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).

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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: (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-diben­zo [b,

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©(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©. 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.
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The Marijuana Scheduling Story

Jon Gettman

Jon Gettman

Jon Gettman wrote an arti­cle in High Times Mag­a­zine by the title Pot Mat­ters: The Resched­ul­ing Trap, on Mon­day, Feb­ru­ary 29, 2016, detail­ing his attempts to have mar­i­jua­na fed­er­al­ly resched­uled. I was a peti­tion­er in Mr. Gettman’s most recent attempt to have mar­i­jua­na resched­uled, and I will share my per­spec­tive.

The trap Mr. Gettman refers to is known in tech­ni­cal legal jar­gon as the ratio­nal basis test[1]. What that means is the expert deci­sion of the admin­is­tra­tive agency charged with keep­ing marijuana’s clas­si­fi­ca­tion cur­rent will not be over­turned by a court if the deci­sion is ratio­nal. Mr. Gettman argued that the clas­si­fi­ca­tion was not ratio­nal. Like many before him and many after him, Mr. Gettman’s argu­ment was reject­ed. It’s an argu­ment that is guar­an­teed to fail. If Mr. Gettman wants to call that a trap, so be it. The out­come was pre­dictable.

Judges are not med­ical experts and dif­fer­ences of opin­ion between med­ical experts on marijuana’s med­ical use are sim­ply resolved in favor of the sta­tus quo. To win the ratio­nal basis argu­ment the wit­ness­es would have to be in total agree­ment[2].

The 1972 Rescheduling Petition

I was a peti­tion­er in the mar­i­jua­na resched­ul­ing peti­tion filed by NORML in 1972. I joined the NORML peti­tion in 1985. The peti­tion was grant­ed by the DEA’s Chief Admin­is­tra­tive Law Judge, Fran­cis L. Young, in 1988[3]. The admin­is­tra­tive law judge’s rul­ing was over­ruled by the DEA Admin­is­tra­tor cit­ing a dif­fer­ence of opin­ion among med­ical experts[4]. The appeal court applied the “ratio­nal basis” analy­sis and upheld the administrator’s denial of the admin­is­tra­tive law judge’s rul­ing cit­ing a dif­fer­ence in opin­ion among the expert wit­ness­es.

My 1983 Rescheduling Petition

I filed a peti­tion with the DEA in 1983 ask­ing for an exemp­tion from fed­er­al sched­ul­ing for the Ethiopi­an Zion Cop­tic Church, sim­i­lar to the one that exists for the sacra­men­tal use of pey­ote by the Native Amer­i­can Church[5]. The Ethiopi­an Zion Cop­tic Church is a Rasta­far­i­an church incor­po­rat­ed in Jamaica in 1976 that uses cannabis as it’s sacra­ment[6]. My request was denied, but the court specif­i­cal­ly said I had Arti­cle III (U.S. Con­sti­tu­tion) stand­ing to access the fed­er­al courts[7].

In 1990, the Unit­ed States Supreme Court reject­ed my request by refus­ing to rec­og­nize a fed­er­al exemp­tion for the sacra­men­tal use of pey­ote[8]. This rul­ing was lat­er over­turned by Con­gress[9]. How­ev­er, the court had the last word and over­ruled Con­gress[10]. So, the end result is that state law trumps a fed­er­al reg­u­la­tion as long as the state law is neu­tral toward reli­gion and gen­er­al­ly applic­a­ble (hold that thought of state law being of greater author­i­ty than a fed­er­al reg­u­la­tion, because I’m going to come back to it again lat­er).

My 1992 Rescheduling Petition

I filed a peti­tion with the DEA in 1992 argu­ing that THC had been resched­uled to fed­er­al sched­ule 2 in 1986 and inter­na­tion­al­ly in 1991. I argued the plant THC comes from should be sched­uled no high­er than the prin­ci­ple psy­choac­tive ingre­di­ent in the plant. My peti­tion was denied because THC was being man­u­fac­tured syn­thet­i­cal­ly and mar­i­jua­na was not used to make it[11].

