the CSA. It is dronabinol which is in Schedule II, not just the
FDA approved product Marinol®.
In 1986, when marijuana became the source of an accepted and
useful medication, dronabinol, it should have been transferred
into the same schedule of the CSA, Schedule II, as the other
plants, coca and opium, which are the sources of the accepted and
useful Schedule II medications cocaine and morphine. It would be
illogical for the DEA to place a plant in a higher schedule than
the drug which caused it to be scheduled in the first place,
especially when there is no difference between Schedule I and
Schedule II with regard to enforcement of the drug laws (the
DEA's only valid concern).
ARGUMENT
1. SYNTHETIC AND NATURAL DELTA-9-THC ARE THE SAME.
The Administrator's decision that synthetic dronabinol in
sesame oil and encapsulated in soft gelatin capsules, but not
dronabinol itself, has been rescheduled, and that dronabinol is
not obtained from marijuana, is beyond the scope of the DEA's
authority. This distinction is strictly a function of the Food
and Drug Administration, and only with regard to the marketing of
a drug, not its scheduling.
In enacting the CSA, "Members of the House repeatedly stated
that the Department of Justice should make judgments based on law
enforcement considerations, while HEW should have the final say
with respect to medical and scientific determinations." NORML v.
DEA, 559 F.2d at 746. The Department of Justice "may not
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schedule a substance under the CSA without first obtaining the
recommendation of the FDA, through its parent agency, HHS, 21
U.S.C. § 811(b), and providing an 'opportunity for a hearing
pursuant to rulemaking procedures prescribed by [the
Administrative Procedures Act].' 21 U.S.C. § 811(a)." Grinspoon
v. DEA, 828 F.2d 881, 890 (1st Cir. 1987). "This request is
filed with the Commissioner of FDA, who has the responsibility
for coordination of activities within [HHS]." NORML v. DEA, 559
F.2d at 749 n.59.
As this Court stated in 1977:
Our interpretation of Section 201(d) ensures proper
allocation of decisionmaking responsibility between the
Attorney General and the Secretary of HEW, in accordance
with their respective spheres of expertise. Section 201(d)
directs the Attorney General, as an initial matter, to make
a legal judgment as to controls necessitated by
international commitments. He then establishes a minimum
schedule or level of control below which placement of the
substance may not fall. Determination of a minimum schedule
ensures that the Secretary's recommendation, which
ordinarily would be binding as to medical and scientific
findings, does not cause a substance to be scheduled in
violation of treaty obligations. However, once that minimum
schedule is established by the Attorney General, the
decision whether to impose controls more restrictive than
required by treaty implicates the same medical and
scientific considerations as do scheduling decisions
regarding those few substances not controlled by treaty.
The Secretary of HEW is manifestly more competent to make
these nonlegal evaluations and recommendations.
NORML v. DEA, 559 F.2d at 747.
Although the FDA has approved a New Drug Application (NDA)
for Marinol® (synthetic dronabinol in sesame oil and
encapsulated in soft gelatin capsules), this does not qualify as
a recommendation, pursuant to 21 U.S.C. § 811(b), to keep the
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dronabinol found in the marijuana plant in Schedule I. FDA did
not recommended that the dronabinol found in marijuana remain in
Schedule I when Marinol® was placed in Schedule II, nor did it
say that synthetic dronabinol was superior to the dronabinol
found in marijuana. [App., p. 15]
This is not the first time the DEA has tried to follow
verbatim text of FDA marketing approval for a New Drug
Application (NDA) in making a scheduling determination. As this
Court stated in 1991:
The First Circuit in Grinspoon v. Drug Enforcement
Administration, 828 F.2d 881, 891-92 (1st Cir. 1987), upon
which petitioners rely, had held that earlier criteria the
Administrator had employed to define "currently accepted
medical use" were contrary to the statute because they were
a carbon copy of those used by the FDA in licensing new
drugs. The present criteria, it is argued, duplicate a
number of those original criteria. But the criteria
challenged in Grinspoon included several elements, such as
the availability of patent information or FDA-required
labeling, which were necessary only to market the drug in
interstate commerce. These criteria are clearly relevant to
the FDA's mission, but not the DEA's, see Grinspoon, 828
F.2d at 887. The First Circuit never suggested the DEA
Administrator was foreclosed from incorporating and relying
on those standards employed by the FDA that are relevant to
the pharmaceutical qualities of the drug. The court merely
held that while FDA approval is sufficient to establish the
existence of an accepted medical use, the converse is not
true -- that absent FDA approval, commonly accepted medical
use cannot be proven. Id. at 890. Nor can we conceive of a
reason the Administrator should be barred from employing
notions developed by a sister agency insofar as those
notions serve the missions of both agencies.
ACT v. DEA, 930 F.2d at 939-40.
In 1987, the First Circuit said,
[W]e find no necessary linkage between failure to obtain FDA
interstate marketing approval and a determination that the
substance in question is unsafe and has no medical use.
