STATE OF OREGON, Plaintiff-Appellee, v. 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.
No. 02-35587
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
368 F.3d 1118
May 7, 2003, Argued and Submitted, Portland, Oregon
May 26, 2004, Filed
SUBSEQUENT HISTORY: US Supreme Court certiorari granted by Gonzales
v. Oregon, 543 U.S. 1145 (2005)
Affirmed by Gonzales v. Oregon, 546 U.S. 243 (2006)
PRIOR HISTORY: Appeal from the United States District Court for
the District of Oregon. D.C. No. CV-01-01647-JO. Robert E. Jones, District Judge,
Presiding.
Oregon. v. Ashcroft, 192 F. Supp. 2d 1077 (D. Or. 2002)
COUNSEL: Gregory G. Katsas, Deputy Asst. Attorney General, Jonathan
H. Levy, and R. Craig Green, U.S. Department of Justice, Washington, D.C., for the
defendants/appellants.
Robert B. Rocklin, Asst. Attorney General, Oregon Department of Justice, Salem,
Oregon, for the plaintiff/appellee.
Eli D. Stutsman, Portland, Oregon; Nicholas W. van Aelstyn, Heller Ehrman White
& McAuliffe, San Francisco, California; and Kathryn L. Tucker, Compassion in
Dying Federation, Seattle, Washington, for the patient plaintiffs-intervenors/appellees.
Daniel Avila, Everett, Massachusetts; Gregory S. Baylor, Annandale, Virginia; Thane
W. Tienson, Landye Bennet & Brumstein, Portland, Oregon; Mark E. Chopko, Washington,
D.C.; Richard E. Coleson, Bobb, Coleson & Bostrom, Terre Haute, Indiana; Rebecca
P. Dick, Swidler Berlin Shereff & Friedman, Washington, D.C.; Donald A. Daugherty,
Jr., Michael Best & Friedrich, Milwaukee, Wisconsin; Robert A. Free, MacDonald,
Hoague & Bayless, Seattle, Washington; Katherine Heekin, Markowitz Herbold Glade
& Mehlhaf, Portland, Oregon; Arthur B. LaFrance, Portland, Oregon; Max Lapertosa,
Chicago, Illinois; Rita L. Marker, Steubenville, Ohio; Mitchell Olejko, Morrison
& Foerster, San Francisco, California; John H. Pickering, Wilmer, Cutler &
Pickering, Washington, D.C.; Wesley J. Smith, Oakland, California; William R. Stein,
Hughes Hubbard & Reed, Washington, D.C.; Joel H. Thornton, Washington, D.C.;
Thomas Triplett, Schwabe Williamson & Wyatt, Portland, Oregon; Harris J. Yale,
New York, New York; and Miles J. Zaremski, Schaumburg, Illinois, for the amici.
JUDGES: Before: Donald P. Lay, * J. Clifford Wallace, and Richard
C. Tallman, Circuit Judges. Opinion by Judge Tallman; Dissent by Judge Wallace.
OPINION BY: Richard C. Tallman
OPINION
[*1120] TALLMAN, Circuit Judge:
A doctor, a pharmacist, several terminally ill patients, and the State of Oregon
challenge an interpretive 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. § 127.800-897. We hold that the Ashcroft Directive
is unlawful and unenforceable because it violates the plain language of the CSA,
contravenes Congress' express legislative intent, and oversteps the bounds of the
Attorney General's statutory authority. See 5 U.S.C. § 706(2)(C), (D). The petitions
for review are granted.
I
We have original jurisdiction over "final determinations, 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 "imposes 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. 2001). We consider the matter transferred to us from the
district court pursuant to 28 U.S.C. § 1631. [Footnote 1]
[*1121] This case is ripe for review because, under the Directive,
health care practitioners risk criminal prosecution 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 ("If
. . . the challenged regulations present[] plaintiffs with the immediate dilemma
to choose between complying with newly imposed, disadvantageous restrictions and
risking 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. [Footnote 2]
II
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 dependence . . . and to strengthen existing law enforcement
authority in the field of drug abuse." Id. 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 designed 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, 46 L.
