[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51403-51412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21064]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 05-16]


Lyle E. Craker, PhD; Order Regarding Officially Noticed Evidence 
and Motion for Reconsideration

    Lyle E. Craker, PhD (Respondent) has requested that I reconsider 
the Final Order I issued on January 7, 2009 (74 FR 2101), which denied 
his application to

[[Page 51404]]

become registered as a bulk manufacturer of marijuana. For the reasons 
provided below, Respondent has failed to demonstrate that the Final 
Order contains any erroneous material findings of fact or conclusions 
of law. Accordingly, Respondent's motion for reconsideration does not 
provide a basis for altering the decision in the Final Order to deny 
his application.

I. Post-Final-Order Proceedings

    Following the issuance of the January 7, 2009, Final Order, 
Respondent submitted a letter to me dated January 21, 2009, noting 
that, in several places in the Final Order, I indicated I was taking 
official notice of certain documents that were not submitted during the 
administrative hearing. With respect to such documents, the Final Order 
states: ``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.'' Thus, Respondent had 
until January 23, 2009, to file a motion for reconsideration of the 
facts of which I took official notice. In his January 21, 2009, letter, 
Respondent requested an extension of this filing deadline until January 
30, 2009. I granted this request for an extension by letter dated 
January 22, 2009.
    On January 30, 2009, Respondent submitted to me a document entitled 
``Request for Opportunity Under 5 U.S.C. 556(e) To Respond to New 
Officially Noticed Evidence and Motion for Reconsideration.'' In this 
document, Respondent provided a preliminary response to those documents 
of which I took official notice. However, Respondent asked for 
additional time to supplement his preliminary response, given the 
length of the Final Order as well as that of the documents of which I 
took official notice. I granted this request, allowing Respondent until 
March 11, 2009, to supplement his response and motion. I further 
instructed that counsel for the Government would have to submit its 
response no later than 15 days after being served with Respondent's 
submission.
    On March 11, 2009, Respondent submitted ``Respondent's Supplemental 
Brief in Support of Request Under 5 U.S.C. 556(e) To Respond to New 
Officially Noticed Evidence and Motion for Reconsideration.'' In this 
document, Respondent provided the legal and factual bases for his 
motion for reconsideration of the Final Order. Also in the document, 
Respondent requested that the administrative hearing be reopened so 
that he may call additional witnesses in view of certain documents of 
which I took official notice in the final order. The Government 
submitted its response on April 13, 2009. In view of these submissions, 
and to clarify Respondent's request, I issued an interim order on May 
18, 2009, directing Respondent to submit a list of all witnesses he 
would call if his request to reopen the administrative hearing were 
granted and to provide a summary of the proposed testimony for each 
witness. This interim order further instructed Respondent to indicate 
precisely which documents he sought to introduce for purposes of his 
motion for reconsideration and, for each document, whether he wanted me 
to take official notice of it, or whether he wished to introduce it 
through witnesses if his request to reopen the hearing were granted.
    On June 5, 2009, Respondent submitted his ``Witness List and 
Document List in Support of Motion for Reconsideration.'' On December 
2, 2010, I issued an order granting in part, and denying in part, 
Respondent's request that I take official notice of certain documents. 
The order denied Respondent's request that I reopen the hearing to 
allow him to call additional witnesses. Having ruled on which new 
documents would be considered part of the record (through my taking 
official notice thereof), the order then gave Respondent an additional 
opportunity to file a final brief in support his motion for 
reconsideration. The order stated that Respondent was required to 
submit such brief on or before March 7, 2011, and that the Government's 
responsive brief was due no later than 30 days after receipt of 
Respondent's brief. Respondent submitted his brief on March 7, 2011 
(hereafter, ``Respondent's latest submission''), and the Government 
submitted its responsive brief on April 1, 2011.

II. Respondent's Additional Proposed Documentary Exhibits

    Respondent's request to introduce additional documents for purposes 
of his motion for reconsideration was addressed at length in my 
December 2, 2010, Order. For each such document Respondent sought to 
introduce, the December 2, 2010, Order stated (pages 23-27) whether I 
would take official notice of the document, and the reasons therefor. 
Only one category of documents that Respondent sought to introduce was 
left unresolved by the December 2, 2010, Order. As to this category, 
the order stated (page 26):

    If Respondent submits all of the correspondence between Chemic 
and HHS (or any of its components) relating to this application 
[Chemic's application to HHS to receive marijuana for research] that 
he has in his possession or can reasonably access (including, but 
not limited to, any such correspondence on the MAPS website, such as 
the January 23, 2009, letter from HHS to Chemic), I will take 
official notice of all such correspondence.

Thus, the only additional documents that might be considered at this 
juncture for inclusion in the record (by my taking official notice 
thereof) are the ``correspondence between Chemic and HHS'' described in 
the above-quoted sentence. Respondent's latest brief seeks to introduce 
11 new documents (which Respondent labels Exhibits A-K). However, only 
four of these documents (Exhibits C, I, J, and K) appear to be 
correspondence between Chemic and HHS. The remaining seven documents 
(A, B, D, E, F, G, and H) do not appear to be correspondence between 
Chemic and HHS, and Respondent makes no assertion in his brief that 
they are such. The Government asserts in its responsive brief that 
these Exhibits A, B, E, F, G, and H are not ``correspondence'' and 
further that ``Respondent has not laid any foundation to demonstrate 
that these exhibits were provided to HHS by Chemic.'' For this reason, 
among others, the Government objects to including these documents in 
the record.
    Accordingly, I rule as follows with respect to these latest 
proposed exhibits:
    (1) I will take official notice of Exhibits C, I, J, and K; and
    (2) As Exhibits A, B, D, E, F, G, and H do not comport with the 
instructions contained in the December 2, 2010, Order, I will not take 
official notice of these documents, and they will not be considered 
part of the administrative record considered by the agency in this 
adjudication.

III. Respondent's Motion for Reconsideration

    Given the number of written submissions made by Respondent 
following the issuance of the January 7, 2009, Final Order, along with 
the Government's responses thereto and the interim orders I issued 
regarding these submissions, it is important to reiterate here the 
purpose for which Respondent was given an opportunity to file a motion 
for reconsideration. That purpose was stated in the January 7, 2009, 
Final Order: ``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

