Lyle E. Craker; Denial of Application, 2101-2133 [E9-521]

Agencies

• Drug Enforcement Administration
• Deparment of Justice

[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Notices]
[Pages 2101-2133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-521]


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DEPARMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 05-16]


Lyle E. Craker; Denial of Application

    On December 10, 2004, the Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause to Lyle E. Craker, 
Ph.D. (Respondent), of Amherst, Massachusetts. The Show Cause Order 
proposed the denial of Respondent's pending application for a 
registration as a bulk manufacturer of marijuana on two grounds. Show 
Cause Order at 1.
    First, the Show Cause Order alleged that Respondent's 
``registration would not be consistent with the public interest as that 
term is used in 21 U.S.C. 823(a).'' Show Cause Order at 1. Second, the 
Show Cause Order alleged that the Respondent's registration would be 
inconsistent ``with the United States'

[[Page 2102]]

obligations under the Single Convention on Narcotic Drugs (Single 
Convention), March 30, 1961, 18 U.S.T. 1407.'' Id.
    With respect to both of these contentions, noting that Respondent 
sought registration ``to supply analytical, pre-clinical and clinical 
researchers with marijuana,'' the Show Cause Order emphasized that the 
``National Institute on Drug Abuse (NIDA), a component [of] the 
National Institutes of Health (NIH)'' and ``the United States 
Department of Health and Human Services [HHS], oversees the 
cultivation, production and distribution of research-grade marijuana on 
behalf of the United States Government.'' Id. at 2.
    With respect to the contention that Respondent's proposed 
registration is inconsistent with the public interest, the Show Cause 
Order stated that, under 21 U.S.C. 823(a), ``DEA must limit the number 
of producers of research-grade marijuana to that which can provide an 
adequate and uninterrupted supply under adequately competitive 
conditions.'' Id. at 4. The Show Cause Order then stated: ``For the 
past 36 years, the University of Mississippi has provided such supply 
under the foregoing criteria, and there is no indication that this 
registrant will fail to do so throughout the duration of its current 
registration. While the University of Massachusetts is free to compete 
with the University of Mississippi to obtain the next NIDA contract to 
produce research-grade marijuana, there is no basis under Section 
823(a) to add an additional producer.'' Id.
    With respect to the contention of Respondent's sponsor, the 
Multidisciplinary Association for Psychedelic Studies (MAPS), that 
marijuana provided by NIDA to researchers was both qualitatively and 
quantitatively inadequate, the Show Cause Order alleged that marijuana 
provided by NIDA was ``of sufficient quantity and quality to meet'' the 
needs of ``legitimate and authorized research[ers].'' Id. at 3.
    The Show Cause Order also noted MAPS's contentions that ``NIDA is 
limited to supplying marijuana for research purposes and cannot supply 
marijuana on a prescription basis,'' that ``this limitation effectively 
prohibits a sponsor * * * from expending the necessary large amounts of 
funds to conduct drug development studies resulting in [a] marijuana 
prescription product,'' and that granting Respondent a registration 
would resolve this problem. Id. In response to these contentions, the 
Show Cause Order alleged that to obtain approval for the marketing of a 
new drug under the Food, Drug, and Cosmetic Act (FDCA), the safety and 
effectiveness of the drug must be demonstrated through three phases of 
clinical trials, and that clinical trials involving marijuana had not 
progressed beyond the first phase (phase 1). Id. at 2-4.
    The Show Cause Order further noted that the policy of HHS for 
approving the distribution of marijuana to researchers ``has not unduly 
limited clinical research with marijuana.'' Id. at 5. More 
specifically, the Show Cause Order alleged that ``[s]ince the year 
2000, there have been or are eleven approved clinical trials utilizing 
smoked marijuana,'' and that approved ``marijuana researchers 
administer marijuana to almost 500 human subjects.'' Id. The Show Cause 
Order also alleged that since 2000, there were ``four approved pre-
clinical trials in laboratory and animal modes.'' Id. at 5. Relatedly, 
the Show Cause Order also asserted that ``DEA has no statutory 
authority to overturn HHS' policy.'' Id.
    With respect to the contention that Respondent's registration would 
be inconsistent with the United States' obligations under the Single 
Convention, the Show Cause Order again referenced that HHS, through 
NIDA, oversees the cultivation, production and distribution of 
research-grade marijuana on behalf of the United States Government and 
alleged that ``[i]n accordance with the Single Convention, the Federal 
Government [is required] to limit marijuana available for clinical 
research to [this] source.'' Id. at 4.
    Respondent timely requested a hearing. The matter was assigned to 
Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a 
hearing on August 22-26 and December 12-14 and 16, 2005. At the 
hearing, the parties put on testimonial evidence and introduced 
documentary evidence. Following the hearing, the parties submitted 
briefs containing their proposed findings of fact, conclusions of law, 
and argument.
    On February 12, 2007, the ALJ issued her recommended decision. 
Therein, the ALJ rejected the Government's contention that the Single 
Convention precluded Respondent's registration. In so holding, the ALJ 
acknowledged that the Convention requires that its signatories maintain 
a ``government monopoly on importing, exporting, wholesale trading, and 
maintaining stocks.'' ALJ at 82. The ALJ reasoned, however, that ``[i]t 
also appears, although it is not entirely clear, that the marijuana 
grown by the National Center \1\ or by any other registrant for 
utilization in research would qualify as either `medicinal' * * * or as 
`special stocks' within the meaning of'' the Convention. Id. at 82 
(citing Single Convention, art. 1, para. (1)(o) & (x)).
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    \1\ The National Center is an entity of the University of 
Mississippi which currently holds the contract with NIDA for growing 
marijuana to supply United States researchers.
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    The ALJ then turned to whether Respondent had established that his 
registration would be consistent with the public interest when 
considering the six enumerated factors of 21 U.S.C. 823(a). With 
respect to the first factor, 21 U.S.C. 823(a)(1), the ALJ first recited 
the relevant text of this provision, which requires DEA to consider 
maintenance of effective controls against diversion by limiting the 
manufacturing of schedule I or II controlled substances ``to a number 
of establishments which can produce an adequate and uninterrupted 
supply of these substances under adequately competitive conditions for 
legitimate medical, scientific, research, and industrial purposes.'' 
ALJ at 82 (quoting Sec.  823(a)(1)). Noting that there is precedent for 
the agency to interpret this provision in two distinct ways regarding 
the issue of adequacy of competition (either by considering or not 
considering the issue),\2\ the ALJ stated that she would evaluate the 
issue in both ways. Id. at 83.
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    \2\ The meaning of 21 U.S.C. 823(a)(1) and the competition issue 
are discussed in detail in part C of the discussion section of this 
final order.
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    Under the first approach of interpreting 21 U.S.C. 823(a)(1) to 
allow DEA to disregard the issue of adequacy of competition as long as 
the agency finds that the applicant for registration would provide 
effective controls against diversion, the ALJ concluded that ``there is 
no evidence or contention that either Respondent or anyone working with 
him would be likely to divert the marijuana from the growing or drying 
or storage areas.'' Id.
    The ALJ next rejected the Government's contention that there was a 
risk of diversion because Mr. Rick Doblin, the Director of MAPS, would 
determine who was to receive the marijuana. In so holding, the ALJ 
reasoned that Mr. Doblin would not have physical possession of the 
marijuana and that Respondent would only send marijuana to researchers 
with DEA registrations and the requisite approval of HHS. ALJ at 84. 
The ALJ thus concluded that ``the research project has procedures in 
place to adequately protect against diversion of the marijuana'' and 
that ``there is minimal risk of diversion.'' Id.