While my appeal was pend­ing in the fed­er­al courts, my attor­ney start­ed a class action based on the ratio­nal basis argu­ment that failed to make it out of fed­er­al dis­trict court in Penn­syl­va­nia[12].

Gettman’s 1995 Rescheduling Petition

Dr. Gettman and High Times Mag­a­zine filed their first peti­tion to resched­ule mar­i­jua­na in 1995. When they tried to appeal from the denial of their request, the Unit­ed States Court of Appeals said they did not have stand­ing to access fed­er­al courts[13]. Stand­ing is a legal term that means a con­crete injury. The court ruled that because Dr. Gettman and High Times were mere­ly advo­cates, they did not have the direct injury required to have Arti­cle III (U.S. Con­sti­tu­tion) stand­ing to access the fed­er­al courts.

Gettman’s 2002 Rescheduling Petition

Dr. Gettman filed anoth­er resched­ul­ing peti­tion in 2002 and asked me and sev­er­al oth­ers, includ­ing Amer­i­cans for Safe Access (ASA) and the Nation­al Orga­ni­za­tion for the Reform of Mar­i­jua­na Laws (NORML), to join as co-peti­tion­ers. Dr. Gettman told me the resched­ul­ing peti­tions I filed in 1983 and 1992 inspired him to file his own resched­ul­ing peti­tions and he want­ed to include me.

My 2008 Rescheduling Petition

I want to come back now to that thought I told you to hold about state laws super­sed­ing fed­er­al reg­u­la­tions. In 2006 the Unit­ed States Supreme Court ruled that state laws defin­ing med­ical use of con­trolled sub­stances to assist in sui­cide were law­ful because the fed­er­al gov­ern­ment does not have the author­i­ty to pre­empt them using fed­er­al reg­u­la­tions[14]. I spoke to Mr. Gettman about this and sug­gest­ed that we amend our peti­tion to include this argu­ment, because there were 8 states that had accept­ed the med­ical use of mar­i­jua­na in 2002 and sev­er­al more by 2006. Mr. Gettman said he did not want to amend the peti­tion and that we were going to win based on sci­ence (the ratio­nal basis argu­ment).

So, in 2008 I filed a peti­tion to resched­ule mar­i­jua­na with the Iowa Board of Phar­ma­cy and the only evi­dence I pre­sent­ed was 12 state laws accept­ing the med­ical use of mar­i­jua­na. I said this was accept­ed med­ical use in the Unit­ed States. Iowa law says mar­i­jua­na must con­tin­ue to have no accept­ed med­ical use in the Unit­ed States, just like fed­er­al law, so I argued the accept­ed med­ical use of mar­i­jua­na in oth­er states was proof that mar­i­jua­na is incor­rect­ly clas­si­fied under both state and fed­er­al law. Fed­er­al sched­ul­ing is done by reg­u­la­tion, not by statute, so I argued state laws super­sede fed­er­al reg­u­la­tions and Iowa law refers to oth­er laws in oth­er states (because Iowa gets that phrase from fed­er­al sched­ul­ing).

The board denied my peti­tion with­out rul­ing on my argu­ment, but an Iowa Dis­trict Court remand­ed the case and ordered them to rule on my argu­ment[15]. The board then ruled unan­i­mous­ly in 2010 that mar­i­jua­na is med­i­cine and should be removed from sched­ule 1. I con­tact­ed Mr. Gettman again and showed him my results. Mr. Gettman still refused to amend our peti­tion, say­ing he was going to win on sci­ence (the ratio­nal basis argu­ment). I then noti­fied all of the par­ties and the DEA that I was with­draw­ing from the oth­er peti­tion­ers and inter­ven­ing sep­a­rate­ly on my own.

