

preclude the Ashcroft Directive from constituting

a “final determination.” In Abbott Laboratories v.

Gardner, 387 U.S. 136, 87 S. Ct. 1507, 18 L. Ed. 2d

681 (1967), overruled on other grounds, Califano v.

Sanders, 430 U.S. 99, 97 S. Ct. 980, 51 L. Ed. 2d 192

(1977), the Supreme Court announced that finality is to

be interpreted “in a pragmatic way,” meaning that even

pre-enforcement regulations that merely state an

agency’s intentions may be final for review. Jd. at 149-

50, 87 S. Ct. 1507; see also Alaska v. EPA, 244 F.3d 748,

750 (9th Cir. 2001) (order) (holding that the EPA’s pre-

enforcement order to invalidate a permit was final).

Because an interpretive rule can be a final order, and

because “final orders” are analytically equivalent to

“final agency actions,” U.S. West Communications, 224

F.3d at 1055, it follows that interpretive rules can

constitute final agency actions under the APA. Thus,

the Ashcroft Directive may qualify as a final agency

action notwithstanding the fact that it has not been

enforced and does not have the force of law.

Turning to the first Bennett requirement, the Ash-

croft Directive clearly marks the consummation of the

Attorney General’s decision making process even

though it is a nonbinding, pre-enforcement, interpretive

rule. The Ashcroft Directive reflects internal agency

deliberation, on a matter of public importance, and com-

mands immediate implementation. Eschewing tenta-

tive or equivocal words, it speaks in the immediate and

imperative language of final agency action. See

Ashcroft Directive, 66 Fed. Reg. at 56,608 (“I hereby

direct the DEA . . . to enforce and apply this

60a

determination. . . .”); accord Nat'l Automatic

Laundry & Cleaning Council v. Shultz, 443 F.2d 689,

702 (D.C. Cir. 1971) (holding that “when [an agency’s]

interpretation is not labeled as tentative or otherwise

qualified by arrangement for reconsideration” there is

“no basis” for concluding that the “‘agency action’ is

‘not final’ for purposes of the APA and judicial re-

view”). The Ashcroft Directive purports to be the

Attorney General's interpretation, not the interpreta-

tion of an underling whose view may be overruled.

Accord Nat'l Automatic Laundry, 443 F.2d at 701

(reasoning that “with the authoritative interpretative

ruling by the [agency head,] the agency’s interpretative

action has come to an end, and there is no fair basis for

saying this process will be disrupted by judicial

review”). In addition, the Attorney General’s decision

to publish the Ashcroft Directive in the Federal

Register, rather than simply issue a press release or

send an opinion letter to a private party, indicates that

the Ashcroft Directive represents the consummation of

his decision-making process. For these reasons, the

Ashcroft Directive clearly satisfies the first Bennett

inquiry.

The next question under Bennett is whether legal

consequences flow from the agency action. 520 U.S. at

178, 117 S. Ct. 1154. Relevant factors include whether

the agency action has a “direct and immediate effect”

on the complaining parties and requires their “immedi-

ate compliance.” Am. Med. Colls., 217 F.3d at 780. As

explained previously, an interpretive rule may be a

final agency action even though it is not legally binding.

The Ashcroft Directive satisfies this second require-

ment as well. Although it may not have the force of

law, the Ashcroft Directive significantly and immedi-

6la

ately alters the legal landscape for Oregon physicians.

See Bennett, 520 U.S. at 178, 117 S. CL 1154 holding

that an agency action met this requirement because it

had similar “direct and appreciable legal conse-

quences”); Abbott Labs., 387 U.S. at 152-53, 87 S. Ct.

1507 (holding that where plaintiffs must either comply

with unfavorable regulations immediately or “risk

serious criminal and civil penalties,” the agency action

satisfies this requirement). The Ashcroft Directive

“direct[s] the DEA, effective upon publication of this

memorandum in the Federal Register, to enforce and

apply” the Attorney General’s interpretation of 21

C.F.R. § 1306.04(a). This instruction created direct and

immediate consequences for physicians who wish to

prescribe controlled substances for assisted suicide.

It is of no moment that physicians will not experience

the Ashcroft Directive’s concrete legal effects unless

they actually choose to prescribe controlled substances

for assisted suicide. An agency 2_tion can be final even

if its concrete legal effects are contingent upon a future

event. City of Fremont v. FERC, 336 F.3d 910, 914 (9th

Cir. 2003) (concluding that agency orders that attach

legal consequences to future proceedings are final for

judicial review). The Ashcroft Directive requires the

physicians’ immediate compliance. Thus, it satisfies

Bennett's second requirement for finality.

Because the Ashcroft Directive constitutes a final

agency action under Bennett, the instant petition for

review falls squarely within this court’s original juris-

diction. I therefore concur in the majority’s assessment

that the district court was without jurisdiction and the

petition should be considered transferred to this court

under 28 U.S.C. § 1631.

62a

V.

Although I am convinced of the merits of my legal

argument, I admit that even if I persuaa 1 one of my

colleagues to join me, my opinion would not be a final

chapter. Those who are uneasy with my position (as I

assume Petitioners will be) should see its limited grasp.

The Ashcroft Directive constitutes a final agency

action, but it surely will not be the last word on

physician-ass.sted suicide. The Ashcroft Directive does

not spell the end of the public’s “earnest and profound

debate about the morality, legality, and practicality of

physician-assisted suicide,” Glucksberg, 521 U.S. at 735,

117 S. Ct. 2258, nor does it halt states’ “extensive and

serious evaluation of physician-assisted suicide and

other related issues,” Glucksberg, 521 U.S. at 736, 737,

117 S. Ct. 2258 (O’Connor, J., concurring). State legis-

lators may supplement the Ashcroft Directive’s sanc-

tions, and they may authorize alternative methods for

assisting suicide that do not involve the prescription of

controlled substances. :

More to my point, the Ashcroft Directive is not even

an immutable expression of federal policy. A change in

presidential administrations or a shift in the current

President or Attorney General’s perspective might

precipitate the Ashcroft Directive’s rescission. Cer-

tainly, Congress is free to enact legislation limiting

or counteracting the Ashcroft Directive’s effects.

Although opinions differ over the propriety of assisted

suicide, I fully subscribe to Justice O’Connor’s canny

observation that there is simply “no reason to think

that the democratic process will not strike the proper

balance between the interests of terminally ill, mentally

competent individuals who would seek to end their

suffering and the [government)’s interests in protecting

63a

those who might seek to end life mistakenly or under

pressure.” Jd. In short, we should trust the democratic

process.