[[Page 2103]]

    Under the second approach of interpreting 21 U.S.C. 823(a)(1) to 
require DEA to consider whether competition is inadequate, the ALJ 
first turned to whether the supply of marijuana currently available to 
researchers through HHS is adequate. In this regard, the ALJ found that 
while ``there have been some problems with the marijuana that the 
National Center produces, * * * a preponderance of the evidence 
establishes that the quality is generally adequate.'' Id. The ALJ 
further found, however, that ``NIDA's system for evaluating requests 
for marijuana for research has resulted in some researchers who hold 
DEA registrations and requisite approval from [HHS] being unable to 
conduct their research because NIDA has refused to provide them with 
marijuana.'' Id. The ALJ thus concluded ``that the existing supply of 
marijuana is not adequate.'' Id. The ALJ also concluded that 
competition is inadequate within the meaning of 21 U.S.C. 823(a)(1). 
Id. \3\ The ALJ thus held that the first public interest factor, 21 
U.S.C. 823(a)(1), supported granting Respondent's application.
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    \3\ In so finding, the ALJ rejected the Government's contention 
that because the NIDA contract is open to competitive bidding, 
adequate competition exists. According to the ALJ, ``[t]he question 
is not * * * whether the NIDA process addresses that agency's needs, 
but whether marijuana is made available to all researchers who have 
a legitimate need for it in their research. As discussed above, I 
answer that question in the negative.'' Id. at 85.
    As further support for her conclusion, the ALJ reasoned that 
``the NIDA contract requires the contractor to analyze'' marijuana 
seized by law enforcement agencies, and that ``a qualified 
cultivator may not be able to fulfill'' this requirement.''Id.
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    Under the second public interest factor, 21 U.S.C. 823(a)(2), the 
ALJ found that there was ``neither evidence nor contention that 
Respondent has not complied with applicable laws'' and thus concluded 
that this factor supported the granting of Respondent's application. 
See id.
    Under the third public interest factor, 21 U.S.C. 823(a)(3), as to 
whether granting Respondent's application would promote technical 
advances in the art of manufacturing controlled substances, the ALJ 
found that Respondent has ``considerable experience in cultivating 
medicinal plants, which might promote technical advances in the 
cultivation of marijuana or developing new medications from it.'' ALJ 
at 85-86. The ALJ nonetheless found that ``there is not sufficient 
evidence in the record on which to base a finding as to whether 
granting Respondent's registration would promote technical advances.'' 
Id. at 86.
    Under the fourth public interest factor, 21 U.S.C. 823(a)(4), the 
ALJ found that it was ``undisputed that Respondent has never been 
convicted of any violation of any law pertaining to controlled 
substances'' and therefore this factor weighed in favor of granting the 
application. Id.
    Under the fifth public interest factor, 21 U.S.C. 823(a)(5), the 
ALJ considered Respondent's ``past experience in manufacturing 
controlled substances and the existence of effective controls against 
diversion.'' Id. The ALJ acknowledged that ``Respondent has no 
experience in manufacturing controlled substances.'' Id. Noting that 
Respondent ``does have experience in growing medicinal plants'' and 
that ``the risk of diversion is minimal,'' the ALJ concluded that this 
factor supported granted the application. Id.
    Finally, under the sixth public interest factor, 21 U.S.C. 
823(a)(6), in analyzing such other factors as are relevant to and 
consistent with public health and safety, the ALJ rejected the 
Government's contention that granting the application would 
``circumvent[]'' HHS's policy with respect to the provision of 
marijuana to researchers. Id. Reasoning that ``the NIH Guidance by its 
own terms applies to marijuana that [HHS] makes available, [and] not 
[to] marijuana that might be available from some other legitimate 
source[,]'' the ALJ concluded that ``the NIH Guidance is not a factor 
in determining whether Respondent's application should be granted.'' 
Id. The ALJ thus concluded that granting Respondent's application 
``would be in the public interest,'' and recommended that I grant his 
application. Id. at 87.
    The Government excepted to the ALJ's decision on numerous grounds, 
and Respondent filed a response to the Government's exceptions. 
Thereafter, the record was forwarded to me for final agency action.
    Having considered the record as a whole, I hereby issue this 
Decision and Final Order. For reasons explained more fully below, I 
reject the ALJ's legal conclusion ``that the Single Convention does not 
preclude registering Respondent.'' Id. at 82. Moreover, I reject the 
ALJ's finding that the proposed registration is consistent with the 
public interest when considering the six factors enumerated in 21 
U.S.C. 823(a). Id. at 82-86. I therefore reject the ALJ's 
recommendation that the application be granted. See id. at 87.

Findings

    Under Federal Law, marijuana and tetrahydrocannabinols (THC) are 
schedule I controlled substances. 21 U.S.C. 812(c), Schedule I(c)(10) & 
(17). Congress placed marijuana and THC in schedule I because the 
substances have ``a high potential for abuse,'' ``no current accepted 
medical use in treatment in the United States,'' and ``a lack of 
accepted safety for use * * * under medical supervision.'' 21 U.S.C. 
812(b)(1). See also 66 FR 20038 (2001) (denying petition to reschedule 
marijuana from schedule I), petition for review dismissed, Gettman v. 
DEA, 290 F.3d 430 (D.C. Cir. 2002).\4\
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    \4\ As related in the Notice, the FDA recommended that marijuana 
be maintained in schedule I of the CSA. The FDA based its finding 
on, inter alia, the extensive evidence that marijuana has a history 
and pattern of abuse, that it is ``[t]he most frequently used 
illicit drug,'' and that it ``has a high potential for abuse.'' 66 
FR at 20047 & 20051. The FDA also found that ``[t]here are not FDA-
approved medical products,'' ``marijuana does not have a currently 
accepted medical use in treatment in the United States or a 
currently accepted medical use with severe restrictions,'' and 
``that, even under medical supervision, marijuana has not been shown 
to have an acceptable level of safety.'' 66 FR at 20052.
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    Marijuana is cultivated from the cannabis plant, which is 
recognized as ``a very adaptive plant [whose] characteristics are even 
more variable than most plants.'' GX 25, at 7. Marijuana, which 
consists primarily of the dried flowering tops and leaves of the 
cannabis plant,\5\ ``is a variable and complex mixture of biologically 
active compounds.'' Id. As of 2001, 483 different chemical constituents 
had been identified in marijuana, including approximately 66 
cannabinoids.\6\ 66 FR at 20041; Tr. 1142, 1147. ``THC \7\ is the main 
psychoactive cannabinoid in marijuana''; the plant, however, also 
contains ``[v]arying proportions of other cannabinoids, mainly 
cannabidiol (CBD) and cannabinol (CBN),'' which ``sometimes [exist] in 
quantities that might modify the pharmacology of THC or cause effects 
of their own.'' Id. at 7-8.
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    \5\ The legal definition of marijuana, as set forth in the CSA, 
21 U.S.C. 802(16), is as follows: The term ``marihuana'' means all 
parts of the plant Cannabis sativa L., whether growing or not; the 
seeds thereof; the resin extracted from any part of such plant; and 
every compound, manufacture, salt, derivative, mixture, or 
preparation of such plant, its seeds or resin. Such term does not 
include the mature stalks of such plant, fiber produced from such 
stalks, oil or cake made from the seeds of such plant, any other 
compound, manufacture, salt, derivative, mixture, or preparation of 
such mature stalks (except the resin extracted therefrom), fiber, 
oil, or cake, or the sterilized seed of such plant which is 
incapable of germination.
    \6\ Cannabinoids are chemical compounds that are unique to the 
cannabis plant (not found in any other plant). Tr. 1140-41.
    \7\ While there are numerous isomers of THC (all of which fall 
within the listing of ``Tetrahydrocannabinols'' in schedule I of the 
CSA and many of which are found in the cannabis plant), delta-9-THC 
is the isomer that is recognized as the primary psychoactive 
component in marijuana and, for this reason the term ``THC'' is 
often used to refer to delta-9-THC. See 66 FR at 20045; Tr. 1146-47.

