Executive Order 13132 of August 4, 1999 ("Federalism")
Federal Register, Vol. 64, No. 153, Tuesday, August 10, 1999, page 43255
Presidential Memorandum of January 20, 2009 ("Memorandum for the Heads
of Executive Departments and Agencies")
Federal Register, Vol. 74, No.
15, Monday, January 26, 2009, page 4435
Presidential Memorandum of January 30, 2009 ("Regulatory Review")
Federal Register, Vol. 74, No.
21, Tuesday, February 3, 2009, page 5977
Presidential Memorandum of May 20, 2009 ("Preemption")
Federal Register, Vol. 74, No. 98, Friday, May 22, 2009, page 24693
UNITED STATES CODE
CONTROLLED SUBSTANCES ACT (DEA web site)
http://www.usdoj.gov/dea/pubs/csa.html
CONTROLLED SUBSTANCES ACT (FDA web site)
http://www.fda.gov/RegulatoryInformation/Legislation/ucm148726.htm
CODE OF FEDERAL REGULATIONS
Title 21 - CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfrv9_08.html
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfr1308_08.html
21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT|
Part F - General Provisions
903. Application of State law
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, including criminal penalties, 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.
(Pub. L. 91-513, title II, Sec. 708, Oct. 27, 1970, 84 Stat. 1284.)
United States v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 483, 492 (2001)
The Attorney General can include a drug in schedule I only if the drug "has no currently accepted medical use in treatment in the United States," "has a high potential for abuse," and has "a lack of accepted safety for use . . . under medical supervision." §§ 812(b)(1)(A)-(C). Under the statute, the Attorney General could not put marijuana into schedule I if marijuana had any accepted medical use.
Gonzales v. Raich, 545 U.S. 1, 5 (2005)
California is one of at least nine States that authorize the use of marijuana for
medicinal purposes. 1 The question presented in this case is whether the
power vested in Congress by Article I, § 8, of the Constitution "[t]o make all Laws
which shall be necessary and proper for carrying into Execution" its authority to
"regulate Commerce with foreign Nations, and among the several States" includes
the power to prohibit the local cultivation and use of marijuana in compliance with
California law.
1 See Alaska Stat. §§ 11.71.090, 17.37.010-17.37.080 (Lexis 2004); Colo. Const.,
Art. XVIII, § 14, Colo. Rev. Stat. § 18-18-406.3 (Lexis 2004); Haw. Rev. Stat. §§
329-121 to 329-128 (2004 Cum. Supp.); Me. Rev. Stat. Ann., Tit. 22, § 2383-B(5)
(West 2004); Nev. Const., Art. 4, § 38, Nev. Rev. Stat. §§ 453A.010-453A.810 (2003);
Ore. Rev. Stat. §§ 475.300-475.346 (2003); Vt. Stat. Ann., Tit. 18, §§ 4472-4474d
(Supp. 2004); Wash. Rev. Code §§ 69.51.010-69.51.080 (2004); see also Ariz. Rev.
Stat. Ann. § 13-3412.01 (West Supp. 2004) (voter initiative permitting physicians
to prescribe Schedule I substances for medical purposes that was purportedly repealed
in 1997, but the repeal was rejected by voters in 1998). In November 2004, Montana
voters approved Initiative 148, adding to the number of States authorizing the use
of marijuana for medical purposes.
Gonzales v. Raich, 545 U.S. 1, 9 (2005)
The obvious importance of the case prompted our grant of certiorari. 542 U.S. 936 (2004). The case is made difficult
by respondents' strong arguments that they will suffer irreparable harm because,
despite a congressional finding to the contrary, marijuana does have valid therapeutic
purposes. The question before us, however, is not whether it is wise to enforce
the statute in these circumstances; rather, it is whether Congress' power to regulate
interstate markets for medicinal substances encompasses the portions of those markets
that are supplied with drugs produced and consumed locally. Well-settled law controls
our answer. The CSA is a valid exercise of federal power, even as applied to the
troubling facts of this case. We accordingly vacate the judgment of the Court of
Appeals.
Gonzales v. Raich, 545 U.S. 1, 28 n.37 (2005)
We acknowledge that evidence proffered by respondents in this case regarding the
effective medical uses for marijuana, if found credible after trial, would cast
serious doubt on the accuracy of the findings that require marijuana to be listed
in Schedule I. See, e.g., Institute of Medicine, Marijuana and Medicine: Assessing
the Science Base 179 (J. Joy, S. Watson, & J. Benson eds. 1999) (recognizing that
"[s]cientific data indicate the potential therapeutic value of cannabinoid drugs,
primarily THC [Tetrahydrocannabinol] for pain relief, control of nausea and vomiting,
and appetite stimulation"); see also Conant v. Walters, 309 F.3d 629, 640-643 (CA9
2002) (Kozinski, J., concurring) (chronicling medical studies recognizing valid
medical uses for marijuana and its derivatives). But the possibility that the drug
may be reclassified in the future has no relevance to the question whether Congress
now has the power to regulate its production and distribution. Respondents' submission,
if accepted, would place all homegrown medical substances beyond the reach of Congress'
regulatory jurisdiction.
