Recognition of Extraordinary Work

Recognition of Extraordinary Work

641 Iowa Administrative Code 154
Rules 641—154.15(124E) to 641—154.65(124E)

October 13, 2017

I would like to compliment the Iowa Department of Public Health for the extraordinarily good work it is doing implementing the Medical Cannabidiol Act.  2017 Iowa Acts 451, Chapter 162 (H.F. 524), Iowa Code § 124E (2017).

As I stated in my comments on September 15, 2017, something should be added to the Iowa statutes or the Iowa regulations (or both) regarding compliance with the existing federal Controlled Substances Act.  Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Public law 91-513, 84 Stat. 1236, 1242, 21 U.S.C. ch. 13 §§ 801 et seq.

The U.S. Court of Appeals has clarified that the federal act does not define the term “medical use,” Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (“neither the statute nor its legislative history precisely defines the term ‘currently accepted medical use’”), and the U.S. Supreme Court has clarified that the term “medical use” under the federal act is defined by state statute.  Gonzales v. Oregon, 546 U.S. 243, 258 (2006):

The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.

The Iowa Department of Public Health has flawlessly interpreted state and federal law by including the following statement on the “Owner Certification” form that all Iowa medical cannabidiol manufacturers and dispensaries must sign:

I further acknowledge I have actual notice that, notwithstanding any state law, Cannabis is a prohibited Schedule I controlled substance under Federal law; any activity not sanctioned by Iowa Code chapter 124E and proposed administrative rules may be a violation of state or federal law and could result in arrest, prosecution, conviction, or incarceration and that the $7,500 license application fee is non-refundable.

http://drive.google.com/file/d/0B-cZdbYdPoLGSnZRQWtBUnFTd2c/view?usp=sharing

This is an extremely important detail.  This topic has come up again and again regarding federal law and state medical marijuana programs.  Other states have failed to address it. We are clearly not authorizing federal criminal activity in Iowa.

After submitting my comments on September 15, 2017, I became aware of a federal transportation regulation from 1973 that makes this abundantly clear.

91.19 Carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances.
(a) Except as provided in paragraph (b) of this section, no person may operate a civil aircraft within the United States with knowledge that narcotic drugs, marihuana, and depressant or stimulant drugs or substances as defined in Federal or State statutes are carried in the aircraft.
(b) Paragraph (a) of this section does not apply to any carriage of narcotic drugs, marihuana, and depressant or stimulant drugs or substances authorized by or under any Federal or State statute or by any Federal or State agency.

https://www.ecfr.gov/cgi-bin/text-idx?SID=2f570630a822fec80462ab1f3f4dc714&mc=true&node=se14.2.91_119&rgn=div8

Originally, §91.12.  Federal Register, Vol. 38, No. 126, Monday, July 2, 1973, p. 17493 (a copy is attached hereto).

Thank you for your prompt attention to this matter.

Carl Olsen, Executive Director
Iowans for Medical Marijuana, Iowa Business No. 334412
Post Office Box 41381, Des Moines, Iowa 50311-0507
http://www.iowamedicalmarijuana.org/

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Comments on Proposed Rules

Comments on Proposed Amendments to
641 Iowa Administrative Code 154
Rules 641—154.15(124E) to 641—154.65(124E)
September 15, 2017

The Medical Cannabidiol Act, 2017 Iowa Acts 451, Chapter 162 (H.F. 524), was signed into law on May 12, 2017, by Governor Terry E. Branstad.

Section 9(1) of the Act, Iowa Code § 124E.5(1) (2017), authorizes the Iowa Department of Public Health to issue a license to a “manufacturer” which allows cultivation and harvesting of cannabis in Iowa.

Section 10(8) of the Act, Iowa Code § 124E.6(8) (2017), requires a “manufacturer owner shall not have been convicted of a disqualifying felony offense.”  See, Section 5(4) of the Act, Iowa Code § 124E.2(4) (2017), referencing 21 U.S.C. § 802(6).

Section 11(1) of the Act, Iowa Code § 124E.7(1) (2017), authorizes the Iowa Department of Public Health to issue a license to a “dispensary” which allows distribution of cannabis products in Iowa.

Section 12(8) of the Act, Iowa Code § 124E.8(8) (2017), requires a “dispensary owner shall not have been convicted of a disqualifying felony offense.”  See, Section 5(4) of the Act, Iowa Code § 124E.2(4) (2017), referencing 21 U.S.C. § 802(6).

As recently as September 10, 2017, Speaker of the Iowa House, Linda Upmeyer, is quoted in the Des Moines Register, stating that the manufacture and distribution of cannabidiol in Iowa is a federal felony offense.  Des Moines Register, September 10, 2017, “AG tells agency to halt part of Iowa’s medical marijuana law.”[Footnote 1]  Speaker Upmeyer is quoted as stating:

no matter what the Legislature has decided, the state still would have been in violation of federal law

So, as stated by Speaker Upmeyer, a disqualifying offense disqualifies someone from participating in a disqualifying offense.  According to Speaker Upmeyer, the Iowa Department of Public Health will be licensing individuals to engage in disqualifying offenses (continuing criminal enterprises) that carry up to life in federal prison and fines of up to $50,000,000.[Footnote 2]

Federal Regulations

Although this author disagrees with Speaker Upmeyer’s assertion that H.F. 524 violates federal law, this clearly demonstrates what we are about to step into.  The Iowa Medical Cannabidiol Act of 2017 doesn’t explain how the intrastate manufacture and distribution of cannabidiol products is consistent with existing federal law.

The Drug Enforcement Administration (DEA) has recently published a notice in the Federal Register clarifying that cannabidiol products are federal schedule 1 controlled substances.[Footnote 3]  The DEA has further clarified that cannabidiol products are federal schedule 1 controlled substances on its website.[Footnote 4]

Without a statement of compliance with existing federal law, the rules the Iowa Department of Public Health is proposing will place manufacturers and distributors in extreme jeopardy, as well as the Iowa patients who will depend on them for their medicine.  Speaker Upmeyer has clearly warned you of the consequences of leaving this matter unsettled.  The fact that she would even put her name on a piece of legislation she thinks violates federal law is astounding.

The Iowa Department of Public Health can and must resolve this problem which has been clearly articulated by Speaker Upmeyer.  The administrative rules implementing this legislation must address the concerns she has raised.

Please see this author’s previous comments from July 25, 2017, for a complete legal analysis explaining why state medical marijuana programs are consistent with existing federal law and exempt from schedule 1.[Footnote 5]

Conclusion

The regulations implementing H.F. 524 must include an explanation of compliance with existing state and federal law.  This can’t be left to the imagination.  The Iowa Department of Public Health has the authority to take corrective action by administrative rule.  Each manufacturer and dispensary license must include a statement that the license immunizes the manufacturer or dispensary from federal prosecution that would result from the false assumption that intrastate medical use of marijuana is included in schedule 1 of the state and federal controlled substances acts.  H.F. 524 satisfies both state and federal requirements because it provides a complete exemption from state and federal schedule 1.

Thank you for your prompt attention to this matter.

Carl Olsen, Executive Director
Iowans for Medical Marijuana, Iowa Business No. 334412
Post Office Box 41381, Des Moines, Iowa 50311-0507
http://www.iowamedicalmarijuana.org/

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Comments on Proposed Rules

Comments on Proposed Amendments to
641 Iowa Administrative Code 154
“Medical Cannabidiol Act Registration Card Program”
July 25, 2017

The Medical Cannabidiol Act, 2017 Iowa Acts 451, Chapter 162 (H.F. 524), was signed into law on May 12, 2017, by Governor Terry E. Branstad.

Section 7(1) of the Act, Iowa Code § 124E.4(1) (2017), authorizes the Iowa Department of Public Health to issue a registration card to a “patient” which then provides that patient with an “affirmative defense” for the possession of cannabidiol products in Iowa.  See Section 15(4)(a) of the Act, Iowa Code § 124E.11(4)(a) (2017).

Section 7(3) of the Act, Iowa Code § 124E.4(3) (2017), authorizes the Iowa Department of Public Health to issue a registration card to a “primary caregiver” which then provides that primary caregiver with an “affirmative defense” for the possession of cannabidiol products in Iowa.  See Section 15(4)(b) of the Act, Iowa Code § 124E.11(4)(b) (2017).

Federal Regulations

The Iowa Medical Cannabidiol Act of 2017 does not explain how possession of cannabidiol products is consistent with existing federal regulations.

The Drug Enforcement Administration (DEA) has recently published a notice in the Federal Register clarifying that cannabidiol products are federal schedule 1 controlled substances.[1]  The DEA has further clarified that cannabidiol products are federal schedule 1 controlled substances on its website.[2]

Attached to this document are two letters from the Iowa Board of Pharmacy dated May 31, 2017, and June 7, 2017, confirming that cannabidiol products are both federal and state schedule 1 controlled substances.

There are no federally approved cannabidiol products.  Without an explanation in the rules the Iowa Department of Public Health is proposing, Iowa patients are left facing a potential hazard.

This document explains why the Iowa Department of Public Health must resolve any inconsistency or doubt by administrative rule.

Federal Penalties

The Federal penalties for possessing cannabidiol products are quite severe, with penalties ranging from 1 to 3 years in federal prison and fines ranging from $1,000 to $5,000.[3]

Federal Enforcement Policy

While Iowa House Speaker Linda Upmeyer has suggested that federal enforcement policy might continue to overlook state medical marijuana programs, recent statements from the United States Attorney General, Jeff Sessions, have indicated otherwise.[4]

Disabled Americans have been Negatively Impacted

Because of the consistent failure of state laws and regulations to address federal regulations appropriately, disabled Americans have been severely and negatively impacted.