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[[Page 2104]]

The National Center and NIDA's Drug Supply Program

    Since 1968, the National Center for Natural Products Research 
(National Center), a division of the University of Mississippi, has 
held a contract with the Federal Government to grow marijuana for 
research purposes and held the requisite registrations under the 
Controlled Substances Act (CSA), as well as the federal law that 
preceded the CSA, authorizing the University to conduct such 
activity.\8\ Tr. 1152-53, 1350-51. See also 21 CFR 1301.13. The 
contract, which is open for competitive bidding at periodic intervals, 
see GX 15, is administered by NIDA, a component of NIH (which is part 
of HHS), pursuant to its Drug Supply Program. RX 1, at 231. Since 1999, 
the term of the contract has been five years. See GXs 13 & 15; Tr. 
1156.
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    \8\ Initially, the National Center obtained a researcher's 
registration; it now also holds a manufacturer's registration.
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    Under the NIDA contract, the National Center ``[g]row[s], 
harvest[s], store[s], ship[s] and analyze[s] cannabis of different 
varieties, as required.'' GX 13, at 6. The contract requires that the 
National Center ``shall serve as NIDA's cannabis drug repository,'' as 
well as ``develop and produce standardized marijuana cigarettes within 
a range of specified THC content, and placebos for use in pre-clinical 
and clinical research programs,'' and maintain minimum stocks of both 
bulk marijuana and marijuana cigarettes of various THC contents, and 
store them in a DEA approved facility. Id. at 6-7.
    Marijuana potency is primarily based on the concentration 
(percentage by weight) of THC in the plant material. Tr. 1148-49. As of 
August 25, 2005, the National Center held on behalf of NIDA 
approximately 1055 kilograms (kg) of marijuana with THC contents 
ranging up to 12.26 percent. See RX 53. This inventory includes six 
batches of marijuana with THC contents ranging from 9.02 to 9.89 
percent,\9\ one batch (of nearly 19 kg) with a THC content of 10 
percent, nearly 25 kg with a THC content of 11.34 percent, and 
approximately 27 kg with a THC content of 12.26 percent.\10\ See id. In 
his testimony, Mahmoud ElSohly, Ph.D., who is the Principal 
Investigator under the NIDA contract, and who has overseen the National 
Center's work with marijuana since 1980, stated that the Center is 
capable of producing marijuana with a THC content of 20 percent or 
more.\11\ Tr. 1130-31, 1152, 1203, 1254-55.
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    \9\ These batches range from approximately 12 to 15 kg in size.
    \10\ As of the date of the hearing, more than 920,000 marijuana 
cigarettes of various THC concentrations including placebo had been 
manufactured pursuant to the NIDA contracts between 1974 and 2003. 
GX 27.
    \11\ 11 As Dr. ElSohly explained, he has grown numerous strains 
of marijuana from seeds that have been obtained from a variety of 
countries and has used them to do ``genetic selection to have 
genetic material of high potency.'' Tr. 1255.
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    The contract also requires the National Center to ``ship to 
research investigators as authorized by the [NIDA] Project Officer upon 
receipt of a shipment order.'' GX 13, at 7. While the NIDA ``Project 
Officer may pre-authorize any normal recurring requests that the 
contractor will then fill once it has received'' various 
assurances,\12\ the contract further states that ``[a]ll other requests 
should be submitted to the NIDA Project Officer for approval.'' Id. at 
8. Moreover, ``[i]f there is a reason to question a particular request, 
the Contractor shall inform the NIDA Project Officer who will make a 
final decision on providing the material and quantity requested.'' Id. 
As these provisions make clear, the National Center has no authority to 
distribute any of the marijuana it produces pursuant to the NIDA 
contract without NIDA's approval.\13\
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    \12\ These include that the researcher have the appropriate DEA 
registration and FDA/IND approvals, provide assurance that the 
marijuana ``will not be resold'' and ``will be used only for 
research or patient purposes,'' that the use of the marijuana will 
adhere to the appropriate Safety Standards for research,'' and that 
the researcher agree ``to comply with all Federal, State and Local 
Safety requirements for use of the materials.'' See GX 13, at 8.
    \13\ Independent of its contract with NIDA, the National Center 
holds an additional registration to manufacture marijuana and THC. 
GXs 75 & 78. The National Center was granted this registration under 
the terms of a Memorandum of Agreement (MOA) entered into with DEA 
in 1999. GX 78. As set forth in the MOA, the purpose of the 
registration was ``to allow the Center to develop a new product 
formulation for effecting delivery of [THC] in a pharmaceutically 
acceptable dosage form suppository * * * and to provide crude THC 
extract to a DEA-registered manufacturer of THC for further 
purification.'' Id. at 2. The MOA further stated that, under the 
terms thereof, the Center would ``manufacture marijuana for the 
purpose of extracting THC therefrom.'' Id. Subsequently, the Center 
submitted a new application for a registration to bulk manufacture 
marijuana and THC ``to prepare marihuana extract for further 
purification into bulk active [THC] for use in launching FDA-
approved pharmaceutical products.'' 70 FR 47232 (2005). DEA has not 
yet issued a final order as to this application. (DEA publishes in 
the Federal Register all final orders on applications for 
registration to bulk manufacture schedule I and II controlled 
substances.)
    The MOA further provided that ``[i]n accordance with articles 23 
and 28 of the Single Convention on Narcotic Drugs * * * private 
trade in `cannabis' is strictly prohibited. Therefore, the Center 
shall not distribute any quantity of marijuana to any person other 
than an authorized DEA employee.'' GX 78, at 2. Continuing, the MOA 
explained that ``[t]he Single Convention does not prohibit private 
trade in `cannabis preparations,' '' and noted that this term, 
``within the meaning of the Single Convention, is a mixture, solid 
or liquid containing cannabis, cannabis resin, or extracts or 
tinctures of cannabis.'' Id. Because ``[t]he THC that the Center 
will extract from marijuana [is] considered such a `cannabis 
preparation[,]' * * * the Center may, in accordance with the Single 
Convention, distribute the crude THC extract to private entities'' 
provided the Center otherwise complies with the CSA and DEA 
regulations. Id. at 2-3. The MOA also set forth a detailed series of 
controls to maintain accountability of the marijuana from 
acquisition of the seeds through the extraction of THC from the 
harvested material. Id. at 3-7.
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    In 1997, the White House Office of National Drug Control Policy 
asked the Institute of Medicine (IOM), a component of the National 
Academy of Sciences, to conduct a review of the scientific evidence 
regarding the potential health benefits and risks of marijuana and its 
constituent cannabinoids. RX 1, at 7. In 1999, the IOM published its 
report. The IOM found, among other things, that ``[d]efined substances, 
such as purified cannabinoid compounds, are preferable to plant 
products, which are of variable and uncertain composition. Use of 
defined cannabinoids permits a more precise evaluation of their 
effects, whether in combination or alone.'' RX 1, at 22. With respect 
to this issue, the IOM reached the following conclusion: ``Scientific 
data indicate the potential therapeutic value of cannabinoid drugs, 
primarily THC, for pain relief, control of nausea and vomiting, and 
appetite stimulation; smoked marijuana, however, is a crude THC 
delivery system that also delivers harmful substances.'' Id. The report 
further stated:

    The therapeutic effects of cannabinoids are most well 
established for THC, which is the primary psychoactive ingredient of 
marijuana. But it does not follow from this that smoking marijuana 
is good medicine.
    Although marijuana smoke delivers THC and other cannabinoids to 
the body, it also delivers harmful substances, including most of 
those found in tobacco smoke. In addition, plants contain a variable 
mixture of biologically active compounds and cannot be expected to 
provide a precisely defined drug effect. For those reasons there is 
little future in smoked marijuana as a medically approved 
medication. If there is any future in cannabinoid drugs, it lies 
with agents of more certain, not less certain, composition.'' \14\
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    \14\ To similar effect, an ad hoc group of experts, who were 
selected by NIH and convened in 1997 as part of a workshop to assess 
the potential medical uses of marijuana, issued a report to the 
Director of NIH, which noted:
    As with any smoked drug (e.g., nicotine or cocaine), 
characterizing the pharmacokinetics of THC and other cannabinoids 
from smoked marijuana is a challenge. A person's smoking behavior 
during an experiment is difficult for a researcher to control. 
People differ. Smoking behavior is not easily quantified. An 
experienced marijuana smoker can titrate and regulate doses to 
obtain the desired acute psychological effects and to avoid overdose 
and/or minimize undesired effects. Each puff delivers a discrete 
dose of THC to the body. Puff and inhalation volume changes with 
phase of smoking, tending to be highest at the beginning and lowest 
at the end of smoking a cigarette. * * * During smoking, as the 
cigarette length shortens, the concentration of THC in the remaining 
marijuana increases; thus, each successive puff contains an 
increasing concentration of THC.
    One consequence of this complicated process is that an 
experienced marijuana smoker can regulate almost on a puff-by-puff 
basis the dose of THC delivered to lungs and thence to brain. A less 
experienced smoker is more likely to overdose or underdose. Thus a 
marijuana researcher attempting to control or specify dose in a 
pharmacologic experiment with smoked marijuana has only partial 
control over the drug dose actually delivered.
    See GX 25, at 9-10 (Workshop on the Medical Utility of 
Marijuana).


[[Page 2105]]


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Id. at 195-96. See also GX 53 (letter from Alice P. Mead, GW 
Pharmaceuticals, P.L.C., to Christine V. Beato, Acting Asst. Sec. for 
Health, HHS (Apr. 12, 2005)) (``[H]erbal cannabis should comprise only 
the starting material from which a bona fide medical product is 
ultimately derived. * * * [S]tandardizing herbal starting material 
represents only the first of many steps necessary to create a modern 
medicine that is safe and effective for use in specific medical 
conditions. * * * [A] final medical product * * * must also be 
delivered in a dosage form that is consistent in composition and that 
allows the patient to obtain an identifiable and reliable amount of 
medication.'') (emphasis in original).
    Accordingly, the IOM recommended that clinical trials using 
cannabinoid drugs should be conducted with ``the goal of developing 
rapid-onset, reliable, and safe delivery systems.'' Id. at 197. The IOM 
also advised that clinical trials involving smoked marijuana ``should 
involve only short-term marijuana use (less than six months), should be 
conducted in patients with conditions for which there is a reasonable 
expectation of efficacy, should be approved by institutional review 
boards, and should collect data about efficacy.'' Id.
    Also in 1999, due in part to an increased interest in marijuana 
research and taking into account the IOM report, HHS decided to change 
the procedures by which it would supply marijuana to researchers. Tr. 
1632-33; GX 24. The new procedures were announced in a document 
released by NIH on May 21, 1999. GX 24, at 1. In the announcement, 
``HHS recognize[d] the need for objective evaluations of the potential 
merits of cannabinoids for medical uses[,]'' and that ``[i]f a positive 
benefit is found, * * * the need to stimulate development of 
alternative, safer dosage forms.'' Id. at 2. Toward this end, NIH 
explained that the new procedures were designed to increase the 
availability of marijuana for research purposes by, among other things, 
making such marijuana ``available on a cost-reimbursable basis.'' Id. 
This new procedure allowed researchers who were privately funded to 
obtain marijuana from HHS by reimbursing the NIDA contractor for the 
cost of the marijuana. Tr. 1633; see also GX 31, at 3. This was a 
departure from the prior practice (pre-1999), whereby HHS only made 
marijuana available to persons who received NIH funding. Id. The new 
procedures implemented by HHS in 1999 remain in effect today. Tr. 1629.
    HHS further stated in 1999 that it intended through the new 
procedures ``to make available a sufficient amount of research-grade 
marijuana to support those studies that are the most likely to yield 
usable, essential data.'' GX 24, at 2. With respect to those 
researchers who do not have NIH funding, HHS explained that ``the 
scientific merits of each protocol will be evaluated through a Public 
Health Service interdisciplinary review process [which] will take into 
consideration a number of factors, including the scientific quality of 
the proposed study, the quality of the organization's peer-review 
process, and the objective of the proposed research.'' Id.
    HHS then identified the criteria it would apply in evaluating 
requests for marijuana:

    The extent to which the protocol incorporates the elements of 
good clinical and laboratory research;
    The extent to which the protocol describes an adequate and well-
controlled clinical study to evaluate the safety and effectiveness 
of marijuana and its constituent cannabinoids in the treatment of a 
serious or life threatening condition;
    The extent to which the protocol describes an adequate and well-
controlled clinical study to evaluate the safety and effectiveness 
of marijuana and its constituent cannabinoids for a use for which 
there are no alternative therapies;
    The extent to which the protocol describes a biopharmaceutical 
study designed to support the development of a dosage form 
alternative to smoking; [and]
    The extent to which the protocol describes high-quality research 
designed to address basic, unanswered scientific questions about the 
effects of marijuana and its constituent cannabinoids or about the 
safety or toxicity of smoked marijuana.

Id. at 3.