Indeed, the FDCA does not even mention the term 'medical
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use.' In short, it is plainly possible that a substance may
fail to obtain interstate marketing approval even if it has
an accepted medical use.
Grinspoon, 828 F.2d at 887. "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." Id.
By definition, a synthetic drug is the same as its naturally
occurring twin. Under this Court's order of June 4, 1982, in
NORML v. DEA, No. 79-1660, the Department of Health and Human
Services (DHHS) was required to submit reports on the status of
its recommendations for the scheduling of THC and marijuana
plants. In reference to the DEA's rescheduling order of May 13,
1986 (51 Fed. Reg. 17,476) the DHHS stated that, "Dronabinol is
structurally the same as THC." [App., p. 8]
In his final order on NORML's petition, the Administrator
adopted in their entirety the findings of the former
Administrator. 57 Fed. Reg. at 10,507. The former
Administrator, in his final order on NORML's petition, stated,
"There is no difference in the pharmacological effect between the
THC isolated from cannabis and the synthetically produced THC
which is now marketed in the United States." 54 Fed. Reg. at
53,774. As this Court noted in 1991, "The First Circuit never
suggested the DEA Administrator was foreclosed from incorporating
and relying on those standards employed by the FDA that are
relevant to the pharmaceutical qualities of the drug." ACT v.
DEA, 930 F.2d at 939. The former Administrator, in agreement
with HHS, recognized that the pharmaceutical qualities of
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synthetic dronabinol are the same as those of the dronabinol
found in marijuana.
In his final order of March 26, 1992, the Administrator
stated, "There are scientific studies showing pure THC (Delta-9-
Tetrahydrocannabinol), one of the many chemicals found in
marijuana, has some effect in controlling nausea and vomiting.
Pure THC is pharmaceutically made in clean capsule form, called
Marinol, and is available for use by the medical community. More
information on Marinol can be found in the 'Physicians' Desk
Reference,' available in most libraries." 57 Fed. Reg. at
10,500. The 1993 Physician's Desk Reference describes Marinol as
follows: "Dronabinol, commonly known as delta-9-THC, is one of
the major active substances in marijuana." Id. at p. 2076. The
Physician's Desk Reference makes no distinction between synthetic
dronabinol and the dronabinol found in marijuana.
In a letter dated July 13, 1993, the FDA states that, "A
synthetic drug ... is identical in all respects to the product
isolated from a plant source. Such a product can be marketed
under the same name.... A synthetic drug would be in the same
schedule as its naturally occurring twin." Letter from the FDA,
July 13, 1993 [App., p. 16].
Clearly, the dronabinol found in marijuana was approved for
medical use by the FDA when it approved Marinol®. "[T]he [DEA]
does not have the authority to impose Schedule I controls on a
drug which has been approved by the [FDA] for medical use."
Grinspoon, 828 F.2d at 890 (citing, 1984 U.S. Code Cong. & Admin.
News 540, 543).
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When the Economic and Social Council of the United Nations
moved delta-9-THC from Schedule I to Schedule II of the
Convention on Psychotropic Substances, it made no distinction
between synthetic delta-9-THC and delta-9-THC found in marijuana.
In 1986, then Administrator John C. Lawn improperly took
upon himself the authority to define synthetic dronabinol and
dronabinol found in marijuana as two separate and distinct
substances under the CSA. 51 Fed Reg. 17476 (1986).
In the course of rescheduling synthetic dronabinol to
Schedule II of the CSA, the original proposal submitted by the
DEA defined it as "the principle psychoactive substance in
Cannabis sativa L., marijuana," 50 Fed. Reg. 42,185 (October 18,
1985) (proposed rule), but this definition was changed to "the
synthetic equivalent of the isomer of delta-9-
tetrahydrocannabinol (THC) which is the principle psychoactive
substance in Cannabis sativa L., marijuana" in the final rule, 51
Fed. Reg. 17,476 (May 13, 1986) (final rule). Whether this
change was accidental or intentional is hard to discern, but it
clearly exceeded the Administrator's authority.
Although it is true that "[a]ppellate courts have neither
the expertise nor the resources to evaluate complex scientific
claims," this is not a complex scientific claim. Grinspoon, 828
F.2d at 896 (citing, Thompson Medical Co. v. FTC, 791 F.2d 189,
196 (D.C. Cir. 1986)). A synthetic drug must first be the same
as its naturally occurring twin before it can receive FDA
marketing approval for distribution in interstate commerce. As a
matter of law, the dronabinol found in marijuana was rescheduled
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to Schedule II of the CSA at the same time as synthetic
dronabinol.
2. MARIJUANA IS IN THE SAME SCHEDULE AS DELTA-9-THC.
As this Court noted in 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.'" ACT v. DEA, 930 F.2d at 938. It is important to note
that medical use is not the only salient concept. As this Court
noted in 1977, "However, placement in Schedule I does not appear
to flow inevitably from lack of currently accepted medical use."
