Alliance for Cannabis Therapeutics, Petitioner v. Drug Enforcement Administration,
Respondent; The National Organization for the Reform of Marijuana Laws, Petitioner
v. Drug Enforcement Administration, Respondent
Nos. 90-1019, 90-1020
UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
930 F.2d 936 (D.C. Cir. 1991)
April 26, 1991
COUNSEL: Thomas C. Collier, Jr., with whom Steven K. Davidson and
Amy W. Lustig were on the brief, for Petitioner Alliance for Cannabis Therapeutics
in 90-1019.
Kevin B. Zeese was on the brief for Petitioner The National Organization for the
Reform of Marijuana Laws in 90-1020.
Charlotte J. Mapes, Attorney, Department of Justice, with whom Margaret A. Grove,
Attorney, Department of Justice, and Stephen E. Stone, Associate Chief Counsel,
Department of Justice, were on the brief, for Respondent in 90-1019 and 90-1020.
Madeline R. Shirley, Attorney, Department of Justice, also entered an appearance
for Respondent.
JUDGES: Silberman, Buckley, and Henderson, Circuit Judges. Opinion
for the Court filed by Circuit Judge Silberman.
[*937] SILBERMAN, Circuit Judge:
This is a petition for review of a final order of the Administrator of the Drug
Enforcement Administration (DEA). The order maintains the classification of marijuana
as a narcotic drug under Schedule I of the Controlled Substances Act, 21 U.S.C.
§§ 801-996. Petitioners, Alliance for Cannabis Therapeutics (ACT) and National Organization
for the Reform of Marijuana Laws (NORML), who claim that marijuana should be reclassified
in Schedule II, argue that the DEA Administrator's decision rests on an improper
application of the statutory standards and an incorrect determination that petitioners
failed to meet them. We think that the Administrator's interpretation of the statute
was in the main acceptable, but he appears to have relied on several factors that
are unreasonable because logically impossible to satisfy; therefore, we remand.
I.
The Controlled Substances Act (CSA) is a comprehensive regulatory measure that divides
the universe of hazardous drugs into five different categories of substances (so-called
schedules), which determine the severity of restrictions on doctors' and patients'
access to controlled drugs. [Footnote 1]
Drugs can be "re-scheduled" or "de-scheduled" only if the DEA
makes certain statutorily-mandated findings. Schedule I drugs are subject to the
most severe controls and give rise to the harshest penalties for violations of these
controls; they are deemed to be the most dangerous substances, possessing no redeeming
value as medicines. The Act sets forth statutory criteria to be used in determining
whether a drug should be placed in Schedule I:
(A) The drug or other substance has a high potential for abuse.
(B) The drug or other substance has no currently accepted medical use in treatment
in the United States.
(C) There is a lack of accepted safety for use of the drug or other substance under
medical supervision.
21 U.S.C. § 812(b)(1).
The Act contains a somewhat different set of criteria for Schedule II:
[*938] (A) The drug or other substance has a high potential for
abuse.
(B) The drug or other substance has a currently accepted medical use in treatment
in the United States or a currently accepted medical use with severe restrictions.
(C) Abuse of the drug or other substance may lead to severe psychological or physical
dependence.
21 U.S.C. § 812(b)(2).
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."
This case turns on the appropriate definition and application of that phrase.
The Administrator is guided by a set of statutory factors in making a classification
decision as to which schedule is appropriate. See 21 U.S.C. § 811. And
two of those factors bear on the Administrator's definition of generally accepted
medical use - the "scientific evidence of [the drug's] pharmacological effect,
if known" and "the state of current scientific knowledge regarding the
drug or other substance." 21 U.S.C. § 811(c)(2), (3).
Petitioners argued below that marijuana has medical uses for the treatment of cancer,
glaucoma, and other diseases and therefore it cannot properly be maintained in Schedule
I. The ALJ agreed with petitioners and found, based on testimony of a number of
physicians and patients, that a "respectable minority" of American physicians
accept those uses, which was sufficient, according to the ALJ, to say that marijuana
had a currently accepted medical use. 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.