    HHS further noted that ``[a] clinical study involving marijuana 
should include certain core elements,'' and that ``[a] study that 
incorporates the [1997] NIH Workshop recommendations will be expected 
to yield useful data and therefore, will be more likely to receive 
marijuana under the HHS program.'' Id.
    Finally, HHS explained that the ``proposed protocols must be 
determined to be acceptable under FDA's standards for authorizing the 
clinical study of investigational new drugs.'' Id. Relatedly, HHS 
stated that ``although FDA's review of Phase 1 submissions will focus 
on assessing the safety of Phase 1 investigations, FDA's review of 
Phases 2 & 3 submissions will also include an assessment of the 
scientific quality of the clinical investigations and the likelihood 
that the investigations will yield data capable of meeting statutory 
standards for marketing approval.'' Id. HHS further made clear that if 
a protocol is approved, ``NIDA will provide the researcher with 
authorization to reference NIDA's marijuana Drug Master File.'' Id. at 
4.
    At the administrative hearing in this case, Steven Gust, Ph.D., 
Special Assistant to the Director of NIDA, explained that, in addition 
to seeking to facilitate research into the possible medical utility of 
marijuana, the new procedures implemented by HHS in 1999 were intended 
``to make the process more standardized, and to * * * provide some 
expertise that did not really exist at NIDA in terms of reviewing 
applications that involved * * * the use of marijuana * * * for 
treatment of diseases.'' Tr. 1632-33. Accordingly, HHS ``established a 
separate peer review process that * * * moved the review into the 
Public Health Service [a component of HHS] * * * where additional 
expertise from other NIH Institutes and other Federal agencies'' could 
be utilized in reviewing the scientific merit of the applications. Id. 
at 1633-34. Dr. Gust further explained that the members of the review 
committee are drawn from the various specialty institutes of NIH, and 
the Substance Abuse and Mental Health Services Administration (SAMHSA). 
Id. at 1692; 1713-15.\15\ Dr. Gust also testified that the ``scientific 
bar has been set very low, [so] that any project that has scientific 
merit is approved,'' and that ``anything that gets approved gets NIDA 
marijuana.'' Id. at 1700-01. As of April 2004, HHS had approved at 
least seventeen pre-clinical or clinical studies of marijuana, which 
were sponsored by the California Center for Medical Cannabis Research 
(CMCR).\16\ GX 31, at

[[Page 2106]]

3. According to one witness who testified on behalf of Respondent, all 
of the CMCR-sponsored researchers who applied to NIDA for marijuana did 
in fact receive marijuana from NIDA. Tr. 694-95.
---------------------------------------------------------------------------

    \15\ Dr. Gust initially testified that someone from FDA sits on 
the committee but later stated that he was not exactly sure if this 
was so. Tr. 1712.
    \16\ The California research studies were conducted pursuant to 
a law enacted by California in 1999 known as the Marijuana Research 
Act of 1999. Cal. Health & Safety Code Sec.  11362.9. This state law 
established the ``California Marijuana Research Program'' to develop 
and conduct studies on the potential medical utility of marijuana. 
Id. (The program is also referred to as the ``Center for Medicinal 
Cannabis Research'' (CMCR). Tr. 396.) The state legislature 
appropriated a total of $9 million for the marijuana research 
studies. Tr. 397. The state law was enacted following the passage of 
Proposition 215, a ballot initiative otherwise known as the 
Compassionate Use Act of 1996. Tr. 395-96; see also United States v. 
Oakland Cannabis Buyers' Cooperative (``OCBC''), 532 U.S. 483, 486 
(2001).
---------------------------------------------------------------------------

Respondent's Application and Contentions

    Respondent is a Professor in the Department of Plant, Soil and 
Insect Sciences at the University of Massachusetts Amherst. Tr. 13. On 
June 28, 2001, Respondent submitted an application to bulk manufacture 
the schedule I controlled substances marijuana and 
tetrahydrocannabinols.\17\ GXs 1 & 3; 21 CFR 1308.11(d). Respondent's 
application is sponsored by the Multidisciplinary Associations for 
Psychedelic Studies (MAPS). GX 3, at 1.
    Because Respondent seeks a registration to manufacture a schedule I 
controlled substance, DEA required that he complete a 
questionnaire.\18\ In response to the question regarding the purpose 
for which he sought registration, Respondent stated that ``[t]he plant 
material will be grown for federally-approved uses only, including 
analytical, pre-clinical, and clinical research,'' and that ``no 
material is intended for illegal use or for medical marijuana patients 
whose use may be legal under state, but not federal law.'' GX 3, at 
1.\19\
---------------------------------------------------------------------------

    \17\ On his application for registration (GX 1), Respondent 
incorrectly checked the box for ``dosage form'' manufacturing when, 
in fact (based on the activity in which he proposes to engage), he 
is seeking to become registered as a ``bulk'' manufacturer. In 
written questions DEA submitted to Respondent as a follow-up to the 
application, DEA properly characterized the activity as ``bulk 
manufacture,'' and Respondent, in his written answers to these 
questions, gave no indication that he disagreed. See GX 3. Also, in 
his testimony at the hearing, Respondent acknowledged that his plan 
was to send marijuana ``in bulk'' to others, who would roll it into 
cigarettes. Tr. at 243. Respondent also testified that MAPS 
President Rick Doblin ``assisted in the response to the bulk 
manufacturer's questions.'' Tr. 352 (emphasis added). Cf. 32 CFR 
1300.02(b)(32) (defining ``drug product'' as ``an active ingredient 
in dosage form that has been approved or otherwise may be lawfully 
marketed under the Food, Drug, and Cosmetic Act for distribution in 
the United States''); 21 CFR 1301.72(a) & 1304.22(a) (listing ``bulk 
materials awaiting further processing'' separately from ``finished 
products'').
    \18\ As set forth in 21 CFR 1301.15: ``The Administrator may 
require an applicant to submit such documents or written statements 
of fact relevant to the application as he/she deems necessary to 
determine whether the application should be granted.''
    \19\ Respondent further testified that it was his intention to 
simply send bulk marijuana to researchers who would then roll their 
own cigarettes. Tr. at 243.
---------------------------------------------------------------------------

    Respondent added that ``[t]he production costs * * * would be 
underwritten by a grant'' from MAPS. Id. According to Respondent, 
``MAPS is seeking to develop the marijuana plant into an FDA-approved 
prescription medicine,'' and that ``[t]he growth of plants at [UMASS] 
is a necessary step for supplying quality marijuana for use in MAPS' 
drug development process.'' Id. Respondent also advised that ``MAPS 
will sponsor research at other institutions using smoked marijuana and 
marijuana delivered through a vaporizer device that heats, but does not 
burn the plant material, thus reducing the products of combustion 
normally found in smoked marijuana.'' Id.
    Respondent further stated that his ``[c]ustomers would include both 
MAPS-sponsored research and research sponsored by other 
organizations.'' Id. at 3. Relatedly, Respondent explained that 
``[r]esearchers conducting MAPS sponsored research would receive 
supplies of the plant material free, while other researchers would 
either receive the marijuana free or through a donation to MAPS.'' Id. 
at 1. See also Tr. 225 (``I may very well be approached by other people 
with approved studies who need a source also.'').
    At the hearing, Mr. Rick Doblin, the President of MAPS,\20\ also 
testified regarding the purpose of Respondent's application. Mr. 
Doblin, who admitted that he engages in recreational use of marijuana 
on a weekly basis, explained that ``[t]he reason we need a supply from 
Dr. Craker is that we are engaged in trying to make marijuana into an 
FDA-approved prescription medicine, and * * * we need to establish a 
drug master file for a particular product, and * * * we need to conduct 
research with that product, and have that product available to us for 
potential marketing should we get FDA approval.'' Tr. 603, 718-19. Mr. 
Doblin testified as to his ``belie[f] that smoked marijuana or 
vaporized marijuana in plant form will successfully compete with 
marijuana extracts on price.'' Id. at 605. He also testified as to his 
belief that the ``efficacy and safety'' of vaporized plant-form 
marijuana ``will be similar'' to drugs containing cannabinoid extracts 
and that ``the efficacy will be similar and safety slightly different 
with smoked'' marijuana than with drugs containing cannabinoid 
extracts. Id.
    Mr. Doblin further testified that he ``disagree[d]'' with the 
Institute of Medicine's conclusion that defined and purified 
cannabinoid compounds ``are preferable to plant products, which are of 
variable and uncertain composition.'' Id. at 654. Mr. Doblin also 
testified that ``what we're trying to do is get the Public Health 
Service and NIDA out of the picture; they're only in the picture just 
for marijuana only because they have a monopoly. And that is what is so 
obstructing the system.'' Id. at 666.
---------------------------------------------------------------------------