[[Page 51405]]

commence with the mailing of the order.'' 74 FR at 2108 n.24. This was 
restated in the interim orders I issued following the Final Order. As 
explained in the Final Order and the December 2, 2010, Order, this 
opportunity to seek reconsideration of facts of which the agency takes 
official notice is derived from the Administrative Procedure Act (5 
U.S.C. 556(e)) and the DEA regulations (21 CFR 1316.59(e)).
    Respondent's post-Final-Order submissions have, in many respects, 
gone beyond seeking reconsideration of facts of which I took official 
notice. Respondent has essentially sought broad reconsideration of the 
factual and legal bases for the Final Order--generally without 
predicating such arguments on the taking of official notice of any 
fact. Neither the Controlled Substances Act (CSA) nor the DEA 
regulations provide for such a broad-based motion for reconsideration 
of a Final Order.\1\ Nonetheless, in the exercise of my discretion, 
taking into account the complex and sometimes novel issues involved in 
this matter, I have considered all of the arguments Respondent has 
submitted in his post-Final-Order submissions--including those that go 
beyond the scope of what is permitted by 5 U.S.C. 556(e) and 21 CFR 
1316.59(e).
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    \1\ The CSA appeal provision, 21 U.S.C. 877, states: ``All final 
determinations, findings, and conclusions of the [Administrator of 
DEA] under this subchapter shall be final and conclusive decisions 
of the matters involved, except that any person aggrieved by a final 
decision of the [Administrator] may obtain review of the decision in 
the United States Court of Appeals * * *.'' This provision suggests 
that--outside of the scenario provided by the DEA regulations and 
APA in which a party, on timely request, seeks the opportunity to 
controvert facts of which the agency took official notice--DEA is 
not obligated to allow parties to seek reconsideration of final 
orders regarding applications for registration. DEA also adheres to 
the Supreme Court's decision in Interstate Commerce Comm'n v. Bhd. 
of Locomotive Eng'rs, 482 U.S. 270 (1987), regarding the reopening 
of proceedings where it is alleged that new evidence or changed 
circumstances render the agency's original order inappropriate. See 
also Fry v. DEA, 353 F.3d 1041, 1044 (9th Cir. 2003).
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    The arguments contained in Respondent's post-Final-Order 
submissions are, for the most part, reiterations of the same arguments 
that were addressed at length and rejected in the Final Order. In a few 
instances, as noted below, Respondent does present some slightly 
different assertions than he previously offered. However, even in these 
instances, Respondent's core contentions remain those that I previously 
rejected. Furthermore, Respondent fails in these latest submissions to 
rebut the fundamental reasons that were provided in the Final Order for 
denying his application.

A. Respondent's Arguments Relating to the Review of Research Protocols 
by the Department of Health and Human Services

    In his post-Final-Order submissions, Respondent continues to focus 
on what was his primary theme throughout the adjudication proceedings 
leading up to the Final Order: his desire to have the Public Health 
Service and the National Institute on Drug Abuse (NIDA) removed from 
the process by which the Department of Health and Human Services (HHS) 
carries out its statutory duty to review proposed research involving 
marijuana. For purposes of context, it is repeated here, as explained 
in the Final Order, that under the CSA (21 U.S.C. 823(f)), the 
Secretary of HHS is responsible for reviewing all proposed research 
involving schedule I controlled substances. Specifically, section 
823(f) provides that, with respect to applications for registration by 
practitioners wishing to conduct research with schedule I controlled 
substances, ``the Secretary * * * shall determine the qualifications 
and competency of each practitioner requesting registration, as well as 
the merits of the research protocol.'' (Emphasis added.) Thus, under 
section 823(f), a research proposal involving marijuana may only go 
forward where the Secretary both (1) Deems the practitioner qualified 
and competent and (2) determines the research protocol to be 
meritorious. Or, as stated by HHS in its 1999 announcement of its 
policies for providing marijuana to researchers: ``To receive such a 
registration [under Sec.  823(f)], a researcher must first be 
determined by HHS to be qualified and competent, and the proposed 
research must be determined by HHS to have merit.'' 74 FR at 2120 n.70 
(emphasis added in Final Order).
    Respondent does not dispute that the statute assigns the foregoing 
functions to the Secretary of HHS. However, Respondent objects to the 
manner in which these functions are carried out within HHS. In 
particular, Respondent seeks to have the Public Health Service and NIDA 
stripped of any role in this process.\2\
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    \2\ See, e.g., 74 FR at 2106 (noting testimony of Rick Doblin, 
the Director of MAPS, that ``what we're trying to do is get the 
Public Health Service and NIDA out of the picture'').
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    For purposes of addressing this issue, it is useful to repeat the 
following parts of the Final Order, which discussed the scientific 
review process that has been utilized by HHS since 1999 to evaluate 
marijuana research proposals:

    [I]n 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. The new procedures were announced in a document 
released by NIH on May 21, 1999. 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.'' 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.'' 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. This was a departure from the prior practice (pre-
1999), whereby HHS only made marijuana available to persons who 
received NIH funding. The new procedures implemented by HHS in 1999 
remain in effect today.

* * * * *
    At the administrative hearing in this case, Steven Gust, PhD, 
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.'' 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. 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). 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.'' 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). 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.

* * * * *
    In his testimony, Dr. Gust explained the term ``peer review'' as 
follows: ``Peer review is a process that has been used, certainly by 
NIH, and I think in other agencies in the Department of Health and 
Human Services, and probably the Federal Government, where outside 
expertise is acquired and outside opinions on the scientific merit 
of specific research proposals.'' Dr. Gust added that the NIH peer 
review committees ``review

[[Page 51406]]

proposals three times a year for the NIH, and there are--
occasionally a Federal employee participates in one of those 
reviews, but probably 90 percent or more of the participants are 
researchers who are in the private sector, for the most part in 
academic institutions.''

74 FR at 2015, 2119 n.67 (footnotes and citations omitted).
    Again, it is Respondent's contention that the involvement of the 
Public Health Service and NIDA in reviewing proposed marijuana research 
protocols has the effect of blocking legitimate research into 
marijuana. Indeed, the primary argument Respondent puts forth in 
support of his proposed registration is that the current system by 
which the United States Government makes marijuana available to 
researchers fails to provide an adequate supply of marijuana within the 
meaning of 21 U.S.C. 823(a)(1)--precisely because, in Respondent's 
opinion, the Public Health Service and NIDA have ``institutional 
biases'' against certain types of marijuana research.
    This argument was carefully examined in the Final Order. See 74 FR 
at 2107-08, 2119-20. Respondent's post-Final-Order submissions as to 
this issue are not materially different from the claims that were 
rejected in the Final Order. In fact, the new documents that Respondent 
has submitted following the Final Order, and of which I have taken 
official notice, provide further confirmation of certain determinations 
made in the Final Order. Respondent's latest submission contains no 
citations to actual evidence in the record that supports his claims of 
``institutional biases'' or ``political'' motivation on the part of the 
Public Health Service and NIDA.
    As to this issue, the Final Order stated, among other things:

    Respondent also introduced into evidence a letter from the 
President of Chemic to HHS responding to several points raised by 
the PHS Committee in denying Chemic's application. Respondent's 
letter does not, however, establish that HHS impermissibly denied 
Chemic's application for marijuana. To the contrary, the evidence 
supports the conclusion that HHS (acting through the PHS Committee) 
made its determination not to supply marijuana on this occasion 
based on scientific considerations, finding that Chemic's then-
latest proposed study was duplicative of prior and ongoing research 
and not likely to provide useful data.