The Rest of the Story

In 2011, the DEA reject­ed Mr. Gettman’s peti­tion cit­ing a dif­fer­ence in expert med­ical opin­ion, and in 2013, the U.S. Court of Appeals reject­ed Mr. Gettman’s peti­tion cit­ing a ratio­nal basis based on con­flict­ing expert tes­ti­mo­ny[16]. The Court did not rule on my argu­ment, but sim­ply said I had a reli­gious inter­est in mar­i­jua­na. The dis­sent­ing judge said my argu­ment was fed­er­al­ism and that was not the argu­ment the oth­er peti­tion­ers were mak­ing.

The most iron­ic part of the case was that the peti­tion­ers almost failed to show stand­ing. They failed to show stand­ing in their open­ing appeal brief, and failed again to show stand­ing in their reply brief. At the oral argu­ment, one of the peti­tion­ers who said he was being denied Vet­er­ans Admin­is­tra­tion ben­e­fits in Vir­ginia (a state that did not allow med­ical use of mar­i­jua­na) said that he lived in Ore­gon part of the year and pos­sessed an Ore­gon med­ical mar­i­jua­na card. The court asked for sup­ple­men­tal briefs and affi­davits on stand­ing and then gave the peti­tion­er stand­ing to lose the case on the mer­its because of the ratio­nal basis analy­sis. It’s iron­ic, because that was my argu­ment. State laws mat­ter.

So, Mr. Gettman’s warn­ing should sim­ply be don’t do what he did. There is an argu­ment for resched­ul­ing, but it’s not the one he made.

[1] Amer­i­cans for Safe Access v. DEA, 706 F.3d 438 (D.C. Cir. 2013); Amer­i­cans for Safe Access v. DEA, 134 S. Ct. 267, 187 L. Ed. 2d 151 (U.S., 2013); Olsen v. DEA, 134 S. Ct. 673, 187 L. Ed. 2d 422 (U.S., 2013).

[2] See, Unit­ed States v. Pickard, 100 F. Supp. 3d 981 (E.D. Cal., Apr. 17, 2015).

[3] DEA Dock­et No. 86–22, Sept. 6, 1988.

[4] Alliance for Cannabis Ther­a­peu­tics v. DEA, 930 F.2d 936, 289 U.S. App. D.C. 214 (1991); 15 F.3d 1131, 304 U.S. App. D.C. 400 (1994).

[5] 21 C.F.R. § 1307.31.

[6] Olsen v. DEA, 279 U.S. App. D.C. 1, 878 F.2d 1458 (1989); Olsen v. DEA, 495 U.S. 906, 110 S. Ct. 1926, 109 L. Ed. 2d 290 (1990); See, Town v. State ex rel. Reno, 377 So.2d 648 (Fla. 1979) (“the Ethiopi­an Zion Cop­tic Church rep­re­sents a reli­gion with­in the first amend­ment to the Con­sti­tu­tion of the Unit­ed States, the use of cannabis is an essen­tial por­tion of the reli­gious prac­tice, the Ethiopi­an Zion Cop­tic Church is not a new church or reli­gion but the record reflects it is cen­turies old and has reg­u­lar­ly used cannabis as its sacra­ment”).

[7] Olsen v. DEA, 878 F.2d 1458 (D.C. Cir. 1989), cert. denied, 495 U.S. 906 (1990). The Court of Appeals found: “Olsen is a mem­ber and priest of the Ethiopi­an Zion Cop­tic Church,” 878 F.2d at 1459, “the Ethiopi­an Zion Cop­tic Church is a bona fide reli­gion with mar­i­jua­na as its sacra­ment” 878 F.2d at 1460, and “even if the DEA were not empow­ered or oblig­ed to act, Olsen would be enti­tled to a judi­cial audi­ence” 878 F.2d at 1461.

[8] Employ­ment Divi­sion v. Smith, 494 U.S. 872 (1990).

[9] Reli­gious Free­dom Restora­tion Act of 1993 (RFRA), Pub­lic Law 103–141, 187 Stat. 1488, Nov. 16, 1993.

[10] Boerne v. Flo­res, 521 U.S. 507 (1997).

[11] 1996 U.S. App. LEXIS 30353; Olsen v. DEA, 519 U.S. 1118, 117 S. Ct. 964, 136 L. Ed. 2d 849 (1997).

