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Rescheduling Memorandum 3/16/11

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This is the memorandum that supplimented my petition on 3/16/11... http://www.mnnorml.org/mnnorml/mnnorml-blog/102-legalization/1054-rescheduling-petition-31611

 

 Minnesota BOARD OF PHARMACY EXAMINERS

 

Petition by Kurt Hanna and                )          

Ed Engelmann For the Removal         )                       MEMORANDUM IN SUPPORT

Of Marijuana From Schedule I           )                       OF PETITION FOR RULE MAKING

Of Minnesota’s Controlled                 )                       OR ACTION

Substance Act                                     )

 

 

MinnesotaBoard of Pharmacy

2829 University Avenue SE, Suite 530

Minneapolis, MN 55414-3251

 

I.                   INTRODUCTION

            Petitioners Kurt Hanna and Ed Engelmann (each a “Petitioner” and collectively “Petitioners”) submit this Memorandum and its accompanying Affidavit of Kurt Hanna in support of Petitioners’ Petition for Rule Making or Action to remove/reclassify marijuanafrom Schedule I of Minnesota’s Controlled Substance Act (“CSA”), pursuant to Minnesota Statute Sec. 152, currently before the Minnesota Board of Pharmacy (the “Board”).[1]

            The Board is vested with a legal duty to annually investigate and evaluate whether a substance currently listed under Schedule I of Minnesota’s CSA should be deleted from that list because it no longer meets the criteria for being so listed.  Minn. Stat. Sec. 152.02, Subd. 8.  As set forth below, the Board can and should remove marijuana from Schedule I because it no longer satisfies two of the mandatory criteria for inclusion in that Schedule.  Marijuana no longer satisfies the requirement that it: a) has no currently accepted medical use in the United States; or b) lacks accepted safety for use under medical supervision.  Minn. Stat. Sec. 152.02(7)(1).  Each of these criteria must be satisfied for marijuana to remain in Schedule I.  The uncontroverted public record evidence set forth herein demonstrates that they do not, and must be removed from Schedule I.

            It is important to be clear about what is being sought by this Petition and what is not.  First, removing marijuana from Schedule I, as petitioned herein, will not result in the immediate or even guaranteed access to medical marijuana by medical patients in Minnesota.  Rather, removal will open the door to debate and deliberation as to the medical value of marijuana by interested professionals and lay parties who are well qualified to fully and fairly explore the medical potential of marijuana.  This is a cautious first step when compared to the rush to pass laws and provide fast access to patients that occurred in California and other states. 

Second, rather than seek voter referendums or the passage of independent and original laws supporting medical marijuana access schemes as occurred in other states, Petitioners seek to follow the course charted by the Minnesota Legislature when it enacted Minnesota’s CSA.  By working with the existing CSA structure and procedures for removing or reclassifying drugs from Schedule I, the careful exploration of marijuana as a medical alternative can avoid the passage of independent medical marijuana access laws that may result in inconsistent laws in Minnesota. 

 

II.                DISCUSSION

 

A. Evidence in Support of Rulemaking: Marijuana Has Currently Accepted Medical Use in the United States and Accepted Safety Standards for Use Under Medical Supervision.

It is a matter of record that a growing number of state governments have, with increasing frequency in the past decade, recognized that marijuana has substantial value in medicinal applications by enacting laws or regulations authorizing such use.  A perusal of these various state regulatory schemes also demonstrates that, as a product of debate and deliberation by government agencies, healthcare professionals and concerned and affected patients, these states have also established acceptable safety standards for the use of marijuana under medical supervision.  The passage and existence of these laws squarely and undeniably support the removal of marijuana from Schedule I.

The following state statutes or regulations provide generally for the decriminalized use of marijuana under state law by qualified patients under medical supervision and conditions:   