The Supreme Court of Colorado recently rejected an employment discrimination claim by a severely disabled person.  Coats v. Dish Network, 350 P.3d 849, 850 (Colorado 2015) (“an activity such as medical marijuana use that is unlawful under federal law is not a ‘lawful’ activity under section 24-34-402.5”); People v. Crouse, 388 P.3d 39, 43 (Colorado 2017) (“Consistent with our holding in Coats, then, we again find that conduct is ‘lawful’ only if it complies with both federal and state law.”)

And see Gonzales v. Raich, 545 U.S. 1 (2015) (possession of marijuana for medical use under state program unlawful under federal classification), while noting marijuana’s federal schedule 1 classification may be invalid, 545 U.S., at 28 n.37; and see Casias v. Walmart, 695 F.3d 428 (6th Cir. 2012) (discrimination in employment allowed against participant in state medical marijuana program); and see James v. Costa Mesa, 700 F.3d 394 (9th Cir. 2012) (Americans with Disabilities Act does not protect participation in state medical marijuana program).

The Iowa Medical Cannabidiol Act of 2017 gives the Iowa Department of Public Health sufficient authority to resolve this potential hazard by administrative rule.   State medical marijuana programs are lawful under federal law.  The federal drug act was never intended to prevent the medical use of controlled substances.  The federal drug act is intended to prevent the abuse, not the authorized medical use, of controlled substances.

As we have noted before, the CSA “repealed most of the earlier antidrug laws in favor of a comprehensive regime to combat the international and interstate traffic in illicit drugs.” Raich, 545 U.S., at 12.  In doing so, Congress sought to “conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.”  Ibid.  It comes as little surprise, then, that we have not considered the extent to which the CSA regulates medical practice beyond prohibiting a doctor from acting as a drug “‘pusher’” instead of a physician.  Moore, 423 U.S., at 143.

Gonzales v. Oregon, 546 U.S. 243, 269 (2006).

Federal Law

States do not surrender their sovereignty when they become members of the union (“united states”).

Congress may not simply “commandeer the legislative processes of the States by directly compelling them to enact and enforce a federal regulatory program.”  Hodel v. Virginia Surface Mining & Reclamation Assn., Inc., 452 U.S. 264, 288 (1981).

New York v. United States, 505 U.S. 144, 161 (1992).  Federal law does not prohibit the state from accepting the medical use of a controlled substance, and federal regulations must maintain that same balance.  What seems like a paradox is a question of balance between state and federal law.

Federal drug law was written to provide flexibility in the classification of controlled substances.  Marijuana is currently classified as a substance with no accepted medical use in the United States.  States have a significant role in federal classification.[5]

See 21 U.S.C. § 903 (2017):

No provision of this subchapter shall be construed as indicating an intent on the part of the 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.

(Pub. L. 91–513, title II, § 708, Oct. 27, 1970, 84 Stat. 1284.)

Marijuana’s placement in federal schedule 1 depends on whether the DEA’s interpretation of the statutory language “currently accepted medical use in treatment in the United States” is lawful.  The DEA adopted its current interpretation in 1992.  A federal appellate court upheld the DEA’s interpretation of that language in 1994, two years before any state had accepted the medical use of marijuana.  See Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994).

Let that sink in for a moment.  Marijuana’s current placement in federal schedule 1 is based upon a federal administrative decision in 1992, affirmed by a federal appellate court in 1994, determining that marijuana had no accepted medical use in the United States at the time it made the decision, just two years before any state had accepted marijuana for medical use, beginning in 1996.

Initial Classification by Congress

The National Commission on Marihuana and Drug Abuse was created by the Controlled Substances Act of 1970, Public Law 91-513, to study the question of marijuana abuse in the United States.  While the Controlled Substances Act was being drafted in a House committee in 1970, Assistant Secretary of Health Roger O. Egeberg had recommended that marijuana temporarily be placed in schedule I, 21 U.S.C. § 812(c), Schedule 1(c)(10) (1970), the most restrictive category of drugs, pending the Commission’s report.  On March 22, 1972, the Commission’s chairman, Raymond P. Shafer, presented a report to Congress and the public entitled “Marihuana, A Signal of Misunderstanding,” which favored ending marijuana prohibition and adopting other methods to discourage use.  No action was taken on the commission’s report and marijuana has remained in federal schedule 1 since that time.

Duty to Update the Classification

DEA is required to update the classifications annually as necessary.  See 21 U.S.C. § 812(a) (1970).  The Attorney General of the United States, in conjunction with the Secretary of Health and Human Services, may add substances to, transfer substances between, or remove substances from the classifications.  See 21 U.S.C. § 811(a) (1970).  The Drug Enforcement Administration (DEA) has been delegated by the Department of Justice to perform this function for the Attorney General, in conjunction with the Food and Drug Administration which has been delegated by the Department of Health and Human Services to perform its responsibilities under the act.  See 21 U.S.C. § 811(b) (1970).

Contextual Analysis

The Medical Cannabidiol Act of 2017 recognizes and accepts a medical use for the marijuana plant in the state of Iowa.  Section 5(6) of the Act, Iowa Code § 124E.2(6) (2017):

“Medical cannabidiol” means any pharmaceutical grade cannabinoid found in the plant Cannabis sativa L. or Cannabis indica or any other preparation thereof that has a tetrahydrocannabinol level of no more than three percent and that is delivered in a form recommended by the medical cannabidiol board, approved by the board of medicine, and adopted by the department pursuant to rule.

(emphasis added).

A federal regulation (schedule 1) says marijuana has no accepted medical use in the states.  See 21 C.F.R. § 1308.11(d)(22)(2017).  The outdated federal regulation has not been updated since 1994, when marijuana actually had no accepted medical use in any state.  The people of Iowa have now accepted the medical use of marijuana in 2017.  Iowa is a state in the union (“in the United States”).  The state of Iowa is not authorizing the “abuse” of marijuana.  The state of Iowa is authorizing “medical use” of marijuana.

Before marijuana became accepted for medical use in any state, federal courts considering this matter determined that Congress did not define the term “currently accepted medical use,” and that accepted medical use in the United States can be solely intrastate without any federal approval for interstate marketing.  The best evidence of “accepted” medical use in the United States is a state law accepting the medical use of marijuana.  Accepted medical use that is solely intrastate is within the meaning of “currently accepted medical use” under existing federal law.

Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):

We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied).  We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.

Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):

Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate.  Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321 (b), 331, 355(a).  Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.

After the ruling in Grinspoon, the federal courts and the DEA began to address the question of how the DEA determines whether a controlled substance has accepted medical use in the United States.

Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991):

The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term “currently accepted medical use”; therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.

In 1992, the DEA acknowledged that Congress did not authorize the DEA to decide whether the states can or should accept the medical use of marijuana.  The DEA can only acknowledge the decision “others” have made.

Marijuana Scheduling Petition, DEA Docket No. 86-22, 57 Fed. Reg. 10499 (March 26, 1992) 10506:

Clearly, the Controlled Substances Act does not authorize the Attorney General, nor by delegation the DEA Administrator, to make the ultimate medical and policy decision as to whether a drug should be used as medicine.  Instead, he is limited to determining whether others accept a drug for medical use.  Any other construction would have the effect of reading the word “accepted” out of the statutory standard.

It would be strange indeed if “others” did not include states.  We are a nation of laws.  State medical marijuana laws are proof beyond any doubt that marijuana has accepted medical use in the United States.  Opinions don’t matter; but laws do.  It is not reasonable, or lawful, for the DEA to reject state laws as evidence of “accepted” medical use.

Gonzales v. Oregon, 546 U.S. 243, 258 (2006):

The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.

State Law

The Iowa Medical Cannabidiol Act of 2017, H.F. 524, Section 5(6), Iowa Code § 124E.2(6) (2017), defines “medical cannabidiol” as a “pharmaceutical grade cannabinoid found the plant Cannabis.”  The Act specifically authorizes the cultivation and harvesting of marijuana plants to make medical cannabidiol products.  See H.F. 524, Section 9(1)(a), Iowa Code § 124E.5(1)(a) (2017).

Iowa has determined that there is an “accepted” medical use for marijuana and the federal courts have determined that state laws accepting the medical use of a controlled substance are harmonious with the federal Controlled Substances Act.  The Iowa legislature hasn’t included this statement of compliance with existing federal law in the Medical Cannabidiol Act.  A statement of compliance needs to be included in 641 IAC 154 so that patients and their families are not left in doubt about their legal status and personal safety.

The Elephant in the Room

“Congress, we have held, does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions – it does not, one might say, hide elephants in mouseholes.” Whitman v. American Trucking Assns., Inc., 531 U.S. 457, 468 (2001).

Gonzales v. Oregon, 546 U.S. 243, 267 (2006):

H.F. 524 also fails to remove marijuana from Iowa schedule 1.  Iowa schedule 1, like it’s federal counterpart, says marijuana has no accepted medical use in treatment in the United States (unless the Iowa Board of Pharmacy says it does by an administrative rule).  Iowa Code § 124.204(4)(m) (2017); Iowa Code § 124.203(1)(b) (2017).  State law, H.F. 524, now says marijuana does have an accepted medical use in the state.

In 2010, the Iowa Board of Pharmacy, which is authorized by law to make recommendations to the legislature pursuant to Iowa Code § 124.201 (2017), recommended that marijuana be removed from Iowa schedule 1.