In a prior proceeding, the Administrator had employed an additional eight factor
test to further elaborate the characteristics of a drug that he thought had a "currently
accepted medical use":
(1) Scientifically determined and accepted knowledge of its chemistry;
(2) The toxicology and pharmacology of the substance in animals;
(3) Establishment of its effectiveness in humans through scientifically designed
clinical trials;
(4) General availability of the substance and information regarding the substance
and its use;
(5) Recognition of its clinical use in generally accepted pharmacopeia, medical
references, journals or textbooks;
(6) Specific indications for the treatment of recognized disorders;
(7) Recognition of the use of the substance by organizations or associations of
physicians; and
(8) Recognition and use of the substance by a substantial segment of the medical
practitioners in the United States.
53 Fed. Reg. 5,156 (1988).
The Administrator, in his opinion in this proceeding, reaffirmed this eight factor
test. See 54 Fed. Reg. 53,783. He stated that "these characteristics
rely heavily on verifiable scientific data and acceptance by the medical community,"
which he thought went "hand in hand" because "most physicians . .
. rely on scientific data in formulating their opinions regarding the safety and
effectiveness of a drug. . . ." 54 Fed. Reg. 53,783 (1988).
Most important to the Administrator was his conclusion that "the chemistry,
toxicology, and pharmacology of marijuana is not established" and its effectiveness
has not been documented in humans with scientifically-designed clinical trials (such
as double-blind studies where neither the patient nor the observer knows who received
the placebo and who received the actual substance). Id. at 53,784. Therefore,
"the vast majority of physicians do not accept marijuana as having a medical
use" and it is "not recognized as medicine in generally accepted pharmacopoeia,
medical references, journals, or textbooks." Id. The Administrator
exercised with a vengeance his prerogative under Universal Camera Corp. v. NLRB,
340 U.S. 474, 477, 95 L. Ed. 456, 71 S. Ct. 456 (1951), to [*939]
reject the ALJ's recommended decision, labelling the ALJ's standard for "currently
accepted medical use" as use by a "respectable minority" of physicians
as "preposterous." [Footnote 2]
54 Fed. Reg. 53,784.
II.
The petitioners renew their argument that the Administrator unreasonably rejected
the evidence they presented (largely anecdotal) that a number of physicians believe
marijuana is medically useful and, instead, improperly predicated his determination
on the absence of demonstrated scientific evidence that the drug is medically useful
and safe. 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. See NLRB v. United Food & Commercial Workers Union,
484 U.S. 112, 123, 98 L. Ed. 2d 429, 108 S. Ct. 413 (1987); Chevron U.S.A. Inc.
v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843-45, 81 L.
Ed. 2d 694, 104 S. Ct. 2778 (1984). And since Congress required the Administrator,
in making scheduling determinations with respect to any drug, to consider the "scientific
evidence of [the drug's] pharmacological effect" and the "state of current
scientific knowledge regarding the drug," 21 U.S.C. § 811(c)(2), (3), we do
not see how it can be thought an unreasonable application of the statutory phrase
to emphasize the lack of exact scientific knowledge as to the chemical effects of
the drug's elements. Perhaps if virtually all doctors in the United States were
vociferous in their espousal of marijuana for medical treatment - notwithstanding
scientific uncertainties - the Administrator's position would be more vulnerable.
But that is not the case; the ALJ's finding (not contested by the petitioners) is
only that a "respectable minority" take that position. The determination
as to how much weight to place on scientific uncertainties as opposed to anecdotal
evidence in applying the statutory phrase "currently accepted medical uses,"
then, is very much a policy judgment which we have no authority to challenge. See
generally Chevron. We certainly have no grounds, on this record, to dispute
the Administrator's premise that without much more complete scientific data American
physicians will not "accept" marijuana.