Gonzales v. Oregon, 546 U.S. 243, 249 (2006):
The dispute before us is in part a product of this political and moral debate, but
its resolution requires an inquiry familiar to the courts: interpreting a federal
statute to determine whether Executive action is authorized by, or otherwise consistent
with, the enactment.
Gonzales v. Oregon, 546 U.S. 243, 251 (2006):
The CSA explicitly contemplates a role for the States in regulating controlled substances,
as evidenced by its pre-emption provision.
"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 . . . and that State law so that the two cannot consistently stand
together." § 903.
Gonzales v. Oregon, 546 U.S. 243, 257 (2006):
The regulation uses the terms "legitimate medical purpose" and "the course of professional
practice," ibid., but this just repeats two statutory phrases and attempts to summarize
the others. It gives little or no instruction on a central issue in this case: Who
decides whether a particular activity is in "the course of professional practice"
or done for a "legitimate medical purpose"? Since the regulation gives no indication
how to decide this issue, the Attorney General's effort to decide it now cannot
be considered an interpretation of the regulation. Simply put, the existence of
a parroting regulation does not change the fact that the question here is not the
meaning of the regulation but the meaning of the statute. An agency does not acquire
special authority to interpret its own words when, instead of using its expertise
and experience to formulate a regulation, it has elected merely to paraphrase the
statutory language.
Gonzales v. Oregon, 546 U.S. 243, 258 (2006):
[W]e turn to the question whether the Interpretive Rule, on its own terms, is a
permissible interpretation of the CSA.
Gonzales v. Oregon, 546 U.S. 243, 258 (2006):
The Attorney General has rulemaking power to fulfill his duties under the CSA. The
specific respects in which he is authorized to make rules, however, instruct us
that he is not authorized to make a rule declaring illegitimate a medical standard
for care and treatment of patients that is specifically authorized under state law.
Gonzales v. Oregon, 546 U.S. 243, 259 (2006):
The CSA gives the Attorney General limited powers, to be exercised in specific ways.
His rulemaking authority under the CSA is described in two provisions: (1) "The
Attorney General is authorized to promulgate rules and regulations and to charge
reasonable fees relating to the registration and control of the manufacture, distribution,
and dispensing of controlled substances and to listed chemicals," 21 U.S.C. A. §
821 (Supp. 2005); and (2) "The Attorney General may 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(b).
As is evident from these sections, Congress did not delegate to the Attorney General
authority to carry out or effect all provisions of the CSA. Rather, he can promulgate
rules relating only to "registration" and "control," and "for the efficient execution
of his functions" under the statute.
Gonzales v. Oregon, 546 U.S. 243, 261 (2006):
The Interpretive Rule thus purports to declare that using controlled substances
for physician-assisted suicide is a crime, an authority that goes well beyond the
Attorney General's statutory power to register or deregister.
Gonzales v. Oregon, 546 U.S. 243, 262 (2006):
The Interpretive Rule works in the opposite direction, however: it declares certain
conduct criminal, placing in jeopardy the registration of any physician who engages
in that conduct.
Gonzales v. Oregon, 546 U.S. 243, 262 (2006):
The problem with the design of the Interpretive Rule is that it cannot, and does
not, explain why the Attorney General has the authority to decide what constitutes
an underlying violation of the CSA in the first place. The explanation the Government
seems to advance is that the Attorney General's authority to decide whether a physician's
actions are inconsistent with the "public interest" provides the basis for the Interpretive
Rule.
Gonzales v. Oregon, 546 U.S. 243, 262-263 (2006):
By this logic, however, the Attorney General claims extraordinary authority. If
the Attorney General's argument were correct, his power to deregister necessarily
would include the greater power to criminalize even the actions of registered physicians,
whenever they engage in conduct he deems illegitimate. This power to criminalize--unlike
his power over registration, which must be exercised only after considering five
express statutory factors--would be unrestrained. It would be anomalous for Congress
to have so painstakingly described the Attorney General's limited authority to deregister
a single physician or schedule a single drug, but to have given him, just by implication,
authority to declare an entire class of activity outside "the course of professional
practice," and therefore a criminal violation of the CSA. See Federal Maritime Comm'n
v. Seatrain Lines, Inc., 411 U.S. 726, 744, 93 S. Ct. 1773, 36 L. Ed. 2d 620 (1973)
("In light of these specific grants of . . . authority, we are unwilling to construe
the ambiguous provisions . . . to serve this purpose [of creating further authority]--a
purpose for which it obviously was not intended").