Attached to this document is the February of 2010 recommendation from the Iowa Board of Pharmacy, the February of 2010 press release from the Iowa Department of Public Health, and the legislation that was pre-filed in December of 2010 by the department and the board in the 84th General Assembly (2011-2012) of Iowa.

Moving forward without addressing marijuana’s classification in schedule 1 can and will have tragic consequences.

The Iowa Senate bill, S.F. 506, that passed by a vote of 45-5 on April 17, 2017, in the Iowa Senate, included the Iowa Board of Pharmacy’s recommendation from February 17, 2010, recommending the removal of marijuana from schedule 1.  The House version did not include the board’s recommendation.  The House version, H.F. 524, wasn’t made publicly available until 3:00 a.m. on the morning of the day after the legislature was scheduled to adjourn for the year on April 21, 2017.  H.F. 524 passed in the Iowa House at 5:30 a.m. on April 22, 2017, and in the Iowa Senate at 6:30 a.m. on April 22, 2017.  The House version was not carefully vetted.

Comparing Classifications

Both state and federal drugs laws reveal that we do not put plants with medical use in schedule 1.[6]

Marijuana has Medical Use in 46 States

Since 1996, four years after the DEA issued it interpretive rule in 1992, thirty states have accepted the medical use of marijuana, and another sixteen states have accepted the medical use of a marijuana extract (cannabidiol), bringing the total to 46 out of 50 states now depending on marijuana plants for medical use or for making extracts for medical use.  In addition, DC, Puerto Rico, and Guam have accepted the medical use of marijuana.

See National Conference of State Legislatures, July 7, 2017, State Medical Marijuana Laws:

http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx

Conclusion

Regulations must include an explanation of compliance with existing state and federal laws.  This can’t be left to the imagination.  Failure to address classification of marijuana in H.F. 524 leaves Iowa patients and their loved ones at risk of losing access to medical cannabidiol and facing severe federal penalties.  The Iowa Department of Public Health has the authority to take corrective action by administrative rule.  Each medical cannabidiol registration card must include a statement that the card immunizes the patient and/or caregiver from federal prosecution that would result from the false assumption that marijuana is lawfully classified as a schedule 1 substance.  The Iowa Board of Pharmacy has the authority to fix the state classification because it has the authority to reclassify marijuana by administrative rule[7].  H.F. 524 satisfies federal requirements because it nullifies federal schedule 1 (either on its face, or as applied).

Thank you for your prompt attention to this matter.

Carl Olsen, Executive Director
Iowans for Medical Marijuana, Iowa Business No. 334412
Post Office Box 41381, Des Moines, Iowa 50311-0507
http://www.iowamedicalmarijuana.org/

[1] Federal Register
Vol.81, No. 240, Wednesday, December 14, 2016, pp. 90194-90196.

[2] DEA Clarification on Cannabidiol
https://www.deadiversion.usdoj.gov/schedules/marijuana/m_extract_7350.html

[3] Federal Penalties

21 U.S.C. § 844(a) (2017)
First offense
$1,000 fine – up to one year in prison
21 U.S.C. § 844(a) (2017)
Second offense
$2,500 fine – up to two years in prison
21 U.S.C. § 844(a) (2017)
Third and subsequent offense
$5,000 fine – up to three years in prison

[4] Media Reports

March 27, 2017, KGLO Radio, Mason City, Iowa, “Upmeyer says legislators working on medical marijuana issue.”
June 13, 2017, The Cannabist, an edition of the Denver Post, Denver, Colorado, “Jeff Sessions has asked Congress to allow him to prosecute medical marijuana providers.”
June 16, 2017, Globe Gazette, Mason City, Iowa, “Sessions wants flexibility to prosecute Iowa medical marijuana program.”
June 23, 2017, Quad City Times, Davenport, Iowa, “Editorial: Jeff Sessions eyes pot crackdown on Iowa, Illinois.”

[5] Federal Classifications

Schedule 1
21 U.S.C. § 812(b)(1) (2017)
no medical use and high potential for abuse without consideration for physical or psychological dependence.
Schedule 2
21 U.S.C. § 812(b)(2) (2017)
medical use with high potential for abuse with physical dependence and high psychological dependence.
Schedule 3
21 U.S.C. § 812(b)(3) (2017)
medical use with low to moderate physical dependence and high psychological dependence.
Schedule 4
21 U.S.C. § 812(b)(4) (2017)
medical use with physical dependence and psychological dependence less than schedule 3.
Schedule 5
21 U.S.C. § 812(b)(5) (2017)
medical use with physical dependence and psychological dependence less than schedule 4.

[6] Classification Comparisons

Schedule 1
Iowa Code § 124.204(4)(m) (2017) Marijuana
Schedule 2
Iowa Code § 124.206(2)(a)(1) (2017) Raw Opium
Iowa Code § 124.206(2)(a)(7) (2017) Codeine
Iowa Code § 124.206(2)(a)(10) (2017) Hydrocodone
Iowa Code § 124.206(2)(a)(13) (2017) Morphine
Iowa Code § 124.206(2)(c) (2017) Opium Poppy and Poppy Straw
Schedule 3
Iowa Code § 124.208(5)(a)(1) (2017) Codeine
Iowa Code § 124.208(5)(a)(2) (2017) Codeine
Iowa Code § 124.208(5)(a)(3) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(4) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(5) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(7) (2017) Opium
Schedule 5
Iowa Code § 124.212(2)(a) (2017) Codeine
Iowa Code § 124.212(2)(b) (2017) Hydrocodone
Iowa Code § 124.212(2)(e) (2017) Opium

[7] Iowa Board of Pharmacy

Iowa Code § 124.204 (2017)
Schedule I.
4. Hallucinogenic substances.
m. Marijuana, except as otherwise provided by rules of the board for medicinal purposes.

Iowa Code § 124.206 (2017)
Schedule II.
7. Hallucinogenic substances.
a. Marijuana when used for medicinal purposes pursuant to rules of the board.

(emphasis added).  See State v. Bonjour, 694 N.W.2d 511 (Iowa 2005), for the history of this authority.

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Overlooking the Medical Boards

Rep. Jarad Klein

Rep. Jarad Klein

July 2, 2017

Jarad Klein
Keota, Iowa

Dear Rep. Klein,

Thank you for your work in expanding the Iowa Medical Cannabidiol Act in 2017.  While Iowans for Medical Marijuana (Iowa Business No. 334412) is concerned the program does not go far enough, production of CBD in Iowa is a huge step forward.

As you mention in your interview with KCII Radio, Washington, IA, on June 30, the new Medical Cannabidiol Advisory Board can recommend expansion of the program.  Production in Iowa is the cornerstone that makes it all possible.

You also mention in your interview that the Medical Cannabidiol Advisory Board is often overlooked by critics of the program.  I would like to point out that the Iowa Board of Pharmacy has also been overlooked throughout this process.  There is a pattern here that deserves your attention.

In 2010, the Iowa Board of Pharmacy recommended the reclassification of marijuana as a substance with accepted medical use in the United States.  The authority for their recommendation can be found in Iowa Code § 124.201 (2017), and the requirement that substances classified in schedule 1 must have no medical use in the United States is found in Iowa Code § 124.203 (2017).

I have included the pharmacy board’s recommendation from February 17, 2010, and the legislation the board filed in 2011, to refresh your memory.

It’s certainly an empty promise if the pharmacy board’s recommendations are not taken seriously.  That could be the reason people are overlooking the significance of this new board now.  We can keep creating boards, but the boards don’t mean much without serious consideration of their recommendations.

I do realize that production of CBD in Iowa has been the biggest obstacle we’ve had to overcome.  I also realize the pharmacy board’s recommendation may have been premature.

However, now that we have agreed on production of CBD in Iowa, let’s get this plant out of schedule 1 so we are not making medicine from a plant classified as having no medical use in the United States.  Forty-six states have accepted the marijuana plant for medical use or extracts[1] from the plant as medicine.  Either way, the plant is essential in all forty-six states.

Compare this to morphine produced from opium plants, or cocaine produced from coca plants.  Opium plants and coca plants are not in schedule 1 and have never been in schedule 1, showing a legislative intent at the time these laws were created to exclude plants with medical use from schedule 1.

It’s time to fix the classification.

Thank you for listening!

Sincerely,

Carl Olsen
http://iowamedicalmarijuana.org/

[1] CBD is one of many cannabinoids.  State laws vary on the level of THC that is allowed in a CBD product, but they don’t specify any levels for the other cannabinoids.  These products are referred to as “marijuana extracts.”

Attachments

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The Elephant We Don’t Talk About

Iowans for Medical Marijuana

The Iowa Medical Cannabidiol Act of 2017
(and the elephant in the room we don’t want to talk about)

June 26, 2017

On April 22, 2017, the Iowa legislature passed the Medical Cannabidiol Act, H.F. 524.  The Medical Cannabidiol Act of 2017 was signed into law on May 12, 2017, by Governor Terry E. Branstad.

Section 9(1)(a) of the Act, Iowa Code § 124E.5(1)(a) (2017), authorizes the Iowa Department of Public Health to license “up to two medical cannabidiol manufacturers to manufacture and to possess, cultivate, harvest, transport, package, process, or supply medical cannabidiol within this state.”