[12] Kuromiya v. Unit­ed States, 37 F. Supp. 2d 717, 1999 U.S. Dist. LEXIS 2627 (E.D. Pa., 1999); Kuromiya v. Unit­ed States, 78 F. Supp. 2d 367, 1999 U.S. Dist. LEXIS 18297 (E.D. Pa., 1999).

[13] Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002).

[14] Gon­za­les v. Ore­gon, 546 U.S 243 (2006).

[15] McMa­hon v. Iowa Board of Phar­ma­cy, No. CV7415 (Iowa Dis­trict Court, Polk Coun­ty, April 21, 2009). I filed the peti­tion and McMa­hon inter­vened in it. McMa­hon filed the appeal and I inter­vened in it. McMa­hon was rep­re­sent­ed by the ACLU of Iowa, and I rep­re­sent­ed myself.

[16] See foot­note 1.

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Massacre at the Iowa Statehouse

Sally Gaer speaks at the Press Conference

Sal­ly Gaer speaks at the Press Con­fer­ence

I spent some time at the State Capi­tol this week attend­ing a press con­fer­ence for House Study Bill 607 on Feb­ru­ary 9 and a sub­com­mit­tee hear­ing on the bill on Feb­ru­ary 17.

Bob Vander Plaats speaks at the Press Conference

Bob Van­der Plaats speaks at the Press Con­fer­ence

Peter Cownie speaks at the Press Conference

Peter Cown­ie speaks at the Press Con­fer­ence

Rep. John Forbes, Rep. Guy Vander Linden, and Rep. Zach Nunn

Rep. John Forbes, Rep. Guy Van­der Lin­den, and Rep. Zach Nunn

I took a few pic­tures and made an audio record­ing of the hear­ing, but I for­got to turn on the record­ing device for the first ten min­utes. The audio record­ing picks up about half way through the first wit­ness, Dr. David Drake.

The hear­ing was bru­tal. The bill that was sup­posed to be on the table was House Study Bill 607, but at the begin­ning of the hear­ing they announced it has been switched for sub­sti­tute amend­ed ver­sion. I did not get a copy of the sub­sti­tute amend­ed ver­sion until the next day. They were hand­ing some­thing out at the hear­ing which could have been a print­ed copy of the sub­sti­tute amend­ed ver­sion, but peo­ple came pre­pared to speak on a bill that was no longer on the table and that was the most sav­age thing I’ve ever seen. The orig­i­nal bill includ­ed sev­er­al med­ical con­di­tions and the sub­sti­tute amend­ed ver­sion only had three. So, peo­ple were there who actu­al­ly had ill­ness­es that were removed from the bill while they were sit­ting there wait­ing to give their tes­ti­mo­ny. Sev­er­al peo­ple had com­plete emo­tion­al break­downs. It was not pret­ty. After this gris­ley affair, the sub­com­mit­tee vot­ed on the sub­sti­tute amend­ed ver­sion favor­ably by a vote of 3–0 and sent it to House Com­mit­tee on Com­merce which then vot­ed favor­ably on it by a vote of 17–6.

Of par­tic­u­lar inter­est to me, the resched­ul­ing of the mar­i­jua­na plant was removed from the sub­sti­tute amend­ed ver­sion. Also, of par­tic­u­lar inter­est to me were the objec­tions from Chip Bal­ti­more, chair of the House Com­mit­tee on Judi­cia­ry. Rep. Bal­ti­more object­ed to the bill because it does not com­ply with fed­er­al sched­ul­ing. The sub­sti­tute amend­ed ver­sion removed resched­ul­ing so it is now com­plete­ly incon­sis­tent with fed­er­al sched­ul­ing. It seems stu­pid to remove resched­ul­ing, but so does get­ting sick peo­ple to fill a room and tes­ti­fy under false pre­tens­es. I hope the pho­to op was worth tor­tur­ing those peo­ple.