Gonzales v. Oregon, 546 U.S. 243, 264 (2006):
As for the federal law factor, though it does require the Attorney General to decide
"[c]ompliance" with the law, it does not suggest that he may decide what the law
says. Were it otherwise, the Attorney General could authoritatively interpret "State"
and "local laws," which are also included in 21 U.S.C. § 823(f), despite the obvious
constitutional problems in his doing so.
Gonzales v. Oregon, 546 U.S. 243, 266-267 (2006):
The structure of the CSA, then, conveys unwillingness to cede medical judgments
to an Executive official who lacks medical expertise. In interpreting statutes that
divide authority, the Court has recognized: "Because historical familiarity and
policymaking expertise account in the first instance for the presumption that Congress
delegates interpretive lawmaking power to the agency rather than to the reviewing
court, we presume here that Congress intended to invest interpretive power in the
administrative actor in the best position to develop these attributes." Martin v.
OSHRC, 499 U.S. 144, 153, 111 S. Ct. 1171, 113 L. Ed. 2d 117 (1991) (citations omitted).
This presumption works against a conclusion that the Attorney General has authority
to make quintessentially medical judgments.
Gonzales v. Oregon, 546 U.S. 243, 267-268 (2006):
The importance of the issue of physician-assisted suicide, which has been the subject
of an "earnest and profound debate" across the country, Glucksberg, 521 U.S., at
735, 117 S. Ct. 2258, 138 L. Ed. 2d 772, makes the oblique form of the claimed delegation
all the more suspect. Under the Government's theory, moreover, the medical judgments
the Attorney General could make are not limited to physician-assisted suicide. Were
this argument accepted, he could decide whether any particular drug may be used
for any particular purpose, or indeed whether a physician who administers any controversial
treatment could be deregistered. This would occur, under the Government's view,
despite the statute's express limitation of the Attorney General's authority to
registration and control, with attendant restrictions on each of those functions,
and despite the statutory purposes to combat drug abuse and prevent illicit drug
trafficking.
Gonzales v. Oregon, 546 U.S. 243, 269 (2006):
The deference here is tempered by the Attorney General's lack of expertise in this
area and the apparent absence of any consultation with anyone outside the Department
of Justice who might aid in a reasoned judgment.
Gonzales v. Oregon, 546 U.S. 243, 269-271 (2006):
In deciding whether the CSA can be read as prohibiting physician-assisted suicide,
we look to the statute's text and design. The statute and our case law amply support
the conclusion that Congress regulates medical practice insofar as it bars doctors
from using their prescription-writing powers as a means to engage in illicit drug
dealing and trafficking as conventionally understood. Beyond this, however, the
statute manifests no intent to regulate the practice of medicine generally. The
silence is understandable given the structure and limitations of federalism, which
allow the States "'great latitude under their police powers to legislate as to the
protection of the lives, limbs, health, comfort, and quiet of all persons.'" Medtronic,
Inc. v. Lohr, 518 U.S. 470, 475, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996) (quoting
Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756, 105 S. Ct. 2380,
85 L. Ed. 2d 728 (1985)).
The structure and operation of the CSA presume and rely upon a functioning medical
profession regulated under the States' police powers. The Attorney General can register
a physician to dispense controlled substances "if the applicant is authorized to
dispense . . . controlled substances under the laws of the State in which he practices."
21 U.S.C. § 823(f). When considering whether to revoke a physician's registration,
the Attorney General looks not just to violations of federal drug laws; but he "shall"
also consider "[t]he recommendation of the appropriate State licensing board or
professional disciplinary authority" and the registrant's compliance with state
and local drug laws. Ibid. The very definition of a "practitioner" eligible to prescribe
includes physicians "licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices" to dispense controlled substances.
§ 802(21). Further cautioning against the conclusion that the CSA effectively displaces
the States' general regulation of medical practice is the Act's pre-emption provision,
which indicates that, absent a positive conflict, none of the Act's provisions should
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."
§ 903.
Gonzales v. Oregon, 546 U.S. 243, 271-272 (2006):
Even though regulation of health and safety is "primarily, and historically, a matter
of local concern," Hillsborough County v. Automated Medical Laboratories, Inc.,
471 U.S. 707, 719, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985), there is no question
that the Federal Government can set uniform national standards in these areas. See
Raich, supra, at 9, 125 S. Ct. 2195, 162 L. Ed. 2d 1. In connection to the CSA,
however, we find only one area in which Congress set general, uniform standards
of medical practice. Title I of the Comprehensive Drug Abuse Prevention and Control
Act of 1970, of which the CSA was Title II, provides that
"[The Secretary], after consultation with the Attorney General and with national
organizations representative of persons with knowledge and experience in the treatment
of narcotic addicts, shall determine the appropriate methods of professional practice
in the medical treatment of the narcotic addiction of various classes of narcotic
addicts, and shall report thereon from time to time to the Congress." § 4, 84 Stat.