What the Medical Cannabidiol Act of 2017 fails to mention is whether growing marijuana to manufacture cannabis products is consistent with existing federal law.  Penalties for growing cannabis are quite severe, with penalties ranging from 5 years in prison to a possible life sentence and fines ranging from $250,000 to $50 million.[1]

While Iowa House Speaker Linda Upmeyer has suggested that federal policy might continue to overlook state medical marijuana programs under the Trump Administration, recent statements from the United States Attorney General, Jeff Sessions, have indicated otherwise.[2]

Recent rulings from the Supreme Court of Colorado highlight this inconsistency.  Coats v. Dish Network, 350 P.3d 849, 850 (Colorado 2015) (“an activity such as medical marijuana use that is unlawful under federal law is not a ‘lawful’ activity under section 24-34-402.5”); People v. Crouse, 388 P.3d 39, 43 (Colorado 2017) (“Consistent with our holding in Coats, then, we again find that conduct is ‘lawful’ only if it complies with both federal and state law.”)

 

Federal Law

Federal law does not prohibit the medical use of marijuana.  Federal law depends upon the classification a controlled substance is placed in.  Initial placement of marijuana was decided by Congress in 1970, but current placement of marijuana is an administrative process under federal law.[3]

 

Initial Classification of Marijuana by Congress

The Controlled Substances Act of 1970, Public Law 91-513, created the National Commission on Marihuana and Drug Abuse to study marijuana abuse in the United States.  While the Controlled Substances Act was being drafted in a House committee in 1970, Assistant Secretary of Health Roger O. Egeberg had recommended that marijuana temporarily be placed in Schedule I, the most restrictive category of drugs, pending the Commission’s report.  See 21 U.S.C. § 812(c), Schedule 1(c)(10) (1970).  On March 22, 1972, the Commission’s chairman, Raymond P. Shafer, presented a report to Congress and the public entitled “Marihuana, A Signal of Misunderstanding,” which favored ending marijuana prohibition and adopting other methods to discourage use.

 

Federal Administrative Process

Congress authorized the Attorney General to keep the classifications current.  The Attorney General of the United States, in conjunction with the Secretary of Health and Human Services, may add substances to, transfer substances between, or remove substances from the classifications.  See 21 U.S.C. § 811(a) (1970).  The Drug Enforcement Administration is delegated by the Department of Justice to perform this function, in conjunction with the Food and Drug Administration which is delegated by the Department of Health and Human Services for this purpose.  See 21 U.S.C. § 811(b) (1970).

 

Federalism

The U.S. Constitution, as well as the Iowa Constitution, divides our government into three branches.  The legislative branch makes the laws.  The executive branch enforces the laws.  The judicial branch resolves questions about the constitutionality of a law and can overrule a law in whole or in part.  The judicial branch can also enforce corrective action if the executive branch (an administrative agency or the chief executive) does not interpret the law correctly.

Federalism is the other fundamental principle in our dual system of government.  The states gave up some of their authority in order to form the federal union and the federal union must respect the individual sovereignty of the states.  In every situation, the question is how much state authority has been removed and how much has been retained.  When Congress makes a law, Congress may, or may not, explain clearly where the lines are drawn.

 

Contextual Analysis

The Medical Cannabidiol Act of 2017 says marijuana has medical use in the state of Iowa (for making an extract) and there is an outdated federal regulation that says marijuana has no medical use in the states.  It might seem like a simple question of who has the greater authority, a state or a federal administrative agency.  But, Congress can authorize a federal administrative agency to interfere with state law, so the analysis starts with the question of whether Congress authorized the Attorney General to interfere with state medical marijuana laws.

To begin the analysis, federal courts have determined that accepted medical use of a controlled substance in the United States can exist without federal interstate marketing approval.

Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):

We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied).  We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.

Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):

Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate.  Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321 (b), 331, 355(a).  Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.

This may seem like a dumb question, but how do we know whether medical use of marijuana has been accepted?  After the ruling in Grinspoon, the federal courts and the administrative agency began to address this question.

Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991):

The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term “currently accepted medical use”; therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.

Marijuana Scheduling Petition, DEA Docket No. 86-22, 57 Fed. Reg. 10499 (March 26, 1992) 10506:

Clearly, the Controlled Substances Act does not authorize the Attorney General, nor by delegation the DEA Administrator, to make the ultimate medical and policy decision as to whether a drug should be used as medicine.  Instead, he is limited to determining whether others accept a drug for medical use.  Any other construction would have the effect of reading the word “accepted” out of the statutory standard.

The answer as to who decides whether a substance has accepted medical use was conclusively determined by the federal courts in 2006.

Gonzales v. Oregon, 546 U.S. 243, 258 (2006):

The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.

 

State Law

The Iowa Medical Cannabidiol Act of 2017, H.F. 524, Section 5(6), Iowa Code § 124E.2(6) (2017), defines “medical cannabidiol” as “any pharmaceutical grade cannabinoid found the plant Cannabis . . . that has a tetrahydrocannabinol level of no more than three percent . . .”  The Act specifically authorizes cultivation and harvesting of marijuana plants for the purpose of manufacturing medical cannabidiol.  See H.F. 524, Section 9(1)(a), Iowa Code § 124E.5(1)(a) (2017).

Because states determine “accept” medical use, marijuana plants “specifically authorized” for medical use are “accepted” for medical use within the meaning of the federal Controlled Substances Act.

 

The Elephant in the Room

H.F. 524 fails to remove marijuana from Iowa schedule 1, which says marijuana has no accepted medical use in treatment in the United States.  Iowa Code § 124.204(4)(m) (2017); Iowa Code § 124.203(1)(b) (2017).

This housekeeping matter has been overlooked and it can have tragic consequences.  The Iowa Senate bill that passed by a vote of 45-5 on April 17, 2017, included the Iowa Board of Pharmacy’s recommendation on February 17, 2010, that marijuana should be removed from Iowa schedule 1.  This was carelessly stripped out of the House version.  The House version, H.F. 524, wasn’t publicly available until 3:00 a.m. on the morning after the day the legislature was scheduled to adjourn for the year.  It was passed in the Iowa House at 5:30 a.m. and in the Iowa Senate at 6:30 a.m.  This was not a carefully thought out, or carefully deliberated, process.

 

Comparing Classifications

A careful reading of both the state and federal drugs laws reveals that we don’t put plants with medical use in schedule 1.[4]

 

Marijuana has Medical Use in 46 States

Since 1996, four years after the DEA issued it interpretive rule in 1992, thirty states have accepted the medical use of marijuana, and another sixteen states have accepted the medical use of marijuana extract (cannabidiol), bringing the total to 46 out of 50 states that now depend on access to marijuana for medical use or for making extracts for medical use.  In addition, DC, Puerto Rico, and Guam have accepted the medical use of marijuana.

Continued placement of marijuana in schedule 1 is both prohibitive and unlawful.

 

Conclusion

As the Supreme Court of Colorado has shown, state law must explain how it complies with existing federal law.  Failure to address classification of marijuana in H.F. 524 leaves Iowa patients at risk of losing access to cannabidiol, and puts growers at risk of federal penalties up to life in prison and fines up to $50 million.  The legislature must address this matter when it reconvenes in 2018.

 

Carl Olsen, Executive Director
Iowans for Medical Marijuana, Iowa Business No. 334412
Post Office Box 41381, Des Moines, Iowa 50311-0507
http://www.iowamedicalmarijuana.org/

 

[1] Federal Penalties

21 U.S.C. § 841(b)(1)(A)(vii) (2017)
1000 kilograms (2204.62 pounds / 1.10231 tons) or more of a mixture or substance containing a detectable amount of marihuana, or 1,000 or more marihuana plants regardless of weight
$10/50 million — 10 years to life in prison

21 U.S.C. § 841(b)(1)(B)(vii) (2017)
100 kilograms (220.462 pounds / 0.110231 tons) or more of a mixture or substance containing a detectable amount of marihuana, or 100 or more marihuana plants regardless of weight
$5/25 million — 5 to 40 years in prison

21 U.S.C. § 841(b)(1)(C) (2017)
50 to 99 kilograms or 50 to 99 plants
$1/5 million — up to 20 years in prison

21 U.S.C. § 841(b)(1)(D) (2017)
less than 50 kilograms of marihuana, except in the case of 50 or more marihuana plants regardless of weight, 10 kilograms of hashish, or one kilogram of hashish oil,
$250,000/$1 million — up to 5 years in prison

 

[2] Media Reports

March 27, 2017, KGLO Radio, Mason City, Iowa, “Upmeyer says legislators working on medical marijuana issue.”

June 13, 2017, The Cannabist, an edition of the Denver Post, Denver, Colorado, “Jeff Sessions has asked Congress to allow him to prosecute medical marijuana providers.”

June 16, 2017, Globe Gazette, Mason City, Iowa, “Sessions wants flexibility to prosecute Iowa medical marijuana program.”

June 23, 2017, Quad City Times, Davenport, Iowa, “Editorial: Jeff Sessions eyes pot crackdown on Iowa, Illinois.”

 

[3] Federal Classifications

Schedule 1
21 U.S.C. § 812(b)(1) (2017)
no medical use and high potential for abuse without consideration for physical or psychological dependence.

Schedule 2
21 U.S.C. § 812(b)(2) (2017)
medical use with high potential for abuse with physical dependence and high psychological dependence.