Thus, the discrete question before this court is a

narrow one: is the Attorney General’s interpretation of

21 C.F.R. § 1306.04 entitled to deference? Nothing in

the Controlled Substances Act’s text or legislative

history authorizes the majority to deny deference to the

Ashcroft Directive. As an interpretive rule, the Ash-

croft Directive is not subject to the APA’s notice-and-

comment rulemaking procedures. It does not violate

the Controlled Substances Act’s nonpreemption pro-

vision. It neither exceeds the Attorney General’s statu-

tory authority under the Controlled Substances Act nor

“push[es] the limit of congressional authority” under

the Commerce Clause. Solid Waste, 531 U.S. at 173,

121 S. Ct. 675. Petitioners have not demonstrated that

the Ashcroft Directive’s interpretation of section

1306.04 is arbitrary and capricious. For these reasons,

firmly established principles of administrative law

formulated by the Supreme Court and our court com-

mand us to defer to the Attorney General’s interpreta-

tion of section 1306.04.

Therefore, I dissent.

64a

APPENDIX B

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF OREGON

No. 01-1647-JO

STATE OF OREGON, PLAINTIFF

AND

PETER A. RASMUSSEN; ETAL.,

PLAINTIFF-INTERVENORS

Vv.

JOHN ASHCROFT, IN HIS OFFICIAL CAPACITY AS

UNITED STATES ATTORNEY GENERAL;

ASA HUTCHINSON, IN HIS OFFICIAL CAPACITY AS

ADMINISTRATOR OF THE DRUG ENFORCEMENT

ADMINISTRATION; KENNETH W. MAGEE, IN HIS

OFFICIAL CAPACITY AS DIRECTOR OF THE

DRUG ENFORCEMENT ADMINISTRATION, PORTLAND

OFFICE; UNITED STATES OF AMERICA;

UNITED STATES DEPARTMENT OF JUSTICE; AND

UNITED STATES DRUG ENFORCEMENT

ADMINISTRATION, DEFENDANTS-APPELLANTS

April 17, 2002

OPINION AND ORDER

Before: ROBERT E. JONES, District Judge.

INTRODUCTION

After surviving voter and legal challenges, the 1994

Oregon Death with Dignity Act (“Oregon Act”), O.R.S.

127.800 et seq, finally went into effect in October 1997.

65a

On November 6, 2001, with no advance warning to

Oregon representatives, Attorney General John Ash-

croft (herein referred to as “Ashcroft”) fired the first

shot in the battle between the state of Oregon and the

federal government over which government has the

ultimate authority to decide what constitutes the

legitimate practice of medicine, at least when schedule

II substances regulated under the Controlled Sub-

stances Act (“CSA”), 21 U.S.C. § 801 et seq, are in-

volved. Ashcroft began the battle by issuing the so-

called “Ashcroft directive,”—a few paragraphs pub-

lished in the Federal Register on November 9, 2001, in

which Ashcroft declares, in relevant part, that

¢ controlled substances may not be dispensed

to assist suicide, thus reversing the position

taken by his predecessor, Attorney General

Janet Reno, in June 1998.

¢ assisting suicide is not a “legitimate medical

purpose” and that prescribing, dispensing, or

administering federally controlled substances

to assist suicide violates the CSA.

¢ prescribing, dispensing, or administering

federally controlled substances to assist

suicide may “render [a physician’s] registra-

tion * * * inconsistent with the public

interest” and therefore subject to possible

suspension or revocation under 21 U.S.C.

§ 824(a)(4).

66 FR 56608 (Nov. 9, 2001).

Through his directive, Ashcroft evidently sought to

stifle an ongoing “earnest and profound debate” in the

various states concerning physician-assisted suicide.

66a

Washington v. Glucksberg, 521 U.S. 702, 735, 117 S. Ct.

2258, 138 L. Ed. 2d 772 (1997). In Glucksberg, the

Supreme Court was called upon to decide whether the

state of Washington’s statutory ban on assisted suicide

violated the Due Process Clause. In a thoughtful

opinion, the Court acknowledged that “[t]hroughout the

Nation, Americans are engaged in an earnest and pro-

found debate about the morality, legality and practi-

cality of physician-assisted suicide.” The Court re-

counted the various states’ “serious, thoughtful exami-

nations” of the issues in this difficult debate, including

Oregon’s 1994 enactment of the Oregon Act. See 521

U.S. at 716-19, 117 S. Ct. 2258. The Court declined to

“strike down the considered policy choice” of the State

of Washington, deferring instead to that state’s re-

solution of the debate. 521 U.S. at 719, 724, 735, 117 S.

Ct. 2258.

In her concurring opinion in Glucksberg, Justice

O’Connor further elaborated that

[t]here is no reason to think the democratic process

will not strike the proper balance between the

interests of terminally ill, mentally competent

individuals who would seek to end their suffering

and the State’s interests in protecting those who

might seek to end life mistakenly or under pressure.

* * * States are presently undertaking extensive

and serious evaluation of physician-assisted suicide

and other related issues. * * * In such circum-

stances, “the . . . challenging task of crafting

appropriate procedures for safeguarding ,

liberty interests is entrusted to the ‘laboratory’ of

the States . . . in the first instance.”

67a

Glucksberg, 521 U.S. at 737, 117 S. Ct. 2258 (O’Connor,

J., concurring) (citations omitted).

As the Court acknowledged in Glucksberg, the

citizens of Oregon, through their democratic initiative

process, have chosen to resolve the moral, legal, and

ethical debate on physician-assisted suicide for them-

selves by voting—not once, but twice—in favor of the

Oregon Act. The Oregon Act attempts to resolve this

“earnest and profound debate” by “strik[ing] the proper

balance between the interests of terminally ill, mentally

competent individuals who would seek to end their

suffering and the State’s interests in protecting those

who might seek to end life mistakenly or under pres-

sure.” Glucksberg, 521 U.S. at 737, 117 S. Ct. 2258

(O’Connor, J., concurring).

With publication of the Ashcroft directive, Ashcroft

essentially nullified the Oregon Act and four years of

Oregon experience in implementing it. In response to

what it perceived as an unwarranted and unauthorized

intrusion into the sovereign interests of Oregon, the

medical practices of Oregon physicians, and the end-of-

life decisions made by terminally-ill Oregonians, plain-

tiff state of Oregon (“plaintiff”) immediately com-

menced this lawsuit to, among other things, enjoin

Ashcroft and the other defendants’ from giving the

Ashcroft directive any legal effect. A temporary

' The defendants are John Ashcroft, Asa Hutchinson in his

official capacity as Administrator of the Drug Enforcement

Agency (“DEA”), Kenneth Magee in his official capacity as

Director of the DEA in Portland, Oregon, the United States, the

United States Department of Justice, and the DEA.

