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.

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One Response to Attention on medical marijuana shifts to Congress

  1. Carl Olsen says:

    The CARERS Act goes beyond sim­ply remov­ing mar­i­jua­na from sched­ule 1 and cre­ates an excep­tion for state med­ical mar­i­jua­na laws from the entire fed­er­al act. It also removes restric­tions on bank­ing for non-med­ical use as well as med­ical use of mar­i­jua­na. I can sup­port both of these ideas, but it does not explain how mar­i­jua­na can be in sched­ule 1 under the cur­rent def­i­n­i­tion of sched­ule 1 as sub­stance with no accept­ed med­ical use in the states. Mar­i­jua­na has been accept­ed by 42 states in the past 20 years, and that fact alone dis­qual­i­fies it from being in sched­ule 1. That is why I say the CARERS Act is over­ly com­plex, because it cre­ates new law rather than enforc­ing exist­ing law.

    I cer­tain­ly rec­og­nize that nobody seems to care about exist­ing law and they just want new law. I’m dis­ap­point­ed by that, but any­thing is bet­ter than noth­ing at this point. Con­gress­man Young is a leader on this issue and I real­ly appre­ci­ate his sup­port.

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