1241, codified at 42 U.S.C. § 290bb-2a.
This provision strengthens the understanding of the CSA as a statute combating recreational
drug abuse, and also indicates that when Congress wants to regulate medical practice
in the given scheme, it does so by explicit language in the statute.
Gonzales v. Oregon, 546 U.S. 244, 274 (2006):
The Interpretive Rule rests on a reading of the prescription requirement that is
persuasive only to the extent one scrutinizes the provision without the illumination
of the rest of the statute. See Massachusetts v. Morash, 490 U.S. 107, 114-115,
109 S. Ct. 1668, 104 L. Ed. 2d 98 (1989). Viewed in its context, the prescription
requirement is better understood as a provision that ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, the provision also bars doctors from peddling to patients
who crave the drugs for those prohibited uses. See Moore, 423 U.S., at 135, 143,
96 S. Ct. 335, 46 L. Ed. 2d 333. To read prescriptions for assisted suicide as constituting
"drug abuse" under the CSA is discordant with the phrase's consistent use throughout
the statute, not to mention its ordinary meaning.
Gonzales v. Oregon, 546 U.S. 244, 274-275 (2006):
The Government's interpretation of the prescription requirement also fails under
the objection that the Attorney General is an unlikely recipient of such broad authority,
given the Secretary's primacy in shaping medical policy under the CSA, and the statute's
otherwise careful allocation of decisionmaking powers. Just as the conventions of
expression indicate that Congress is unlikely to alter a statute's obvious scope
and division of authority through muffled hints, the background principles of our
federal system also belie the notion that Congress would use such an obscure grant
of authority to regulate areas traditionally supervised by the States' police power.
It is unnecessary even to consider the application of clear statement requirements,
see, e.g., United States v. Bass, 404 U.S. 336, 349, 92 S. Ct. 515, 30 L. Ed. 2d
488 (1971); cf. BFP v. Resolution Trust Corporation, 511 U.S. 531, 544-546, 114
S. Ct. 1757, 128 L. Ed. 2d 556 (1994), or presumptions against pre-emption, see,
e.g., Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 387, 122 S. Ct. 2151, 153
L. Ed. 2d 375 (2002), to reach this commonsense conclusion. For all these reasons,
we conclude the CSA's prescription requirement does not authorize the Attorney General
to bar dispensing controlled substances for assisted suicide in the face of a state
medical regime permitting such conduct.
NORML v. Ingersoll, 497 F.2d 654, 656-657 (D.C. Cir. 1974):
Congress contemplated that the classification set forth in the Act as originally
passed would be subject to continuing review by the executive officials concerned,
notably in the Department of Justice and the Department of Health, Education and
Welfare. Provision was made for further consideration, one taking into account studies
and data not available to Congress when the Act was passed in 1970. Section 202
of the CSA, 21 U.S.C. § 812, establishing the schedules of controlled substances,
provides that "such schedules shall initially consist of the substances listed."
(Emphasis added.) Subsection (c) provides "Schedules I, II, III, IV and V shall,
unless and until amended pursuant to [21 U.S.C. § 811] consist of the following
drugs. . . ." In subsection (a) of § 201 of the Act, 21 U.S.C. § 811, Congress provides
that the Attorney General shall apply the provisions of the Act to the controlled
substances listed in the schedules (in § 202) and other drugs added to such schedule,
and "may, by rule," add substances to a schedule, transfer them between schedules,
or "remove any drug or other substance from the schedule."
NORML v. DEA, 559 F.2d 735, 737 n.4 (D.C. Cir. 1977):
The Act's initial schedules of controlled substances are contained in § 202(c),
21 U.S.C. § 812(c). These listings are subject to amendment pursuant to § 201, 21
U.S.C. § 811, and have, in fact, been amended on several occasions. Cf. 21 C.F.R.
§ 1308.11 (1976).
NORML v. DEA, 559 F.2d 735, 737 n.8 (D.C. Cir. 1977):
In § 502(a) (6), 21 U.S.C. § 872(a) (6), Congress expressly authorized the Attorney
General to undertake "studies or special projects to develop information necessary
to carry out his [rescheduling] functions under section 811 of this title." In addition,
§ 601 of the CSA, 21 U.S.C. § 801 note, established a presidential Commission on
Marihuana and Drug Abuse and directed the Commission to conduct a study of marihuana
and submit reports containing recommendations for legislative and administrative
action. See also NORML v. Ingersoll, supra note 1, 497 F.2d at 656-657.