Alaska(Medical Uses of Marijuana for Persons Suffering from Debilitating Medical Conditions Act, Alaska Statutes Sec.17.37.010-17.37.080 (2005); Arizona (Drug Medicalization, Prevention and Control Act, Arizona Revised Statutes Sec. 13-3412 (A)(8) – 13-3412.01 (2010)); California (Compassionate Use Act, Cal. Health & Safety Code Sec. 11362.5 (2005)); Colorado (Const. Col. Art. XVIII, Sec. 14, CSRA Sec. 18-18-406.3 (1996)); Hawaii (Medical Use of Marijuana Act, Hawaii Revised Statutes Sec. 329-121-128 (2000)); Maine (Maine Medical Marijuana Act, 22 Maine Revised Statutes Annotated Sec. 2383-B(5) (1999)); Michigan (Michigan Medical Marijuana Act, Michigan Compiled Laws Sec. 33.26421-333.26430 (2008)); Montana (Montana Medical Marihuana Act, Michigan Code Annotated Sec. 50-46-101 to 50-46-210 (2005)); Nevada (Medical Use of Marijuana Act, Nevada Revised Statutes Sec. 453A.010 -- 453A.810 (2000)); New Jersey (Compassionate Use Medical Marijuana Act, N.J. Statutes Annotated Sec. 24:61-1-Pub. L. (2010); New Mexico (Lynn and Erin Compassionate Use Act, N.M. Stat. Ann. Sec. 26-2B-1-26-2B-7 (2007); Oregon (Medical Marijuana Act, O.R.S. Sec. 475.300 – 475.346 (1998)); Rhode Island (Edward G. Hawkins and Thomas C. Slater Medical Marijuana Act, 2005 R.I. Pub. Laws Ch. 05-442; Vermont (Marijuana Use by Persons with Severe Illness Act, 18 VSA Sec. 4472-4474d (2005)); Washington (Medical Use of Marijuana Act, RCWA Sec. 69.51A.005—69.51A.092 (1999)); District of Columbia (Legalization of Marijuana for Medical Treatment Initiative Amendment Act of 2010, D.C. Bill 18-622).  

Given the substantial body of states recently authorizing marijuana for supervised medical treatments, it is simply implausible to suggest that there is “no” accepted medical use for marijuana in the United States or that “no” safely controlled conditions have been determined for such use as, as evidenced by medical marijuana regulatory/dispensary programs that have been developed in such states.

In addition to the statutory and regulatory schemes identified above, there is substantial other evidence of the growing recognition of the medicinal value of marijuana that squarely supports Petitioner’s request for reclassification:

 

In 1986, “the principal psychoactive substance in Cannabis sativa L., marijuana” was transferred to Schedule II of the CSA. Volume 51, Federal Register, Number 92, Page 17476, Tuesday, May 13, 1986, Rules and Regulations. See Exhibit 2.

 

At its 1045th  meeting, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, 1971, decided that delta?9?tetrahydrocannabinol (also referred to as delta?9?THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. See Exhibit 3.

 

In 1999, “the major psychoactive component of Cannabis sativa L. (marijuana)” was transferred to Schedule III of the CSA. Volume 64, Federal Register, Number 127, Page 35928, Friday, July 2, 1999, Rules and Regulations. See Exhibit 4.

 

In 2003, the U.S. Department of Health and Human Services registered a patent on the extraction of cannabinoids from marijuana. United States Patent No. 6,630,507 B1, October 7, 2003 (“Cannabinoids as Antioxidants and Neuroprotectants”). See Exhibit 5.

 

In 2009, the American Medical Association recommended that marijuana be removed from Schedule I of the CSA:

 

         Conclusions. Results of short term controlled trials indicate that smoked

         cannabis reduces neuropathic pain, improves appetite and caloric intake

         especially in patients with reduced muscle mass, and may relieve spasticity and

         pain in patients with multiple sclerosis. However, the patchwork of state?based

         systems that have been established for “medical marijuana” is woefully

         inadequate in establishing even rudimentary safeguards that normally would be

         applied to the appropriate clinical use of psychoactive substances. The future of

         cannabinoid?based medicine lies in the rapidly evolving field of botanical drug

         substance development, as well as the design of molecules that target various

         aspects of the endocannabinoid system. To the extent that rescheduling

         marijuana out of Schedule I will benefit this effort, such a move can be

         supported.

         November 10, 2009. See Exhibit 6.

 

In 2010, after a four month long investigation, the Iowa Board of Pharmacy recommended that marijuana be removed from Schedule I of the Iowa Uniform Controlled Substances Act. February 17, 2010. See Exhibit 7. http://www.iowa.gov/ibpe/pdf/2010 02 17minutes.pdf They proposed legislation to transfer marijuana from Schedule I to II on November 29, 2010; http://petition.iowamedicalmarijuana.org/pdf/ibpe _proposal_20101124.pdf ;

 

In 2010, the National Association of Boards of Pharmacy awarded the Iowa Board of Pharmacy the Fred T. Mahaffey Award for recommending removal of marijuana from Schedule I of the Iowa CSA. 

After a number of public hearings, many hours spent listening to patients, doctors, pharmacists, and legislators, as well as reviewing hundreds of medical articles and other state laws, the Board moved forward in its decision to recommend that the Iowa state legislature reclassify marijuana as a Schedule II controlled substance, which would allow medical uses of marijuana.

106th Annual Meeting, held May 22?25, 2010, in Anaheim, CA. See Exhibit 7.