74 FR at 2109 (emphasis added; footnote and citation omitted). As 
noted, I granted Respondent's post-Final-Order request to introduce 
additional correspondence between Chemic and HHS relating to Chemic's 
proposed research protocol involving marijuana. Respondent produced six 
additional pieces of correspondence between Chemic and HHS relating to 
this matter that were not produced in the administrative hearing. As 
indicated above and in the December 2, 2010, Order, I have taken 
official notice of all six of these documents. Each of these documents 
further confirms that HHS's rejection of the Chemic protocol was--as 
the Final Order found--based purely on scientific merit.
    It is difficult to understand why Respondent would seek to 
introduce at this juncture six letters between Chemic and HHS that 
reaffirm what was found in the Final Order--and how Respondent 
construes these letters as ``rebuttal'' evidence. The statements by HHS 
in these letters are, without question, focused entirely on the 
scientific inadequacies of various iterations of Chemic's research 
proposal. The letters demonstrate that the HHS scientists have actively 
engaged in a dialogue with Chemic for many years, and have gone to 
great lengths to explain to Chemic each of the areas in which Chemic 
needs to revise its protocol so that it can be deemed scientifically 
meritorious. The letters thereby reaffirm that HHS (including, but not 
limited to, the Public Health Service and NIDA) has never indicated any 
opposition (political, philosophical, or otherwise) to any category of 
marijuana research. To the contrary, the letters--particularly the most 
recent one submitted by Respondent, dated January 23, 2009--actually 
show that HHS is interested in Chemic's proposal and willing to supply 
Chemic with marijuana, provided that Chemic provides validation data 
that is necessary to support Chemic's scientific measurements. In 
short, the evidence continues to point squarely to the conclusion that 
HHS is doing precisely what it is required to do under 21 U.S.C. 
823(f): Allow only those schedule I research proposals that it 
determines to be scientifically meritorious to go forward. As the Final 
Order stated: ``That Respondent finds this process to be scientifically 
rigorous--and thereby not automatically accepting of any proposed study 
sponsored by MAPS--provides no basis for any valid objection or any 
contention that the HHS supply of marijuana is inadequate.'' 74 FR at 
2120 (footnotes omitted).\3\
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    \3\ It is unclear whether Respondent is suggesting that I should 
refuse to accept at face value what HHS stated in its correspondence 
with Chemic and instead conclude--without any evidentiary basis for 
doing so--that the HHS scientists who are responsible for reviewing 
proposed marijuana research have conspired for years to carry out an 
elaborate ruse aimed at thwarting marijuana research. If this is 
Respondent's mind-set, adopting it would be the antithesis of the 
principle inherent to the Administrative Procedure Act (APA) that 
agency action must be presumed to be valid where a reasonable basis 
exists for its decision. See, e.g., Kern County Farm Bureau v. 
Allen, 450 F.3d 1072, 1076 (9th Cir. 2006). It is also at odds with 
the APA concept that bars a reviewing court--much less a member of 
the public--from substituting its judgment for that of the agency. 
Id.
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    Moreover, Respondent's ``institutional bias'' theory is belied by 
the following crucial fact. As stated in the Final Order: ``The record 
reflects that since HHS changed its policies in 1999 to make marijuana 
more readily available to researchers (by, among other things, allowing 
privately funded researchers to obtain marijuana), every one of the 17 
CMCR [California Center for Medical Cannabis Research]-sponsored pre-
clinical or clinical studies that requested marijuana from NIDA was 
provided with marijuana.'' 74 FR at 2119. Despite the enormity of this 
fact in relation to Respondent's ``institutional bias'' claim, 
Respondent makes only the following vague reference to it in his latest 
submission (page 9): ``Though the DEA points to other marijuana 
research that NIDA has allowed, none of these studies aimed to develop 
marijuana into a legal prescription medicine.'' What Respondent 
downplays as ``other marijuana research that NIDA has allowed'' is, in 
fact, seventeen different clinical trials involving marijuana proposed 
by CMCR--all of which were approved by the Public Health Service and 
NIDA. As stated in the Final Order:

    Any suggestion that the HHS scientific review process is unduly 
rigorous is belied by the testimony of Dr. Gust 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'' (Tr. at 1700-01) as well as the 
uncontroverted evidence that every one of the 17 CMCR-sponsored 
research protocols submitted to HHS was deemed scientifically 
meritorious by HHS and was supplied with marijuana (GX 31, at 3; Tr. 
694-95).

74 FR at 2120 n.71.
    As for Respondent's contention that ``none of these studies aimed 
to develop marijuana into a legal prescription medicine,'' this too is 
contradicted by the record. As stated in the Final Order:

    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

[[Page 51407]]

appropriated a total of $9 million for the marijuana research 
studies. Tr. 397.

74 FR at 2105-06 n.16. It is thus beyond question that the CMCR studies 
were aimed at what Respondent characterizes as ``develop[ing] marijuana 
into a legal prescription medicine.'' \4\
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    \4\ The process by which FDA approves new drugs for marketing is 
summarized in the Final Order. 74 FR at 2106 n.21.
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    For the same reasons, the record contradicts Respondent's related 
claim that the involvement of the Public Health Service and NIDA in 
determining the scientific merit of proposed marijuana research 
``renders the supply [of marijuana] inadequate because entire 
categories of legitimate medical research are effectively foreclosed.'' 
Respondent fails to explain what ``categories of legitimate medical 
research'' are supposedly being foreclosed. Again, it seems (but is 
unclear) that Respondent is suggesting that the Chemic research 
proposal, and/or Dr. Russo's proposal (see below), were more geared 
toward ``develop[ing] marijuana into a legal prescription medicine'' 
than were the 17 CMCR studies. In other words, Respondent appears to be 
suggesting that the Public Health Service and NIDA went into their 
alleged ``institutional bias'' mode when reviewing the Chemic and Russo 
proposals, but turned off that mode when reviewing the 17 CMCR 
proposals because the latter were less geared toward developing 
marijuana into an FDA-approved medicine. If this is what Respondent is 
suggesting, there is no evidentiary foundation for such a claim as 
neither Chemic's proposal nor Dr. Russo's could be characterized as 
closer than the CMCR studies to the goal of obtaining FDA approval of 
marijuana as a drug.\5\
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    \5\ As stated in the Final Order, no clinical trials involving 
marijuana--not even the 17 CMCR studies--have advanced beyond Phase 
1 of the three phases required for FDA approval of a new drug. 74 FR 
at 2107 n.23. The proposed Chemic study does not even appear to be a 
clinical trial, let alone a study more advanced in the phases of FDA 
approval than the CMCR studies.
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    To address further the portion of Respondent's latest submission 
pertaining to Dr. Russo, the following part of the Final Order is 
recited:

    [Dr. Ethan Russo] sought funding from NIDA to study the use of 
marijuana to treat migraine headaches beginning around 1996. 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.) 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. 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.'' 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. 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. When asked when this 
last denial by NIDA occurred, Mr. Doblin testified: ``I think it was 
1999.''
    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.