NORML v. DEA, 559 F.2d 735, 743 n.41 (D.C. Cir. 1977):
The letter, reproduced at 40 FED. REG. 44165 (1975), reads in full:
APRIL 14, 1975
JERRY N. JENSON.
Acting Deputy Administrator, Drug Enforcement Administration,
Department of Justice, 1405 I Street NW., Washington, D.C. 20537.
DEAR MR. JENSON:
At your request, we have prepared the following statement giving our position on
the medical uses of Cannabis sativa L. (marihuana).
There is currently no accepted medical use of marihuana in the United States. There is no approved New Drug Application
for Cannabis sativa L. (Marihuana) or tetrahydrocannabinol, the active principle
in marihuana. There are Investigational New Drug Applications on file to determine
possible therapeutic uses and potential toxic effects of the substance.
We have
included for your information a copy of the most recent report on these studies
and a copy of the FDA policy regarding clinical studies with marihuana.
Sincerely yours,
THEODORE COOPER, M.D.,
Acting Assistant Secretary for Health.
The implications of the lack of a New Drug Application are discussed more fully
in note 65 infra.
NORML v. DEA, 559 F.2d 735, 747 n.54 & n.55 (D.C. Cir. 1977):
Moreover, we think it not insignificant that the Office of Legal Counsel of the
Department of Justice, in a memorandum dated August 21, 1972, 54 adopted the following
construction of Section 201(d): The Attorney General is directed to determine the
CSA schedule that will satisfy the nation's obligation under the Single Convention;
to the extent that there is latitude to schedule a substance consistent with treaty
obligations, "the Attorney General [is] obliged to follow the prescribed procedures
in obtaining a medical and scientific evaluation from the Secretary of Health, Education,
and Welfare." Petitioner's Appendix F at 14. Thus in rejecting DEA's interpretation
of Section 201(d), we embrace the same interpretation urged by staff counsel to
DEA's parent agency, the Department of Justice. 55
54 The memorandum, entitled "Petition
to Decontrol Marihuana, Interpretation of Section 201 of the Controlled Substances
Act of 1970," was prepared by Deputy Assistant Attorney General Mary C. Lawton at
the request of the Director of BNDD for the Justice Department's legal opinion on
the procedures to be followed with respect to the then recently filed NORML petition
for rescheduling. DEA supplied the memorandum to NORML in response to a general
request for documents.
55 We note too that this court in NORML v. Ingersoll,
supra
note 1, 497 F.2d at 660-661, expressed its "doubts" that the delegee of the Attorney
General could, "without any reason," decide not to reschedule marihuana. We think
it insufficient answer to say that the Acting Administrator did not act without
reason because he sought out "expert opinion as to treaty and medical questions."
Respondent's br. at 9. The statute requires more than an informal canvassing of
opinion.
NORML v. DEA, 559 F.2d 735, 748 (D.C. Cir. 1977):
Admittedly, Section 202(b), 21 U.S.C. § 812(b), which sets forth the criteria for
placement in each of the five CSA schedules, established medical use as the factor
that distinguishes substances in Schedule II from those in Schedule I.
NORML v. DEA, 559 F.2d 735, 751 n.70 (D.C. Cir. 1977):
See note 63 supra. New studies have indicated that the dangers of marihuana use
are not as great as once believed. A recent report of a federal panel representing,
inter alia, HEW, DEA, the State Department, and the White House, concluded that
marihuana use entails a "relatively low social cost," and suggested that decriminalization
be considered. Washington Post, Dec. 12, 1976, at A1, col. 1; Washington Star, Dec.
12, 1976, at A7, col. 1. See United States v. Randall, supra note 61, at 2254 (characterizing
marihuana as "a drug with no demonstrably harmful effects"). Indeed, in NATIONAL
COMMISSION ON MARIHUANA AND DRUG ABUSE, SECOND REPORT, DRUG USE IN AMERICA: PROBLEM
IN PERSPECTIVE, Vol. I, at 235 (1973), the Commission recommended that "the United
States take the necessary steps to remove cannabis from the Single Convention on
Narcotic Drugs (1961), since this drug does not pose the same social and public
health problems associated with the opiates and coca leaf products."
Grinspoon v. DEA, 828 F.2d 881, 882 n.1 (1st Cir. 1987):
The Act's initial scheduling of substances can be found in 21 U.S.C. § 811. These
listings are subject to amendments and additions pursuant to 21 U.S.C. § 811.
Grinspoon v. DEA, 828 F.2d 881, 884-885 (1st Cir. 1987):
A. Standard of Review.
The Administrator argues correctly that we must review his
interpretation of the CSA in light of the guidelines set forth by the Supreme Court
in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837,
81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984). In Chevron the Court explained that [HN4]
a reviewing court must employ a two-step analysis that focuses initially on the
intentions of Congress:
First, always, is the question whether Congress had directly spoken to the precise
question at issue. If the intent of Congress is clear, that is the end of the matter;
for the court, as well as the agency, must give effect to the unambiguously expressed
intent of Congress.
