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QUESTIONS PRESENTED FOR REVIEW
I. Whether the Administrator of the Drug Enforcement
Administration erred in ruling that the final rule of May 13,
1986, placing synthetic dronabinol in sesame oil and encapsulated
in soft gelatin capsules in Schedule II did not included the
rescheduling of delta-9-tetrahydrocannabinol itself.
II. Whether the Administrator of the Drug Enforcement
Administration erred in ruling that the final rule of May 13,
1986, placing synthetic dronabinol in sesame oil and encapsulated
in soft gelatin capsules in Schedule II did not included the
rescheduling of marijuana.
III. Whether the Administrator of the Drug Enforcement
Administration erred procedurally by refusing to accept the
petition and ruling on its merit, simultaneously.
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 October 23, 1992. My Petition for Review was received
by this Court on November 12, 1992, and assigned Docket No. 92-
8041. My Petition for Review was subsequently filed in forma
pauperis by this Court on February 8, 1993, and reassigned Docket
No. 93-1109 [App., p. 17]. 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 the two classifications that
provides for the most severe restrictions.
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,
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 Acting Administrator of the Drug
Enforcement Administration (DEA) pursuant to 28 C.F.R. §§
0.100(b) & 0.132(d) (1992).
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
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
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
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.
There are currently two other petitions for review, seeking
to have marijuana moved from Schedule I to Schedule II of the
CSA, now pending before this Court. Alliance for Cannabis
Therapeutics v. Drug Enforcement Administration, No. 92-1168, and
Drug Policy Foundation v. Drug Enforcement Administration, No.
92-1179. The Alliance for Cannabis Therapeutics (ACT) and the
Drug Policy Foundation (DPF) allege that marijuana has accepted
medical use in treatment in the United States, 21 U.S.C. §
812(b)(2)(B), and seek rescheduling on that basis. They are
seeking review of a final order of the Drug Enforcement
Administration (DEA), issued on March 26, 1992, finding that
marijuana does not have accepted medical use in treatment in the
United States. 57 Fed. Reg. 10,499.
The scheduling of marijuana under the Controlled Substances
Act (CSA), 21 U.S.C. § 812, as well as under international
obligations, has been under consideration 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); and, ACT
v. DEA, 930 F.2d 936 (D.C. Cir. 1991). The issue is still
pending before this Court in ACT v. DEA, No. 92-1168, and DPF v.
DEA, No. 92-1179.
ACT and DPF inherited their case from NORML which filed a
petition to have marijuana removed from the CSA with the Bureau
of Narcotics and Dangerous Drugs (BNDD) on May 18, 1972. The
BNDD refused to accept the petition for filing, and this Court
had to order the DEA to 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 belongs. NORML v. DEA, 559
F.2d 735, 757 (D.C. Cir. 1977).
In the final order for which ACT and DPF seek review, 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 went on to explain why marijuana
failed to satisfy the remaining four criteria, but these four
will not be repeated here, because failure to satisfy the first
criterion would almost certainly mean failure to satisfy the
remaining four.
After reading the Administrator's final ruling of March 26,
1992, I sent a letter to the Administrator on July 21, 1992,
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 (neither are
reproducible in standardized dosages) [App., p. 1].
On August 17, 1992, the Administrator replied 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." Letter from the Administrator,
dated August 17, 1992 [App., p. 5]. The Administrator also
stated that "the petition to reschedule marijuana did not involve
the scheduling of any medically useful compound to be extracted
from the plant material." Id.
Interpreting the Administrator's statements regarding
scheduling of coca and opium poppy plants and scheduling of a
medically useful compound extracted from marijuana as general
rules, I then filed my own Petition to Reschedule Marijuana based
on the fact that in 1986 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, and, therefore, marijuana must be moved into the
same schedule as dronabinol [App., p. 2]. 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).
The Administrator responded to my petition by stating, "In
a final rule published on May 13, 1986, then Administrator John
C. Lawn placed a very specific substance, synthetic dronabinol in
sesame oil and encapsulated in soft gelatin capsules, in Schedule
II. Administrator Lawn's action did not involve the rescheduling
of delta-9-tetrahydrocannabinol itself, nor did it include any
form of dronabinol other than the synthetic." Final rule of the
Administrator, October 23, 1992 [App., p. 7].
The Administrator stated further, "Since I am not accepting
your petition on the grounds that dronabinol is a wholly
synthetic substance, not obtained from marijuana, it is
unnecessary for me to consider the broader question of whether
the rescheduling of marijuana would be appropriate if accepted
medications were indeed obtained from that source." Id.
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