74 FR at 2108 (citations omitted).
    In his post-Final-Order submissions, Respondent submitted a letter 
dated February 1, 2000, from the Public Health Service and NIDA to Dr. 
Russo (Exhibit C to Respondent's March 11, 2009, Supplemental Brief). 
In the December 2, 2010, Order, I granted Respondent's request to take 
official notice of this document. As Respondent indicates, this letter 
was issued after HHS announced in 1999 its new procedures for providing 
marijuana to researchers. Even assuming, arguendo, that this letter 
demonstrates that the third protocol submitted by Dr. Russo was 
evaluated by HHS under the new procedures established in 1999,\6\ this 
does not materially alter the conclusions in the Final Order. This is 
because the Final Order stated, in essence, that even if Dr. Russo's 
proposal had been evaluated by HHS under the post-1999 procedures, 
``the evidence indicates that the denials involving * * * Dr. Russo 
were based on HHS finding [his] protocols to be lacking in scientific 
merit.'' See 74 FR at 2119 n.68.
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    \6\ While the letter itself is dated February 1, 2000, 
Respondent failed to present evidence indicating when Dr. Russo 
submitted his third protocol, or when HHS began its review of that 
protocol. Thus, it remains uncertain whether this third protocol was 
evaluated under the pre-1999 or post-1999 HHS procedures.
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    The most recent document submitted by Respondent regarding Dr. 
Russo (the February 1, 2000, letter from Public Health Service to Dr. 
Russo) confirms yet again that the Public Health Service and NIDA focus 
on scientific merit in reviewing proposed marijuana research. The 
February 1, 2000, letter advised Dr. Russo that a scientific review of 
his protocol had been conducted by the Center for Scientific Review 
(CSR) of the National Institutes of Health on behalf of the Public 
Health Service, and that the CSR recommended certain changes to the 
protocol. If, the letter continued, such changes were incorporated into 
a new protocol and submitted by Dr. Russo, the Public Health Service 
would reconsider his request. Among the specific changes that Dr. Russo 
was advised to make were the following: Including a placebo arm; taking 
steps to account for possible attrition of research subjects; and 
ensuring that research subjects received equivalent doses of THC. These 
are quintessentially scientific refinements that the researcher was 
being asked to make--not, as Respondent alleges, a refusal to allow a 
category of research to take place.
    Thus, even when viewing Respondent's newly submitted evidence 
regarding Dr. Russo as an example of a denial by HHS of marijuana under 
the post-1999 HHS procedures, it is in the same category as the Chemic 
protocols: A denial based on scientific merit under the post-1999 
procedures. This would bring the total figures under the post-1999 
procedures to the following: 17 studies approved and supplied with 
marijuana; two studies denied until the researcher makes certain 
changes in the protocol to render the proposal scientifically 
meritorious. Stated alternatively, under the post-1999 procedures, 
HHS's approval rate for marijuana studies is at least 89.5 percent, 
with the possibility of that figure rising to 100 percent if two of the 
researchers were willing to make adjustments to their protocols to make 
them scientifically meritorious.
    Respondent's latest submission also refers to certain documentary 
and testimonial statements by NIDA officials, which Respondent contends 
support his claim of ``institutional bias.'' As these statements were 
part of the record that the parties addressed in their pre-Final-Order 
submissions, and since the Final Order already addressed this type of 
argument by Respondent, it is not necessary to reexamine this issue at 
length here. Moreover, the actions by HHS in response to actual 
research proposals are by far the best evidence of the agency's true 
willingness to supply marijuana to researchers, and these actions 
render inconsequential any attempt by Respondent to surmise 
``institutional bias'' from abstract statements isolated from the 
documents

[[Page 51408]]

and testimony. The same considerations apply with respect to 
Respondent's argument that NIDA's mission stands as an obstacle to 
allowing legitimate marijuana research to take place. This argument was 
addressed in the Final Order and is overwhelmingly refuted by the 
evidence of HHS's actual track record in supplying marijuana to 
researchers.\7\
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    \7\ Although HHS's actual record in supplying marijuana to 
researchers is the best evidence of its willingness to do so, the 
following testimony of Dr. Gust at the hearing explains how HHS took 
steps in 1999 to ensure the availability of marijuana to 
researchers--including those interested in pursuing medical uses of 
marijuana--irrespective of NIDA's mission:
    It was about this time [1999] when there was some increased 
interest in research, in pursuing the medical use of marijuana, and 
in an effort to make the process more standardized, and to basically 
provide some expertise that did not really exist at NIDA in terms of 
reviewing applications that involved primarily the use of marijuana 
or any other substance for that matter for treatment of diseases, 
which did not really fall within NIDA's mission, the department 
[HHS] established a separate peer review process that made the 
review--that moved the review into the Public Health Service at the 
time where additional expertise from other NIH Institutes and other 
Federal agencies could be brought to bear to help--and help provide 
reviews, appropriate reviews, of the scientific merit of these 
applications.
    Tr. 1632-33. Thus, Respondent's attempt to focus on NIDA's 
particular mission, without regard to the mission of other 
components of HHS involved in review of marijuana research 
proposals, and without regard to the overall aims of the procedures 
established by HHS in 1999 for providing marijuana to researchers, 
is misplaced.
---------------------------------------------------------------------------

    Respondent also asserts that two provisions of the Federal Food, 
Drug, and Cosmetic Act (FDCA) and an FDA regulation mandate that the 
FDA--and not NIDA--must carry out the Secretary of HHS's responsibility 
under 21 U.S.C. 823(f) to determine the scientific merit of proposed 
marijuana research. Specifically, Respondent cites 21 U.S.C. 393(b) 
(FDA's mission statement), 21 U.S.C. 355 (new drug approval process), 
and 21 CFR 312.22(a) (general principles of submission of an 
investigational new drug application (IND)), in support of this 
assertion.
    This assertion is mistaken in a number of respects, including, but 
not limited to, the following. First, the fact that the FDA's statutory 
mission statement lists certain functions by no means precludes other 
agencies within HHS from having overlapping functions.\8\ Second, while 
FDA is indeed the agency within HHS that is chiefly responsible for 
administering the new drug approval process under 21 U.S.C. 355, this 
is a distinctly different function than the determination under 21 
U.S.C. 823(f) of the scientific merit of proposed research involving 
schedule I controlled substances. There is certainly no basis for 
Respondent (or any other member of the public) to dictate to the 
Secretary that the same agency within HHS that carries out the former 
function must also carry out the latter.\9\ Third, although the review 
by FDA of an IND may (depending on the phase of the investigation) be 
similar in certain respects to the review under Sec.  823(f) of a 
schedule I research proposal, the two types of reviews are distinct 
administrative functions carried out within HHS. This is evident from 
the first sentence of the very regulation that Respondent cites, 21 CFR 
312.22(a), which states: ``FDA's primary objectives in reviewing an IND 
are, in all phases of the investigation, to assure the safety and 
rights of subjects, and in Phase 2 and 3, to help assure that the 
quality of the scientific evaluation of drugs is adequate to permit an 
evaluation of the drug's effectiveness and safety.'' Thus, in reviewing 
an IND for a Phase 1 investigation, FDA's primary objective is to 
assure the safety and rights of subjects--not to assess the scientific 
quality of the clinical investigation. This is especially notable 
since, as stated above, none of the clinical trials involving marijuana 
that have been proposed to HHS has advanced beyond Phase 1.
---------------------------------------------------------------------------