Petitioners, however, mount something of a flanking attack on that premise. They
assert that the Administrator's eight factor test, which emphasizes, in factors
1, 2 and 3, scientific knowledge of the chemistry of the drug and its effectiveness
in humans established through scientifically-designed clinical trials, is improperly
drawn from the Food, Drug and Cosmetic Act (administered by the Food and Drug Administration)
and not the Controlled Substances Act which the Administrator is authorized to apply.
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
labelling, which were necessary only to market the drug in interstate commerce.
These criteria are clearly relevant to the FDA's mission, but not to 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. [*940] 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. [Footnote 3]
Which brings us to the most troubling part of the Administrator's decision - the
part which we think obliges us to order a remand. Petitioners, almost in passing,
point out that three of the factors in the Administrator's eight-factor test appear
impossible to fulfill and thus must be regarded as arbitrary and capricious. Impossible
requirements imposed by an agency are perforce unreasonable: "Conditions imposed
by [the] order are . . . unreasonable by virtue of being impossible to meet."
D.C. Transit Sys., Inc. v. Washington Metropolitan Area Transit Comm'n,
151 U.S. App. D.C. 223, 466 F.2d 394, 402 (D.C. Cir.), cert. denied, 409
U.S. 1086, 93 S. Ct. 688, 34 L. Ed. 2d 673 (1972). These three factors are:
(4) General availability of the substance and information regarding the substance
and its use;
(5) Recognition of its clinical use in generally accepted pharmacopeia, medical
references, journals or textbooks;
(8) Recognition and use of the substance by a substantial segment of the medical
practitioners in the United States.
Petitioners argue that one cannot logically show that a drug enjoys general "availability"
or "use" by a substantial segment of medical practitioners if the drug
remains in Schedule I. One of the very purposes in placing a drug in Schedule I
is to raise significant barriers to prevent doctors from obtaining the drugs too
easily. DEA regulations require doctors who wish to use such drugs to submit a scientific
research protocol to the FDA for approval and permit use only in accordance with
the protocol. And the FDA insists that a developed scientific study program be presented
in order to gain approval of the protocol. See 21 C.F.R. § 1301.33(b) (requiring
compliance with 21 C.F.R. § 130.3). The DEA regulations further impose mandatory
registration with the DEA and mandatory record-keeping and safe-keeping requirements,
presenting additional barriers to widespread use, see 21 C.F.R. § 1301.33,
1301.42. We are therefore hard-pressed to understand how one could show that any
Schedule I drug was in general use or generally available. We are also concerned
that the fifth factor "recognition of [a drug's] clinical use in generally
accepted pharmacopeia, medical references, journals, or textbooks" might be
subject to the same objection. Petitioners assert that if a drug is not widely prescribed
- regardless of its safety or use - it will not appear in a pharmaceutical listing
of medically useful drugs. Since the government did not respond clearly to the argument,
we are left in doubt as to the argument's validity. Under these circumstances, we
think the appropriate course is to remand to the agency for an explanation as to
how all three of these factors were utilized by the Administrator in reaching his
decision. [Footnote 4]
To be sure, the Administrator did not explicitly rely on factors (4) and (8) in
the analytical portion of his opinion (he did say "marijuana is not recognized
as a medicine in generally accepted pharmacopeia, medical references, and textbooks,"
indicating his reliance on factor (5)). But since he did reaffirm the eight criteria's
applicability to this case, we simply cannot be certain what role, if any, factors
(4) and (8) played in his [*941] decision. Under our governing
cases, we must remand for the requisite explanation. See MCI Telecommunications
Corp. v. FCC, 286 U. S. App. D.C. 316, 917 F.2d 30, 39-40 (D.C. Cir. 1990);
City of Vernon v. FERC, 269 U.S. App. D.C. 297, 845 F.2d 1042, 1046-49
(D.C. Cir. 1988).
* * *
For the foregoing reasons, the case is remanded.
It is so ordered.