Ed. 2d 333, 96 S. Ct. 335 (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 dispense controlled substances without
a federal registration. 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
practitioners. § 303(f), 84 Stat. at 1255. The Attorney General could revoke a practitioner's
federal registration only if the practitioner falsified his or her registration
application, was convicted of a felony related to a controlled substance, or had
his or her state license suspended or revoked. Id. § 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 effective must be issued for a
[*1122] 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 not a 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 controlled substances.
21 C.F.R. § 1306.04 (originally designated as 21 C.F.R. § 306.04). This regulation
exposed 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 ("In practical effect, [Dr. Moore] acted
as a large-scale 'pusher' not as a physician."); 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 prescription 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 authority;
(2) The applicant's expertise in dispensing . . . 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.
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 considered[.]"
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 prescribe lethal doses of controlled substances to terminally ill Oregon residents
according to procedures designed to protect vulnerable patients and ensure that
their decisions are reasoned and voluntary. See id. [Footnote 3] 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.
[*1123] Soon thereafter, several members of Congress, including
then-Senator John Ashcroft, urged then-Attorney General Janet Reno to declare that
physician assisted suicide violated the CSA. She declined to do so. In a 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 determination as to what constitutes legitimate medical practice."
She concluded that "the CSA does not authorize [the Drug Enforcement Administration
("DEA")] to prosecute, or to revoke DEA registration of, a physician who
has assisted in a suicide in compliance with Oregon law." [Footnote 4]
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."
Id. [Footnote 5]
III
To be perfectly clear, we take no position on the merits or morality of physician
assisted suicide. We express 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 Congress' 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
[*1124] profound debate about the morality, legality, and practicality
of physician-assisted suicide" belongs among state lawmakers. Washington v.
Glucksberg, 521 U.S. 702, 735, 138 L. Ed. 2d 772, 117 S. Ct. 2258, 117 S. Ct. 2302
(1997). In Glucksberg, Justice O'Connor emphasized that "states are presently
undertaking extensive and serious 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." Id. at 737 (O'Connor, J., concurring)
(citations and quotation marks omitted); cf. Cruzan v. Director, 497 U.S. 261, 293,
111 L. Ed. 2d 224, 110 S. Ct. 2841 (Scalia, J., concurring) ("When it is demonstrated
. . . that a patient no longer wishes certain measures to be taken to preserve his
or her life, it is up to the citizens [of the 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 ("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 primary responsibility for evaluating
physician assisted suicide follows from our concept of federalism, which requires
that state lawmakers, not the federal government, 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 (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 government."
Linder v. United States, 268 U.S. 5, 18, 69 L. Ed. 819, 45 S. Ct. 446 (1925); see
also Barsky v. Bd. of Regents, 347 U.S. 442, 449, 98 L. Ed. 829, 74 S. Ct. 650 (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). [Footnote 6]
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 "alters the 'usual constitutional balance between
the States and the Federal Government.' " Gregory v. Ashcroft, 501 U.S. 452,
461, 115 L. Ed. 2d 410, 111 S. Ct. 2395 (1991) (quoting Atascadero State Hosp. v.
Scanlon, 473 U.S. 234, 242, 87 L. Ed. 2d 171, 105 S. Ct. 3142 (1985)). Under these
circumstances, "it is incumbent on the federal courts to be certain of Congress'
intent" before finding that federal authority [*1125] supercedes
state law. Gregory, 501 U.S. at 460 (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 (quoting Atascadero State Hosp.,
473 U.S. at 242); see also Solid Waste Agency of N. Cook County v. U.S. Army Corps
of Eng'rs, 531 U.S. 159, 173, 148 L. Ed. 2d 576, 121 S. Ct. 675 (2001) ("This
concern is heightened where an administrative interpretation alters the federal-state
framework by permitting federal encroachment upon a traditional state power.");
United States v. Bass, 404 U.S. 336, 349, 30 L. Ed. 2d 488, 92 S. Ct. 515 (1971)
("Unless 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 interpretation that
"where an otherwise acceptable construction 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. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council,
485 U.S. 568, 575, 99 L. Ed. 2d 645, 108 S. Ct. 1392 (1988).
The Ashcroft Directive is invalid because Congress has provided no indication --
much less an "unmistakably 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; 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; Pa. Dep't of Corr.