 

Monday, November 2, 2010, the U.S. Drug Enforcement Administration petitioned itself to put naturally extracted THC in Schedule III (where synthetic THC has been listed since 1999); Vol. 75 Federal Register, No. 210, pages 67054-67059, showing that the DEA now considers marijuana to be a legitimate source of FDA-approved pharmaceuticals.  See Exhibit 8.

 

The existence of these above regulatory schemes, the growing acceptance of medical marijuana in the medical and scientific community exemplified above, when examined in light of Minnesota’s statutory explicit requirements for listing a drug in Schedule I of the CSA, unquestionably establish that marijuana no longer qualifies as a drug that can be listed under Schedule I. Consistent with the Board’s mission of regulating the practice of dispensing of medications in Minnesota, Petitioners respectfully submit that the Board must remove marijuana from Schedule I.

 

B. The Duties and Powers of the Minnesota Board of Pharmacy Support the Reclassification of Marijuana as Sought by the Petition.

The authority of the Board is set forth at Minn. Stat. Sec. 152.06 et seq. (Powers and Duties), which confers a broad duty to regulate the practice of pharmacy and the manufacture and sale of drugs in Minnesota.  Id. at 151.06(a)(1)(2).  The Board is broadly authorized to “perform such other duties and exercise such other powers as the provisions of the act may require.”  Of prime importance to this Petition, the Board is specifically empowered to delete and/or reschedule substances listed in Minnesota’s CSA, and it is directed to undertake an annual review of such scheduling before May 1 of each year (the Board “shall annually, on or before May 1 of each year, conduct a review of the placement of controlled substances in the various schedules.”).  Minn. Stat. 152.02, Subd. 8 Add, delete, or reschedule substances.  This constitutes an annual statutory directive to the Board to investigate whether substances listed in Schedule I no longer meet the criteria for inclusion in that Schedule.  The Board would have been well within its authority to undertake the review petitioned herein at any time after 1996, the date of the passage of California’s “Prop 215”, the first medical marijuana access law.  It is unquestionably within that authority today with the adoption of medical marijuana laws in nearly one third of the states.

The Minnesota Supreme Court has specifically interpreted and defined the statutory mandate of the legislature to the Board to itself make such changes to the Minnesota CSA schedule and ruled that the Board’s power to reclassify is independent of any action that may or may not be taken by the Minnesota Legislature as to such classification.  In State of Minnesota v. King, 257 N.W.2d 693, 697 (Minn. S. Ct. 1977), the court upheld the reclassification power of the Board as a constitutionally valid delegation of power to the Board to make factual determinations regarding the applicability of a statute to a particular substance at issue.  The Court further observed that such an interpretation of independent authority was consistent with the sort of professional expertise that would be necessary to fairly and fully evaluate the statutory standards applicable to decisions regarding the removal and reclassification of substances.  Id. The King decision squarely supports the assertion that the Board has the authority to undertake this requested action, and that it need not, and indeed should not, defer fulfilling its statutory duty to reclassify substances to the Minnesota legislature. 

Petitioners are aware that the Board has in the past contended that the Board’s power to reclassify substances pursuant to Minn. Stat. 252.02, Subd. 8 is merely a permissive power and that the Board has no affirmative obligation to undertake such a reclassification as to any particular substance, even if requested by petition and supported by evidence.[2]  The Board has relied upon the word “may” in one sentence of Subdivision 8, while ignoring the clear mandatory language “shall” review the placement of substances for changes.  Petitioners respectfully disagree.  The explicit language of the rule says that the Board “shall annually, on or before May 1 of each year, conduct a review of the placement of controlled substances in various schedules.”   Id. (emphasis added).  Petitioners submit that a practical interpretation of the statutory scheme and language, as well as case precedent (see King, supra), demonstrates the opposite.  The statutory duty to annually “review” would be meaningless if there were no corresponding duty to act on the results of such a review.[3]  This is particularly apparent where one considers the degree of expertise required to make such reclassification decisions, as recognized by the King court.

Notwithstanding the Board’s earlier position on this question, its Executive Director Cody Wiberg has recently been quoted representing to the Minnesota public via television interviews that the Board considers that its taking actions to add new substances to the Minnesota CSA Schedule I list is “required” and not within the discretion of the Board to act or not.  See Transcript of Televised Interview of C. Wiberg; See Exhibit 9, quoting portion of Mr. Wiberg’s statement characterizing the Pharmacy Board’s efforts to add synthetic marijuana to Schedule 1 as mandated by the same statutory language relied on by Petitioner herein).  Petitioners agree with Mr. Wiberg’s quoted assertions that it is, indeed, the duty of the Board to act to modify the list of substances in Schedule I in appropriate cases.  Petitioners submit that this Petition is such an appropriate case.