68a

restraining order, issued on November 8, 2001, remains

in effect.”

Despite the enormity of the debate over physician-

assisted suicide, the issues in this case are legal ones

and, as pertain to my disposition, are fairly narrowly

drawn. My resolution of the legal issues does not

require any delving into the complex religious, moral,

ethical, medical, emotional or psychological contro-

versies that surround physician-assisted suicide or

“hastened death” (as the parties sometimes describe it),

because in Oregon, those controversies have been—for

now—put to rest.

The case presently is before me on several motions:

(1) plaintiff's motion for summary judgment (# 111); (2)

intervenors’ motions for summary judgment or partial

summary judgment (## 85, 101); and (3) defendants’

motion to dismiss and alternative motion for summary

judgment (# 133). For the reasons stated below, I grant

plaintiff's and intervenors’ motions for summary judg-

ment in part and today enter a permanent injunction

enjoining defendants from enforcing, applying, or

otherwise giving any legal effect to the Ashcroft direc-

tive at issue in this case. Those portions of plaintiff's

and intervenors’ motions not addressed in this opinion

are denied as moot.’ Defendants’ motion to dismiss and

alternative motion for summary judgment are denied.

2 The procedural history of this case is discussed more fully

below.

8 The patient intervenors also filed a motion for class certifi-

cation (# 41). During the hearing on March 22, 2002, defendants

agreed not to object to the addition or substitution of new patient

plaintiffs as needed to continue the viability of patient-plaintiffs’

claims in this action. Patient-plaintiffs remain concerned, however,

so I have included in the injunction language prohibiting defen-

69a

FACTUAL AND PROCEDURAL

BACKGROUND

1. The Controlled Substances Act

Congress enacted the CSA, 21 U.S.C. §§ 801-950, as

Title II of the Comprehensive Drug Abuse Prevention

and Control Act of 1970. The CSA provides a compre-

hensive federal scheme for regulation and control of

certain drugs and other substances. The congressional

findings supporting Title II reveal that Congress’

overarching concern in enacting the CSA was the prob-

lem of drug abuse and illegal trafficking in d S

21 U.S.C. § 801. oe

The CSA establishes five schedules of controlled sub-

stances, ranging from schedule I substances, which

have no accepted medical use and can be utilized only in

very limited contexts, to schedules II, III, IV, and V

substances, which have recognized uses and can be

manufactured, distributed, possessed and used, subject

to the restrictions of the CSA. See 21 U.S.C. §§ 812,

841. The CSA sets forth initial schedules, 21 U.S.C.

§ 812(c), and specifies procedures by which the

Attorney General may add, remove, or transfer sub-

stances to or between schedules. 21 U.S.C. § 811.

The CSA makes it unlawful for any person to manu-

facture, distribute, or dispense any controlled substance

“le]xcept as authorized by [the CSA].” 21 U.S.C.

§ 841(a)(1). As pertinent in this case, physicians who

prescribe controlled substances and pharmacists who

fill the prescriptions are considered “practitioners” who

dants from objecting to additions or substitutions of patients

during the pendency of this case. In view of defendants’ agree-

ment and the injunction, the motion for class certification is denied.

70a

“dispense” controlled substances. 21 U.S.C. § 802(10)

and (21). To obtain authorization to do so, practitioners

must register with the Attorney General and obtain

a Drug Enforcement Agency (“DEA”) certificate of

registration. 21 U.S.C. § 822.

Under the CSA as originally enacted, state-licensed

practitioners were entitled to be registered with the

DEA as a matter of right. See 21 U.S.C. § 823(f)(1983)

(“Practitioners shall be registered to dispense * * *

controlled substances in schedule II, III, IV, or V if

they are authorized to dispense * * * under the law of

the State in which they practice”); see also United

States v. Moore, 423 U.S. 122, 140-41, 96 S. Ct. 335, 46 L.

Ed. 2d 333 (1975) (registration mandatory if applicant

authorized under state law). The Attorney General

could suspend or revoke a practitioner’s registration

only if the registrant (1) materially falsified an applica-

tion; (2) was convicted of a felony relating to controlled

substances; or (3) had his or her state license or regis-

tration suspended or revoked. See 21 U.S.C. § 824(a)

(1983).

Congress has amended the CSA many times since

1970. See Oregon’s Memorandum in Support of Motion

for Summary Judgment, p. 4 n. 22 (amendments cited).

With each amendment, Congress further attempted to

address the problems of drug abuse and illegal traf-

ficking in drugs. In 1984, apparently concerned with

the domestic diversion of otherwise legitimate medical

controlled substances into the illegal market by regis-

tered practitioners, Congress again amended the CSA.

As pertinent here, the 1984 amendment empowered the

Attorney General to deny, suspend, or revoke a prac-

titioner’s DEA registration if the Attorney General

“determines that the issuance of such registration

Tla

would be inconsistent with the public interest.” 21

U.S.C. § 823(f); see also 21 U.S.C. § 824(1)(4).

In 1971, under authority delegated by the Attorney

General pursuant to 21 U.S.C. § 871(a), the predecessor

to the Administrator of the DEA‘ adopted formal

regulations implementing the CSA. One of the regula-

tions, now codified at 21 C.F.R. § 1306.04, provides, in

relevant part:

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. * * * An

order purporting to be a prescription issued not in

the usual course of professional treatment or in

legitimate and authorized research is not a pre-

scription within the meaning and intent of section

309 of the Act (21 U.S.C. § 829) and the person

knowingly filling such a purported prescription, as

well as the person issuing it, shall be subject to the

penalties provided for violations of the provisions of

law relating to controlled substances.

21 C.F.R. § 1306.04(a)(emphasis added).

2. Tie Oregon Death with Dignity Act

In November 1994, Oregon voters enacted the

Oregon Act through the initiative process. Having sur-

vived legal challenges, see Lee v. State of Or., 891 F.

Supp. 1429 (D. Or. 1995) (Oregon Act does not provide

sufficient safeguards for terminally ill persons and

therefore violates the Equal Protection Clause), va-

* The predecessor agency was the Bureau of Narcotics and

Dangerous Drugs.