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New Bipartisan Iowa Medical Cannabidiol Act Filed

hf2097

Iowa rep­re­sen­ta­tives Tedd Gassman, Lar­ry Sheets, Ron Jor­gensen, Char­lie McConkey, Scott Ourth, and Mary Lynn Wolfe

A new bipar­ti­san med­ical cannabid­i­ol act has been filed in the Iowa House, HF 2097, by three Iowa House Repub­li­cans, Tedd Gassman (R. Scarville), Lar­ry Sheets (R. Moul­ton), Ron Jor­gensen (R. Sioux City), and three Iowa House Democ­rats, Char­lie McConkey (D. Coun­cil Bluffs), Scott Ourth (D. Ack­worth), and Mary Lynn Wolfe (D. Clin­ton).

As many of us know, Iowa cre­at­ed a Med­ical Cannabid­i­ol Act in 2014. Cannabid­i­ol has got­ten a lot of atten­tion recent­ly, includ­ing a U.S. Sen­ate Cau­cus on Inter­na­tion­al Nar­cotics Con­trol hear­ing co-chaired by Iowa Sen­a­tor Charles Grass­ley and Cal­i­for­nia Sen­a­tor Diane Fein­stein in 2015. Cannabid­i­ol (“cannabis oil”) was includ­ed in the Iowa Repub­li­can Par­ty state plat­form in 2014.

As crit­ics have point­ed out, there are two prob­lems with the Med­ical Cannabid­i­ol Act. First, it expires on July 1, 2017. Sec­ond, it does not pro­vide any means of access. Pro­po­nents have called it a decrim­i­nal­iza­tion bill, but exam­ples of decrim­i­nal­iza­tion bills that require a cer­ti­fi­ca­tion from a spe­cial­ist in neu­rol­o­gy and an iden­ti­fi­ca­tion card from the Iowa Depart­ment of Pub­lic Health are just impos­si­ble to find. This law uses the word “med­ical” which just doesn’t make any sense. Decrim­i­nal­iza­tion means it’s still a crime and we’re just reduc­ing the penal­ties or pro­vid­ing an exemp­tion. Legal­iza­tion is the term we use for things that are not crimes. It would be hard to imag­ine that we are now using the word “med­ical” to describe some­thing we are only decrim­i­nal­iz­ing. If we con­tin­ue down this path, we’re going to ren­der lan­guage mean­ing­less. Of course, this law could have been inten­tion­al­ly writ­ten poor­ly to invoke exact­ly these kinds of objec­tions, so there may be a method to the legislature’s mad­ness.

Dis­cus­sions were held by the leg­is­la­ture in 2014 and one of the rec­om­men­da­tions of the Cannabid­i­ol Imple­men­ta­tion Study Com­mit­tee on Sep­tem­ber 11, 2014, was to grow the cannabis to make the cannabid­i­ol, which would have solved the prob­lem of lack of access. The three rec­om­men­da­tions were:

  • Devel­op a reg­u­lat­ed pro­gram to pro­duce, process, and dis­pense med­ical cannabis and fur­ther rec­om­mend that med­ical cannabis not be taxed by the state at any stage of pro­duc­ing, pro­cess­ing, or dis­pens­ing the med­ical cannabis.
  • Resched­ule mar­i­jua­na from a sched­ule I con­trolled sub­stance to a sched­ule II con­trolled sub­stance.
  • Fur­ther inves­ti­gate access, stan­dard­iza­tion, and legal­iza­tion of cannabid­i­ol.