    \20\ When asked during the hearing about the title of his 
organization (Multidisciplinary Association for Psychedelic Studies) 
and, in particular the term ``Psychedelic,'' Mr. Doblin explained, 
in part, ``it's about tools and procedures that bring to the surface 
people's subconscious and unconscious and, you know, deeper 
emotions.'' Tr. 474.
---------------------------------------------------------------------------

    Finally, Mr. Doblin testified that MAPS would only need between $5 
to $10 million ``to make marijuana into a medicine'' through the 
various stages of the FDA new drug approval (NDA) process.\21\ Id. at 
701; see also id. at 703. In his testimony, Mr. Doblin did not, 
however, identify a single instance in which an entity (whether for-
profit or nonprofit) had taken a drug--let alone a botanical substance 
with known safety issues, See, e.g., GX 43, at 9--through the multi-
faceted NDA process for a similar cost.\22\ Moreover, while Mr.

[[Page 2107]]

Doblin testified that ``the mission statement [of MAPS] is to develop 
psychedelics and marijuana into FDA-approved medicines and then to 
educate the public about that'' (Tr. 478), the vagaries of his 
testimony prevent a clear determination of how far along in that goal 
he envisions MAPS to be.\23\
---------------------------------------------------------------------------

    \21\ In a recent Supreme Court decision, Justice Ginsberg, in a 
dissenting opinion, summarized the process by which FDA approves new 
drugs for marketing as follows:
    The process for approving a new drug begins with preclinical 
laboratory and animal testing. The sponsor of the new drug then 
submits an investigational new drug application seeking FDA approval 
to test the drug on humans. See 21 U.S.C. 355(i); 21 CFR 312.1 et 
seq. (2007). Clinical trials generally proceed in three phases 
involving successively larger groups of patients: 20 to 80 subjects 
in phase I; no more than several hundred subjects in phase II; and 
several hundred to several thousand subjects in phase III. 21 CFR 
312.21. After completing the clinical trials, the sponsor files a 
new drug application containing, inter alia, ``full reports of 
investigations'' showing whether the ``drug is safe for use and * * 
* effective''; the drug's composition; a description of the drug's 
manufacturing, processing, and packaging; and the proposed labeling 
for the drug. 21 U.S.C. 355(b)(1).
    Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1018-19 n.15 (2008) 
(Ginsburg, J., dissenting).
    \22\ While Respondent produced evidence establishing that the 
$800-880 million costs of bringing a new drug to market includes 
research and development costs incurred for drugs that are not 
approved, as well as opportunity costs (the cost of investing in 
research rather than something else), see Tr. 161, 734-36, 
Respondent has not shown a single instance in which an entity has 
obtained FDA approval of a drug through the NDA process for the cost 
range which Mr. Doblin claimed would be sufficient to obtain 
approval of plant-form marijuana.
    Moreover, the IOM Report states that the average cost of a 
Supplemental New Drug Application (SNDA), which is used when a 
company seeks to obtain FDA approval to market a drug (which has 
already gone through the three phases of clinical trials and been 
approved for marketing) for a new indication, was $10 to 40 million. 
RX 1, at 214. It should be noted, however, that in taking a drug 
through the three phases, its sponsor will have obtained extensive 
data regarding the drug's safety including ``adverse effects of the 
drug [and] clinically significant drug/drug interactions.'' 21 CFR 
314.50(d)(5)(vi).
    In support of his assertion that MAPS could obtain FDA approval 
for only $5 to $10 million, Mr. Doblin testified that marijuana is 
different than other drugs that go through the FDA approval process. 
Mr. Doblin based this assertion on his contentions that: marijuana 
has been used by ``tens of millions of people'' while others drugs 
going though the NDA process are only used by a few thousand; there 
is ``an enormous body of evidence about [marijuana's] safety * * * 
that we don't need to replicate;'' and sufficient data to satisfy 
the FDA as to marijuana's safety and efficacy could be obtained by 
testing only 500 to 600 people. Id. at 737-38.
    The FDA's guidance document for botanical drug products makes 
plain that ``[a] botanical drug product that is not generally 
recognized as safe and effective for its therapeutic claims is 
considered a new drug under Sec.  201(p) of the [Food, Drug, and 
Cosmetic] Act,[]'' and that ``any person wishing to market a 
botanical drug product that is a new drug is required to obtain FDA 
approval of an NDA * * * for that product.'' GX 92A, at 7. Moreover, 
``an NDA must contain substantial evidence of effectiveness derived 
from adequate and well-controlled clinical studies, evidence of 
safety, and adequate CMC [chemistry, manufacturing, and controls] 
information.'' Id. See also GX 92A, at 27-38 (specifying the 
information that must be provided to FDA for phase 3 clinical 
studies of a botanical product to meet the requirements of the FDA 
regulations governing the contents of INDs). Finally, with respect 
to the nonclinical safety assessment required to support phase 3 
clinical trials, the FDA guidance states:
    To support safety for expanded clinical studies or to support 
marketing approval of a botanical drug product, toxicity data from 
standard toxicology studies in animals may be needed * * * . A 
botanical product submitted for marketing approval as a drug will be 
treated like any other new drug under development. Safety data from 
previous clinical trials conducted in foreign countries will be 
considered in determining the need for nonclinical studies. However, 
previous human experience may be insufficient to demonstrate the 
safety of a botanical product, especially when it is indicated for 
chronic therapy. Systematic toxicological evaluations could be 
needed to supplement available knowledge on the general toxicity, 
teratogenicity, mutagenecity, and carcinogenicity of the final drug 
product.
    Id. at 34. While Mr. Doblin asserted that MAPS would not ``need 
to replicate all those studies about the genetics, * * * the effect 
on reproduction, the effect in all sorts of bodily systems,'' Tr. 
737, he did not identify any specific studies performed in other 
countries that establish the safety of marijuana for testing in 
phase 3 clinical studies. While millions of people have undoubtedly 
used marijuana, few have done so subject to the scientific rigor of 
a controlled clinical trial. Nor did Respondent produce any credible 
evidence establishing that the various types of animal studies which 
FDA usually requires to support phase 3 clinical trials would not 
have to be performed. GX 92A, at 35-37.
    \23\ As indicated above, based on the record, no clinical trials 
involving marijuana have advanced beyond phase 1. Moreover, each 
sponsor must submit to FDA his/her own IND to be authorized to 
conduct clinical investigation with a new drug (such as marijuana). 
See 21 CFR 312.20, 312.23. Again, given the vagaries of Mr. Doblin's 
testimony, it cannot be determined whether there is sufficient 
existing preclinical laboratory and animal studies data to support a 
submission of an IND for whatever proposed indications that Mr. 
Doblin has in mind for his envisioned FDA-approved marijuana 
medicine. But even assuming, arguendo, that MAPS could successfully 
submit an IND based on existing data, it would still have to proceed 
through extensive clinical trials (see 21 CFR 312.21), and then--
assuming that such trials are fully successful at demonstrating the 
basis for safety and efficacy (which often is not the case with 
clinical trials)--MAPS would still have to submit and obtain 
approval of an NDA. All of these steps, and the uncertainties as to 
the outcomes of each step, further call into question Mr. Doblin's 
estimate of being able to obtain FDA approval of marijuana for only 
$5 to $10 million.
---------------------------------------------------------------------------