72a

cated 107 F.3d 1382 (9th Cir. 1997), and an initiative

that would have repealed it, the Oregon Act went into

effect in October 1997.

The Oregon Act provides a detailed procedure by

which a mentally competent, terminally ill patient may

make a written requ*t ‘or medication “for the purpose

of ending his or her life in a humane and dignified

manner * * *.” O.R.S. 127.805(1). Once a valid

request has been properly documented and all waiting

periods have expired, the attending physician may

prescribe, but not administer, medication to enable the

patient to take his or her own life. Physicians and

pharmacists are immune from civil and criminal liability

and any adverse disciplinary action for participating in

good faith compliance with the Oregon Act. See gen-

erally O.R.S. 127.805-.885; see also Affidavit of Stephen

Bushong (“Bushong Aff.”), Exh. 5, pp. 1-2.

Since 1997, the Oregon Act has been utilized by

approximately 70 terminally ill Oregonians. Although

defendants quibble somewhat with the data,’ the

parties appear to agree that these patients all utilized

medications that are listed as schedule II controlled

substances under the CSA.

3. Events Giving Rise to This Action

On July 27, 1997, Senator Orrin Hatch and Repre-

sentative Henry Hyde sent a letter to the Administra-

tor of the DEA advocating an interpretation of the CSA

that would, in effect, permit the DEA to revoke the

5 Defendants state that they have not been provided data

from which they can verify whether controlled substances were

utilized by all patients. See Defts.’ Response to Plaintiff Stave of

Oregon’s Concise Statement of Material Facts, 4 2.

73a

registrations of physicians and pharmacists who take

actions authorized by the Oregon Act. See Bushong

Aff., Exh. 1. In late October 1997, Hatch and Hyde sent

a second letter to the DEA, expressing “heightened

* * * urgency” resulting from the United States

Supreme Court’s decision to deny certiorari in Lee v.

State of Or., supra, which had, until then, kept the

Oregon Act from going into effect. Bushong Aff.,

Exhibit 2. The second letter included a memorandum

that purported to provide a legal basis for a proposed

interpretation of the CSA that would make it illegal to

prescribe controlled substances for the purpose of

assisted suicide. Bushong Aff., Exh. 2, pp. 4-7.

On November 5, 1997, then-DEA Administrator

Thomas Constantine wrote Hyde a letter in which he

expressed the opinion that

delivering, dispensing or prescribing a controlled

substance with the intent of assisting a suicide

would not be under any current definition a “legiti-

mate medical purpose.” As a result, the activities

that you described in you[r] letter to us would be, in

our opinion, a violation of the CSA.

x * *

DEA must examine the facts on a case-by-case basis

to determine whether a physician’s actions conflict

with the CSA. If the facts indicate that a physician

has acted as set forth in your letter, however, then

DEA would have a statutory basis to initiate re-

vocation proceedings.

Bushong Aff., Exh. 3.

74a

By letter dated December 3, 1997, Oregon Deputy

Attorney General David Schuman, Ph.D., J.D., a noted

constitutional scholar and former Professor of Law,

University of Oregon, wrote to Jonathan Schwartz of

the United States Department of Justice (“USDOJ”)

urging USDOJ to reconsider the DEA’s position.

Bushong Aff., Exh. 4. After considering Oregon’s re-

sponse and making her own evaluation, on June 5, 1998,

then-Attorney General Janet Reno responded to

Hyde’s “request concerning the question whether the

Department of Justice, through the [DEA], may invoke

the [CSA] * * * to take adverse action against any

physicians who assist patients in ending their lives by

prescribing controlled substances.” Bushong Aff., Exh.

5. Reno stated that the USDOJ “has reviewed the

issue thoroughly” and has concluded that “the federal

government’s pursuit of adverse actions against Oregon

physicians who fully comply with that state’s Death

with Dignity Act would be beyond the purpose of the

CSA.” Bushong Aff., Exh. 5, pp. 1, 4, USDOJ’s opinion

was confirmed by letter to Oregon Attorney General

Hardy Myers the same day. See Bushong Aff., Exh. 6.

Between 1998 and 2000, two separate federal legis-

lative attempts to preempt the Oregon Act failed to

pass.” On February 2, 2001, Hardy Myers wrote to

newly-appointed Attorney General John Ashcroft

asking that “[i)f the current interpretation of the CSA

in relation to [the Oregon Act] is to be reexamined,”

® The Lethal Drug Abuse and Prevention Act of 1998, which

was introduced in Congress in 1998 and which would have pre-

empted the Oregon Act, failed to reach the floor of either the

House or the Senate. The Pain Relief Promotion Act of 1999

passed the House in 1999, but failed to reach the Senate floor for a

vote. See Bushong Aff., { 8.

T5a

Oregon representatives be given an opportunity to

meet with USDOJ representatives to discuss the issue.

Bushong Aff., Exh. 7. Two months later, on April 17,

2001, a representative of USDOJ wrote Myers on be-

half of Ashcroft, stating that

I am aware of no pending legislation in Congress

that would prompt a review of the Department’s

interpretation of the CSA as it relates to physician-

assisted suicide. Should such a review be com-

menced in the future, we would be happy to include

your views in that review.

Bushong Aff., Exh. 8 (emphasis added).

On June 27, 2001, two USDOJ attorneys, Sheldon

Bradshaw and Robert Delahunty, sent a “Memorandum

for the Attorney General” that reexamined, in great

detail, the then-existing USDOJ interpretation of the

CSA in relation to the Oregon Act. Bushong Aff., Exh.

9. Notwithstanding the assurances made on Ashcroft’s

behalf in April 2001, that “we would be happy to include

[Oregon’s] views in that review,” the 24-page memo-

randum evidently was researched and written without

any request for or consideration of Oregon data or com-

ments of Oregon representatives. The memorandum

was not disclosed to Oregon Attorney General Myers

until November 6, 2001. Bushong Aff., 4 10. Thus, the

Attorney General of the United States completely

ignored his earlier promise to the Oregon Attorney

General to ascertain Oregon’s views. In doing so, he

lost the opportunity to evaluate carefully the scienti-

fically conducted epidemiological studies of the Oregon

Act, and the excellent analysis of the multiple issues as

set forth in the briefs submitted by plaintiff and inter-

venors in these proceedings.

76a

On November 6, 2001, Ashcroft issued a memo-

randum to DEA Administrator Asa Hutchinson. This

memorandum, the so-called “Ashcroft directive,” relies

on the June 27, 2001, Bradshaw/Delahunty memo-

randum as “the legal basis for my [Ashcroft’s] decision.”

