|
|
SUMMARY OF ARGUMENT
By definition, a synthetic drug is the same as its natural
occurring twin. Delta-9-THC is only one substance, not two. In
1986, Health and Human Services (HHS) recognized that synthetic
delta-9-THC is the same as its naturally occurring twin. The DEA
must accept this 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.
Neither can the DEA rely on FDA marketing approval of
Marinol, synthetic dronabinol "in sesame oil and encapsulated in
soft gelatin capsules," as a reason for keeping all other forms
of delta-9-THC in Schedule I. Sesame oil and gelatin capsules
are simply foods, which are not subject to control under the CSA.
It is delta-9-THC 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, delta-9-THC, 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 medications cocaine and morphine.
ARGUMENT
1. SYNTHETIC AND NATURAL DELTA-9-THC ARE THE SAME.
The Administrator's decision that synthetic delta-9-THC in
sesame oil and encapsulated in soft gelatin capsules, but not
delta-9-THC itself, has been rescheduled, and that delta-9-THC is
not obtained from marijuana, is beyond the scope of the DEA's
authority.
This Court must review the DEA's decision to schedule delta-
9-THC simultaneously in two different schedules 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 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 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
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 delta-9-THC in sesame oil and encapsulated
in soft gelatin capsules, this does not qualify as a
recommendation to the DEA for purposes of scheduling. FDA has
never recommended that delta-9-THC remain in Schedule I while
Marinol is in Schedule II, nor has it said that synthetic delta-
9-THC is better than delta-9-THC itself. [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 in 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 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.
A synthetic drug is the same as its naturally occurring
twin, by definition. 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]
The Administrator says that marijuana is not the source of
an accepted and useful medication, but there is considerable
evidence to the contrary. 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 synthetic delta-9-THC are the same as those of delta-9-THC
itself.
In his final order on NORML's petition, 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.
Synthetic delta-9-THC is an exact duplicate of its naturally
occurring twin, delta-9-THC. "Following the isolation and
characterization of delta-9-THC as the major active component of
marijuana by Mechoulam and colleagues, a technique for producing
synthetic material was developed." Plasse, T.; Gorter, R.;
Krasnow, S.; Lane, M.; Shepard, K.; Wadleigh, R. Recent Clinical
Experience With Dronabinol. Pharmacology Biochemistry &
Behavior, Vol. 40, pp. 695-700; 1991 (Gaoni, Y.; Mechoulam, R.
The isolation and structure of 1-tetrahydrocannabinol and other
neutral cannabinoids from hashish. J. Am. Chem. Soc. 93:217-224;
1971) (Petrzilka, T.; Haefliger, W.; Sikemeier, C. Synthesis of
hashish components. Part 4. Helv. Chim. Acta 52:1102-1134; 1969).
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, delta-9-THC itself 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).
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 itself.
In 1986, then Administrator John C. Lawn improperly took
upon himself the authority to define synthetic delta-9-THC and
delta-9-THC itself as two separate substances under the CSA.
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 be the same as the
naturally occurring twin before it can receive FDA marketing
approval for distribution in interstate commerce. As a matter of
law, delta-9-THC itself was rescheduled to Schedule II of the CSA
at the same time as synthetic delta-9-THC, and this Court should
so find.
2. MARIJUANA IS IN 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. "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.
The explanation given by the Administrator for the placement
of coca and opium poppy plants in Schedule II is that coca and
opium poppy plants have been "recognized as the source for a
variety of accepted and useful medications." Petition, Exhibit
A. According to this explanation, marijuana should be
transferred to Schedule II, because it has now become the source
of an accepted and useful medication, after its initial placement
in Schedule I of the CSA in 1970.
In the final order under review in this case, the
Administrator stated that, "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." Final Order, October 23,
1992.
Again, the standard of review is that of Chevron, 467 U.S.
837. 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." Petition, Exhibit A.
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 cannot be placed in a
schedule higher than Schedule II. 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.
To quote the Administrator, "Those who insist marijuana has
medical uses would serve society better by promoting or
sponsoring more legitimate scientific research, rather than
throwing their time, money and rhetoric into lobbying, public
relations campaigns and perennial litigation." 57 Fed. Reg. at
10,503. Since marijuana belongs in Schedule II of the CSA, the
DEA should not even be involved in the debate on marijuana's
medical use. Congress intended the FDA to handle this debate.
Scientific research will be promoted by treating marijuana
exactly the same as coca and opium poppy plants, the DEA will be
removed from the debate on marijuana's medical use, clearing the
way for the FDA to take over, and needless perennial litigation
will cease.
Since accessibility for research 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).
3. THE PETITION MUST BE ACCEPTED BEFORE IT IS DENIED.
Another question presented is whether the Administrator
followed proper procedure in refusing to accept the petition by
denying the petition on its merits. Pursuant to 21 C.F.R. §
1308.44(c):
Within a reasonable period of time after the receipt of a
petition, the Administrator shall notify the petitioner of his
acceptance or nonacceptance of the petition, and if not accepted,
the reason therefor. The Administrator need not accept a
petition for filing if any of the requirements prescribed in
paragraph (b) of this section is lacking or is not set forth so
as to be readily understood. If the petitioner desires, he may
amend the petition to meet the requirements of paragraph (b) of
this section. If accepted for filing, a petition may be denied
by the Administrator within a reasonable period of time
thereafter if he finds the grounds upon which the petitioner
relies are not sufficient to justify the initiation of
proceedings.
The Administrator's streamlined procedure in this case appears to
be in conflict with DEA regulations. This Court dealt with a
similar procedural question in 1974:
[T]he rejection of a filing is a "peremptory" response "which
classically is used not to dispose of a matter on the merits but
rather as a technique for calling on the filing party to put its
papers in proper form and order. Its use is not limited to
defects of form. It may be used by an agency where the filing is
so patently a nullity as a matter of substantive law, that
administrative efficiency and justice are furthered by obviating
any docket at the threshold rather than opening a futile docket."
146 U.S.App.D.C. at 299, 450 F.2d at 1346.
NORML v. Ingersoll, 497 F.2d at 659 n.10. My petition was not
such a patent nullity, as matter of law, to justify either
refusal to accept the petition for filing, or denial of the
petition on its merits. I was denied the opportunity to present
additional evidence to support my petition, and I am objecting to
this streamlined approach.
CONCLUSION
Based on the foregoing, I respectfully request this Court to
rule that: (1) as a matter of law, delta-9-THC itself 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.
Respectfully submitted,
Carl Eric Olsen, pro se
Post Office Box 4091
Des Moines, Iowa 50333
August 4, 1993
|