My last blog post on Jan­u­ary 23, 2016, Iowa Repub­li­can Sen­a­tors File Mar­i­jua­na Reclas­si­fi­ca­tion Bill, explained how the Iowa Sen­ate has been try­ing to change the clas­si­fi­ca­tion of mar­i­jua­na. Repub­li­cans in the Iowa Sen­ate have a straight for­ward approach, fil­ing a stand-alone mar­i­jua­na resched­ul­ing bill (SF 2025). Democ­rats in the Iowa Sen­ate, on the oth­er hand, have tried to attach mar­i­jua­na resched­ul­ing to a med­ical mar­i­jua­na bill that doesn’t have strong Repub­li­can sup­port in the Iowa House (SF 484) and a syn­thet­ic mar­i­jua­na bill that had strong sup­port in the Iowa House (HF 567) until the Iowa Sen­ate Democ­rats attached a mar­i­jua­na resched­ul­ing amend­ment to it. Both SF 484 and HF 567 seem dead now. Iowa Demo­c­ra­t­ic Rep­re­sen­ta­tive Bruce Hunter has recent­ly filed a bill sim­i­lar to SF 484, but with­out mar­i­jua­na resched­ul­ing (HF 2087). Anoth­er syn­thet­ic mar­i­jua­na bill with­out mar­i­jua­na resched­ul­ing has been filed in the Iowa House (HF 2049) to replace HF 567.

There is a good rea­son why SF 2025 is the best approach to mar­i­jua­na sched­ul­ing in Iowa. When our law was writ­ten in 1971, the leg­is­la­ture real­ized it did not have the exper­tise to sched­ule con­trolled sub­stances and they gave the respon­si­bil­i­ty of rec­om­mend­ing an appro­pri­ate sched­ule to the Iowa Board of Phar­ma­cy. State v. Bon­jour, 694 N.W.2d 511, 514 (Iowa 2005) (“That pro­ce­dure is to defer to the Board of Phar­ma­cy Exam­in­ers, which is far bet­ter equipped than this court — and the leg­is­la­ture, for that mat­ter — to make crit­i­cal deci­sions regard­ing the med­ical effec­tive­ness of mar­i­jua­na use and the con­di­tions, if any, it may be used to treat.”). In 2010, the Iowa Board of Phar­ma­cy rec­om­mend­ed that mar­i­jua­na be resched­uled from a sched­ule 1 con­trolled sub­stance to a sched­ule 2 con­trolled sub­stance in Iowa. Repub­li­cans are fol­low­ing the law. I don’t want to be too crit­i­cal of the Democ­rats, because they have tried to attach mar­i­jua­na resched­ul­ing to oth­er bills as amend­ments. But, the Repub­li­cans work­ing on this issue are def­i­nite­ly fol­low­ing the let­ter of the law.

So, you might ask, what does HF 2097 have to do with any of this? HF 2097 does three things.

  • It makes the Med­ical Cannabid­i­ol Act per­ma­nent by remov­ing the July 1, 2017, expi­ra­tion date.
  • It replaces the word “neu­rol­o­gist” with the word “physi­cian” which makes it eas­i­er to find a doc­tor to make the rec­om­men­da­tion.
  • It replaces the word “epilep­sy” with the phrase “debil­i­tat­ing med­ical con­di­tion” and adds two more med­ical con­di­tions.

What HF 2097 does not do is pro­vide access to cannabid­i­ol. It will still be ille­gal to make it or dis­trib­ute it. It also has no mech­a­nism for the Iowa Depart­ment of Pub­lic Health to add more med­ical con­di­tions. Although these are seri­ous prob­lems, this is def­i­nite­ly an improve­ment over the 2014 ver­sion. Pos­ses­sion, man­u­fac­ture, and dis­tri­b­u­tion of cannabid­i­ol are fed­er­al crimes, but it’s fair­ly estab­lished by now that the fed­er­al gov­ern­ment is not pros­e­cut­ing patients or doc­tors who rec­om­mend cannabid­i­ol (and whole cannabis in some states). This pro­pos­al would be anoth­er step in the right direc­tion.

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Iowa Republican Senators File Marijuana Reclassification Bill

sf2025

Iowa sen­a­tors Mark Chel­gren, Charles Schnei­der, Jason Schultz, Steven Sod­ders, Wal­ly Horn, and Joe Bolk­com

Three Iowa Repub­li­can sen­a­tors, Charles Schnei­der, Mark Chel­gren, and Jason Schultz, have filed a stand alone mar­i­jua­na reclas­si­fi­ca­tion bill in the Iowa Sen­ate, SF 2025, this week. Two pre­vi­ous bills, SSB 1205 and SF 282, that would do the same thing were filed sep­a­rate­ly by two Iowa Demo­c­ra­t­ic sen­a­tors, Steven Sod­ders and Joe Bolk­com, in 2015.

