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QUESTIONS PRESENTED FOR REVIEW
I. Whether the Administrator of the Drug Enforcement
Administration erred in ruling that marijuana must have an
accepted medical use in treatment in the United States
before it can be transferred from Schedule I to Schedule II
of the federal Controlled Substances Act of 1970.
II. Whether the Administrator of the Drug Enforcement
Administration erred in ruling that only synthetic
dronabinol in sesame oil and encapsulated in soft gelatin
capsules, not dronabinol itself, was transferred to Schedule
II of the federal Controlled Substances Act of 1970.
III. Whether the Administrator of the Drug Enforcement
Administration erred by ruling that marijuana is not the
source of a Schedule II controlled substance under the
federal Controlled Substances Act of 1970.
IV. Whether the Administrator of the Drug Enforcement
Administration erred by ruling that the scheduling of
dronabinol is irrelevant to the scheduling of marijuana
under the federal Controlled Substances Act of 1970.
STATUTES AND REGULATIONS
The pertinent statues and regulations are set forth in an
addendum bound with this brief.
JURISDICTION
The final order of the Drug Enforcement Administration was
issued on May 16, 1994 [App., p. 17]. I received the final order
by mail on May 19, 1994. My Petition for Review, with attached
Motion to Proceed in Forma Pauperis, was filed by this Court on
June 17, 1994, and assigned Docket No. 94-8015. My Motion to
Proceed in Forma Pauperis was subsequently denied, and my
Petition for Review was refiled by this Court on September 16,
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1994, and reassigned Docket No. 94-1605. This Court has
jurisdiction of this petition for review of a final order of the
Drug Enforcement Administration pursuant to 21 U.S.C. § 877.
STATEMENT OF THE CASE
1. THE CONTROLLED SUBSTANCES ACT.
In 1970 Congress enacted the Controlled Substances Act
(CSA), a comprehensive statute designed to rationalize federal
control of dangerous drugs. The Act contains five categories of
controlled substances, designated as Schedules I through V and
defined in terms of dangers and benefits. 21 U.S.C. § 812(b)(1)-
(5). The control mechanisms imposed on manufacture, acquisition,
and distribution of substances listed under the Act vary
according to the schedule in which the substance is contained.
Substances in Schedules I & II are subject to the most severe
restrictions, and substances in Schedule V are subject to the
least severe restrictions. In drafting the CSA Congress placed
marijuana in Schedule I, one of two classifications that provide
for the most severe restrictions (the other is Schedule II).
Recognizing that the results of continuous research might
cast doubt on the wisdom of initial classification assignments,
Congress created a procedure by which changes in scheduling could
be effected. Pursuant to Section 201(a) of the Act, 21 U.S.C. §
811(a), the Attorney General "may, by rule," add a substance to a
schedule, transfer it between schedules, or remove it from the
schedules. A reclassification rule promulgated under this
section must be made on the record after opportunity for hearing,
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in accordance with the rulemaking procedures prescribed by the
Administrative Procedure Act, 5 U.S.C. ch. 5, subch. II. Section
201(a) further provides that rescheduling proceedings may be
initiated by the Attorney General on his [or her] own motion, at
the request of the Secretary of Health and Human Services (HHS),
or, as in the present case, on petition of any interested party.
Section 501(a) of the CSA, 21 U.S.C. § 871(a), authorizes
the Attorney General to "delegate any of his functions under this
subchapter to any officer or employee of the Department of
Justice." The functions vested in the Attorney General by the
CSA have been delegated to the Administrator of the Drug
Enforcement Administration (DEA) pursuant to 28 C.F.R. §§
0.100(b) & 0.132(d).
DEA's Acting Administrator must share his [or her] decision-
making function under the Act with the Secretary of HHS. Section
201(b), 21 U.S.C. § 811(b), provides that, prior to commencement
of reclassification rulemaking proceedings, the Attorney General
must "request from the Secretary a scientific and medical
evaluation, and his [or her] recommendations, as to whether such
drug or other substance should be so controlled or removed as a
controlled substance." The evaluation prepared by the Secretary
must address the scientific and medical factors enumerated in
Section 201(c), 21 U.S.C. § 811(c); these factors relate to the
effects of the drug and its abuse potential. Pursuant to Section
201(b), the Secretary's recommendations "shall be binding on the
Attorney General as to such scientific and medical matters, and
if the Secretary recommends that a drug or other substance not be
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controlled, the Attorney General shall not control the drug or
other substance."
Section 201(d) of the Act, 21 U.S.C. § 811(d), contains a
limited exception to the referral procedures detailed in Section
201(b)-(c). Subsection (d)(1) provides:
If control is required by United States obligations
under international treaties, conventions, or protocols in
effect on October 27, 1970, the Attorney General shall issue
an order controlling such drug under the schedule he [or
she] deems most appropriate to carry out such obligations,
without regard to the findings required by subsection (a) of
this section or section 812(b) of this title and without
regard to the procedures prescribed by sections (a) and (b)
of this section.