Defendants’ Opposition to Plaintiffs’ Motion for Pre-

liminary Injunction, Exhibit 1, p. 1. The Ashcroft direc-

tive reinstates the “original DEA determination,” and

directs the DEA to “enforce and apply this deter-

mination” upon publication in the Federal Register. /d.

at p. 2. Significantly for purposes of the present pro-

ceeding, the Ashcroft directive states:

I hereby determine that assisting suicide is not a

“legitimate medical purpose” within the meaning of

21 C.F.R. § 1306.04 (2001), and that the prescribing,

dispensing, or administering federally controlled

substances to assist suicide violates the CSA.

Id. at p. 1.

The Ashcroft directive was published in the Federal

Register on November 9, 2001. See Bushong Aff,

Exhibit 10. Before publication, defendants did not con-

sult with Oregon public officials, provide any not.ce to

them or to the Oregon general public, or provide any

opportunity for any public comment anywhere.

PROCEDURAL BACKGROUND

On November 7, 2001, plaintiff state of Oregon com-

menced this action by filing a complaint for declaratory

and injunctive relief together with a motion for a

temporary restraining order (“TRO”) or a preliminary

injunction to enjoin defendants from enforcing, apply-

ing, or otherwise giving any legal effect to the Ashcroft

directive pending further order of the court. Following

77a

a hearing on November 8, 2001, I granted plaintiff's

motion and entered a TRO. I also granted motions to

intervene filed by Peter Rasmussen, M.D., and David

Hochhalter, Rph, and by certain terminally-ill patients’

(together, the “intervenors”).

On November 20, 2001, I held a full hearing on

plaintiff's and intervenors’ motions for preliminary in-

junction. Following the hearing, I continued the TRO

and established a briefing schedule for the parties’

dispositive motions. In mid-January 2002, a second

group of patients sought and were granted leave to

intervene.

On March 22, 2002, I held a full hearing on the merits

of the pending motions. Following the hearing, I took

the motions under advisement. I have reviewed and

thoroughly considered the parties’ arguments and sub-

missions, as well as the submissions of the numerous

amici curiae.”

As I suggested to the parties during the March hear-

ing, the resolution of this case turns on the CSA and

does not require constitutional analysis. As did former

Attorney General Reno almost four years ago, I con-

clude that Congress did not intend the CSA to override

7 Although I granted the individual patients’ motion to

intervene, I denied intervenor status to the organization, Com-

passion in Dying of Oregon.

8 Amici curiae briefs have been filed on behalf of the following:

New York Physicians, ACLU Foundation of Oregon, Inc.,

Association of the Bar of the City of New York, Surviving Family

Members, Autonomy, Inc., et al, American Academy of Pain Man-

agement, et al, Coalition of Mental Health Professionals, Not Dead

Yet, et al, National Right to Life Committee and Oregon Right to

Life, and the Family Research Council. The court thanks all amici

for their valuable and insightful submissions.

78a

a state’s decisions concerning what constitutes legiti-

mate medical practice, at least in the absence of an

express federal law prohibiting that practice. Similarly,

I conclude that Congress never intended, through the

CSA or through any other current federal law, to grant

blanket authority to the Attorney General or the DEA

to define, as a matter of federal policy, what constitutes

the legitimate practice of medicine.

Moreover, while I tend to agree with plaintiff and

intervenors that the Ashcroft directive fails to pass

muster as a matter of administrative law,’ I decline to

resolve this case on “ist basis. Whether characterized

as a substantive or an interpretative rule, the fact

remains that the Ashcroft directive exceeds the author-

ity delegated to the defendants under the CSA.

DISCUSSION

I. Defendants’ Motion to Dismiss

For the first time in this proceeding, defendants

challenge this court’s subject matter jurisdiction over

plaintiffs and intervenors’ claims. Defendants maintain

that under 21 U.S.C. § 877, exclusive jurisdiction to re-

view the Ashcroft directive rests with the courts of

appeals. Section 877 provides:

% The Ashcroft directive bears little similarity to another

alleged “interpretive rule” recently issued under the CSA. That

rule, which was brought to the court’s attention as supplemental

authority by defendants, serves to underscore how hastily the

Ashcroft directive appears to have been crafted and published.

See Notice of Filing Supplemental Authority in Support of

Defendants’ Motion to Dismiss (Order in Hemp Industries

Associationl v. DEA, No. 01-71662 (9th Cir. March 7, 2002)); see

also 66 FR 51530, 51535, and 51539 (Oct. 9, 2001).

79a

All final determinations, findings, and conclusions

of the Attorney General under this subchapter shall

be final and conclusive decisions of the matters

involved, except that any person aggrieved by a

final decision of the Attorney General may obtain

review of the decision in the United States Court of

Appeals for the District of Columbia or for the

circuit in which his principal place of business is

located upon petition filed with the court and

delivered to the Attorney General within 30 days

after notice of the decision. Findings of fact by the

Attorney General, if supported by substantial

evidence, shall be conclusive.

According to defendants, the Ashcroft directive is a

“final determination” within the meaning of that pro-

vision.

There is little pertinent authority to inform my

decision on this issue. Two matters, however, are cer-

tain. First, defendants do not contend and could not

maintain any argument that plaintiff did not initiate

this action within 30 days after notice of Ashcroft’s

decision. See Transcript of Proceedings (“TR”) (March

22, 2002), pp. fi-52."° Second, although in their motion,

defendants insist that this action must be dismissed,

they now agree that if this court should decide that

section 877 divests jurisdiction, transfer to the Ninth

10 See Nutt v. Drug Enforcement Admin., 916 F.2d 202, 204 n. 2

(5th Cir. 1990) (district court could cure jurisdictional defect

caused by petitioner’s failure to timely file petition for review of

agency decision in court of appeals by transferring the petition

pursuant to 28 U.S.C. § 1631).

80a

Circuit Court of Appeals pursuant to 28 U.S.C. § 1631

would be appropriate." Jd. at p. 50.