    \8\ Moreover, not even those functions expressly listed in FDA's 
statutory mission statement are carried out solely by the FDA. As 
stated in the very next subsection after the one cited by 
Respondent, 21 U.S.C. 393(c), which is entitled ``Interagency 
collaboration'': ``The Secretary [of HHS] shall implement programs 
and policies that will foster collaboration between the [FDA], the 
National Institutes of Health, and other science-based Federal 
agencies, to enhance the scientific and technical expertise 
available to the Secretary in the conduct of the duties of the 
Secretary with respect to the development, clinical investigation, 
evaluation, and postmarket monitoring of emerging medical therapies, 
including complementary therapies. * * *''
    \9\ Under 21 U.S.C. 823(f), Congress assigned to the Secretary 
of HHS sole discretion to determine how HHS carries out its 
responsibility to review the scientific merit of schedule I research 
proposals.
---------------------------------------------------------------------------

    The foregoing discussion also sheds light on another assertion made 
by Respondent in his latest submission: That ``several research 
projects have been blocked by NIDA in spite of FDA-approved 
protocols.'' \10\ Preliminarily, it should be noted that Respondent 
fails to specify exactly what he means here by ``several research 
projects.'' The record reveals only two clinical research proposals 
submitted to HHS involving marijuana that did not receive marijuana: 
Dr. Abrams's proposal (in the pre-1999 era) and Dr. Russo's 
proposal.\11\ In addition, it is important at this juncture to correct 
an error in terminology. FDA does not ``approve'' INDs. Rather, the IND 
process works as follows. An investigator seeking to use an 
investigational new drug in a clinical trial must submit an IND for the 
drug to the FDA. 21 CFR 312.40. The IND automatically goes into effect 
30 days after the FDA receives the IND,\12\ unless the FDA notifies the 
sponsor that the investigation is subject to a clinical hold. Id.
---------------------------------------------------------------------------

    \10\ Respondent uses this particular wording on page 9 of his 
latest submission, and he reiterates the assertion numerous times in 
the document.
    \11\ As Respondent seems to concede, Chemic's proposed research 
involving marijuana is not a clinical trial. Accordingly, Respondent 
does not appear to be suggesting that Chemic submitted an IND to the 
FDA for its research proposal. Thus, it does not appear that 
Respondent is including the Chemic situation in his category of 
``research projects [that] have been blocked by NIDA in spite of 
FDA-approved protocols.''
    \12\ The FDA may also notify the investigator that the clinical 
investigation may begin earlier than 30 days after the FDA receives 
the IND. 21 CFR 312.40(b)(2).
---------------------------------------------------------------------------

    Thus, it is incorrect for Respondent to state that the FDA 
``approved'' any ``protocols'' for proposed marijuana research.\13\ 
More accurately stated, the most that can be inferred from the evidence 
is that the FDA reviewed INDs submitted by Dr. Abrams and Dr. Russo, 
and that the FDA did not place a clinical hold on either proposed 
investigation.\14\ However, as just explained, the FDA regulations 
indicate that, for Phase 1 investigations, FDA's review of an IND 
focuses primarily on the safety and rights of subjects--not the 
scientific quality of the clinical investigation. Thus, while the FDA 
appears to have concluded that allowing Dr. Russo's and Dr. Abrams's 
Phase 1 studies to proceed would not have presented an unacceptable 
risk of harm to the human research subjects,\15\ there is no 
evidentiary basis to conclude that FDA evaluated the scientific quality 
of either proposal--and particularly no basis to conclude that FDA 
determined that the studies were scientifically meritorious within the 
meaning of 21 U.S.C. 823(f).
---------------------------------------------------------------------------

    \13\ The word ``approve'' (or ``approval'') is a term of art in 
the FDCA. The FDA ``approves'' new drug applications upon an 
adequate showing of safety and efficacy for the uses in the proposed 
labeling, which allows a drug to be legally marketed. 21 U.S.C. 355; 
21 CFR 314. An effective IND is considered ``accepted,'' not 
``approved,'' by FDA.
    \14\ I am assuming, for the sake of discussion, that Dr. Russo 
and Dr. Abrams submitted INDs and that the FDA did not issue 
clinical holds, even though Respondent did not introduce such INDs 
or call Dr. Russo or Dr. Abrams to testify.
    \15\ See 21 CFR 312.42(b) (grounds for imposition of a clinical 
hold of a Phase 1 study under an IND).
---------------------------------------------------------------------------

    As stated in the Final Order, under the procedures implemented by 
HHS in 1999 for reviewing proposed marijuana research, the review by 
FDA on an IND is one part of that process.\16\ Yet, Respondent seems to 
want FDA's

[[Page 51409]]

review of an IND for Phase 1 investigations--which focuses on the 
safety and rights of subjects, rather than the scientific quality of 
the clinical investigation--to serve as the entire review process, 
i.e., to supplant the full-fledged evaluation of the scientific merit 
required by 21 U.S.C. 823(f). Had Congress intended such a result, it 
could have easily stated in 21 U.S.C. 823(f) that the only scientific 
prerequisite to conducting research with a schedule I controlled 
substance is that an IND be in effect with respect to such 
research.\17\ But it is evident from the language of Sec.  823(f) that 
Congress intended HHS to conduct a different type of evaluation of the 
scientific merit of research proposals than that which will suffice for 
purposes of an IND. It is unclear whether Respondent fails to 
understand this distinction between the review by FDA of a Phase 1 IND 
and the review of the scientific merit of a research proposal under 
Sec.  823(f), or if Respondent does understand this distinction and 
simply wishes that the less rigorous review (the Phase 1 IND review) 
would suffice so that even those marijuana research proposals that lack 
scientific merit could be carried out.\18\ For the reasons noted above, 
neither of the foregoing is a legally valid position.
---------------------------------------------------------------------------

    \16\ See 74 FR at 2105.
    \17\ Several provisions of the CSA reference the IND provision 
of the FDCA. For example, 21 U.S.C. 827(c)(2)(A) expressly excludes 
``research conducted in conformity with an exemption granted under 
[21 U.S.C. 355(i)]'' from the CSA's recordkeeping requirements.
    \18\ Illustrative of this point is Respondent's statement in his 
latest submission (page 14) that ``if a research protocol is good 
enough for the FDA, it should be good enough to be carried out.''
---------------------------------------------------------------------------