v. Yeskey, 524 U.S. 206, 208-09, 141 L. Ed. 2d 215, 118 S. Ct. 1952. We need not,
and therefore do not, decide whether the Ashcroft Directive actually exceeds Commerce
Clause boundaries, but only that it "invokes the outer limits of Congress'
power" without explicit authority from Congress. Solid Waste Agency, 531 U.S.
at 172 (citing Edward J. DeBartolo Corp., 485 U.S. at 575); see also Pa. Dep't of
Corr. v. Yeskey, 524 U.S. 206, 208-09, 141 L. Ed. 2d 215, 118 S. Ct. 1952 (1998)
("Absent an unmistakably clear expression of intent to alter the usual constitutional
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).
B
The Ashcroft Directive not only lacks clear congressional 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. [Footnote
7] [*1126] 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 (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., 532 U.S. 483, 502, 149 L.
Ed. 2d 722, 121 S. Ct. 1711 (2001) (Stevens, J. concurring) ("Federal 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 Enforcement v.
Dillingham Constr., N.A., Inc., 519 U.S. 316, 325, 136 L. Ed. 2d 791, 117 S. Ct.
832 (1997) ("As is 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 carefully circumscribed the Attorney General's role. The Attorney
General may not define the scope of legitimate medical practice. See Pub. Law No.
91-513, 84 Stat. at 1241 (now codified at 42 U.S.C. § 290bb-2a). [Footnote 8] In
Moore, the Supreme Court held that the CSA "requires" the Secretary of
Health and Human Services "to determine the appropriate methods of professional
practice" [*1127] under the statute. 423 U.S. at 144 (quoting
42 U.S.C. § 290bb-2a); see also Rosenberg, 515 F.2d at 194-95.
The Attorney General, on the other hand, is authorized 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 authority. 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. [Footnote 9] 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. "the recommendation
of the appropriate State licensing board or professional disciplinary 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 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 determination
that may not be made by the Attorney General. [Footnote 10] 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[.]").
C
The CSA's legislative record confirms that the Attorney General has exceeded the
scope of his authority. 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
[*1128] issue, our approach to statutory interpretation is to look
to legislative history.") (citation and quotation marks omitted).
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) ("It cannot be overemphasized
that the . . . [CSA] is designed to crack-down 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'[.]" Id. 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
medical decisions under the Act. See H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N. at
4581 ("The committee is concerned about the appropriateness of having federal
officials determine 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[.]" 423 U.S. at 144. (emphasis
added) (quotation 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 (citation omitted). Although only tangentially related to this
case, the 1974 amendment is noteworthy because it evinces Congress's intent to "preserve[]
the distinctions found in the Controlled Substances Act between the functions of
the Attorney General and the Secretary [of Health and Human Services]. . . . All
decisions 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 manufacturers
and distributers of controlled substances. See id. at 3449 ("The broader considerations
for registration of practitioners set out in [the amendments] . . . are similar
to those applicable under current law to registration applications on the part of
manufacturers and distributors of controlled [*1129] substances.").
By enacting the 1984 amendments, Congress merely intended to close "loopholes"
in the original legislation by authorizing the Attorney General to revoke physician
registrations 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 Congress' clear intent to prevent the
Attorney General from revoking health care practitioners' DEA registrations 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 intended the
Attorney General to consider all five factors under § 823(f) before determining
whether physician conduct contravenes public interest. Congress specifically intended
that the Attorney General must "continue 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 undisputed 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 Department of Justice.
D
The Ashcroft Directive proclaims that physician assisted suicide constitutes an
illegitimate medical practice under 21 C.F.R. § 1306.04. Just as the Attorney 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 regulation.