C. Deleting Marijuana from Schedule I Will Not Result in an Impermissible Conflict Between the Minnesota or Federal Laws Criminalizing Marijuana and the State Regulations Governing Dispensing of Medications.

Granting Petitioners’ requested removal of marijuana will not result in the legalization of marijuana in Minnesota. It will not even guarantee any access of medical marijuana to patients in Minnesota.  The Board’s review of the deletion of marijuana will result in a process of inquiry and deliberation by qualified persons, and the result of such deliberation could potentially be reclassification of marijuana into a category that will still make marijuana unavailable to most Minnesota patients, or at least not as available as it currently is in many of the states cited in the list above.  Moreover, and as noted briefly above, Petitioners submit that the removal requested pursuant to Minn. Stat. 252.02, Subd. 8 is a rational and conservative approach to dealing with the growing acceptance of medical marijuana by utilizing the very scheme for such “review” envisioned by the Legislature when it enacted this statute and so empowered this Board. 

The majority of the states enacting medical marijuana laws have done so by utilizing referendum or public initiatives or legislative actions which originated new and independent laws – and not by petitioning the Pharmacy Boards of the various states.[4]  In most cases, this has resulted in some inconsistent results, as in, for example, California, where medical marijuana is highly available in state-licensed dispensaries, publicized and acknowledged, yet marijuana continues to be listed in California’s CSA Schedule I.[5]  And to date, Petitioners are unaware of any state attempting to petition the federal government (via United States Drug Enforcement Agency rules, not dissimilar to Minnesota’s CSA rules for reclassifying Schedule I drugs) to remove marijuana from the federal CSA Schedule I.  One can only conclude that these states have not found it necessary to petition for a change to the federal CSA rule at this time.  But the existence of these inconsistencies in current laws may also stem from the rush to enact legislation that occurred in many states when such efforts became popular enough for passage – laws were passed quickly and perhaps haphazardly as independent laws rather than working their way up through existing processes such as the process in Minnesota’s CSA for reclassifying drugs in Subd. 8, infra.  It is Petitioners’ earnest belief that this request to the Board to bring its definitions of marijuana as a scheduled drug (or not) up to date with current acceptance standards in the United States is a methodical and legislatively endorsed vehicle to responsibly address this important issue.

In the United States, it is the states – and not the federal government – that define the bounds of acceptable medical practice and what drugs or substances have accepted medical use.  See Gonzales v. Oregon, 546 U.S. 243, 126 S.Ct. 904 (2006) (holding that federal Controlled Substance Act did not give Attorney General power to decide standards of medical practice by proscribing use of certain drugs for use in physician assisted suicide).  Consequently, the proper classification of substances and drugs on the basis of their medical utility is entirely a function of decisions about medical practice made by the individual states.  To date, at least 15 states have recognized by statute that marijuana has accepted medical use in treatment of various medical conditions and that it is acceptable for medical use under medical supervision.  Thus, marijuana does have “accepted medical use in the United States” and no longer meets the statutory criteria for listing in Schedule I of the Minnesota CSA.

The Board has previously taken the position that Gonzales v. Raich, 545 U.S. 1 (2005),  supported the Board’s decision that reclassifying marijuana out of Schedule I would result in an impermissible conflict between federal criminal laws and state regulation of medicines.  In Raich, the Supreme Court upheld Congress’ authority under the Interstate Commerce Clause of the U.S. Constitution to prohibit the local cultivation of marijuana in California, even where California’s medical marijuana laws exempted such activities from state criminal laws banning marijuana cultivation.   Although the Raich court expressed that it was troubled by Congress’ enforcement of the federal Controlled Substances Act under the circumstances (i.e., to prohibit medical treatment activities that are lawful under California law where the effect may be to deny a patient a treatment), Congress’ authority under the Commerce Clause was clear.  

Raich is simply not controlling nor even persuasive for several reasons.  First, the Raich decision does not excuse the Board from its legal duty to make statutorily required determinations regarding whether substances continue to meet the mandatory criteria for their current statutory classifications under the State of Minnesota’s Controlled Substance Act.  Nothing in the statutory criteria for which drugs shall be placed into Schedule I of Minnesota’s CSA authorizes inclusion of a drug simply because it is listed on the federal CSA’s Schedule I.[6]  The determining criteria for purposes of this Petition are whether the drug has accepted medical use in the United States and whether accepted safety standards exist for use of such drugs under medical supervision.  