The Iowa Med­ical Cannabis Act, SF 484, bare­ly squeaked through last year on a heav­i­ly par­ti­san vote (26 to 19, with one Repub­li­can and one Demo­c­rat cross­ing par­ty lines), but it was amend­ed on April 15, 2015, with an amend­ment, S-3123, that would reclas­si­fy mar­i­jua­na. That amend­ment passed by a vote of 44–0-6. So, you can see there is some momen­tum for reclas­si­fy­ing mar­i­jua­na in Iowa.

I am extreme­ly encour­aged that Repub­li­cans are now bring­ing some com­mon sense to the table. Reclas­si­fy­ing mar­i­jua­na does not make it legal for any­thing. It would take both state and fed­er­al reclas­si­fi­ca­tion of mar­i­jua­na to make research eas­i­er, but state reclas­si­fi­ca­tion is a step in the right direc­tion. Reclas­si­fi­ca­tion does not oblig­ate the state to do any­thing fur­ther, so it should not be a dif­fi­cult issue.

SF 2025 is cur­rent­ly pend­ing in the Iowa Sen­ate Com­mit­tee on Judi­cia­ry, and has been assigned to a sub­com­mit­tee con­sist­ing of sen­a­tor Charles Schnei­der, Steven Sod­ders, and Wal­ly Horn. Please let them know you sup­port this bill.

Posted in States | 8 Comments

Iowa Board of Pharmacy Open Records Request 2015

This is an update to my two pre­vi­ous arti­cles:

On Jan­u­ary 14, 2015, the Office of Drug Con­trol Pol­i­cy (ODCP) made changes to the Iowa Board of Phar­ma­cy (IBPE) leg­isla­tive pro­pos­al for 2015, with­out noti­fy­ing me.

Rul­ing to Main­tain Mar­i­jua­na in Sched­ule 1 Jan­u­ary 5, 2015: Rul­ing on Mar­i­jua­na 45 KB
Rul­ing to Trans­fer Cannabid­i­ol to Sched­ule 2 Jan­u­ary 5, 2015: Rul­ing on Cannabid­i­ol 48 KB
Min­utes from the Jan­u­ary 5–6 Meet­ing Jan­u­ary 10, 2015: IBPE Meet­ing Min­utes 5,568 KB
Email to Carl Olsen and ODCP with the 2 Rul­ings Jan­u­ary 14, 2015: Email to Carl Olsen and ODCP 65 KB
Email to ODCP with the Revised Cannabid­i­ol Rul­ing Jan­u­ary 14, 2015: Email to ODCP 146 KB
Revised Rul­ing on Cannabid­i­ol Jan­u­ary 14, 2015: Revised Rul­ing on Cannabid­i­ol 50 KB

Not only was I not noti­fied, the Jan­u­ary 10, 2015, meet­ing min­utes were altered with­out any doc­u­men­ta­tion not­ing the change or who autho­rized it. You can see the sub­sti­tut­ed rul­ing attached to those min­utes, which are still signed and dat­ed on Jan­u­ary 10, 2015. These changes were not sig­nif­i­cant, as far as my peti­tion is con­cerned, but it does show a com­plete dis­re­gard for due process. The Office of Drug Con­trol Pol­i­cy got a copy of the changed rul­ing on my peti­tion, but the cour­tesy was not extend­ed by send­ing me a copy of the changed rul­ing when they made the changes to it.

But, the pur­pose of my open records request was not to uncov­er chi­canery. I want­ed to know what hap­pened to the cannabid­i­ol pro­pos­al. Was the gov­er­nor noti­fied? Was the leg­is­la­ture noti­fied? The typ­i­cal process the Iowa Board of Phar­ma­cy fol­lows is to pre­file a bill before the leg­isla­tive ses­sion begins, which they did in 2012, 2014, and 2015 and are doing now for 2016. Iowa Code § 2.16 allows state agen­cies to pre­file leg­is­la­tion 45 days in advance of a ses­sion. Cannabid­i­ol is not in the pro­posed leg­is­la­tion for 2015 or 2016, so what hap­pened to it?