    In sum, Respondent's motion for reconsideration provides no basis 
for deviating from the conclusions in the Final Order relating to the 
process by which HHS determines the scientific merit of proposed 
marijuana research pursuant to 21 U.S.C. 823(f). Congress assigned to 
the Secretary of HHS responsibility for deciding how to carry out that 
function within HHS, and the evidence demonstrates that the procedures 
established by HHS in 1999, including the Public Health Service 
interdisciplinary review process, properly focus on the scientific 
merit of research proposals. As the Final Order indicated, that process 
makes marijuana available to all researchers who meet the criteria of 
Sec.  823(f), and Respondent's post-Final-Order submissions provide no 
evidence suggesting otherwise. Respondent's desire to substitute his 
opinion for that of the Secretary as to what type of scientific review 
should be carried out under Sec.  823(f), and who within HHS should 
carry it out, is legally untenable.
    Respondent's claim that the supply of marijuana is inadequate is 
dependent on his supposition that the current HHS process for supplying 
marijuana to researchers improperly denies marijuana to researchers. 
That supposition was found in the Final Order to be without merit, and 
his latest submission warrants no departure from that finding, as 
explained above. Accordingly, Respondent has provided no basis to 
change the conclusion in the Final Order that he failed to meet his 
burden of proving that the supply of marijuana is inadequate within the 
meaning of 21 U.S.C. 823(a)(1).

B. Respondent's Arguments Relating to the Single Convention on Narcotic 
Drugs, 1961

    Respondent seeks reconsideration of the determinations in the Final 
Order relating to the Single Convention on Narcotic Drugs, 1961 (Single 
Convention). Respondent's post-Final-Order arguments relating to the 
Single Convention are not predicated on the taking of official notice 
of any fact. Nonetheless, as indicated, I have considered these 
arguments. Respondent's core contentions regarding the Single 
Convention were addressed in the Final Order and, therefore, it is 
unnecessary to repeat all of that discussion here. However, in view of 
his latest submissions, a few points warrant reiteration and/or 
clarification.
    Under 21 U.S.C. 823(a), DEA must deny an application by a person 
seeking to become registered as a bulk manufacturer of a schedule I 
controlled substance if the agency determines that such registration 
would be inconsistent with United States obligations under applicable 
international drug control treaties--i.e., the Single Convention. When 
it comes to marijuana (referred to under the treaty as ``cannabis''), 
one of the key principles of the Single Convention is that the federal 
government maintain a monopoly over the wholesale distribution of the 
drug. As to this point, the Final Order recited the following statement 
from the Official Commentary to the Single Convention:

    Countries * * * which produce * * * cannabis * * *, [i]n so far 
as they permit private farmers to cultivate the plants * * *, cannot 
establish with sufficient exactitude the quantities harvested by 
individual producers. If they allowed the sale of the crops to 
private traders, they would not be in a position to ascertain with 
reasonable exactitude the amounts which enter their controlled 
trade. The effectiveness of their control r[eacute]gime would thus 
be considerably weakened. In fact, experience has shown that 
permitting licensed private traders to purchase the crops results in 
diversion of large quantities of drugs into illicit channels. * * * 
[T]he acquisition of the crops and the wholesale and international 
trade in these agricultural products cannot be entrusted to private 
traders, but must be undertaken by governmental authorities in the 
producing countries. Article 23 * * * and article 28 * * * therefore 
require a government monopoly of the wholesale and international 
trade in the agricultural product in question in the country which 
authorizes its production.

74 FR at 2115 (citing Commentary at 278).
    As indicated in the Final Order, the United States has, since 1968, 
implemented this aspect of the treaty through the following system 
carried out within HHS. NIDA enters into a contract with a private 
grower, with the grower being obligated under the contract to produce 
the amount and quantity of marijuana specified by NIDA and to produce 
marijuana cigarettes to supply researchers as directed by NIDA.\19\ 
Throughout the 44 years since the United States ratified the Single 
Convention in 1967, the entire United States supply of marijuana for 
researchers has been distributed through this system. In this manner, 
the United States Government has always monopolized the wholesale trade 
in marijuana, consistent with its obligations under the treaty.
---------------------------------------------------------------------------

    \19\ Prior to 1999, NIDA entered into two contracts: one with 
the grower and one with the entity that produced the cigarettes. In 
1999, NIDA decided that a single contract should be awarded for both 
activities, which resulted in the contractor (a division of the 
University of Mississippi) continuing to grow the marijuana, but 
subcontracting to Research Triangle Institute the responsibility of 
producing the cigarettes. 74 FR at 2122 n.79.
---------------------------------------------------------------------------

    It is true, as Respondent points out in his post-Final-Order 
submissions, that the Single Convention (article 23, paragraph 3) calls 
upon parties to carry out the functions of article 23 by a single 
government agency. It is also true, as Respondent indicates, that the 
United States fails to adhere strictly to this provision of the treaty 
as both DEA and HHS carry out certain functions set forth in article 
23, paragraph 2.\20\ Specifically, DEA carries out those functions of 
article 23 paragraph 2 that are encompassed by the DEA registration 
system, and HHS (through NIDA) carries out those functions relating to 
purchasing the marijuana and maintaining a monopoly over the wholesale 
distribution. That these

[[Page 51410]]

functions are divided among the two agencies--rather than being carried 
out by a single agency--is a result of the existing statutes, 
regulations, and Congressional appropriations.\21\ Nonetheless, when 
evaluating an application for registration under 21 U.S.C. 823(a), DEA 
must attempt to conform with the provisions of the Single Convention to 
the fullest extent possible under the existing statutory and regulatory 
framework. Accordingly, even in the absence of a single government 
agency carrying out all the functions referred to in article 23, 
paragraph 2, DEA must seek to adhere to the other provisions of this 
article that are attainable within the existing statutory and 
regulatory framework, including that which calls upon the United States 
Government to monopolize the wholesale distribution of marijuana.\22\
---------------------------------------------------------------------------

    \20\ Respondent is incorrect, however, in asserting that the 
Final Order stated that NIDA carries out all the functions under 
article 23, paragraph 2. No such statement appears in the Final 
Order.
    \21\ Whether, in the absence of Congressional action, DEA could 
promulgate regulations that would result in DEA alone carrying out 
all the functions of article 23 is beyond the scope of this 
adjudication.
    \22\ Although Respondent argues that the Government does not 
take actual physical possession of the marijuana grown by the NIDA 
contractor (as contemplated by article 23, paragraph 2(d)), one 
could conclude that the NIDA contract process does fulfill this 
obligation. For the reasons indicated above, this does not compel 
DEA to abandon the provision of article 23 requiring a government 
monopoly on the wholesale distribution of marijuana. See 74 FR at 
2114 (``taking possession and engaging in wholesale distribution are 
two separate activities under the Convention'').
---------------------------------------------------------------------------