After careful consideration of this question, I con-

clude that the Ashcroft directive, however it is char-

acterized, is not a final determination, finding, or con-

clusion within the meaning of section 877. Although the

correct answer to this question is by no means clear, in

the balance I am persuaded that section 877 applies in

situations where the Attorney General makes a quasi-

judicial determination that resolves disputed facts in a

specific case after some level of administrative pro-

ceedings; for example, in classifying a substance under

section 811, or in denying, suspending, or revoking a

DEA registration under sections 823 or 824, and the

like. See, e.g., Humphreys v. Drug Enforcement

Admin., 96 F.3d 658 (3rd Cir. 1996) (appellate court

review of DEA revocation of physician’s registration);

Nutt v. Drug Enforcement Admin., 916 F.2d 202 (5th

Cir. 1990) (appellate court had jurisdiction to review

DEA revocation of physician’s registration). Section

877 may also, at least theoretically, apply where the

Attorney General undertakes formal rulemaking, which

1 28 U.S.C. § 1631 provides:

Whenever a civil action is filed in a court * * * or an

appeal, including a petition for review of administrative action,

is noticed for or filed with such a court and that court finds

that there is a want of jurisdiction, the court shall, if it is in the

interest of justice, transfer such action or appeal to any other

such court in whic. the action or appeal could have been

brought at the time it was filed or noticed, and the action or

appeal shall proceed as if it had been filed in or noticed for the

court to which it is transferred on the date upon which it was

actually filed in or nuticed for the court from which it is

transferred.

8la

he did not do in this case.” Those types of proceedings

“under this subchapter” produce administrative records

susceptible to review by an appellate court.

In this present case, in contrast, the Attorney

General essentially kept his own counsel, did not

provide notice or an opportunity for comment, did not

take any vidence, did not decide disputed facts, and

more importantly, did not produce an administrative

record. Instead, the only record with respect to the

Ashcroft directive is the one currently being created in

this court.

Moreover, even defendants appear to concede that

section 877 is not exclusive, recognizing that “plaintiffs

can obtain district court review only one way, by

demonstrating that the review provision is inapplicable

to their particular claim.” Memorandum in Support of

Defendants’ Motion (“Defendants’ Memorandum”), p.

10. In McNary v. Haitian Refugee Center, Inc., 498

U.S. 479, 111 S. Ct. 888, 112 L. Ed. 2d 1005 (1991), the

Supreme Court examined an Immigration and Nation-

ality Act provision that, similar to section 877, provided

for only a single level of review in the courts of appeals.

In ruling that the district court retained jurisdiction to

2 In this regard, I acknowledge defendants’ submission of

supplemental authority, Hemp Industries Association v. DEA, No.

01- 71662 (9th Cir.), which consists of a Ninth Circuit order staying

operation of a DEA “Interpretive Rule” pending a hearing of the

appeal on the merits. There is nothing before this court to suggest

that the issues in that case and this one are in any respect similar.

Moreover, defendants have themselves raised in Hemp the

question of whether a DEA interpretive rule is subject to review

under section 877. See Oregon Response to Notice of Filing of

Supplemental Authority, Exh. 1, p. 5. Finally, it does not appear

that the Ninth Circuit has determined that it in fact has juris-

diction to review the DEA interpretive rule under section 877.

82a

hear constitutional and statutory challenges to INS

procedures, the Court explained:

[I}t is unlikely that a court of appeals would be in a

position to provide meaningful review of the types

of claims raised in this litigation. * * * Not only

would a court of appeals * * * most likely not have

an adequate record * * * but it also would lack the

factfinding and record-developing capabilities of a

federal district court. * * * [S]tatutes that provide

for only a single level of judicial review in the court

of appeals “are traditionally viewed as warranted

only in circumstances where district court fact-

finding would unnecessarily duplicate an adequate

administrate record—circumstances that are not

present * * * where district court factfinding is

essential given the inadequate administrative re-

cord.”

McNary, 498 U.S. at 497, 111 S. Ct. 888 (citation

omitted).

In summary, I conclude that this court has subject

matter jurisdiction over plaintiff's and intervenors’

broad statutory, procedural, and constitutional chal-

lenges to the Ashcroft directive. Because, however, in

the inevitable appeal that will follow this decision the

Ninth Circuit might decide otherwise, I hereby find

that if there is a “want of jurisdiction” in this court,

then in the interests of justice transfer to the Ninth

Circuit Court of Appeals would be appropriate under 28

U.S.C. § 1631. See Intern. Broth. of Teamsters v. Dept.

of Transp., 932 F.2d 1292, 1298 (9th Cir. 1991) (“Juris-

dictional substance, rather than procedural niceties or

magic words, governs the propriety of transfers under

section 1631”).

83a

II. The Issue of Oregon’s Standing

Earlier in this case, defendants moved to dismiss the

state of Oregon for lack of standing. The parties

briefed the issue and I heard argument on it during the

November 20, 2001, hearing. I then entered an order

denying the motion “at this juncture.”

Defendants have not again raised the issue of Ore-

gon’s standing and, despite an invitation to do so (TR at

23), failed to argue or even mention standing during the

March 22, 2002, hearing. Although defendants’ silence

on this issue suggests that they now concede standing,

to put this matter firmly to rest, I hereby find that the

state of Oregon meets the statutory requirements for

standing under the Declaratory Judgment Act, 28

U.S.C. § 2201, the Administrative Procedures Act, 5

U.S.C. § 702, as well as under any prudential principles

that might apply. Oregon also meets the constitutional

requirements for standing under Article III of the

United States Constitution. Oregon has alleged and

proved a sufficient injury to its sovereign and legiti-

mate interest in the continued enforceability of its own

statutes. See, e.g., Maine v. Taylor, 477 U.S. 181, 187,

106 S. Ct. 2440, 91 L. Ed. 2d 110 (1986) (“a State clearly

has a legitimate interest in the continued enforceability

of its own statutes”); Bowen v. Public Agencies Op-

posed to Social Sec., 477 U.S. 41, 50 n. 17, 106 S. Ct.

2390, 91 L. Ed. 2d 35 (1986) (state had “judicially cog-

nizable interest in the preservation of its own sover-

eignty”); see also State of Alaska v. U.S. Dept. of

Transp., 868 F.2d 441, 443 n. 1 (D.C. Cir. 1989) (“Inas-

much as the States’ sovereign interest in law enforce-

84a

ment is sufficient to support standing, we need not

delve into the issue of parens patriae standing”)."

III. Cross-Motion. ‘or Summary Judgment

I now turn to the central substantive issue in this

case, whether the Ashcroft directive, which declares

that prescribing controlled substances to assist patient.

suicide is not a “legitimate medical purpose,” is author-

ized under the CSA and its implementing regulations.