Correspondence Pertaining to the Application

    Subsequent to Respondent's submission of his application for a DEA 
registration, on March 4, 2003, the Chief of DEA's Drug and Chemical 
Evaluation Section wrote to Respondent noting that ``it appears that 
the basis for your application is the purported need for a higher 
potency and higher 'quality' marijuana product than that currently 
available from the National Institute on Drug Abuse.'' GX 29, at 1. The 
DEA letter further explained that the Agency had ``contacted NIDA, the 
Department of Health and Human Services * * * and some current 
researchers'' and had ``determined that * * * the quality of marijuana 
available from NIDA is acceptable,'' that a high potency product with a 
THC content of 7 to 8 percent was currently ``available to bona fide 
research protocols,'' and that if ``[i]n the future, should federally 
approved research protocols require a higher potency marijuana (i.e. 15 
percent THC), all believe that it could be supplied by NIDA.'' Id.
    Thereafter, on June 2, 2003, Respondent wrote to DEA acknowledging 
that during a visit with several agency Diversion Investigators, the 
discussion had ``primarily focused[ed] on the need for an alternative 
source of plant material to that grown at the University of Mississippi 
under contract to the National Institute of Drug Abuse (NIDA).'' GX 30. 
Continuing, Respondent stated that ``[a] second source of plant 
material is needed to facilitate privately-funded, FDA-approved 
research into medical uses of marijuana, ensuring a choice of sources 
and an adequate supply of quality, research-grade marijuana for 
medicinal applications.'' Id. Consistent with these statements, 
Respondent has declined to bid on the NIDA contract. Tr. 252-53.
    Respondent further asserted that while ``the primary researchers 
now receiving plant material may openly state to you that they are 
satisfied with the current source, * * * in private conversations these 
same researchers indicate a fear of having the current supply 
eliminated if they complain about the available source material.'' GX 
30. As support for his contention regarding the level of researcher's 
satisfaction with NIDA's marijuana, Respondent attached two items: a 
reprint of a newspaper article and a letter from a Dr. Ethan Russo to 
the then-Chief of DEA's Drug and Chemical Evaluation Section. See GX 
30a & 30b.
    At the hearing, Respondent testified that at the time he filed his 
application, he had become concerned, based on conversations he had 
with ``other people,'' that the marijuana provided by the National 
Center ``may have been of relatively low quality, and that [it] was not 
readily available to run the clinical trials which some people wanted 
to run.'' Tr. 215. When asked to provide the names of these ``other 
people'' who had told him this, Respondent said he did not recall. Id.

Respondent's Contentions Regarding the Inadequacy of NIDA Marijuana

    Respondent makes three principal claims in support of his 
contention that the supply of marijuana currently available through 
NIDA is inadequate. First, he claims that ``NIDA does not provide 
medical marijuana to all legitimate researchers'' and that ``NIDA has 
refused to provide marijuana to at least three legitimate 
researchers.'' Resp. Prop. Findings at 12. Second, he claims that ``the 
quality of the NIDA marijuana raises concerns for researchers and 
patients.'' Id. at 16. Third, he claims that ``the NIDA supply was 
inadequate because a pharmaceutical developer could not reasonably rely 
on NIDA marijuana to take marijuana through the FDA new drug approval 
process.'' Respondent's Response to Govt.'s Exceptions (hereafter, 
``Respondent's Resp.'') at 16.

HHS's Denials of Researcher's Requests for NIDA Marijuana

    Respondent's first claim is based on three incidents over a decade-
long time period in which he alleges that researchers were improperly 
denied access to NIDA's marijuana. The first incident, which occurred 
in 1995, involved an application submitted by Donald Abrams, M.D., who 
sought

[[Page 2108]]

marijuana from NIDA to study its effects on persons with HIV-related 
wasting syndrome. RX 15, at 1. NIDA rejected Dr. Abrams's application 
``based upon issues of design, scientific merit and rationale.'' \24\ 
Dr. Abrams subsequently submitted a revised research protocol that NIDA 
found to be scientifically meritorious and for which NIDA supplied 
marijuana in 1997.\25\ See GX 21, at 1. NIDA also supplied Dr. Abrams 
with marijuana for subsequent studies. Id.; Tr. 689. In any event, for 
purposes of determining the relevance of the 1995 incident in which Dr. 
Abrams' original protocol was rejected by NIDA, it is notable that this 
occurred before HHS adopted its new guidelines for the provision of 
marijuana for research purposes. As Dr. Gust testified, in 1995, HHS's 
practice was to provide marijuana only to researchers who obtained NIH 
funding--a practice that was abandoned by HHS in 1999 when the agency 
adopted its new procedures for facilitating marijuana research 
(allowing privately funded researchers to also obtain marijuana). Tr. 
1749.
---------------------------------------------------------------------------