Schedule 3
21 U.S.C. § 812(b)(3) (2017)
medical use with low to moderate physical dependence and high psychological dependence

Schedule 4
21 U.S.C. § 812(b)(4) (2017)
medical use with physical dependence and psychological dependence less than schedule 3

Schedule 5
21 U.S.C. § 812(b)(5) (2017)
medical use with physical dependence and psychological dependence less than schedule 4

 

[4] Classification Comparisons

Schedule 1
Iowa Code § 124.204(4)(m) (2017) Marijuana

Schedule 2
Iowa Code § 124.206(2)(a)(1) (2017) Raw Opium
Iowa Code § 124.206(2)(a)(7) (2017) Codeine
Iowa Code § 124.206(2)(a)(10) (2017) Hydrocodone
Iowa Code § 124.206(2)(a)(13) (2017) Morphine
Iowa Code § 124.206(2)(c) (2017) Opium Poppy and Poppy Straw

Schedule 3
Iowa Code § 124.208(5)(a)(1) (2017) Codeine
Iowa Code § 124.208(5)(a)(2) (2017) Codeine
Iowa Code § 124.208(5)(a)(3) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(4) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(5) (2017) Hydrocodone
Iowa Code § 124.208(5)(a)(7) (2017) Opium

Schedule 5
Iowa Code § 124.212(2)(a) (2017) Codeine
Iowa Code § 124.212(2)(b) (2017) Hydrocodone
Iowa Code § 124.212(2)(e) (2017) Opium

 

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Medical Cannabis and the 2017 Iowa Legislative Session

This legislative session began with four proposals for medical cannabis programs, two in the Iowa Senate, one by Democrats (S.F. 205) and one by Republicans (S.S.B. 1176 / S.F. 506), and two in the Iowa House, one by Democrats (H.F. 198 / H.F. 199) and one by Republicans (H.S.B. 132), and two proposals to extend the current Medical Cannabidiol Act of 2014, one by Senate Republicans (S.F. 470) and one by House Republicans (H.F. 520).  What we ended up with is a hybrid of bits and pieces from each of these six proposals (H.F. 524).

Cultivation, manufacture, and distribution

H.F. 524 extends the Medical Cannabidiol Act of 2014, with the addition of more medical conditions and cultivation, manufacture, and distribution of cannabidiol in Iowa.  The limit on THC remains the same, 3%.  Most people are saying this is not a big step forward, but cultivation, manufacture, and distribution in Iowa seem like huge steps forward to me.  Because there were proposals in both chambers, from both parties, early in the year to cultivate, manufacture, and distribute cannabis products in Iowa, this was not a total surprise.  The disagreement was mainly about how much THC there can be in the products.  Both Senate proposals would have eliminated the limits on THC, and the House was split (Republicans in favor of the 3% limit on THC and Democrats in favor of eliminating any limit on THC).  Because Republicans control both chambers and the governor’s office, the 3% limit on THC prevailed.

This is a stunning result, considering the National Academies of Science reported earlier this year that there is conclusive evidence that higher levels of THC are effective in the treatment of chronic pain and multiple sclerosis (Chapter 4, Section 1), and no or insufficient evidence to support or refute the conclusion that cannabis or cannabinoids are an effective treatment for epilepsy (Chapter 4, Section 6).  The reason given for the the low THC limit was that it provides an effective treatment for epilepsy.

Introduced at 3:00 a.m.

Although I am optimistic, H.F. 524 is not well written.  H.F. 524 was negotiated in secret meetings in the wee hours of the morning on Saturday, April 22, 2017, just before the legislature adjourned for the year.  I was not able to obtain a copy of the bill until 3:00 a.m. on Saturday morning, April 22, 2017.  I left the capitol around 5:00 a.m. (after sitting in the balcony overlooking the House floor for 16 hours), because it was obvious to me H.F. 524 wasn’t going to be amended and H.F. 524 would either pass or fail as written.  I watched the debate from the House floor and the Senate floor after I got home later in the morning.  The legislature’s plan was to adjourn the 2017 session that morning, so I was fairly confident the bill was going to pass as written.  The vote in the Iowa House was 83-11-6 at 6:00 a.m., H.J. 1135, and 33-7-10 at 6:30 a.m. in the Iowa Senate, S.J. 1122.  Both chambers adjourned for the year at 7:15 a.m.

There is no explanation of federal law in the bill

In my opinion, there is a critical element left out of both the initial proposals and the final bill that passed.  There is not a single mention of federal law in the proposals or in the final bill, and yet most of the media coverage during the session reported legislators expressing concern about federal law.  That seems like a huge flaw to me.  If federal law is a concern, it should be addressed in the bill.  For example, a hemp bill was introduced, S.F. 329, that contains a section entitled “Compliance with Federal Law.”  S.F. 329 proves that legislators understand there is a federal law involved whenever cannabis is being considered.  Leaving that out of every proposal, and in the final bill, H.F. 524, is a critical oversight.

Iowa Public Radio, April 12, 2017, Advocates Plead for Medical Marijuana; Senate Committee Approves Bill: “You’re still breaking federal law.” -House Speaker Linda Upmeyer.

KGLO AM 1300, March 27, 2017, Upmeyer says legislators working on medical marijuana issue: “She says they are already anticipating doing this bill with the possibility of breaking two federal laws.”

What do we know about federal law?

First

We can read S.F. 329, which says it complies with 7 U.S.C. § 5940 (Pub. L. 113–79, title VII, § 7606, Feb. 7, 2014, 128 Stat. 912; Pub. L. 114–95, title IX, § 9215(f), Dec. 10, 2015, 129 Stat. 2166).

7 U.S.C. § 5940 says it provides an exception to 21 U.S.C §§ 801 et seq., The Controlled Substances Act, title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242.

7 U.S.C. § 5940 defines hemp as cannabis with no more than .3% THC.

The Iowa Medical Cannabidiol Act of 2014 defines cannabidiol as cannabis with no more than 3% THC (ten times the amount of THC as defined in 7 U.S.C. § 5940).

Second

Congress has temporarily suspended enforcement of 21 U.S.C. §§ 801 et seq. in the past two federal appropriations bills, and in the extensions for 2017 through May 5, 2017.  See, Congressional Research Service, R44782, “The Marijuana Policy Gap and the Path Forward“, March 10, 2017, p. 15.

Pub. L. No. 113-235, § 538, 128 Stat. 2130, 2217 (2014) (“None of the funds made available in this Act to the Department of Justice may be used … to prevent such States from implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana”).

Pub. L. No. 114-113, § 542, 129 Stat. 2242, 2332-33 (2015) (“None of the funds made available in this Act to the Department of Justice may be used … to prevent any of them from implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana”).

Pub.L. No. 114-254, § 101(1), 130 Stat. 1005, 1005-06 (2016) (extending the date to April 28, 2017).

H.J.Res.99 — 115th Congress (2017-2018) (extending the date to May 5, 2017).

See, Congressional Research Service, R44782, “The Marijuana Policy Gap and the Path Forward“, March 10, 2017.

Update (May 1, 2017): Congress is set to re-authorize the suspended enforcement until September of 2017.

Obviously, a temporary suspension of enforcement is not a promise that enforcement will not be resumed.

Third

The U.S. Department of Justice has created enforcement guidelines that say enforcement of 21 U.S.C. §§ 801 et seq. will not likely be used against state medical marijuana programs.  Again, see, Congressional Research Service, R44782, “The Marijuana Policy Gap and the Path Forward“, March 10, 2017. p. 12.

The Ogden Memorandum of October 19, 2009 states that, “no State can authorize violations of federal law.”

The Cole Memorandum of August 29, 2013 states that, “Neither the guidance herein nor any state or local law provides a legal defense to a violation of federal law, including any civil or criminal violation of the CSA.”

Obviously, federal enforcement guidelines do not provide a legal defense for state medical marijuana programs, nor do they allow states to authorize violations of federal law.

So, what federal law allows states to enact medical marijuana programs?

The federal Controlled Substances Act (CSA), enacted in 1970, originally classified cannabis as a substance with no currently accepted medical use in treatment in the United States.  The Attorney General was given the duty of keeping the classification (schedules) of controlled substances updated as circumstances changed.  21 U.S.C. § 811(a) (2017).  The Attorney General may “add substances to,” “transfer substances between,” or “remove substances from” the schedules.  Since 1996, when California became the first state in the United States to accept the medical use of cannabis, a total of 45 states have accepted the medical use of cannabis or cannabis extracts.  By contrast, nothing else in schedule 1 (the schedule cannabis was placed in by Congress in 1970) has been accepted by even a single state in the United States.

Congress never defined the term, “currently accepted medical use.”  Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936, 939 (D.C. Cir. 1991) (“neither the statute nor its legislative history precisely defines the term ‘currently accepted medical use'”).  Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987) “Congress did not intend ‘accepted medical use in treatment in the United States’ to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance”).

“The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”  Gonzales v. Oregon, 546 U.S. 243, 258 (2006).

The last time the Attorney General interpreted “currently accepted medical use” of cannabis was in 1991.  In 1991, there were no states in the United States that had accepted the medical use of cannabis.  The 2009 and 2013 federal enforcement guidelines appear to rely on this outdated interpretation.  In fact, if you look at the state medical cannabis laws enacted since 1996, you’ll notice that none of them includes a statement of compliance with federal law.  Failure to explain how the state medical cannabis law complies with existing federal law deprives the Attorney General of the opportunity to update the classification of cannabis. 

Conclusion

Failure to explain compliance with federal law is a critical flaw in H.F. 524.  The governor should call the legislators back in a special session to address this error before signing this legislation.

Any legislator, or the governor, can request an opinion from the attorney general, as set forth in Iowa Code § 13.2(3) (2017) and 61 Iowa Administrative Code § 1.5 (2017).