But another reason that Raich is not dispositive of this issue is the current stance of the federal government -- that it will not enforce federal regulations as to activities lawful under state law where application of the federal regulation would substantially undermine the state law, specifically including state medical marijuana laws.  See October 19, 2009 U.S. Department of Justice Guidelines declining federal prosecution of activities that are legal under state marijuana regulatory schemes; see also May 20, 2009 memoranda released by the Obama administration instructing federal agencies not to use federal regulations to preempt state laws; all attached at Exhibit 10.   

The facts leading to the Raich decision occurred on or about 2002 and thus the decision did not contemplate the current environment of limited or no enforcement of federal marijuana laws that are lawful under state law.  The federal enforcement environment is thus substantially different today. 

Appellate courts have rejected the argument that state medical marijuana laws create an improper conflict between federal and state law.  See City of Garden Grove v. Superior Court, 68 Cal. Rptr.3d 656 (Cal. 4th Dist. 2007) (rejecting the City’s argument that the federal government had preempted the field of regulation of drugs and discussing preemption fundamentals).  The Garden Grove court stressed that California’s medical marijuana legislation did not “purport to make legal any conduct prohibited by federal law; it merely exempts certain conduct by certain persons from California drug laws.”  The court clarified that, had the California legislature attempted to go further and actually exempt marijuana from prosecution under federal laws, the result would have been an irreconcilable conflict between state and federal law, which was expressly rejected by the US Supreme Court in Raich.  But the mere fact that the federal government has the constitutional capacity to preempt state laws in cases where Congress has clearly indicated a desire to entirely occupy a field of law/regulation, does not mean that state law based medical marijuana schemes are barred or even improper.  This is because Congress has not demonstrated any attempt to preempt state law respecting the regulation of medicine and drugs.  See Gonzales v. Oregon, supra (acceptable medical practices and medicinal drugs are determined by state law, not federal law).[7]

III.              CONCLUSION

Based on the authorities and the discussion set forth above, Petitioners respectfully request that the Board grant Petitioners the relief sought and remove marijuana from Schedule I of Minnesota’s Controlled Substance Act.

                                                Respectfully submitted this 16th day of March, 2011

                                                _________________________

                                                Kurt Hanna

                                                1935 S. Fremont Avenue – Apt. 5

                                                Minneapolis, MN 55403

 

______________________

                                                Edwin Herman Engelmann

                                                62657 430th Street

                                                Franklin, MN 55333-1069



[1] Petitioners seek the removal of marijuana from Schedule I because it does not meet the required criteria.  Petitioners expect that the rulemaking process springing from the Board’s decision to so remove marijuana will result in deliberations to determine the appropriate Schedule to reclassify marijuana to, if any, following removal from Schedule I.  Petitioners await the outcome of such a deliberative process before taking a position on which, if any, Schedule of Minnesota’s CSA is appropriate.

[2] See July 22, 2010 letter from the Board (Cody Wiberg, Executive Director) to prior petitioner Kurt Hanna regarding reasons for denying a similar petition involving the reclassification of marijuana.

[3] It is noteworthy that the Pharmacy Board sent a report to the Legislature asking that it have its power to remove substances from Schedule I expressly removed.  If the Board did not understand that it – at present – indeed has such an obligation to remove substances, then it certainly would not need to request express authority to take that very same position.  This fact supports Petitioners’ interpretation of the statutory duty as the correct one.

[4] A notable exception is Iowa, whose Pharmacy Board has acted to remove marijuana from Schedule I by recommendation to the Iowa Legislature, as required by the Iowa Board rules.  See references to Iowa Pharmacy Board activity above.  The Iowa Board recommendation and resulting legislative action are, at the time of writing, still in Committee and not expected to be effective until 2012.

[5] Petitioners can only speculate why many of the 15 states enacting medical marijuana schemes have failed to also modify their own State’s CSA Schedule I listing of marijuana.  Oregon has deleted marijuana from Schedule I but most have not.

[6] As noted above, it is an odd result that many states have not modified their own CSA Schedule I lists to delete marijuana, and an odd result that none have petitioned the federal government to similarly change the listing of marijuana in the federal CSA Schedule I.  Petitioners submit that it is logical that if more states follow the path of using existing statutory schemes such as the Board’s to follow existing rules and methodically proceed toward change rather than pass special interest laws haphazardly, then more will follow the lead of Iowa and Minnesota.

[7] Title 21, U.S.C. Controlled Substance Act, Section 903.  Application of State law:

No provision of this subchapter shall be construed as indicating an intent on the part of Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.

See Exhibit 11; http://www.deadiversion.usdoj.gov/21usc/903.htm .

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