Id. at 842-43 (emphasis supplied). In the absence of congressional intent, however,
the court must proceed to a second inquiry:
If . . . the court determines Congress has not directly addressed the precise question
at issue, the court does not simply impose its own construction on the statute,
as would be necessary in the absence of an administrative interpretation. Rather,
if the statute is silent or ambiguous with respect to the specific issue, the question
for the court is whether the agency's answer is based on a permissible construction
of the statute.
Id. at 843 (footnote omitted; emphasis supplied).
Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):
We add, moreover, that the Administrator's clever argument conveniently omits any
reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads "in
the United States," (emphasis supplied). We find this language to be further
evidence that the Congress did not intend "accepted medical use in treatment in
the United States" to require a finding of recognized medical use in every state
or, as the Administrator contends, approval for interstate marketing of the substance.
Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):
The CSA clearly provides that a substance may not be placed in Schedule I unless
it lacks both a "currently accepted medical use in treatment in the United States"
and "accepted safety for use . . . under medical supervision."
Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):
Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions
do not apply to drugs manufactured and marketed wholly intrastate. Compare 21 U.S.C.
§ 801(5) with 21 U.S.C. § 321 (b), 331, 355(a). Thus, it is possible that a substance
may have both an accepted medical use and safety for use under medical supervision,
even though no one has deemed it necessary to seek approval for interstate marketing.
Grinspoon v. DEA, 828 F.2d 881, 890 (1st Cir. 1987):
Third, in 1984, Congress legislatively placed the drug methaqualone in Schedule
I. Despite its reputation as a widely abused substance, methaqualone was universally
acknowledged to have an accepted medical use and had been approved for interstate
marketing by the FDA. The House Committee Report concerning the scheduling of methaqualone
stated:
the [DEA] does not have authority to impose Schedule I controls on a drug which
has been approved by the [FDA] for medical use. The statutory findings required
for agency scheduling decisions clearly state that the agency may not, in the absence
of Congressional action, subject drugs with a currently accepted medical use in
the United States to Schedule I controls.
H.R. Rep. No. 534, 98th Cong., 2d Sess. 4 (1984), reprinted in 1984 U.S.
Code Cong. & Ad. News 540, 543.
In the Matter of Marijuana Rescheduling, DEA Docket No. 86-22 (Sept. 6, 1988) 32:
The DEA, on the other hand, is charged by 21 U.S.C. § 812(b)(1)(B) and (2)(B) with
ascertaining what it is that other people have done with respect to a drug or substance:
"Have they accepted it?;" not "Should they accept it?"
In the Matter of Marijuana Rescheduling, DEA Docket No. 86-22 (Sept. 6, 1988) 33:
In the MDMA third final order DEA is actually making the decision that doctors have
to make, rather than trying to ascertain the decision which doctors have made. Consciously
or not, the Agency is undertaking to tell doctors what they should or should not
accept. In so doing the Agency is acting beyond the authority granted in the Act.
In the Matter of Marijuana Rescheduling, DEA Docket No. 86-22 (Sept. 6, 1988) 33-34:
At oral argument Government counsel conceded that "the FDA system is constructed
for pharmaceutical companies. I won't deny that."
15
15 Tr. XV-37.
In the Matter of Marijuana Rescheduling, DEA Docket No. 86-22 (Sept. 6, 1988) 68:
... there is no lack of accepted safety for use of it under medical supervision ...
DEA Docket No. 86-22, 54 Fed. Reg. 53767 (December 29, 1989) 53784
(explaining why the DEA cannot establish national standards for drug use):
By placing a substance in Schedule II, the Administrator, and through him the Federal
Government, establishes a national standard for drug use.
Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 937 (D.C. Cir.
1991):
Drugs can be "re-scheduled" or "de-scheduled" only if the DEA makes certain statutorily-mandated
findings.
Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 938 (D.C. Cir.
1991):
As is apparent, one salient concept distinguishing the two schedules is whether
a drug has "no currently accepted medical use in treatment in the United States."
Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 938 (D.C. Cir.
1991):
The Administrator rejected the ALJ's recommendation, however, determining that the
phrase "currently accepted medical use" required a greater showing than that a minority
- even a respectable minority - of physicians accept the usefulness of a given drug.
Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir.
1991):
The difficulty we find in petitioners' argument is that neither the statute nor
its legislative history precisely defines the term "currently accepted medical use";
therefore, we are obliged to defer to the Administrator's interpretation of that
phrase if reasonable.
DEA Docket No. 86-22, 57 Fed. Reg. 10499 (March 26, 1992) 10499:
... marijuana has no currently accepted medical use ...