Posted in Federal, States | 1 Comment

March 3 is the legislative funnel date

A variety of medical cannabis bills have been filed in the Iowa legislature this year. One, HSB 132, has actually passed in a Republican controlled subcommittee. The end of this week, Friday, March 3, 2017, is the funnel date when bills have to be passed by a full committee to remain eligible for further debate. There are exceptions to the funnel date and amendments can be filed to bills that are still viable after the funnel date, so don’t be completely distraught if none of these bills passes out of committee by Friday.

I’m going to describe several of the bills by grouping them by their similarity.

Whole Plant Cannabis

SF 205 and HF 199 are very similar. Both bills would allow whole plant cannabis to be grown and used for a variety of medical conditions in Iowa. These two bill have only Democrat cosponsors and no Republican cosponsors. Both bills look similar to SF 484 from 2015 which passed by a narrow partisan vote in a Democrat controlled Iowa Senate in 2015 and then died in a Republican controlled Iowa House in 2016. SF 205 has been assigned to a subcommittee in the Republican controlled Iowa Senate. HF 199 has not been assigned to a subcommittee in the Republican controlled Iowa House. I’ve registered in favor of both of these two bills, SF 205 and HF 199.

Cannabidiol Only

Iowa State Representative Clel Baudler

Iowa State Representative Clel Baudler

I’m guessing that the reason HF 199 has not been assigned to a subcommittee in the Republican controlled Iowa House is probably because the Chair of the House Committee on Public Safety, Greenfield Republican Representative Clel Baudler, has filed his own medical cannabis bill, HSB 132. Chairman Baudler’s bill actually passed by a 3-0 vote in a subcommittee on February 24, 2017, and Republicans are saying this is the bill that will eventually make it through the full committee before the funnel date this Friday. However, the chair of the committee, Clel Baudler, now says he will not let the committee vote on it, because there are only 4 Republicans willing to vote in favor of it. Rep. Baudler says he will not allow a vote on a bill that only a majority of Democrats will support and the majority of his party will not support. I’ve registered in favor of this bill, HSB 132.

Seriously?

Iowa State Senator Brad Zaun

Iowa State Senator Brad Zaun

Finally, there are three bills that all have a very unusual similarity. SF 282, filed by the chair of the Senate Judiciary Committee, Brad Zaun, and HSB 159, and HSB 164, filed by Rep. Baudler, all seem to be filed on behalf of a pharmaceutical company, GW Pharmaceuticals (going by the name of Greenwich Biosciences, Inc.). All three of these bills have been assigned to subcommittees, but it’s unclear if any of them will be approved by those subcommittees. I have registered against all three of these bills, SF 282, HSB 159, and HSB 164.

Complaint with the Iowa Board of Pharmacy

It just doesn’t seem appropriate to me for a pharmaceutical company to by lobbying in Iowa for their product (without mentioning the product by name in the bill) when the usual course of action with a pharmaceutical drug is to have a product approved by the FDA, classified as a prescription drug by the DEA, and then approved by the state legislature after the federal approvals have been completed. I’ve filed a complaint with the Iowa Board of Pharmacy that will be considered at their meeting on Wednesday, March 8, 2017.

Congressman Young and Senator Whitver

Congressman David Young

Congressman David Young

I met with Iowa Congressman David Young and Iowa Senate President Jack Whitver on Friday, February 17, 2017, to, among other things, let them know about my complaint with the pharmacy board about SF 282. I received a nice post card from Congressman Young following the meeting.

Postcard from Congressman Young

Postcard from Congressman Young

Iowa State Senator Jack Whitver

Iowa State Senator Jack Whitver



Summary

I’m not into conspiracy theories, but it does seem strange that the bill we were expecting, HSB 132, has suddenly lost the support of Chairman Baudler, and now Chairman Baudler is sponsoring two crazy bills for a pharmaceutical company. A legislator on the subcommittee that approved HSB 132 (Rep. Kristi Hager) told a mother of a child with epilepsy (Erin Miller) that

Erin, I know this is a difficult place to be. HSB 132 did not pass committee so it won’t go anywhere at this time.

However HSB 164 was introduced which essentially extends the cannabidiol sunset. Rep Klein, Kacena, and myself have been assigned as the subcommittee to this.

One of the reasons HSB 132 failed is in light of the current Federal Law stating “while states can decriminalize marijuana, federal law is clear that a state cannot issue licenses or otherwise sell marijuana.” This bill called for licensing fees. Another concern was the use of Carver College of Medicine and College of Pharmacy for providing the scientific trials without the allocation of funds to do this. There were other concerns around this in assuring a uniform product, etc.

Thanks again for reaching out . . . Kristi

And then:

Erin, thank you. Your mom also wrote me and mentioned the need your son has. I added a reminder note to look at an amendment to cover individuals receiving cannabidiol oil now who may not fall inside the Epidiolex guidelines to allow them to continue receiving current therapy. We’ll have our subcommittee I’m guessing on Monday or Tuesday.

Greenwich Biosciences, Inc., is registered in support of HSB 159, but has not registered any position on SF 282 or HSB 164. It still looks suspicious to me. It looks to me like SF 282 and HSB 164 are compromise positions to HSB 159 intended to keep the Iowa parents of children with epilepsy in favor of the modified versions of the GW Pharmaceutical bill. That’s just my personal opinion. I have been following this closely.

A scientist who works for GW Pharmaceutical helped me win my case with the Iowa Board of Pharmacy in 2010, and that same scientist was involved in setting up clinical trials of the product here in Iowa with the University of Iowa medical school. Just to be clear, I have nothing against GW Pharmaceutical. I just don’t support what GW Pharmaceutical is trying to do with these bills. Not everyone responds well to the GW Pharmaceutical product (which has no THC in it). Current Iowa law allows for cannabidiol products with up to 3% THC in them.


Clarification

I support sections 2 and 3, of SF 282 and HSB 164, which extend the current law. If you’re covered now, you would still be covered.

And, I am not opposed to rescheduling Epidiolex, either.

What I am opposed to is mentioning federal scheduling that has not happened, and may never happen.

Show me proof that Epidiolex will ever be scheduled.

The board has always recommended the same changes to state scheduling as the federal government makes, but only after the federal government actually makes the change (not before it).

So, we don’t need a law telling the board to do what it already does.

I see these bills would allow the board to make an emergency rule that would be effective until the legislature approves it, but it’s still based on something our state has no control over (whether the federal government approves Epidiolex, or not).

Another problem I have is that the bill does not actually say Epidiolex. Why not? What other products are there?

I’m only opposed to the part on federal scheduling. We can reschedule Epidiolex right now. Show me a law that says we can’t.

We rescheduled natural THC products in 2008, and the federal government still hasn’t approved any. What is that all about?

Iowa Code § 124.208(9)(b) (2017):

Any drug product in tablet or capsule form containing natural dronabinol (derived from the cannabis plant) or synthetic dronabinol (produced from synthetic materials) for which an abbreviated new drug application (ANDA) has been approved by the United States food and drug administration under section 505(j) of the federal Food, Drug, and Cosmetic Act and which references as its listed drug the drug product identified in paragraph “a”.

Federal scheduling only allows “synthetic” dronabinol (THC). The federal government proposed rescheduling natural dronabinol in 2007.

Federal Register, Vol. 72, No. 184, Monday, September 24, 2007

This happened again in 2010.

Federal Register, Vol. 75, No. 210, Monday, November 1, 2010

But, neither of these proposed federal rules were ever approved.

The listing for THC still says only “synthetic.”

21 C.F.R. § 1308.13(g) (2017):

Hallucinogenic substances. (1) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product—7369.
[Some other names for dronabinol: (6aRtrans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]

Obviously, we can reschedule Epidiolex before the federal government does. If that’s what we want to do, let’s do it. This nonsense about waiting for the federal government is clearly a stall tactic.

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Is the DEA wrong about marijuana’s medical value?

The Question Presented

I’ve been asked to explain the U.S. Drug Enforcement Administration (DEA) decision on July 19, 2016, not to accept the Marijuana Rescheduling Petition filed by the states of Washington and Rhode Island on November 30, 2011.  See Page 53688 of the Federal Register, Vol. 81, No. 156, Friday, August 12, 2016.

My Background

I have special expertise because I was one of the petitioners in the Marijuana Rescheduling Petition filed by the National Organization for the Reform of Marijuana Laws (NORML) in 1972 (I joined that case in 1985 and my name is on the cover of the Administrative Law Judge’s Ruling on September 6, 1988), and finally resolved in the U.S. Court of Appeals in 1994 (I did not participate in that appeal).  Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991); Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994).  I was also one of the original petitioners in the Marijuana Rescheduling Petition filed by the Coalition for Cannabis Rescheduling in 2002, and finally resolved in the U.S Court of Appeals in 2013 (I did participate in that appeal, and I filed my own Petition for Writ of Certiorari in the U.S. Supreme Court).  Americans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2013).  The five part test that was developed in the first petition and applied in the second is the same test that was just recently applied again by the DEA in the most recent petition filed by the states of Washington and Rhode Island.

Dividing the Question

So, there are two questions we need to ask.  First, the question most people are asking, did the DEA apply the five part test correctly?  The second question is one you won’t hear from anyone but me, and that is whether the five part test is even valid.  I’m not going to address the first question, because I don’t think its relevant whether DEA applied the five part test correctly.  I’m going to divide the second question further and ask whether the five part test was ever valid at all, and then, if it was valid, I’m going to ask if the five part test is still valid today.

The Five-Part Test

On Page 938, Alliance for Cannabis Therapeutics, 930 F.2d 936 (D.C. Cir. 1991), the court explains the difference between schedule 1 and schedule 2, “is whether a drug has ‘no currently accepted medical use in treatment in the United States.’  This case turns on the appropriate definition and application of that phrase.”