The Attorney General's interpretation of § 1306.04 exceeds the CSA's limited mandate
to combat prescription drug abuse and addiction. See 21 U.S.C. § 801(2)-(6); Pub.
L. No. 91-513, 84 Stat. 1236 (preamble); 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. While the 1984 amendments to the CSA do extend the Attorney General's
authority over federal registration of practicing physicians, these changes neither
impact § 1306.04 nor provide the Attorney General the authority to determine the
scope of legitimate medical practice in the manner attempted here.
IV
Given the plain language of the CSA and its legislative 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, 81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984); see
also Solid Waste Agency, 531 U.S. at 172-74. Agency determinations that squarely
conflict with governing statutes are not entitled to deference. Chevron, 467 U.S.
at 842-43. We "must, of course, set aside [agency] decisions which rest on
an erroneous legal foundation." NLRB v. Brown, 380 U.S. 278, 291-92, 13 L.
Ed. 2d 839, 85 S. Ct. 980 (1965) (citation and quotation marks omitted); cf. FDA
v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 146 L. Ed. 2d 121, 120
S. Ct. 1291 (2000).
As already explained, the Ashcroft Directive exceeds the scope of the CSA and
[*1130] 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
"regardless 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, 89 L. Ed. 124, 65 S.
Ct. 161 (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, 150 L. Ed. 2d 292, 121 S. Ct. 2164 (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; 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, 111 L. Ed.
2d 94, 110 S. Ct. 2759 (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. 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 authority under
the CSA to the field of drug abuse and addiction. See Pub. L. No. 91-513, 84 Stat.
1236 (preamble); 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). [Footnote 11]
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, 129 L. Ed. 2d 405, 114 S. Ct. 2381 (1994)
(quoting Gardebring v. Jenkins, 485 U.S. 415, 430, 99 L. Ed. 2d 515, 108 S. Ct.
1306 (1988)). Here, the Attorney General asserts that the CSA and its implementing
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 enforcement authorities. See id.
[*1131] 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 enforced.
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.
DISSENT BY: J. Clifford Wallace
DISSENT
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 determined 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 attending physician may "write
a prescription for medication to enable a qualified patient to end his or her life,"
id. § 127.815(1)(k), and the attending physician, the pharmacist, or a third person
may dispense the medication to the patient, id. § 127.815(1)(l). To date, 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 suicide, 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 Controlled 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 dispense controlled substances [*1132] only if they have previously
registered with the Attorney General. Id. §§ 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 effective[,] must be
issued for a legitimate medical purpose," 21 C.F.R. § 1306.04(a). The Attorney
General may revoke or suspend a physician's registration if the registrant 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 Controlled Substances Act. Letter
from Constantine, DEA Administrator, to Henry J. Hyde, Congressman (Nov. 5, 1997),
available at
http://www.house.gov/judiciary/constantine.htm. Seven months later, however,
then-Attorney General Janet Reno rejected the DEA Administrator's opinion letter,
concluding that "the [Controlled 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:
There 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 'legitimate medical purpose' within the meaning of 21 C.F.R. § 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). Id. at 56608. 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." Id.
Before the Department of Justice took action to enforce the Ashcroft Directive,
a group of physicians, patients, and the state of Oregon (collectively Petitioners)
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. [*1133] 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.
II.
The Petitioners do not dispute that the Controlled Substances Act prohibits physicians
from dispensing and prescribing controlled substances except for legitimate 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, 46 L. Ed. 2d 333, 96 S. Ct. 335 (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. 1990) (stating that the Controlled
Substances Act prohibits "prescribing controlled substances for reasons other
than legitimate medical purposes"); United States v. Rosenberg, 515 F.2d 190,
193 (9th Cir. 1975) (interpreting 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 substances").
Instead, they argue that the Ashcroft Directive 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 procedures; (2) the Ashcroft
Directive violates the Controlled 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 proposed 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 APA does not require
notice and comment here, because 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 ordinarily apply to interpretive rules). If the Ashcroft Directive
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 effectively amends a prior legislative rule."