    Therefore, for the reasons detailed in the Final Order, 
Respondent's stated goal of becoming registered for the purpose of 
ending the Government monopoly on the wholesale distribution of 
marijuana to researchers is directly at odds with the Single 
Convention, which independently warrants denial of his application. 
Respondent seems to continue to either ignore and/or misunderstand this 
fundamental aspect of the treaty. In his latest submission, Respondent 
states (pages 20-21): ``It is certainly true Dr. Craker seeks to 
cultivate marijuana outside NIDA's monopoly, but it does not follow 
that Dr. Craker seeks to cultivate marijuana outside the structures of 
any government regulation. * * * Dr. Craker and [Mr. Doblin] are in no 
way opposed to the regulation of marijuana by [DEA].'' (Emphasis in 
original.) This statement suggests that Respondent believes 
incongruously that as long as he agrees to comply with the DEA 
regulations relating to registration and security, his proposed 
registration should be deemed consistent with the Single Convention. 
Based on this flawed assumption, Respondent is effectively arguing that 
the provision of the Single Convention requiring a Government monopoly 
over the wholesale distribution of marijuana may be jettisoned whenever 
an applicant for registration promises to comply with the DEA 
regulations governing registration and security.
    Respondent also continues to argue that the marijuana he seeks to 
grow is ``exempt'' from the Single Convention requirement of a 
government monopoly over the wholesale distribution of marijuana. 
According to Respondent, because he is seeking to supply marijuana to 
researchers for the purpose of conducting research that he hopes will 
someday lead to the FDA approval of marijuana as medicine, the 
marijuana he is seeking to grow should be deemed ``medicinal cannabis'' 
within the meaning of the Single Convention and thus the government 
monopoly set forth in article 23, paragraph 2(e) should be considered 
inapplicable to his proposed activity. The Government correctly 
suggests in its responsive brief (pages 8-9) that Respondent's 
interpretation would vitiate the language of article 23, paragraph 
2(e). As I stated in the December 2, 2010, Order, it is theoretically 
possible that a marijuana-derived drug might be approved by the FDA in 
the future that would constitute ``medicinal cannabis'' within the 
meaning of the Single Convention. However, no drug product derived from 
marijuana has been approved by the FDA and, therefore, there is 
currently no such thing as ``medicinal cannabis'' in the United States. 
For this reason, the exception in article 23, paragraph 2(e) for 
``medicinal cannabis'' has no bearing on this adjudication.
    For purposes of the Single Convention, the marijuana that 
Respondent seeks to produce is clearly ``cannabis'' subject to the 
government monopoly under article 23, paragraph 2(e). As to this point, 
the Final Order observed:

    In its 2005 Annual Report, the [International Narcotics Control 
Board] reiterated: ``Articles 23 and 28 of the [Single] Convention 
provide for a national cannabis agency to be established in 
countries where the cannabis plant is cultivated licitly for the 
production of cannabis, even if the cannabis produced is used for 
research purposes only.''

74 FR at 2115 (footnote omitted).
    Respondent also makes the following statement in his latest 
submission (pages 15-16): ``Additionally, the conduct of the one 
currently DEA-licensed manufacturer, who has been permitted by DEA to 
grow large amounts of marijuana outside of the NIDA contract, disproves 
the theory that marijuana grown for any purpose other than to supply 
NIDA-approved research would violate the Convention.'' (Emphasis in 
original.) Respondent is referring here to the cultivation of marijuana 
by the National Center for Natural Products Research (National Center), 
a division of the University of Mississippi.\23\ As explained in the 
Final Order, in 1999, DEA and the National Center entered into a 
Memorandum of Agreement (MOA) under which the National Center was 
granted an additional registration to manufacture marijuana and THC 
independent of its contract with NIDA. 74 FR at 2104 n.13. The Final 
Order further explained:
---------------------------------------------------------------------------

    \23\ For ease of understanding, the National Center is sometimes 
referred to here and in the Final Order as ``the University of 
Mississippi.''

    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.'' The MOA 
further stated that, under the terms thereof, the Center would 
``manufacture marijuana for the purpose of extracting THC 
therefrom.'' 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.'' 
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.'' 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.'' 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. 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. (emphasis added; citations omitted). The Final Order further 
stated:


[[Page 51411]]


    In 2005, the University of Mississippi applied for a new 
registration to manufacture marijuana ``to prepare marihuana extract 
for further purification into bulk active [THC] for use in launching 
FDA-approved pharmaceutical products.'' DEA has not yet issued a 
final order as to this application and the University therefore does 
not currently have DEA authorization to undertake such activity. As 
with Respondent's application, DEA may only grant the pending 
University of Mississippi application if the agency determines that 
the University has demonstrated that the registration would be 
consistent with United States treaty obligations and the public 
interest. In making such determinations, DEA will not simply rely on 
the prior issuance of registration under the 1999 MOA but will 
consider the application anew, in view of the current circumstances 
and consistent with this final order. Among other things that must 
be considered with respect to the pending University of Mississippi 
application, I note that the Commentary to the Single Convention 
states the following with respect to the exemption for ``opium 
preparations'' under Article 23, paragraph (e): ``Opium-producing 
countries may thus authorize private manufacture of, and private 
international and domestic wholesale trade in, medicinal opium and 
opium preparations. The opium other than medicinal opium needed for 
such manufacture must however be procured from the national opium 
agency.'' Commentary at 284 (emphasis added). Whether the University 
of Mississippi's proposed registration would be consistent with this 
aspect of the treaty has not yet been determined by DEA and is not 
the subject of this adjudication.

74 FR at 2118 n.61 (emphasis in original; citations omitted).
    When viewing the foregoing statements from the Final Order in 
juxtaposition with Respondent's latest assertions regarding the 
National Center, two points should be considered. First, the above 
statements reflect that as part of the 1999 MOA with the National 
Center, DEA insisted--as it has in Respondent's case--on adherence to 
the principle under the Single Convention of prohibiting private 
trading in cannabis. The National Center has never been permitted to 
distribute marijuana to any persons except upon the specific 
instructions of NIDA through the system described above. Second, 
contrary to Respondent's assertion, DEA has never taken the position 
that ``marijuana grown for any purpose other than to supply NIDA-
approved research would violate the Convention.'' Rather, as just 
noted, DEA has consistently taken the position that, in accordance with 
the Single Convention, the Government must maintain a monopoly on the 
wholesale distribution of cannabis.
    One other argument made by Respondent in his latest submission 
warrants a brief response. Respondent repeatedly makes erroneous 
assertions about the legal and factual circumstances surrounding his 
application, then denounces the situation as a ``catch-22.'' For 
example, on page 17 of his latest submission, Respondent describes the 
following as a ``catch-22'': ``Medical marijuana does not exist, 
according to DEA, unless it is an FDA-approved medicine, but Dr. 
Craker's license to supply marijuana for the research necessary to test 
such a medicine and secure FDA approval cannot be granted because 
medical marijuana does not exist.'' In fact, not only DEA, but also the 
United States Supreme Court, interpreting the text of the CSA, has 
stated--unanimously--that marijuana is not medicine. In United States 
v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 483, 491 (2001), the 
Court stated: ``[F]or purposes of the [CSA], marijuana has 'no 
currently accepted medical use' at all.'' Moreover, Respondent, in 
denouncing the notion that marijuana must gain FDA-approval to be 
considered medicine, is objecting to what has been a cornerstone of the 
FDCA for 50 years--that a drug may not be marketed as medicine in this 
country unless the FDA has determined, based on submissions of 
scientific evidence established in clinical trials, that the drug is 
safe and effective for the treatment of a disease or condition. As for 
Respondent's contention that marijuana research cannot go forward 
unless he becomes registered to grow marijuana, as explained above in 
section A., this is flatly refuted by the fact that HHS and DEA 
authorized 17 of the last 17 marijuana research proposals submitted by 
CMCR--all of which were aimed at establishing a scientific foundation 
for the FDA approval of marijuana. Thus, Respondent's use of the term 
``catch-22'' is empty rhetoric.