On Page 938, the court goes on to explain, “In a prior proceeding, the Administrator had employed an additional eight factor test to further elaborate the characteristics of a drug that he thought had a ‘currently accepted medical use’:”

  1. Scientifically determined and accepted knowledge of its chemistry;
  2. The toxicology and pharmacology of the substance in animals;
  3. Establishment of its effectiveness in humans through scientifically designed clinical trials;
  4. General availability of the substance and information regarding the substance and its use;
  5. Recognition of its clinical use in generally accepted pharmacopeia, medical references, journals or textbooks;
  6. Specific indications for the treatment of recognized disorders;
  7. Recognition of the use of the substance by organizations or associations of physicians; and
  8. Recognition and use of the substance by a substantial segment of the medical practitioners in the United States.

53 Fed. Reg. 5,156 (1988).

On Page 939, Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991), explains why the DEA is creating tests for determining “currently accepted medical use.”  “The difficulty we find in petitioners’ argument is that neither the statute nor its legislative history precisely defines the term ‘currently accepted medical use’; therefore, we are obliged to defer to the Administrator’s interpretation of that phrase if reasonable.” So, the DEA is trying to define a term used in the statute that Congress did not define.

What is important to note is that the eight-part test was the result of a previous test that was found invalid.  In Grinspoon v. DEA, 828 F.2d 881, 891 (1st Cir. 1987), the court found that the Administrator applied an incorrect standard in determining the meaning of the phrase “currently accepted medical use in treatment in the United States.”  53 Fed. Reg. 5,156 (1988).  The DEA has had a difficult time creating a valid interpretation of the language used in the statute.

In Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994), the DEA’s “Final Order discards the earlier formulation and applies a new five-part test for determining whether a drug is in ‘currently accepted medical use’:”

  1. The drug’s chemistry must be known and reproducible;
  2. there must be adequate safety studies;
  3. there must be adequate and well-controlled studies proving efficacy;
  4. the drug must be accepted by qualified experts; and
  5. the scientific evidence must be widely available.

57 Fed. Reg. 10,506 (1992).

So, the five-part test is the third time the DEA has tried to define a term that Congress did not define in the statute, “currently accepted medical use in treatment in the United States.” We should be asking ourselves if the DEA got it right on the third try.

Federalism

So, this brings us up to 1994 and the final ruling from the courts is that the five part test is a valid interpretation of the language used in the statute. What happens in 1996 is that California becomes the first state to enact a law accepting the medical use of marijuana. We now have a total of twenty-six (26) states that have accepted the medical use of marijuana, and an additional sixteen (16) states that have accepted the medical use of a marijuana extract. Let’s do a little review here. In 1987, the DEA’s interpretation of “currently accepted medical use in treatment in the United States” was found to be invalid. In 1991, the DEA’s interpretation of “currently accepted medical use” was found to be invalid. Notice how the words got truncated to completely ignore “in treatment in the United States.” Then, in 1994, the DEA’s interpretation of “currently accepted medical use” was found to be valid. So, why did the words “in treatment in the United States” get left out? In 1994, there were no states that had accepted the medical use of marijuana.

A couple of graphics illustrate the point.

States with Medical Marijuana laws (1994)

States with Medical Marijuana laws (2016)

Did the DEA apply the five-part test correctly?

Yes, under the five-part test, no plant could ever be approved for medical use by the DEA, which makes perfect sense.  DEA has never rescheduled a plant.  All the plants are in the same schedule Congress originally put them in.  Doctors are not writing prescriptions for plants in schedule 2.  If opium plants and coca plants had to pass the DEA’s five-part test, they would fail the same way marijuana does.  So, the test is being applied correctly, the same way it would be applied to any other plant.  Congress did not give the DEA any directions on what to do if a plant is in the wrong schedule.  Because schedule 1 prevents their medical use, these plants will remain without medical use until Congress removes them from schedule 1.

Was the five-part test valid in 1994?

It’s hard to say whether a test for medical use of a plant in schedule 1 could ever be valid, because schedule 1 prevents them from being used for medicine.  However, the court did approve this test, so it was valid from that perspective.  The five-part test was not contested, so it was valid from that perspective.  In 1994, there were no states that had accepted the medical use of marijuana, and there were no states that had accepted the medical use of marijuana in 1970 when the law was written.  So, there wasn’t a better interpretation of “currently accepted medical use” in 1994.  Apparently, nobody wanted to state the obvious, a test for medical use of a plant in schedule 1 is an oxymoron.  Accepted medical use in a state is a state decision, but there were none in 1994 or in 1970.

Is the five-part test valid in August of 2016?

The problem with the petition filed by the states of Washington and Rhode Island is that it cedes state sovereignty to a federal administrative agency by accepting the DEA’s ability to interpret the meaning of “accepted medical use in treatment in the United States” without regard to state laws defining marijuana as medicine  If the DEA is going to interpret the meaning of “accepted medical use in treatment in the United States” without considering state laws on the matter then the five-part test is the only approved test for making that determination.  Both the states of Washington and Rhode Island classify marijuana as a schedule 1 substance with no accepted medical use in treatment in the United States in their own state drug laws, in clear violation of the Full Faith and Credit Clause of the U.S. Constitution.  Revised Code of Washington §§ 69.50.203(a)(2) and 69.50.204(c)(22) (2016); State of Rhode Island General Laws, §§ 21-28-2.03(2) and 21-28-2.08(d)(10) (2016).  The states of Washington and Rhode Island will not appeal from the DEA’s denial of their petition, because they have no grounds on which to appeal (they have 30 days from the date of publication in the Federal Register to appeal), thereby proving they knew they had no valid legal argument when they filed their petition.

So, the question is why the DEA is still being asked to interpret the meaning of “accepted medical use in treatment in the United States” when we have forty-two states as of August of 2016 that have accepted it for medical use.  One explanation is that the states of Washington and Rhode Island have marijuana classified as having no accepted medical use in the United States in their own state drug laws, despite the fact both states have defined marijuana as medicine in those same state drug laws.  How could a state act against its own interests in this way?

Back to Federalism

Notice how the phrase “accepted medical use in treatment in the United States” is interpreted by the court in Grinspoon v. DEA, 828 F.2d 881, 886 (1st Cir. 1987):

We add, moreover, that the Administrator’s clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads “in the United States,” (emphasis supplied).  We find this language to be further evidence that the Congress did not intend “accepted medical use in treatment in the United States” to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance.

And, notice in that case the phrase is not truncated to only say “currently accepted medical use.”  Grinspoon v. DEA, 828 F.2d 881, 887 (1st Cir. 1987):

Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate.  Compare 21 U.S.C. § 801(5) with 21 U.S.C. § 321 (b), 331, 355(a).  Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing.

So, the DEA’s five-part test, just like approval for interstate marketing, does not take into account individual states.  The five-part test is for “every state,” just like the approval for interstate marketing, because it would require a finding of recognized medical use in every state.  This leaves absolutely no doubt, the five-part test is no longer valid.

This is not the first time state officials in states such as Washington and Rhode Island have acted against the interests of the people who elected them.  In New York v. United States, 505 U.S. 144, 181-182 (1992), the U.S. Supreme Court asked, “How can a federal statute be found an unconstitutional infringement of state sovereignty when state officials consented to the statute’s enactment?”  The context was different in that case, but the idea is the same as it is here.  State officials in the states of Washington and Rhode Island have consented to the DEA interpreting a statute in a manner that infringes on their own state sovereignty.

What the states of Washington and Rhode Island should have done is tell the DEA it has no business interpreting a term Congress has not defined (“medical use”) when the state has a law that defines the “medical use” of marijuana.  See, Gonzales v. Oregon, 546 U.S. 243 (2006), for an example of how this works.  Gonzales v. Oregon, 546 U.S. 243, 258 (2006):

The Attorney General has rulemaking power to fulfill his duties under the CSA.  The specific respects in which he is authorized to make rules, however, instruct us that he is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.

DEA is the federal agency that acts for the U.S. Department of Justice in making scheduling decisions.  In Gonzales v. Oregon, the Attorney General tried to tell the state of Oregon that the use of controlled substances to assist in suicide was not a lawful “medical use” of controlled substances, but the court disagreed and said the state has the authority to decide what is “accepted for medical use” because Congress did not make those decisions in the federal statute.  The court said Congress could make decision on “medical use,” but hasn’t.  Gonzales v. Oregon, 546 U.S. 243, 271-272 (2006):

Even though regulation of health and safety is “primarily, and historically, a matter of local concern,” Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719, 105 S. Ct. 2371, 85 L. Ed. 2d 714 (1985), there is no question that the Federal Government can set uniform national standards in these areas.  See Raich, supra, at 9, 125 S. Ct. 2195, 162 L. Ed. 2d 1. In connection to the CSA, however, we find only one area in which Congress set general, uniform standards of medical practice.  Title I of the Comprehensive Drug Abuse Prevention and Control Act of 1970, of which the CSA was Title II, provides that

“[The Secretary], after consultation with the Attorney General and with national organizations representative of persons with knowledge and experience in the treatment of narcotic addicts, shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts, and shall report thereon from time to time to the Congress.”  § 4, 84 Stat. 1241, codified at 42 U.S.C. § 290bb-2a.

This provision strengthens the understanding of the CSA as a statute combating recreational drug abuse, and also indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute.

It’s clear that Congress never intended to tell states what they can accept for medical use within their own borders.  But, we have states telling the DEA it’s a federal decision when it’s not.  The DEA simply refuses to budge until someone gives them a valid legal argument for removing marijuana from schedule 1.