2. THE SINGLE CONVENTION ON NARCOTIC DRUGS.
In 1948, in order to simplify existing treaties and
international administrative machinery, members of the United
Nations undertook codification of a single convention on
international narcotics control. In 1961, after three
preliminary drafts, the Single Convention on Narcotic Drugs,
1961, 18 U.S.T. 1407 (1967), 520 U.N.T.S. 204 (1964), was opened
for signature. The United States ratified the Single Convention
in 1967 -- three years prior to enactment of the CSA.
Like the CSA, the Single Convention establishes several
classifications or "schedules" of substances, to which varying
regimes of control attach. Schedule I of the Single Convention
contains substances considered to carry a relatively high abuse
liability; included in this category are heroin, methadone,
opium, coca leaf, and cocaine. Schedule II and III contain those
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substances regarded as less susceptible to abuse. Finally,
Schedule IV of the Single Convention -- unlike CSA schedule IV --
embraces certain Schedule I substances, such as heroin, the abuse
liability of which is not offset by substantial therapeutic
advantages. Marijuana (cannabis) is listed in Schedules I and IV
of the Single Convention. However, delta-9-tetrahydrocannabinol
(delta-9-THC) is not listed in the schedules of the Single
Convention.
3. THE CONVENTION ON PSYCHOTROPIC SUBSTANCES.
In 1978 Congress enacted the Psychotropic Substances Act
(PSA), Pub. L. 95-633, Nov. 10, 1978, 92 Stat. 2768, to coincide
with the Convention on Psychotropic Substances, signed at Vienna,
Austria on February 21, 1971 [The Convention entered into force
in respect to the United States on July 15, 1980], 1019 U.N.T.S.
175 (1976), Treaty No. 14,596. Section 101 of the PSA, 21 U.S.C.
§ 801a, provides, in part:
The United States has joined with other countries in
executing an international treaty, entitled the Convention
on Psychotropic Substances and signed at Vienna, Austria, on
February 21, 1971, which is designed to establish suitable
controls over the manufacture, distribution, transfer, and
use of certain psychotropic substances.
The Convention on Psychotropic Substances contains four
categories of controlled substances, designated as Schedules I
through IV and defined in terms of dangers and benefits. The
international control mechanisms imposed on manufacture,
acquisition, and distribution of substances listed under the
Convention on Psychotropic Substances vary according to the
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schedule in which the substance is contained. Substances in
Schedule I are subject to the most severe restrictions, and
substances in Schedule IV are subject to the least severe
restrictions.
In drafting the Convention on Psychotropic Substances the
parties placed tetrahydrocannabinols in Schedule I, the
classification that provides for the most severe restrictions.
However, "At its 1,045th meeting, on April 29, 1991, the
Commission on Narcotic Drugs, in accordance with article 2,
paragraphs 5 and 6, of the Convention on Psychotropic Substances,
1971, decided, by a vote of 33 in favor and 5 against, with no
abstentions, that delta-9-tetrahydrocannabinol (also referred to
as delta-9-THC) and its stereochemical variants should be
transferred from Schedule I to Schedule II of that Convention."
Official Records of the Economic and Social Council, 1991,
Supplement No. 4 (E/1991/24, Supp. No. 4), pp. 23 and 98 [App.,
p. 10]. The five States voting against the decision were
Colombia, Ivory Coast, Egypt, France and Pakistan. Id.
4. HISTORY OF THIS CASE.
The scheduling of marijuana under the Controlled Substances
Act (CSA), 21 U.S.C. § 812, as well as under international
obligations, has been considered by this Court on several prior
occasions. NORML v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974);
NORML v. DEA, 559 F.2d 735 (D.C. Cir. 1977); ACT v. DEA, 930 F.2d
936 (D.C. Cir. 1991); and ACT v. DEA, 15 F.3d 1131 (D.C. Cir.
1994).
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All of these cases originated from one petition filed with
the Bureau of Narcotics and Dangerous Drugs (BNDD) on May 18,
1972. NORML filed the petition seeking to have marijuana removed
from the CSA. The BNDD refused to accept the petition for
filing, and this Court then ordered the DEA to accept the
petition and respond. NORML v. Ingersoll, 497 F.2d 654 (D.C.
Cir. 1974). Upon remand the DEA held that international treaty
obligations required it to place marijuana in Schedule I of the
CSA. This Court then remanded the petition back to the DEA
again, holding that marijuana can be placed in either Schedule I
or Schedule II of the CSA without violating international treaty
obligations, and requiring the DEA to hold hearings to determine
in which of the two schedules, Schedule I or Schedule II,
marijuana properly belonged. NORML v. DEA, 559 F.2d 735, 757
(D.C. Cir. 1977).