C. Respondent's Arguments Relating to the Involvement of Rick Doblin in 
Respondent's Proposed Activities

    Respondent also seeks reconsideration of my determinations in the 
Final Order relating the involvement of Rick Doblin in Respondent's 
application and proposed activities. Again, in the exercise of my 
discretion, I have considered Respondent's post-hearing submissions as 
to this issue, even though they do not arise out of the taking of 
official notice of any fact.
    To briefly recap, the Final Order listed the various ways in which 
Mr. Doblin was involved in Respondent's application process and how Mr. 
Doblin would have a role in Respondent's activities if the application 
were granted. 74 FR at 2126. The Final Order then stated:

    In short, Mr. Doblin has mapped out and assisted in most acts, 
if not every act, that Respondent has taken toward applying for a 
registration to manufacture marijuana and, if the registration were 
granted, Mr. Doblin would continue to maintain responsibility for 
managing and monitoring the activities of the registrant. Given this 
level of involvement by Mr. Doblin--and the passive, if not 
subservient, nature of Respondent's involvement--it is appropriate 
under factor six to consider the following conduct by Mr. Doblin 
relating to controlled substances. First, Mr. Doblin admits that he 
smokes marijuana for ``recreational use'' on a weekly basis. Thus, 
Mr. Doblin violates federal and state laws relating to controlled 
substances on a weekly basis. This demonstrates that Mr. Doblin has 
disregard for the controlled substances laws. It is simply 
inconceivable that DEA would--consistent with its obligations under 
the CSA--grant a registration to engage in certain activities 
involving controlled substances where it is clear that a person who 
will have any role in the oversight and management of such 
activities routinely engages in the illegal use of controlled 
substances. It is still more untenable where that person has the 
level of oversight and management that Mr. Doblin would have--and 
where the controlled substance he illegally uses is the very 
controlled substance the applicant seeks to produce. Indeed, it is 
remarkable that Mr. Doblin would--given his admitted illegal 
involvement in controlled substances--ask DEA to effectively grant 
him permission to take on such a prominent role in the manufacture 
of the most widely abused illegal controlled substance in the United 
States.

Id. (emphasis in original; citations and footnotes omitted).
    In his latest submission, Respondent points out that in the Final 
Order, under the fifth public interest factor (21 U.S.C. 823(a)(5)), I 
concluded that if the registration were granted, Respondent would have 
in the establishment (i.e., in his growing facility) effective controls 
against diversion. 74 FR 2125-26. Respondent contends that this 
conclusion precludes me from concluding under the sixth public interest 
factor (21 U.S.C. 823(a)(6)) that Mr. Doblin's involvement in 
Respondent's activity weighs against granting his application.
    It is plain when comparing the text of factor five with that of 
factor six that a favorable finding with respect to factor five does 
not preclude an unfavorable finding under factor six. As explained in 
the Final Order, under public interest factor five, ``the existence in 
the establishment of effective control against diversion'' includes, 
among other considerations, appropriate physical security and employee 
screening as required by the DEA

[[Page 51412]]

regulations as confirmed through a DEA on-site inspection of the 
premises. 74 FR at 2128 (citing 21 CFR 1310.71-1301.93). Factor six, in 
contrast, is a catchall category that is designed to give DEA wide 
latitude to consider all evidence that might reasonably bear on the 
suitability of an applicant for registration. In other words, even if a 
registrant has promised to undertake security procedures sufficient to 
obtain a favorable finding under factor five, if other evidence (not 
covered by factors one through five) casts doubt on whether the 
applicant can be entrusted with the responsibility of a DEA 
manufacturing registration, such evidence may be considered under 
factor six.
    Consider, for example, if a person were seeking to become 
registered as a manufacturer of oxycodone, and the applicant promised 
to install and maintain in the facility all the physical security 
measures and employee screening procedures required by the regulations. 
Assume further that evidence came to light that the main investor in 
the facility, who planned to make the decisions as to how the facility 
would distribute oxycodone, admitted that he obtains oxycodone 
illegally and uses it for ``recreational'' purposes on a weekly basis. 
In such circumstances, it would certainly be appropriate for DEA to 
draw an adverse inference under factor six based on such person's 
illicit activity involving oxycodone--regardless of whether the 
applicant made assurances that it would comply with the security 
regulations. Thus, I cannot adopt Respondent's suggestion that Mr. 
Doblin's regular marijuana use should be ignored as a factor relevant 
to his application.
    Nonetheless, it bears repeating that the ultimate decision in this 
matter did not turn on consideration of Mr. Doblin's marijuana 
activity. As stated in the Final Order, two other independent grounds 
existed for denying the application and, therefore, the same result 
would have been reached had I determined that Mr. Doblin's marijuana 
activity were irrelevant.
    To be clear, if I determined that the proposed registration were 
consistent with United States obligations under the Single Convention 
and further that the supply of marijuana available to researchers in 
the United States were inadequate within the meaning of 21 U.S.C. 
823(a)(1), it is conceivable that arrangements could have been made to 
mitigate the concerns regarding Mr. Doblin's marijuana activity. For 
example, under a conditional grant of registration or memorandum of 
agreement, sufficient terms perhaps could have been imposed to ensure 
that Mr. Doblin would not be allowed to have access to the growing 
facility and would have no role in any decision making relating to 
management of the facility or the distribution of marijuana. However, 
consideration of such an approach was not feasible here given the other 
grounds for denying the application.

IV. Conclusion

    For the foregoing reasons, Respondent's motion for reconsideration 
is hereby denied. The administrative record is modified as indicated 
herein and in my December 2, 2010, order. The January 14, 2009, Final 
Order, as supplemented by this order, is effective on September 7, 
2011.

    Dated: August 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-21064 Filed 8-17-11; 8:45 am]
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