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Washington and Rhode Island Governors petion feds for rescheduling of cannabis


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November 30, 2011
Michele Leonhart, Administrator
Drug Enforcement Administration
Attn: Administrator
8701 Morrissette Drive
Springfield, VA 22152
Subject: Rulemaking petition to reclassify cannabis for medical use from a
Schedule I controlled substance to a Schedule II
Dear Administrator Leonhart:
Pursuant to Section 1308.43 of Title 21 of the Code of Federal Regulations (CFR), we hereby
petition to initiate proceedings for the issuance of an amendment of a rule or regulation pursuant to
Section 201 of the Controlled Substances Act (CSA). Specifically, we petition for the
reclassification of medical cannabis (also known as marijuana) from Schedule I to Schedule II of
the CSA.
Attached hereto and constituting a part of this petition are the following as required by the CSA and
the CFR:
Exhibit A — The proposed rule. We seek the amendment of an existing rule, so pursuant to
21 C.F.R. §1308.43(6), we have included the existing rule together with a reference to the
section in the CFR where it appears, along with our proposed amendment for your
Exhibit B — A statement of the grounds upon which we rely for the issuance of an
amendment of the rule. As required, the grounds we rely on include a reasonably concise
statement of the facts, including a summary of relevant medical or scientific evidence in the
form of an eight factor analysis that the CSA specifies a petitioner must address (21 U.S.C.
§811(c)). The Secretary of the United States Department of Health and Human Services
(HHS) through the Food and Drug Administration (FDA) will consider these factors in a
report to you for purposes of informing your final decision. The factors include: (1) actual
and potential for abuse; (2) pharmacology; (3) other current scientific knowledge; (4) history
and current pattern of abuse; (5) scope, duration and significance of abuse; (6) public health
risk; (7) psychic or physiological dependence liability; and (8) whether it is an immediate
precursor of a controlled substance.
Michele Leonhart, Administrator
Drug Enforcement Administration
November 30, 2011
Page 2
The attached statement of grounds about the scientific and medical record, considering these
eight factors, supports recognition of the accepted medical use of cannabis in the United
States. Accordingly, we request you to open rulemaking to reschedule cannabis for medical
purposes under the CSA from a Schedule I to a Schedule II controlled substance.
We are concerned that patients with serious medical conditions who could benefit from medical use
of cannabis do not have a safe and consistent source of the drug. As you know, sixteen states and
the District of Columbia have decriminalized cannabis for limited medical purposes. Each of these
jurisdictions is struggling with managing safe access to medical cannabis for patients with serious
medical conditions. Our work with the federal agencies has not resolved the matter. Federal
enforcement policies acknowledge the "compassionate use" for seriously ill patients, but the
policies do not provide means for safe access of medical cannabis for patients in need.
The divergence in state and federal law creates a situation where there is no regulated and safe
system to supply legitimate patients who may need medical cannabis. State and local governments
cannot adopt a regulatory framework to ensure a safe supply is available for — and limited to —
legitimate medical use without putting their employees at risk of violating federal law. As some
states seek to increase regulation, United States Attorneys have warned that the federal government
would prosecute "vigorously against individuals and organizations that participate in unlawful
manufacturing and distribution activity involving marijuana, even if such activities are permitted
under state law." Yet in the absence of state or local regulatory systems, there exists wide spread
confusion and proliferation of unregulated activities.
More to the point, it is clear that the long-standing classification of medical use of cannabis in the
United States as an illegal Schedule I substance is fundamentally wrong and should be changed.
The federal government could quickly solve the issue if it reclassified cannabis for medical use
from a Schedule I drug to a Schedule II drug. Most recently the DEA, as noted in your letter dated
June 21, 2011 (published July 8, 2011 in the Federal Register), denied a 2002 petition to initiate
proceedings to reschedule marijuana based on an outdated 2006 HHS/FDA scientific review. With
respect to marijuana, the 2006 HHS/FDA review found: (1) the medical substance has a high
potential for abuse; (2) has no currently accepted medical use in treatment in the United States; and
(3) lacks accepted safety for use under medical supervision.
Upon review of the enclosed petition, we believe you will find that the mounting evidence refutes
the 2006 review and shows that: (1) cannabis for medical purposes has a relatively low potential for
abuse, especially in comparison with other Schedule II drugs; (2) the medical community has
concluded that cannabis has accepted medical use in treatment in the United States; and (3)
cannabis has accepted safety for use under medical supervision and pharmacy based access. It is
now the DEA's responsibility to make appropriate decisions and update the scheduling of drugs
based on the changing scientific evidence and the opinion of the medical community. We submit
that evidence herein.
Michele Leonhart, Administrator
Drug Enforcement Administration
November 30, 2011
Page 3
The American medical community supports rescheduling, and there are safe pharmacy-based
methods to dispense medical cannabis:
The medical community supports rescheduling medical cannabis. In 2009, the American Medical
Association (AMA) reversed its earlier position that supported Schedule I classification of cannabis.
The AMA now supports investigation and clinical research of cannabis for medicinal use, and urged
the federal government to reassess the Schedule I classification. The American College of
Physicians recently expressed similar support. A great many other groups also support
The National Academy of Sciences, Institute of Medicine perhaps states it best: "Marijuana is not,
to be sure, a completely benign substance. It is a powerful drug that affects the body and mind in a
variety of ways. However, except for the damage caused by smoking [which this petition clearly
describes non-smoking methods for medical use], its adverse effects resemble those of many
approved medications." [Italics added]
Categorizing medical cannabis as a Schedule II drug would also allow pharmacy dispensing. It
requires federal changes to allow pharmacy dispensing and regulated manufacturing and
distribution, otherwise pharmacies and pharmacists put their DEA license numbers at risk. There
are acceptable methods to safely prescribe and dispense medical cannabis. A pharmacy based
method is an existing and effective model that could provide safe and reliable access for patients in
need, just like it provides for other controlled substances. The well regulated pharmacy system is
perfectly suited to providing controlled access to drugs for legitimate medical use.
Recent scientific development like affordable DNA analysis also supports the pharmacy model.
With modern DNA analysis, it is easy to obtain an accurate characterization of the plant's beneficial
compound. At the pharmacy level, with current technology readily available today, a compounding
pharmacist could easily and inexpensively quantify the levels of cannabinoids, and then use the
appropriate cannabis blend to create a customized medication for an individual patient.
Compounding is now increasingly offered by community pharmacies. Moreover, studies have
shown that pharmacists providing compounding reported increased quality of pharmaceuticals and
improved collaboration between the patient, physician, and pharmacist. This paradigm would allow
safe access to a medicine with proven efficacy and acceptable safety, in a manner that does not
endanger the patient and allows for reasonable governmental oversight. It is important to note that
medical cannabis can be vaporized, not smoked. Additionally cannabis can be ingested orally, or
applied topically in a liniment. These issues are fully addressed in Exhibit B.
A public rulemaking process would allow all interested parties to contribute their comments and
expertise, and provide a full record for decision. These interested parties include patients and
medical professionals and the sixteen states and the District of Columbia, or nearly one-third of the
nation's population, that have decriminalized limited possession and use of cannabis for serious
medical conditions, and at least ten other states are considering similar measures.
Michele Leonhart, Administrator
Drug Enforcement Administration
November 30, 2011
Page 5
Please send all notices regarding this petition to:
Jason T. McGill, Executive Policy Advisor, Health Care
Governor's Executive Policy Office
PO Box 43113
Olympia, WA 98504-3113
Phone: (360) 902-0448
Fax: (360) 586-8380

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