Id. "If the answer to any of these questions is affirmative, we have a legislative,
not an interpretive rule." Sweet v. Sheahan, 235 F.3d 80, 91 (2d Cir. 2000),
quoting Am. Mining Cong. v. Mine Safety & Health Admin., 302 U.S. App. D.C.
38, 995 F.2d 1106, 1112 (D.C. Cir. 1993).
[*1134] 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. § 829(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 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 Interpretative 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 interpretive rules, the Ashcroft Directive
is "essentially hortatory 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 (explaining 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 Substances Act's nonpreemption 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 . . .
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 Ashcroft 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 Ashcroft Directive does not effect a "positive
conflict" with state law because it does not make "the federal role .
. . so 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 Directive does not prohibit.
More relevant for present purposes, the Ashcroft Directive proscribes only one
[*1135] method of assisting suicide: prescription, dispensation, and
administration of controlled substances. The majority vastly exaggerates the Ashcroft
Directive's scope by intimating that it "bans physician-assisted suicide outright."
A closer examination of the Ashcroft Directive's text reveals that "[assisting]
suicide is not a 'legitimate medical purpose'" only "within the meaning
of 21 C.F.R. § 1306.04" (prescription of controlled substances). Ashcroft 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. Id., 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) (discussing
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, "occupy 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).
C.
Petitioners maintain -- and the majority agrees -- that the Ashcroft Directive is
not entitled to deference because 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 limit federal authority under the [Controlled Substances
Act] to the field of drug abuse" while preserving states' discretion to authorize
other life-threatening applications of controlled substances. By what authority?
True, the Controlled Substances Act's preamble arguably manifests Congress's intent
"to strengthen existing law enforcement authority in the field of drug abuse,"
Comprehensive Drug Abuse Prevention 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
[*1136] Act's text precludes its application 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. Discerning 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, 115 L. Ed.
2d 348, 111 S. Ct. 2354 (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, but the record also specifically identifies "suicides and attempted
suicides" as a "misuse 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 "drugs 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 regulation under sections 823 and 824. Rust v. Sullivan, 500 U.S. 173, 190,
114 L. Ed. 2d 233, 111 S. Ct. 1759 (1991). Controlling precedent thus compels the
conclusion that the Controlled Substances Act's "legislative history . . .
cannot form the basis for enjoining [the Attorney General's] regulation[]."
Id.; see also Student Loan Fund of Idaho, Inc. v. U.S. Dep't 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, 90 L. Ed. 1172, 66 S. Ct. 992 (1946)
("What meaning Congress intended is a federal question we must determine.").
Although federal law occasionally incorporates state-law definitions by reference,
see, e.g., De Sylva v. Ballentine, 351 U.S. 570, 580-82, 100 L. Ed. 1415, 76 S.
Ct. 974 (1956) (defining the word "children" in a federal statute according
to state law), recourse to state law is the exception rather than the norm. "In
the absence of a plain indication to the contrary, . . . Congress when it enacts
a statute [does] not make the application of the federal act dependent on state
law." Miss. Band of [*1137] Choctaw Indians v. Holyfield,
490 U.S. 30, 43, 104 L. Ed. 2d 29, 109 S. Ct. 1597 (1989) (quoting Jerome v. United
States, 318 U.S. 101, 104, 87 L. Ed. 640, 63 S. Ct. 483 (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(f) (instructing the Attorney General to consider state-law
violations when deciding whether a physician's registration would be contrary to
the public interest), but nothing in the Controlled Substances Act plainly evinces
a congressional intent to define "the public interest" solely according
to state law. 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." Id. 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, 138 L.
Ed. 2d 772, 117 S. Ct. 2258, 117 S. Ct. 2302 (1997) (O'Connor, J., concurring),
for the position that the Attorney General must defer to the Oregon Act because
"physician-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
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 "there 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." Id. at 737. Simply put, courts should defer to the political
process instead of interposing hasty constitutional constraints.