There are three ways that could happen: (1) an executive order declaring marijuana has accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1; (2) a ruling from a court declaring marijuana has accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1; and, finally (3) a clarification from Congress explaining that state laws are accepted medical use in the United States as a matter of law would clarify that the DEA has no authority to keep marijuana in schedule 1.  There are some bills pending in Congress (S. 683 and H.R. 1538, for example) that would do this, but they are not as clean as simply enforcing the existing law (they would place marijuana into another schedule, which an executive or judicial ruling would not do, for the best example).

Congress has withheld funding for enforcement of federal schedule 1 against medical use of marijuana in states that have accepted it.  See United States v. Marin Alliance, 3:98-cv-00086-CRB (N.D. Cal., 12/18/2015); and United States v. Steve McIntosh, No. 15-10117 (9th Cir., 8/16/2016).  These cases demonstrate the difficulty imposed on the federal courts, because the court has to determine if the defendant was in compliance with a state medical marijuana law, and then has to determine if the money being appropriated for the prosecution of the case falls within the time period that Congress has forbidden the appropriation of such funds for such purposes.  Wow!

International Law

Finally, the DEA ruling published in the Federal Register on August 12, 2016, relies on international treaty obligations.  If a schedule is required by an international treaty, then the DEA is precluded from applying some or all of the scheduling criteria.  21 U.S.C. § 811(d)(1).  The courts have previously determined that international treaty obligations prevent marijuana from being scheduled any lower than schedule 2.  NORML v. DEA, 559 F.2d 735, 751 (D.C. Cir. 1977).  Because the abuse potential for schedule 1 and schedule 2 is the same, the only relevant question then is whether marijuana has “currently accepted medical use in treatment in the United States.”  Abuse potential is not relevant, because the international treaties prevent the DEA from considering it.

Because the states of Washington and Rhode Island ceded the authority to define “medical use” to a federal administrative agency, they also limited the choices to schedule 1 or schedule 2, regardless of whether marijuana actually belongs in either of those classifications.

But, the international treaties themselves provide the answer.  Only one of the treaties is specifically mentioned, the Single Convention on Narcotic Drugs, 1961 (As amended by the 1972 Protocol), but all of the treaties use the same language in their enforcement sections:

Article 36(2) “Subject to the constitutional limitations of a Party, its legal system and domestic law, . . .”

The treaty does not apply if there is a domestic law that allows the activity.  A domestic law would be intrastate and solely within the borders of a state.  State medical marijuana laws are exempt from the international treaties.

The states of Washington and Rhode Island have not only ceded their state sovereignty to a federal administrative agency, but they have also ceded their state sovereignty to an international administrative agency, the United Nations Commission on Narcotic Drugs.  This is treachery of the highest magnitude.

Posted in Federal | 8 Comments

Attention on medical marijuana shifts to Congress

Attention has shifted from state legislation to Congress and candidates running for federal office. While rumors have been spreading around that the DEA is going to reschedule marijuana in July of 2016, on July 6, Congressman David Young became the first federal elected official from Iowa to co-sponsor H.R. 1538: the CARERS Act of 2015.

david_young

Congressman David Young

Although the CARERS Act is overly complex, it would remove marijuana from federal schedule 1 and recognizes that marijuana does have medical use. I have asked Congressman Young to file an amendment to the CARERS Act that would simply remove marijuana from federal schedule 1 and require the federal administrative agencies to work with the states to come up with reasonable regulations.

On July 4, I wrote Senator Chuck Grassley asking him why his prediction that the DEA would reclassify cannabidiol in the first half of 2016 had not materialized. On July 5, I got a call from David Bleich in Senator Grassley’s DC office. What I learned is that the DEA is telling Senator Grassley that they will rule on the marijuana rescheduling petition filed in November of 2011 by the states of Washington and Rhode Island within the next couple of weeks.

Mr. Bleich referred to a series of letters from Senator Elizabeth Warren requesting updates on the status of pending FDA reviews on cannabis and cannabidiol. Letter of July 9, 2015; Letter of October 15, 2015; Letter of December 21, 2015; Letter of April 4, 2016; Letter of June 23, 2016.

Recent editorials from John Hudak and Grace Wallack at the Brookings Institution on May 27, 2016, and from Jacob Sullum at Reason Magazine on July 4, 2016, explain why they think rescheduling of marijuana by the DEA is very unlikely.

Mr. Bleich also mentioned a new bill being introduced in the Senate Judiciary Committee that seems to have strong bipartisan support, S. 3077: the MEDS Act.  When I wrote to Congressman David Young to thank him for cosponsoring the CARERS Act, I also suggested that he cosponsor the companion bill in the U.S. House of Representatives, H.R. 5549: the Medical Marijuana Research Act of 2016. Again, H.R. 5549 is overly complex and could simply be amended to remove marijuana from federal schedule 1 and instruct the federal agencies to work with the states to come up with reasonable regulations.

What these two bills scream out is that there is something wrong with the way cannabis is classified under federal law. Congress seems to be trying to bend over backward to avoid addressing the issue. S. 3077 and H.R. 5549 would create a slew of exceptions to schedule 1 for marijuana. For example, it would allow a doctor who has a license to prescribe drugs in schedule 5 to conduct research with marijuana without having a schedule 1 license. I’m asking my representatives in Congress to support these bills, even though they are extraordinarily complex, because something is better than nothing. But, I have also asked them to file amendments to simplify these bills.

Finally, Mr. Bleich said he did not expect the FDA review of cannabidiol to be completed before the end of the year. The FDA is still doing safety studies and it will take them an additional 6 months to analyze the 8 factors in 21 U.S.C. § 811(c). Mr. Bleich agrees there is no precedent for rescheduling a molecule and this is the first time the FDA has considered rescheduling a molecule that is not contained in a drug product being submitted for commercial marketing approval. Mr. Bleich said this FDA review was in response to a request from Senator Grassley and Senator Feinstein and was considered to be a petition for rescheduling of CBD. Mr. Bleich said clinical trials with Epidiolex are going well and that pharmaceutical grade CBD may be avaible from GW Pharmaceuticals in the next year or two. And, finally, Mr. Bleich said a company in the southwestern United States is working on manufacturing synthetic CBD.

Special thanks to Paul Armentano, Deputy Director at NORML for sending me information on the company making the synthetic CBD:

FYI: For those interested, the company is Insys Therapuetics and they received FDA orphan drug status for synthetic CBD two years ago:
http://finance.yahoo.com/news/insys-therapeutics-cannabidiol-gets-orphan-193003258.html

They also have a synthetic alternative THC drug (aka Syndros) that recently gained FDA approval: http://www.marketwatch.com/story/insyss-stock-soars-after-cannabis-based-oral-drug-gets-fda-approval-2016-07-05?siteid=yhoof2 joining a handful of other synthetic THC analogues in the market.

This is not an OTT stock but a larger US-based biotech.

Posted in Uncategorized | 1 Comment

Ankeny Legislative Forum April 9 2016

Rep. Kevin Koester

Rep. Kevin Koester

I live in an interesting Iowa House district. My state representative is a Republican. His name is Kevin Keoster and his profession is school administration. Another interesting character who lives in our neighborhood is Dale Woolery, Deputy Director of the Office of Drug Control Policy. As you can imagine, Kevin and Dale know each other and have worked together in the past.

Last week I got an email from Kevin saying that he was going to meet with the medical staff at the University of Iowa to follow up on the study that was called for in the 2014 Medical Cannabidiol Act. He said he might have some questions after that meeting. I didn’t hear from him and I was busy writing my trial brief which was due on Friday.

At our legislative forum yesterday, I asked Kevin how his meeting went with the medical staff. He said it sounded positive for CBD and epilepsy, which of course was the only thing the 2014 Medical Cannabidiol Act asked the University of Iowa to look at. Nevertheless, I was glad to hear the results were positive.

There were three couples there supporting medical marijuana. Two of them spoke and said they had Crohns Disease and wondered why Crohns Disease had been stripped from the bill that is currently pending, HF 2384. Kevin said that legislators were having a hard time understanding the science. The couple asked him what kind of science he was looking for, because they had it. Kevin said he would not understand it if he saw it.

I’ve been following this in the news a lot, and it seems like every legislator in Iowa says they support moving forward on this issue, but none of them can agree on what to do.

After the forum, I met another couple that had contacted me earlier in the week and were just there to listen. Another couple was talking to Kevin and they had a medical condition (I can’t remember if it was a child with epilepsy). A man sitting next to me said he knew one of the patients that spoke at the capitol on March 22, 2016. I’m amazed at how many people are expressing support for medical marijuana at these forums.

Kevin told the couple talking to him that I had single handedly presented this issue to the Iowa Board of Pharmacy in 2009 and the board agreed it was medicine. I told Kevin that we presented evidence to the Iowa Board of Pharmacy in 2009 because the law says that board is the authority in Iowa, but the legislators would not listen. So, that is why the legislators don’t understand the science now. When the board looked at it, as they are required by law to do, the legislators did not want to hear it. So, now medical decisions are being made by legislators who can’t agree on what to do. Oh my!

I asked Kevin if he could send me anything from the University of Iowa presentation earlier in the week and he sent me these two files. The first one is the slide presentation Dr. Joshi presented to the Iowa House legislators last week. The second one is a presentation by Dale Woolery of the Office of Drug Control Policy.

Stay tuned for further developments on this story.

Posted in Uncategorized | 2 Comments