DEA Docket No. 86-22, 57 Fed. Reg. 10503 (March 26, 1992) 10499:
My comments - Even if the administrator was correct about the problems associated
with smoking marijuana, putting sick people in jail is worse than giving them marijuana.
DEA Docket No. 86-22, 57 Fed. Reg. 10504 (March 26, 1992) 10499:
It must be emphasized that while the existence of adequate safety tests is a separate
analytical question, the ultimate determination of whether a drug is safe for a
specific use is not a distinct issue. Safety and effectiveness are inextricably
linked in a risks- benefits calculation. A determination that a drug is ineffective
is tantamount to a determination that it is unsafe. United States v. Rutherford,
442 U.S. 544 (1970).
The scheduling criteria of the Controlled Substances Act appear to treat the lack
of medical use and lack of safety as separate considerations. Prior rulings of this
Agency purported to treat safety as a distinct factor. 53 FR 5156 (February 22,
1988). In retrospect, this is inconsistent with scientific reality. Safety cannot
be treated as a separate analytical question.
DEA Docket No. 86-22, 57 Fed. Reg. 10506 (March 26, 1992) 10499:
Clearly, the Controlled Substances Act does not authorize the Attorney General,
nor by delegation the DEA Administrator, to make the ultimate medical and policy
decision as to whether a drug should be used as medicine. Instead, he is limited
to determing whether others accept a drug for medical use. Any other construction
would have the efect of reading the word "accepted" out of the statutory standard.
Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1133 (D.C. Cir.
1994):
A drug is placed in Schedule I if (1) it "has a high potential for abuse," (2) it
has "no currently accepted medical use in treatment in the United States," and (3)
"there is a lack of accepted safety for use of the drug ... under medical supervision."
21 U.S.C. § 812(b)(1) (1988) (emphasis added). The Schedule II criteria are somewhat
different: (1) the drug "has a high potential for abuse," (2) it "has a currently
accepted medical use in treatment in the United States or a currently accepted medical
use with severe restrictions," and (3) "abuse of the drug ... may lead to severe
psychological or physical dependence." 21 U.S.C. § 812(b)(2) (1988) (emphasis added).
Petitioners' central claim is that the Administrator misinterpreted the language
italicized above.
DEA Denial of Petition, 66 Fed. Reg. 20038 (April 18, 2001) 20038-20039:
DEA's denial of your petition is based exclusively on the scientific and medical
findings of HHS, with which DEA concurs, that lead to the conclusion that marijuana
has a high potential for abuse. Nonetheless, independent of this scientific and
medical basis for denying your petition, there is a logical flaw in your proposal
that should be noted.
You do not assert in your petition that marijuana has a currently accepted medical
use in treatment in the United States or that marijuana has an accepted safety for
use under medical supervision. Indeed, the HHS scientific and medical evaluation
reaffirms expressly that marijuana has no currently accepted medical use in treatment
in the United States and a lack of accepted safety for use under medical supervision.
Nor do you dispute that marijuana is a drug of abuse. That is, you do not contend
that marijuana has no potential for abuse such that it should be removed entirely
from the CSA schedules. Rather, your contention is that marijuana has less than
a "high potential for abuse" commensurate with schedules I and II and, therefore,
it cannot be classified in either of these two schedules.
Congress established only one schedule-schedule I-for drugs of abuse with "no currently
accepted medical use in treatment in the United States" and "lack of accepted safety
for use * * * under medical supervision." 21 USC 812(b). To be classified in schedules
II through V, a drug of abuse must have a "currently accepted medical use in treatment
in the United States." 3 Id.
This is why the CSA allows practitioners to prescribe only those controlled substances
that are listed in schedules II through V. 21 USC 829. Drugs listed in schedule
I, by contrast, may not be prescribed for patient use; they may only be dispensed
by practitioners who are conducting FDA-approved research and have obtained a schedule
I research registration from DEA. 21 USC 823(f); 21 CFR 5.10(a)(9), 1301.18, 1301.32.
That schedule I controlled substances are characterized by a lack of accepted medical
use was recently reiterated by Congress, when it declared, in a provision entitled,
"NOT LEGALIZING MARIJUANA FOR MEDICINAL USE":
It is the sense of the Congress that-
(1) certain drugs are listed on Schedule I of the Controlled Substances Act if they
have a high potential for abuse, lack any currently accepted medical use in treatment,
and are unsafe, even under medical supervision;
(2) the consequences of illegal use of Schedule I drugs are well documented, particularly
with regard to physical health, highway safety, and criminal activity;
(3) pursuant to section 401 of the Controlled Substances Act, it is illegal to manufacture,
distribute, or dispense marijuana, heroin, LSD, and more than 100 other Schedule
I drugs;
(4) pursuant to section 505 of the Federal Food, Drug and Cosmetic Act, before any
drug can be approved as a medication in the United States, it must meet extensive
scientific and medical standards established by the Food and Drug Administration
to ensure it is safe and effective;
(5) marijuana and other Schedule I drugs have not been approved by the Food and
Drug Administration to treat any disease or condition.