As the issue became more narrowly focused, the Alliance for
Cannabis Therapeutics (ACT) became the lead petitioner in the
case. The ACT, and the other parties seeking rescheduling,
advanced the argument that marijuana has accepted medical use in
treatment in the United States, 21 U.S.C. § 812(b)(2)(B), and
sought rescheduling solely on that basis. The DEA administrator
again denied the petition, listing several criteria for
determining accepted medical use which marijuana failed to meet,
and this Court then remanded the case for clarification of the
DEA administrator's final order. ACT v. DEA, 930 F.2d 936 (D.C.
Cir. 1991). The DEA administrator clarified and affirmed his
prior ruling in a subsequent final order, issued on March 26,
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1992, finding that marijuana does not have accepted medical use
in treatment in the United States. 57 Fed. Reg. 10,499. The ACT
sought review of the March 26, 1992, final order, and this Court
affirmed the final order of the DEA. ACT v. DEA, 15 F.3d 1131
(D.C. Cir. 1994).
In ACT v. DEA, 15 F.3d 1131 (D.C. Cir. 1994), the
Administrator listed five criteria for determining accepted
medical use, and found that marijuana failed to satisfy all five
criteria. The Administrator said, "First, marijuana's chemistry
is neither fully known, nor reproducible." 57 Fed. Reg. at
10,507. The Administrator's findings that marijuana failed to
satisfy the remaining four criteria are due to the failure to
satisfy the first criterion, which would necessarily dictate
failure to satisfy the remaining four.
After reading the Administrator's final ruling of March 26,
1992, 57 Fed. Reg. 10,499, I sent a letter to the Administrator
on July 21, 1992 [App., p. 1], asking why coca and opium poppy
plants are scheduled in Schedule II of the CSA, since both of
these plants are subject to the same variances in chemistry as
the marijuana plant and neither are reproducible in standardized
dosages.
On August 17, 1992, the Administrator replied [App., p. 5]
by stating that "these plant materials [coca and opium poppy]
have historically been recognized as the source for a variety of
accepted and useful medications." The Administrator also stated
that "the petition to reschedule marijuana did not involve the
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scheduling of any medically useful compound to be extracted from
the plant material."
Interpreting the Administrator's statements regarding the
scheduling of coca and opium poppy plants as general rules of
statutory construction, I then filed my own Petition to
Reschedule Marijuana [App., p. 2] based on the fact dronabinol,
delta-9-tetrahydrocannabinol (delta-9-THC), the principle
psychoactive substance in the marijuana plant, was rescheduled to
Schedule II of the Controlled Substances Act in 1986, and,
therefore, because marijuana is the source of dronabinol, it must
be moved into the same schedule as dronabinol. See Final Order
of the Drug Enforcement Administration, May 13, 1986, 51 Fed.
Reg. 17,476 (placing dronabinol in Schedule II).
My petition was filed on September 11, 1992, pursuant to 21
U.S.C. § 811 and 21 C.F.R. § 1307.03, in the form prescribed by
21 C.F.R. § 1308.44(b).
In his final order of May 16, 1994, the Deputy
Administrator responded to my petition [App., p. 23] by stating,
"Only the pharmaceutical product was transferred from Schedule I
to Schedule II, i.e., 'dronabinol (synthetic) in sesame oil and
encapulated in a soft gelatin capsule in a U.S. Food and Drug
Administration approved drug product.' No rescheduling action
was taken with regard to (-) delta-9-trans-THC, i.e., dronabinol,
which remains in Schedule I of the CSA."
The Deputy Administrator further stated [App., p. 24],
"Under the CSA, the regulation of chemicals and the plant
material are distinct from each other. The classification of
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delta-9-THC has no bearing on the classification of marijuana.
Under the CSA, a proposed change in the schedule of either a
tetrahydrocannabinol or the plant marijuana requires the Attorney
General to proceed independently." Id.
SUMMARY OF ARGUMENT
By definition, a synthetic drug is the same as its natural
occurring twin. Dronabinol is only one substance, not two.
Synthesizing, adding sesame oil and encapsulating in soft gelatin
capsules, while having significance to the Food and Drug
Administration (FDA) for marketing purposes, does not make
dronabinol into another drug for scheduling purposes. In 1986,
Health and Human Services (HHS) recognized that synthetic delta-
9-THC is the same as its naturally occurring twin [App., p. 8].
The DEA must accept the scientific and medical findings of HHS.
The DEA is trying to do something with delta-9-THC that it
doesn't do with any other drug, placing the synthetic drug in a
different schedule than its naturally occurring twin. The DEA is
not authorized to make such distinctions. The DEA must defer to
HHS for scientific and medical findings regarding the structure
of a drug.
The DEA cannot rely on FDA marketing approval of Marinol®
(synthetic dronabinol "in sesame oil and encapsulated in soft
gelatin capsules"), as a reason for keeping the dronabinol found
in the marijuana plant in Schedule I. Sesame oil and gelatin
capsules are simply foods, which are not subject to control under
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