Having carefully considered this matter, I conclude that

nothing in the plain language of the CSA or its legis-

lative history demonstrates Congress’ intent to grant

defendants the authority under the CSA to determine

that prescribing controlled substances for purposes of

physician-assisted suicide in compliance with Oregon

law is not a “legitimate medical purpose” under 21

C.F.R. § 1306.04(a).

I begin with the axiom that an administrative

agency’s power is limited to the authority delegated by

Congress. In re Altabon Foods, Inc., 998 F.2d 718, 719

(9th Cir. 1993), (citing Bowen v. Georgetown University

Hospital, 488 U.S. 204, 208, 109 S. Ct. 468, 102 L. Ed. 2d

493 (1988) (“agency’s power to promulgate legislative

regulations is limited to the authority delegated by

Congress”)). In defining the bounds of its regulatory

authority, “‘an agency may appropriately look to the

'8 As did the D.C. Circuit, I, too, decline to “delve into the issue

of parens patriae standing.” State of Alaska v. U.S. Dept. of

Transp., 868 F.2d 441, 443 n. 1 (D.C. Cir. 1989). I also note that

defendants do not challenge the patient-intervenors’ standing, and,

recognizing that five of the initial nine patients in this case have

died, have agreed to permit additional patients to join as plaintiff-

intervenors to “keep the case alive” and get “this issue resolved.”

Transcript of Proceedings (March 22, 2002), pp. 90-91.

85a

legislative history and underlying policies of its statu-

one grants of authority.’” Altabon Foods, 998 F.2d at

719 (quoting United States v. Riverside Bayview

Homes, Inc., 474 U.S. 121, 132, 106 S. Ct. 455, 88 L. Ed.

2d 419 (1985)). This court’s concomitant inquiry must

“‘focus on the language, structure, and legislative his-

tory of the CSA, with the primary goal of determin[ing]

the intent of Congress.’” Altabon Foods, 998 F.2d at

719-20 (quoting California v. Block, 663 F.2d 855, 860

(9th Cir. 1981)).

1. The Plain Language of the CSA Does Not Support

the Ashcroft Directive.

Defendants contend that the CSA authorizes the

Ashcroft directive because provisions of the statute

“plainly contemplate the existence of federal stan-

dards.” Defendants’ Memorandum, p. 20. According to

defendants, certain provisions are “directly controlling

here”:

that a “practitioner” must dispense controlled sub-

stances “in the course of professional practice

[§ 802(21) ], that a controlled substance cannot be

distributed “other than for a medical purpose

[$ 829(c) ], and that a prescription “must be issued

for a legitimate medical purpose” (21 C.F.R.

§ 1306.04) * * *.

Defendants’ Memorandum, p. 20. Defendants also point

to the rulemaking authority set forth in sections 821

and 871(b), the reference to “federal” control of drug

trafficking in section 801(6), the reference to “this sub-

chapter” in section 841(a), and the language that limits

registered persons to dispensing controlled substances

only “to the extent authorized by their registration and

in conformity with the other provisions of this sub-

86a

chapter.” 21 U.S.C. § 822(b); see Defendants’ Memo-

randum, pp. 20-21. Defendants find further significance

in the CSA scheduling provisions, specifically sections

811(a)(1) (Attorney General may by rule assign con-

trolled substances to schedules), and 812(b) (required

findings for schedules I V include consideration of any

“currently accepted medical use in treatment in the

United States”). Defendants’ Memorandum, p. 21.

Defendants urge the court to conclude that taken

together, these gleaned bits and pieces of statutory

language demonstrate Congress’ intent that federal,

rather than state, standards control the determination

of what medical practices are authorized under the CSA

with respect to controlled substances. In this regard, I

agree with plaintiff that defendants’ analysis, which

focuses on “isolated words or sentences” to discern

Congress’ intent, is contrary to accepted principles of

statutory construction. U.S. Nat. Bank of Or. v.

Independent Ins. Agents, 508 U.S. 439, 455, 113 S. Ct.

2173, 124 L. Ed. 2d 402 (1993).

In U.S. Nat. Bank, the Supreme Court emphasized

that it has “over and over * * * stressed that ‘ijn

expounding a statute, [the court] must not be guided by

a single sentence or member of a sentence, but look to

the provisions of the whole law, and to its object and

policy.’” Jd. at 455, 113 S. Ct. 2173 (quoting United

States v. Heirs of Boisdore, 49 U.S. (8 How.) 113, 122, 12

L. Ed. 1009 (1849) and noting that Boisdore’s has been

quoted in more than a dozen cases). Indeed, it is a

“‘fundamental canon of statutory construction that the

words of a statute must be read in their context and

with a view to their place in the overall statutory

scheme.’” FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120, 133, 120 S. Ct. 1291, 146 L. Ed. 2d 121

87a

(2000); see also Lexecon Inc. v. Milberg Weiss Bershad

Hynes, 523 U.S. 26, 36, 118 S. Ct. 956, 140 L. Ed. 2d 62

(1998) (central tenet of interpretation is that statute is

to be considered in all its parts when construing any

one of them).

Thus,

[a] court must * * * interpret the statute “as a

symmetrical and coherent scheme,” * * * and

“fit, if possible, all parts into an harmonious whole”

* * * Tn addition, [a court] must be guided to a de-

gree by common sense as to the manner in which

Congress is likely to delegate a policy decision of

such * * * political magnitude to an administrative

agency.

FDA v. Brown & Williamson, 529 U.S. at 133, 120 S.

Ct. 1291 (citations omitted).

It is undisputed that under the CSA, the Attorney

General and the DEA have broad authority to regulate

controlled substances. No provision of the CSA,

however, alone (as defendants urge) or viewed as a

“symmetrical and coherent scheme” demonstrates or

even suggests that Congress intended to delegate to

the Attorney General or the DEA the authority to

decide, as a matter of national policy, a question of such

magnitude as whether physician-assisted suicide con-

stitutes a legitimate medical purpose or practice.

Nor, as defendants propose, did the 1984 amend-

ments to the CSA delegate such authority. As

amended, section 823(f) permits the Attorney General

to deny an application for registration as “inconsistent

with the public interest” after consideration of the

following factors:

88a

(1) The recommendation of the appropriate State

licensing board or professional disciplinary

authority.

(2) The applicant’s experience in dispensing, or

conducting research with respect to controlled

substances.

(3) The applicant’s conviction record under

Federal or State laws relating to the manufacture,

distribution, or dispensing of controlled substances.

(4) Compliance with applicable State, Federal, or

local laws relating to controlled substances.

