Registrant Actions - 2011
[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51403-51412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21064]
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]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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