* * * * *
Pub. L. No. 105-277, Div. F., 112 Stat. 2681-760 to 2681-761 (1998) (emphasis added).
Thus, when it comes to a drug that is currently listed in schedule I, if it is undisputed
that such drug has no currently accepted medical use in treatment in the United
States and a lack of accepted safety for use under medical supervision, and it is
further undisputed that the drug has at least some potential for abuse sufficient
to warrant control under the CSA, the drug must remain in schedule I. In such circumstances,
placement of the drug in schedules II through V would conflict with the CSA since
such drug would not meet the criterion of "a currently accepted medical use in treatment
in the United States." 21 USC 812(b).
Therefore, even if one were to assume, theoretically, that your assertions about
marijuana's potential for abuse were correct (i.e., that marijuana had
some potential for abuse but less than the "high potential for abuse" commensurate
with schedules I and II), marijuana would not meet the criteria for placement in
schedules III through V since it has no currently accepted medical use in treatment
in the United States-a determination that is reaffirmed by HHS in the attached medical
and scientific evaluation.
For the foregoing reasons, your petition to reschedule marijuana cannot be granted
under the CSA and is, therefore, denied.
Sincerely,
Donnie R. Marshall,
Administrator.
Attachments.
Department of Health and Human Services,
Office of the Secretary, Office of the Public
Health and Science, Assistant Secretary for
Health, Surgeon General, Washington, D.C.
20201.
January 17, 2001.
Mr. Donnie R. Marshall,
Deputy Administrator, Drug Enforcement
Administration, Washington, D.C. 20537.
Dear Mr. Marshall: In response to your request dated December 17, 1997, and pursuant
to the Controlled Substances Act (CSA), 21 U.S.C. § 811 (b), (c), and (f), the Department
of Health and Human Services (DHHS) recommends that marijuana * * * continue to
be subject to control under Schedule I. * * * Marijuana and the tetrahydrocannabinols
are currently controlled under Schedule I of the CSA. Marijuana continues to meet
the three criteria for placing a substance in Schedule I of the CSA under 21 U.S.C.
812(b)(1). As discussed in the attached analysis, marijuana has a high potential
for abuse, has no currently accepted medical use in treatment in the United States,
and has a lack of accepted safety for use under medical supervision. Accordingly,
HHS recommends that marijuana * * * continue to be subject to control under Schedule
I of the CSA.
You will find enclosed two documents prepared by FDA's Controlled Substance Staff
that are the bases for the recommendations.
Sincerely yours,
David Satcher,
Assistant Secretary for Health and Surgeon
General.
Enclosure.
3 A controlled substance in schedule
II must have either "a currently accepted medical use in treatment in the United
States or a currently accepted medical use with severe restrictions." 21 USC 812(b)(2)(B).
DEA Denial of Petition, 66 Fed. Reg. 20038 (April 18, 2001) 20051-20052:
2. Marijuana Has No Currently Accepted Medical Use in Treatment in the United States
The FDA has not approved a new drug application for marijuana. The opportunity for
scientists to conduct clinical research with marijuana has increased recently due
to the implementation of DHHS policy supporting clinical research with botanical
marijuana. While there are INDs for marijuana active at the FDA, marijuana does
not have a currently accepted medical use for treatment in the United States nor
does it have an accepted medical use with severe restrictions.
A drug has a "currently accepted medical use" if all of the following five elements
have been satisfied:
a. The drug’s chemistry is known and reproducible;
b. There are adequate safety studies;
c. There are adequate and well-controlled studies proving efficacy;
d. The drug is accepted by qualified experts; and
e. The scientific evidence is widely available.
Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir.
1994).
Although the chemistry of many cannabinoids found in marijuana have been characterized,
a complete scientific analysis of all the chemical components found in marijuana
has not been conducted. Safety studies for acute or subchronic administration of
marijuana have been carried out through a limited number of Phase 1 clinical investigations
approved by the FDA, but there have been no studies that have scientifically assessed
the efficacy of marijuana for any medical condition. A material conflict of opinion
among experts precludes a finding that marijuana has been accepted by qualified
experts. At this time, it is clear that there is not a consensus of medical opinion
concerning medical applications of marijuana.
Alternately, a drug can be considered to have "a currently accepted medical use
with severe restrictions" (21 U.S.C. 812(b)(2)(B)). Although some evidence exists
that some form of marijuana may prove to be effective in treating a number of conditions,
research on the medical use of marijuana has not progressed to the point that marijuana
can be considered to have a "currently accepted medical use with severe restrictions."