Glucksberg does not require the Attorney General to interpret the Controlled Substances
Act and its implementing 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 argument: "The Attorney General
may deny an application for . . . registration [of a practitioner to dispense drugs]
if he determines that the issuance of such registration 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 [*1138] 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 consult with the Attorney General as
to effective procedures 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 discretionary 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 registrations. Id. § 823(f). The
explanation for this omission is perfectly clear: section 823 authorizes the Attorney
General -- not the Secretary -- to decide whether a 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 Addiction," which is located in a different title of the legislation.
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 only 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 standards of professional practice, the Attorney General
may not prosecute them under the Controlled Substances Act. Moore, 423 U.S. at 144.
The Court recognized, however, that "the negative implication [of this provision]
is that physicians who go beyond approved practice remain subject to serious criminal
penalties." Id. In other words, section 290bb-2a prevents the Attorney General
from enforcing the Controlled Substances Act and its implementing regulations 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 physicians whose
practices do not qualify for protection under the Secretary's specific safe-harbor
guidelines. We explained that the Secretary's authority to
[*1139] 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 quotations 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 "determined the appropriate method
of the practice of medicine . . . through . . . criminal prosecutions" and
suggesting that these prosecutions should continue subject to the Secretary's limited
guidelines for treatment of narcotic addiction); see also H.R. REP. NO. 93-884 (1974),
reprinted in 1974 U.S.C.C.A.N. 3029, 3034 (recognizing that "the registration
required under [the section of the Controlled Substances governing treatment of
narcotic addiction] is separate and distinct from regular registration under the
Controlled Substances Act," which is administered by the Attorney General (emphasis
added)).
Here the Petitioners have not shown and do not contend that the Secretary's guidelines
approve physician-assisted suicide as an "appropriate method[] of professional
practice in the medical treatment of . . . 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 "inconsistent
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 "in determining the public interest, the following
factors shall be considered":
(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 the public health and safety.
21 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 subsections 823(f)(1)-(4) [*1140]
(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 registration
. . . 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" 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 prompt
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 statutory 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, 52 L. Ed. 2d 172, 97 S. Ct. 1723 (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 purpose" under 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.
5.
Finally, the majority argues that the Ashcroft Directive exceeds the Attorney General's
statutory authority because Congress has not clearly authorized the Attorney General
to upset the delicate balance between federal regulation of controlled substances
and state control of medical practices. As support for this conclusion, 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, 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 our prudential desire not to needlessly reach constitutional
issues and our assumption that Congress does not casually authorize administrative
agencies to interpret a statute to push the limit of congressional authority. This
concern is heightened where the administrative interpretation alters the federal-state
framework by [*1141] permitting federal encroachment upon a traditional
state power.
Id. at 172-73 (internal citations omitted), citing Edward J. DeBartolo Corp. v.
Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 575, 99 L. Ed.
2d 645, 108 S. Ct. 1392 (1988). See generally id. at 172-74 (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 interpretation of a statute," id. at 172 (emphasis
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 objections
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, 316 U.S. App. D.C. 139, 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 "raises
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 (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 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 statement
in this case because controlling precedent compels the conclusion that the Attorney
General's interpretation did not invoke "the outer limits" of Congress's
Commerce Clause power. Solid Waste, 531 U.S. at 172; see also Republican Nat'l Comm.,
76 F.3d at 409 ("Because we can easily resolve the [constitutional] challenges
through the application of controlling precedent . . ., we do not face the sort
of serious constitutional questions 'that would lead us to assume Congress did not
intend to authorize the [regulation's] issuance.'" (quoting Rust, 500 U.S.
at 191)).