NORML v. DEA, 559 F.2d at 748. "The legislative history of the
CSA indicates that medical use is but one factor to be
considered, and by no means the most important one." Id.
Moreover, DEA's own scheduling practices support the
conclusion that substances lacking medical usefulness need
not always be placed in Schedule I. At the hearing before
ALJ Parker DEA's Chief Counsel, Donald Miller, testified
that several substances listed in CSA Schedule II, including
poppy straw, have no currently accepted medical use. Tr. at
473-474, 488. He further acknowledged that marihuana could
be rescheduled to Schedule II without a currently accepted
medical use. Tr. at 487-488. Neither party offered any
contrary evidence.
Id.
This Court must review the DEA's final order not to transfer
marijuana to Schedule II 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, 104 S.Ct. 2778, 81 L.Ed.2d
694 (1984). In Chevron, the Court explained that a reviewing
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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, 104 S.Ct. at 2781 (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, 104 S.Ct. at 2781-82 (footnote omitted; emphasis
supplied).
In this matter, the agency has interpreted the construction
of the statute at issue. The explanation given by the
Administrator for the placement of coca and opium poppy plants in
Schedule II is that Congress recognized coca and opium poppy
plants "as the source for a variety of accepted and useful
medications." [App., p. 5]. According to this explanation,
marijuana should have been transferred to Schedule II when it
became the source of an accepted and useful medication. The U.S.
Congress provided a mechanism for transferring marijuana to
Schedule II (or lower), after its initial placement of marijuana
in Schedule I of the CSA in 1970, and the DEA's interpretation of
the statute is reasonable.
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It is apparent from reading the CSA that Congress intended
to include coca and opium poppy plants in Schedule II because
useful medications were being derived from these plant sources
when the CSA was created in 1970. The apparent distinction that
Congress made between marijuana and coca and opium poppy plants,
when the schedules were created in 1970, was that coca and opium
poppy plants were the sources of useful and accepted medications,
while marijuana was not. The Administrator has provided his
interpretation of the statute by stating "Congress was very much
aware that these plant materials [coca and opium poppy] have
historically been recognized as the source for a variety of
accepted and useful medications." [App., p. 5].
The Administrator's interpretation reinforces what is
apparent from the face of the statute, that plants which are the
source of accepted and useful medications are placed in the same
schedule as the drugs themselves. For example, peyote, a plant
which contains the Schedule I drug mescaline, is also in Schedule
I, while opium poppy, a plant which contains the Schedule II drug
morphine, is in Schedule II.
Since control for enforcement purposes is exactly the same
under either Schedule I or Schedule II, there is no reason for
the DEA not to move marijuana into Schedule II, since DEA's only
legitimate concern under the CSA is drug diversion. "Congress
was particularly concerned with the diversion of drugs from
legitimate channels to illegitimate channels." United States v.
Moore, 423 U.S. 122, 135 (1972).
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In his final ruling of May 16, 1994, the DEA Deputy
Administrator said, "Whether or not marijuana is a source of
delta-9-THC is irrelevant to the status of marijuana under the
CSA." Final Order, p. 4 [App., p. 20]. In 1975, the United
States Court of Appeals for the District of Columbia Circuit gave
detailed consideration to this question in the case of United
States v. Walton, 514 F.2d 201 (D.C. Cir. 1975). The court said,
"Looking at the history of this latter law [the Marijuana Tax Act
of 1937], we find that the definition of marijuana was intended
to include those parts of marijuana which contain THC and to
exclude those parts which do not." Id. 514 F.2d at 203. "The
legislative history is absolutely clear that Congress meant to
outlaw all plants popularly known as marijuana to the extent
those plants possessed THC." Id. 514 F.2d at 203-204. Although
the Deputy Administrator said, "The classification of delta-9-THC
has no bearing on the classification of marijuana," [Final Order
of May 16, 1994, p. 8; App., p. 24], this Court has already ruled
otherwise.
CONCLUSION
Based on the foregoing, I respectfully request this Court to
rule that: (1) as a matter of law, the dronabinol found in
marijuana is in Schedule II of the CSA; (2) as a matter of law,
marijuana is in Schedule II of the CSA; and (3) such other or
further relief be granted as this Court may deem necessary under
the circumstances.
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Respectfully submitted,
__________________________________
Carl Eric Olsen, pro se
Post Office Box 4091
Des Moines, Iowa 50333
(515) 262-6957
CERTIFICATE OF SERVICE
I hereby certify that two copies of the foregoing
Petitioner's Brief were mailed to Harry J. Matz, Narcotic and
Dangerous Drug Section, Criminal Division, P.O. Box 27312,
Central Station, Washington, D.C. 20530, on this 18th day of
September, 1995.
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