Senator Steven J. Sodders

Sen­a­tor Steven J. Sod­ders

So, we’ve estab­lished through this open records request that the usu­al process used to noti­fy the leg­is­la­ture did not take place. On Jan­u­ary 16, 2015, Sen­a­tor Steven Sod­ders invit­ed the exec­u­tive direc­tor of the phar­ma­cy board to attend the hear­ing on his pro­pos­al (SSB1005) to trans­fer mar­i­jua­na from sched­ule 1 to sched­ule 2. Remem­ber now, the board just vot­ed against this on Jan­u­ary 5, 2015. But, the board actu­al­ly did vote to trans­fer mar­i­jua­na from sched­ule 1 to sched­ule 2 in 2010. Can you say mixed sig­nals?

Invi­ta­tion to Hear­ing on SSB1005 Jan­u­ary 16, 2015: Invi­ta­tion to Hear­ing on SSB1005 50 KB
Can­cel­la­tion of Hear­ing on SSB1005 Jan­u­ary 20, 2015: Can­cel­la­tion of Hear­ing on SSB1005 15 KB

The last entry for SSB1005 is Jan­u­ary 14, 2015. The pro­posed meet­ing on Jan­u­ary 20, 2015, nev­er took place.

How­ev­er, this was not the end of it. Toward the end of the leg­isla­tive ses­sion, the Democ­rats decid­ed to get aggres­sive and intro­duced a med­ical mar­i­jua­na bill. In prepa­ra­tion, the phar­ma­cy board was again invit­ed to par­tic­pate. The exec­u­tive direc­tor of the phar­ma­cy board resigned sud­den­ly and unex­pect­ed­ly at the end of March 2015. So, the inter­im direc­tor, Ter­ry Witkows­ki, pro­vid­ed input to the Repub­li­can Cau­cus Staff. I’m guess­ing this is because Sen­a­tor Charles Schnei­der sent me an email on April 19, 2015, remind­ing me that he vot­ed in favor of trans­fer­ring mar­i­jua­na from sched­ule 1 to sched­ule 2 at the inter­im study com­mit­tee hear­ing on Sep­tem­ber 11, 2014.

Email from Ter­ry Witkows­ki to Josh Bron­sink April 7, 2015: Email to Repub­li­can Cau­cus Staff 438 KB
Attach­ment #1 Jan­u­ary 14, 2015, Rec­om­men­da­tion from the Phar­ma­cy Board 341 KB
Attach­ment #2 Feb­ru­ary 17, 2010, Rec­om­men­da­tion from the Phar­ma­cy Board 9 KB
Attach­ment #3 Feb­ru­ary 17, 2010, Min­utes from the Phar­ma­cy Board 95 KB

On April 14, 2015, Sen­a­tor Sod­ders filed an amend­ment to SF 484, which would trans­fer mar­i­jua­na from sched­ule 1 to sched­ule 2, S-3123. All of the Repub­li­cans in atten­dance on April 15, 2015, vot­ed in favor of S-3123 by a vote of 44–0-6, but then vot­ed against SF 484 which nar­row­ly passed by a vote of 26–19-5.

Again, on April 30, 2015, Sen­a­tor Sod­ders filed an amend­ment to HF 567, which would trans­fer mar­i­jua­na from sched­ule 1 to sched­ule 2, S-3148, which nar­row­ly passed on May 5, 2015, by a vote of 27–23.

These two bills, SF 484 and HF 567 are cur­rent­ly pend­ing in the Iowa House of Rep­re­sen­ta­tives. HF 567 has already been passed in the Iowa House, but the amend­ment, H-1340 (S-3148 in the Iowa Sen­ate), must still be con­sid­ered before it becomes final.

Posted in Uncategorized | 3 Comments