The Commerce Clause empowers Congress to regulate (1) "the use of the channels
of interstate commerce"; (2) "the instrumentalities of interstate commere,
or persons or things in interstate commerce"; and (3) "those activities
that substantially affect interstate commerce." United States v. Lopez, 514
U.S. 549, 558-59, 131 L. Ed. 2d 626, 115 S. Ct. 1624 (1995). Our court has long
recognized that "the Commerce Clause empowers the federal government to regulate
prescription drugs," In re Grand Jury Proceedings, 801 F.2d 1164, 1169 (9th
Cir. 1986) (per curiam); accord Rosenberg, 515 F.2d at 198. We have steadfastly
upheld the Controlled Substances Act against Commerce Clause [*1142]
challenges, even in cases involving wholly intrastate activity. See, e.g., United
States v. Tisor, 96 F.3d 370, 375 (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 Controlled 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 commerce or any sort of economic enterprise;
2) whether the statute contains any express jurisdictional 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
interstate 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-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 controlled 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; McCoy, 323 F.3d at
1123-24, and we assess individual provisions as "parts 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 substantial 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 ordinarily 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 assist suicide is not open
to serious question. That ends the matter in this circuit and, of course, for this
case.
[*1143] The majority cannot have it otherwise. Their argument 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 U.S. 5,
18, 69 L. Ed. 819, 45 S. Ct. 446 (1925) (emphasis added). Unless and until the Supreme
Court directs us differently, our opinions and other binding precedent compel the
conclusion that Congress acts comfortably within its Commerce Clause power when
it regulates the prescription and dispensation of controlled substances. See Minor
v. United States, 396 U.S. 87, 98 n.13, 24 L. Ed. 2d 283, 90 S. Ct. 284 (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, 5 L. Ed. 2d 249, 81 S. Ct. 260 (1960) (referring to Congress's
"undoubted power to enact the narcotics laws"); Tisor, 96 F.3d at 375
("Drug trafficking is a commercial activity which substantially affects interstate
commerce."); Kim, 94 F.3d at 1250 n.4 (recognizing that Congress may regulate
controlled substances pursuant to the Commerce Clause even when legislation "intrudes
into an area traditionally regulated by states"); Rosenberg, 515 F.2d at 198
(dubbing an analogous constitutional challenge "singularly unpersuasive").
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, the clear statement rule does not apply, and we must evaluate the Ashcroft
Directive according to ordinary standards of deference.
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 arbitrary 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 that the Oregon Act's procedures have not been used disproportionately
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, 77 L. Ed. 2d 443, 103 S. Ct. 2856 (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, uneducated,
or uninsured could have strengthened his conclusion that physician-assisted suicide
is not a "legitimate 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 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 [*1144] 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 Assistant 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 Implementing the 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).
III.
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.
If the Ashcroft Directive represents a statutory interpretation, it enjoys deference
as defined in Skidmore v. Swift & Co., 323 U.S. 134, 89 L. Ed. 124, 65 S. Ct.
161 (1944). Omohundro v. United States, 300 F.3d 1065, 1067-68 (9th Cir. 2002).
Under Skidmore, "the weight of such a judgment in a particular case will depend
upon the thoroughness evident in its consideration, 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. 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 & Ornamental
Iron Workers, 434 U.S. 335, 351, 54 L. Ed. 2d 586, 98 S. Ct. 651 (1978).
If the Ashcroft Directive interprets an agency regulation, rather than the Controlled
Substances Act itself, we must accord it "substantial deference." Thomas
Jefferson Univ. v. Shalala, 512 U.S. 504, 512, 129 L. Ed. 2d 405, 114 S. Ct. 2381
(1994). Under this highly deferential standard,
our task is not to decide which among several competing interpretations best serves
the regulatory 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 [*1145] view [it] believes
to have been grounded upon a mistaken legal interpretation." Id. at 517 (internal
quotation marks and citation omitted). "Where 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." Id. (internal quotation marks
and citation 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 interpretive
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 Ashcroft'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 the Controlled Substances Act, however, but an explanation of the logical consequences
flowing from General Ashcroft's interpretation of 21 C.F.R. § 1306.04. If assisting
suicide is not a "legitimate medical purpose," the direct result is that
a physician cannot prescribe controlled substances for this purpose without 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 inconsistent with the public interest); id. § 824(a)(4) (providing 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 "practitioner." Thus,
the Ashcroft Directive qualifies for Thomas Jefferson's highly deferential standard
of review.