    \24\ That the above-quoted grounds were the bases upon which 
NIDA denied Dr. Abrams' original application is implicit from the 
letter that Dr. Abrams submitted to NIDA in response to the denial 
(RX 15). These bases are explicitly stated in NIDA's April 19, 1995, 
letter to Dr. Abrams, which appears on MAPS' Web site (at https://
www.maps.org/mmj/leshner.html) and of which I take official notice. 
This letter from NIDA stated, among other things, the following:
    Our decision here is based upon issues of design, scientific 
merit and rationale. We believe that your study will not adequately 
answer the question posed.
    Although the study propose[d] seeks to make a dose-effect 
comparison of smoked marijuana to delta-9-tetrahydrocannabinol 
(THC), there is no real dosing control. The marijuana is to be taken 
home and there is no requirement and way to ensure that the subjects 
smoke all available materials on any fixed schedule. Additionally, 
that they are given a two-week supply of marijuana at one time 
further confounds the study design. Thus, we believe the dose-effect 
component is confounded since the study cannot correlate variability 
in weight gain with dosage.
    We also believe the study lacks adequate sample size to make any 
inferences regarding the dose-effect relationship. . . . Another 
confounding variable not adequately controlled for in your proposed 
study is diet. Neither the total daily caloric intake nor the 
percentages of the composition of the foodstuffs is assessed.
    In accordance with the Administrative Procedure Act (APA), an 
agency ``may take official notice of facts at any stage in a 
proceeding--even in the final decision.'' U.S. Dept. of Justice, 
Attorney General's Manual on the Administrative Procedure Act 80 
(1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with 
the APA and DEA's regulations, Respondent is ``entitled on timely 
request to an opportunity to show to the contrary.'' 5 U.S.C. 
556(e); see also 21 CFR 1316.59(e). To allow Respondent the 
opportunity to refute the facts of which I take official notice, 
Respondent may file a motion for reconsideration within fifteen days 
of service of this order which shall commence with the mailing of 
the order.
    \25\ Following the 1996 passage of proposition 215, NIDA 
contacted Dr. Abrams and asked him if he would redesign his study to 
determine whether marijuana usage by persons who were HIV-positive 
(but who did not have AIDS-wasting syndrome) increased viral load as 
well as the interaction of marijuana with protease inhibitors. Tr. 
523-24. Dr. Abrams agreed to do so and NIDA provided him with a $1 
million grant to fund the study.
---------------------------------------------------------------------------

    The second incident involved an application by Dr. Ethan Russo, a 
neurologist, who sought funding from NIDA to study the use of marijuana 
to treat migraine headaches beginning around 1996. Tr. 527-28. The 
precise dates of the events related to Dr. Russo are somewhat unclear 
as Respondent presented these events through the testimony of Mr. 
Doblin. (Dr. Russo did not testify.) Id. Based on Mr. Doblin's 
testimony, it appears that during 1996-97, NIDA twice rejected Dr. 
Russo's protocol for reasons which are not clearly established by the 
record. Id. at 527, 691-92. However, according to Mr. Doblin, Dr. Russo 
conceded that, on both of these two occasions when NIDA rejected his 
protocol, NIDA's bases for doing so did include ``some valid 
critiques.'' Tr. 692. Mr. Doblin testified that Dr. Russo subsequently 
attempted for a third time to obtain marijuana from NIDA, but on this 
third occasion he decided not to seek government funding but to seek 
private funding to purchase the marijuana from NIDA. Id. at 692. 
According to Mr. Doblin, this third protocol submitted by Dr. Russo was 
approved by both the FDA and Dr. Russo's institutional review board, 
but NIDA again refused to supply marijuana. Id. at 692-93. When asked 
when this last denial by NIDA occurred, Mr. Doblin testified: ``I think 
it was 1999.'' Id. at 693.
    As noted above, NIH announced on May 21, 1999, HHS's new procedures 
for making marijuana available to researchers. Bearing in mind that 
Respondent had the burden of proving any proposition of fact that he 
asserted in the hearing, 21 CFR 1301.44(a), nothing in Mr. Doblin's 
testimony, or any other evidence presented by Respondent, established 
that HHS denied Dr. Russo's request for marijuana under the new 
procedures implemented by the agency in 1999. Indeed, Respondent 
produced no evidence showing that HHS has denied marijuana to any 
clinical researcher with an FDA-approved protocol subsequent to the 
adoption of the 1999 guidelines.
    The third incident involved an application by Chemic Laboratories 
(Chemic), which--at the request of Mr. Doblin--sought marijuana from 
NIDA in 2004 \26\ for a proposed study involving a device known as the 
``Volcano Vaporizer'' (hereafter ``Volcano''). RX 49 & 52B. To 
understand the nature and purpose of this proposed study, some earlier 
facts that were disclosed at the hearing need to be considered. 
According to Mr. Doblin's testimony, prior to this incident (i.e., 
before Chemic applied to NIDA for marijuana in 2004), Mr. Doblin had 
devised an elaborate arrangement whereby Chemic received marijuana to 
conduct an earlier study with the Volcano using marijuana obtained 
outside of the HHS process and without the knowledge or approval of HHS 
or DEA. Specifically, Mr. Doblin admitted that he encouraged persons 
who obtained marijuana from ``buyers' clubs'' in California as well as 
persons who obtained their marijuana from NIDA under HHS's 
``compassionate use program'' \27\ to anonymously send their marijuana 
to a DEA-registered drug testing laboratory so that MAPS could compare 
the potency of the ``buyers' clubs'' marijuana with that supplied by 
NIDA.\28\ Tr. 668-82. Acting at the behest of Mr. Doblin, once the drug 
testing laboratory completed its analysis of the marijuana it received 
through these sources, it delivered the ``extra'' marijuana to Chemic, 
so that Chemic could conduct testing on the Volcano. Id. Chemic did 
conduct such testing,\29\

[[Page 2109]]

which was funded by MAPS and the California National Organization for 
the Reform of Marijuana Laws (CaNORML), and Chemic published its 
results in two reports, one of which was co-authored by CaNORML.\30\ 
See id.
---------------------------------------------------------------------------

    \26\ It appears from the record that Chemic initially applied to 
HHS for marijuana in 2003 but, at HHS's request, Chemic submitted a 
revised protocol, which HHS considered to be submitted in 2004. See 
GXs 49 & 52B.
    \27\ See Kuromiya v. United States, 78 F.Supp.2d 367 (E.D. Pa. 
1999) (describing compassionate use program under which less than 10 
persons currently receive marijuana from HHS).
    \28\ Because marijuana is a schedule I controlled substance, 
human use is limited to ``Government-approved research'' in 
accordance with 21 U.S.C. 823(f). See OCBC, 532 U.S. at 491-492 and 
n.5. In accordance with Sec.  823(f) and the DEA regulations, where 
a schedule I controlled substance is used in research--including the 
HHS compassionate use program--the activities involving the 
substance must be limited to those authorized in the research 
protocol. See 21 CFR 1301.13(e)(1)(v), 1301.18. Research activities 
beyond those specified in the protocol are prohibited absent the 
submission and approval of a supplemental protocol. 21 CFR 
1301.18(d). Respondent made no attempt to assert that any of the 
research protocols associated with the compassionate use program 
allow for the distribution of marijuana to a drug testing 
laboratory, as there is no basis for such an assertion. The CSA 
prohibits the distribution of any controlled substance except as 
authorized by the Act, 21 U.S.C. 841(a)(1), and the Act makes no 
allowance for ultimate users (including research subjects) to 
distribute their controlled substances to others.
    \29\ Chemic was not registered with DEA under 21 U.S.C. 823(f) 
to conduct research with marijuana and when DEA later learned that 
Chemic was seeking to conduct a second marijuana study (when Chemic 
subsequently sought to obtain marijuana directly from NIDA and 
sought DEA's authorization for doing so), the agency so advised 
Chemic that this activity required a research registration. See RX 
49, at 2. DEA registrants are only authorized to conduct activities 
with controlled substances ``to the extent authorized by their 
registration and in conformity with other provisions of [the CSA].'' 
21 U.S.C. 822(b).
    \30\ The first report, which was submitted by Chemic in 2003 to 
MAPS and CaNORML, is titled ``Evaluation of Volcano(r) Vaporizer for 
the Efficient Emission of THC, CBD, CBN and the Significant 
Reduction and/or Elimination of Po