(5) such other conduct which may threaten th

public health and safety. r ible

The revocation section, § 824(a)(4), as amended, in-

cludes as a ground for revocation or suspension “such

acts as would render his registration under section 823

. he * inconsistent with the public interest as deter-

mined under such section.” Defendants read these

amendments, together with 21 C.F.R. § 1306.04, as sup-

plying evidence that Congress intended to expand the

Attorney General’s and the DEA’s authority to include

the power to define the parameters of legitimate

medical practices. I do not, however, read the CSA or

the 1984 amendments as containing—either explicitly

or implicitly—such a remarkable grant of power.

89a

2. The Legislative History of the CSA Does Not

Support the Ashcroft Directive.

As observed by Professor William Funk of the Lewis

and Clark Law School in his review of Justice Scalia’s

essay“ on legislative interpretation:

The legitimacy of legislative history as a means of

interpreting statutes, at least when they are un-

clear, is, rightly or wrongly, well established. Other

than Justice Thomas, no Justice seems interested in

adopting Justice Scalia’s rejection of legislative

history or his rejection of the notion of legislative

intent.

William Funk, Review Essay Faith in Texts—Justice

Scalia’s Interpretation of Statutes and the Constitu-

tion: Apostasy for the Rest of Us? 49 Admin. L. Rev.

825 (1997). Both sides in this controversy resort to

certain congressional comments and reports to buttress

their views of what Congress intended in enacting and

amending the CSA. Nothing in the legislative history

suggests, however, that anyone in Congress intended

the CSA to restrict or proscribe prescriptions for con-

trolled substances that might be used legitimately

under state law to assist suicide or hasten death. To

the contrary, the legislative history of both the 1970

enactment and the 1984 amendments overwhelming

support a conclusion that Congress’ intent was to

address problems of drug abuse, drug trafficking, and

diversion of drugs from legitimate channels to illegiti-

4 A MATTER OF INTERPRETATION: FEDERAL

COURTS AND THE LAW. An Essay by Antonin Scalia with

Commentary by Amy Gutmann, editor, Gordon S. Wood, Laurence

H. Tribe, Mary Ann Glendon, and Ronald Dworkin. Princeton:

Princeton University Press, 1997.

90a

mate channels. See United States v. Moore, 423 U.S.

122, 134-35, 96 S. Ct. 335, 46 L. Ed. 2d 333 (1975) (“Con-

gress was concerned with the nature of the drug trans-

action, rather than with the status of the defendant”).

The best defendants can produce in the way of

supportive legislative history is a vague comment by

one congressman, Representative Gillman, to the effect

that by amending the CSA, Congress wanted to “make

it easier” for the DEA to suspend or revoke the author-

ity of physicians who write or dispense prescriptions in

a way that is threatening to public health or safety, and

an equally curious reference from the House Com-

mittee report, which states:

Although the Committee is concerned about the

appropriateness of having federal officials deter-

mine the appropriate method of the practice of

medicine, it is necessary to recognize that for the

last 50 years this is precisely what has happened,

through criminal prosecution of physicians whose

methods of prescribing narcotic drugs have not

conformed to the opinions of federal prosecutors of

what constitutes appropriate methods of profes-

sional practice.

Defendants’ Memorandum, pp. 16-17.

What does this add to the issue at hand? I have

already explained that the core objective of the CSA

was to permit federal prosecution of drug dealers, drug

abusers, and “practitioners” who engage in the illegal

diversion and distribution of drugs. Defendants cannot

seriously conclude from the above-quoted language that

Congress delegated to federal prosecutors the author-

ity to define what constitutes legitimate medical prac-

9la

tices." To state the proposition is to refute it. Federal

prosecutors have never possessed such powers, and the

vagueness of the reference would render any alleged

violation based on a prosecutor’s subjective views about

medical practice patently unenforceabie.

Having served in the state legislature, I do not give

much credence to floor speeches or even committee

reports as representing the intent of a legislative body.

As many have observed in watching Congress at work,

members of Congress often speak about legislative

intent to an empty room, or place material prepared by

staff, lobbyists and the like into the congressional

record. To construe this as revealing legislative intent

defies reality and more often than not ignores the plain

meaning of the statute in favor of the subjective beliefs

of individual members of Congress, an extremely unre-

liable approach to statutory interpretation.”® As Justice

Scalia observed in his essay" and in his concurring

opinion in Conroy v. Aniskoff, 507 U.S. 511, 519, 118 S.

Ct. 1562, 123 L. Ed. 2d 229 (1993):

‘5 The case law defendants cite belies this conclusion. As dis-

cussed in the next portion of this decision, even in cases where a

doctor or pharmacist is a “drug pusher” or blatantly operates a

“pill mill,” the issue of whether the conduct is outside the normal

course of professional or medical practice is entrusted to a jury, to

decide the issue as mixed subjective-objective question of fact

under instructions based on community standards, not on some

national standard adopted as a federal regulation.

16 In contrast, carefully prepared advisory committee notes,

when officially adopted by a legislative body, can be exceedingly

helpful in interpreting statutes and rules. E.g., Federal Rules of

Civil Procedure; Federal Rules of Evidence.

7 See footnote 14, supra.

92a

Judge Harold Leventhal used to describe the use of

legislative history as the equivalent of entering a

crowded cocktail party and looking over the heads of

the guests for one’s friends.

Here, neither side has presented any convincing

relevant comment from friend or foe to reliably demon-

strate that Congress ever considered assisted suicide in

enacting or amending the CSA. Moreover, no legis-

lative history supports defendants’ theory that Con-

gress intended the 1984 amendments to “alter{ ] the

federal-state framework by permitting federal en-

croachment upon a traditional state power.” Solid

Waste Agency v. Army Corps of Engineers, 531 U.S.

159, 173, 121 S. Ct. 675, 148 L. Ed. 2d 576 (2001) (cita-

tion omitted). Thus, I need not determine the merit or

lack of merit of the legislative history, simply because

there is none on point.

3. The Case Law Does Not Support the Ashcroft

Directive.

The cases defendants cite as “equally clear that

federal law determines what medical practices are

authorized by the CSA,”" United States v. Moore,

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

Cir. 1975), United States v. Hayes, 794 F.2d 1348 (9th

Cir. 1986), United States v. Boettjer, 569 F.2d 1078 (9th

Cir. 1978), and U.S. v. Leal, 75 F.3d 219 (6th Cir. 1996),

do not advance their position. All involved criminal

proceedings against DEA registered physicians or

pharmacists whose activities fell far outside any

definition of the usual or accepted course of professional

medical practice. In none

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