Applying the Thomas Jefferson standard, I have no trouble upholding the Ashcroft
Directive from Petitioners' attack. As the Office of Legal Counsel concluded:
The 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 medical
and nursing professions, establish that assisting in suicide is not an activity
undertaken in the course of professional medical practice and is not a legitimate
medical purpose. Indeed, we think it fair to say that 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
Glucksberg, the Supreme Court offered a similar assessment: "opposition to
and condemnation 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 (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 [*1146]
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 discussion 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 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." Id. at 1085.
A more thorough analysis is therefore needed to determine whether the Ashcroft Directive,
which by its terms is an interpretive rule, is a "final determination"
within the meaning of 21 U.S.C. § 877 over which we would have jurisdiction.
Section 877 provides that "all final determinations, findings, and conclusions
of the Attorney General under this sub-chapter 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." Id. Significantly, the Ashcroft
Directive echoes the language of this provision by "advising . . . that the
original DEA determination is reinstated and should be implemented." Ashcroft
Directive, 66 Fed. Reg. at 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 Attorney 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
877's requirements for review. In order to respond to the district court's argument,
therefore, I must reason by analogy and look to general principles of administrative
law formulated under the APA. See U.S. W. 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 contrary 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, 137 L. Ed. 2d 281,
117 S. Ct. 1154 (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
(internal citations and quotation marks omitted). In evaluating whether an agency
action meets these conditions, relevant considerations include: (a) whether the
action is a "definitive statement of an agency's position," (b) whether
it has a "direct and immediate [*1147] 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).
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, 18 L. Ed. 2d 681, 87 S. Ct. 1507
(1967), overruled on other grounds, Califano v. Sanders, 430 U.S. 99, 51 L. Ed.
2d 192, 97 S. Ct. 980 (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. Id. at 149-50;
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. W. 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 Ashcroft Directive clearly marks the
consummation of the Attorney General's decision making process even though it is
a non-binding, pre-enforcement, interpretive rule. The Ashcroft Directive reflects
internal agency deliberation, on a matter of public importance, and commands immediate
implementation. Eschewing tentative 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 determination
. . . ." ); accord Nat'l Automatic Laundry & Cleaning Council v. Shultz,
143 U.S. App. D.C. 274, 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
review"). The Ashcroft Directive purports to be the Attorney General's interpretation,
not the interpretation 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. Relevant factors include whether the agency action has
a "direct and immediate effect" on the complaining parties and requires
their "immediate 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 requirement as well. Although it may
not have the force of law, the Ashcroft Directive significantly and immediately
alters the legal landscape for Oregon physicians. [*1148] See Bennett,
520 U.S. at 178 (holding that an agency action met this requirement because it had
similar "direct and appreciable legal consequences"); Abbott Labs., 387
U.S. at 152-53 (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 "directs
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 action 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 jurisdiction.
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.
V.
Although I am convinced of the merits of my legal argument, I admit that even if
I persuaded 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-assisted 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, nor does it halt states' "extensive and serious
evaluation of physician-assisted suicide and other related issues," Glucksberg,
521 U.S. at 736, 737 (O'Connor, J., concurring). State legislators may supplement
the Ashcroft Directive's sanctions, 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. Certainly, 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
those who might seek to end life mistakenly or under pressure." Id. In short,
we should trust the democratic process.
Thus, the discrete question before this court is a narrow one: is the Attorney
[*1149] 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 Ashcroft Directive is not subject to the APA's notice-and-comment rulemaking
procedures. It does not violate the Controlled Substances Act's nonpreemption provision.
It neither exceeds the Attorney General's statutory authority under the Controlled
Substances Act nor "pushes the limit of congressional authority" under
the Commerce Clause. Solid Waste, 531 U.S. at 173. 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 command us to defer to the Attorney
General's interpretation of section 1306.04.
Therefore, I dissent.