Author Archives: Benesch

The Ohio Department of Commerce Proposes “Factsheet” in Advance of Publishing Draft Cultivator Rules

By: Rachel Winder, Government Relations Manager, and Jeff McCourt, Attorney

On November 1, 2016, the Ohio Department of Commerce released its “Cultivator Rules” factsheet, which outlines the key elements of its initial draft rules for cultivation licenses under the Ohio Medical Marijuana Control Program. The rules have not been proposed in full yet, though it appears likely they will be released later in the day.

The rules contemplate two levels of cultivation licenses, “Level I” and “Level II.” The rules cap the total number of Level I cultivation licenses at 12, and require a $20,000 application fee and $180,000 license fee. Level II cultivation licenses are more restricted in number, to six total licenses, but cost 1/10th the amount of the Level I licenses, with application fees set at $2,000 and license fees set at $18,000. The multiple levels of licenses suggest that Commerce is looking to facilitate both large cultivation facilities and smaller, possibly craft, cultivation facilities.

The licenses will initially be provisional when granted, and the cultivator must pass inspection and be prepared to cultivate within nine months of issuance. In addition, a cultivation license applicant must include quality assurance and security plans upon application, as well as demonstrate “adequate capital to meet facility plans and operational needs.” Capital requirements in other states have created a significant barrier to entry, so this requirement will be of particular interest to market participants, particularly those targeting Level II cultivation licenses.

The factsheet does not provide detail on critical items such as canopy limits or geographic distribution of the cultivators, though these items may be covered in the full rules once released.

The factsheet states that the first opportunity to comment will be starting tomorrow November 2, 2016 and be open through November 15th. The full factsheet and related information is available on the Ohio Medical Marijuana Control Program’s website (medicalmarijuana.ohio.gov).

Members of Benesch’s Regulated Industries Group will continue to monitor and provide updates on the Medical Marijuana Advisory Committee meetings and rulemaking process.

Senators Introduce the CREATES Act

by Darrell Taylor and Kristopher Chandler

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act.  The CREATES Act is intended to give low priced, generic alternatives to brand-name drugs an easier path into the marketplace.

The CREATES Act is designed to facilitate access to samples of branded pharmaceuticals and the related safety protocols.  Currently, generic manufactures must prove that their low-cost alternative is as safe and effective as its brand-name competitor.  Access to the samples of the brand-name drug are needed in order to make the necessary comparisons.  Pharmaceutical companies with branded products are reticent to provide samples of the brand-name drug to generic companies.  Without samples, generic manufacturers are limited in their ability to do the comparisons needed to fast track FDA approval to bring their lower-cost alternatives to market as soon as possible.

Pharmaceutical companies, in addition to limiting access to their proprietary samples, also restrict generic manufacturers’ access to shared safety protocols for distribution of drugs.  To gain FDA approval for certain types of drugs, generic manufacturers are required to join brand-name competitors in a shared Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use (“REMS”) distribution safety protocol.  Pharmaceutical companies often refuse to negotiate a shared safety protocol with generic manufacturers because they would be undermining their market share, which likely would have a negative impact on their business.

As drafted, the CREATES Act allows generic manufacturers to seek injunctive relief from federal courts against both these practices.  The CREATES Act allows generic manufacturers to obtain a court order compelling the pharmaceutical company to supply samples of brand-name drugs for comparison testing.  The CREATES Act also allows generic manufacturers to seek a court order compelling a brand-name manufacturer to enter into a shared REMS with the generic manufacturer or demonstrate that the FDA has waived the requirement to be a part of a shared REMS.  Finally, the CREATES Act allows a generic manufacturer to seek an award for damages from a federal court against a brand-name pharmaceutical that will not provide samples or access to shared REMS.

The CREATES Act is supported by the American Hospital Association, the Generic Pharmaceutical Association, and many other advocacy groups that are trying to lower the costs to obtain prescription drugs.  With the heighten scrutiny over drug pricing, it will be interesting to see where the CREATES Act goes from here.  The entire text of the introduced bill can be found here.

Please contact a member of the Benesch Health Care & Life Sciences team if you have any questions about how the CREATES Act may impact your business.

Darrel Taylor is a partner in Benesch’s Health Care & Life Sciences group.  Kristopher Chandler is a law clerk at Benesch.

Policy Perspectives Dominate The Discussion As The Medical Marijuana Task Force Looks To The Experts For Answers

By Ted Bibart, Legislative Analyst[1]

Another marathon evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”) was held on Thursday, March 10, 2016, as the Task Force heard testimony past 11 p.m. Chairman Kirk Schuring (R-Canton) was faced with the daunting task of managing a docket of fifteen witnesses and a packed house in the committee room.  Members of Benesch’s Regulated Industries Group (the “RIG”) were there to analyze the witness testimony and Task Force inquiries.

The evening’s expert testimony began with “A Perspective From Maryland” as Commissioner Deborah Miran, one of the fifteen members of the Maryland Medical Marijuana Commission, provided an in-depth discussion of the robust regulatory scheme crafted by the Maryland legislature. The Task Force members were clearly intrigued by the pertinent experience of Commissioner Miran. Having sat on the task force that in 2014 helped to overhaul Maryland’s prior (and largely unsuccessful) attempts to legalize medical cannabis, Commissioner Miran empathized with the enormity of the Task Force’s responsibilities in considering the question.  Her expertise, based on more than twenty years in the pharmaceutical industry, made for persuasive testimony.  Commissioner Miran took part in drafting and promulgating the regulations that govern medicinal cannabis in Maryland, which rely heavily on the regulatory schemes implemented in Arizona, Nevada, and Rhode Island.  Although Maryland’s medicinal market is not yet open to patients, industry experts have praised the comprehensiveness of its regulatory scheme, particularly with regard to product safety measures.  Commissioner Miran acknowledged that it had not been an easy road to legislation, and more wrinkles would have to be ironed out.  But she encouraged the Task Force to follow Maryland’s lead by not “reinventing the wheel” when crafting Ohio’s regulatory scheme.  Maryland identified the most effective and  robust elements of the various state approaches and innovated where necessary to serve the contours of Maryland’s market.  She thought a similar approach might be warranted for Ohio.

Another national expert, Dr. Malik Burnett, MD, MBA, a preventative medicine physician from Johns Hopkins University who trained in medicine and business administration at Duke University, advised the Task Force on the intersection of medicinal cannabis and public health.  His experience collaborating with policymakers and public health officials around the world provided a powerful medical perspective on some of the most complex regulatory questions that the Task Force members hope to answer.  State Representative Dan Ramos (D-Lorain), Jimmy Gould (Walnut Group/Responsible Ohio), and Dr. Brian Santin (Ohio State Medical Association) asked probing questions regarding physician autonomy, medical management, and patient access to a broad range of medical cannabis therapeutic options.  In all respects, Dr. Burnett advocated that any regulatory scheme must protect the sanctity of the doctor-patient relationship, and that patient access to medicinal cannabis should not be overly encumbered by the unnecessary, bureaucratic constraints, such as those that have crippled markets in Illinois and New York.  Linda Hondros, representing the Ohio Chamber of Commerce, presented a novel question, not yet posed by the Task Force, regarding information sharing by way of electronic medical records.  Dr. Burnett opined as to the possible benefits for patient care, as well as to the challenges such a system would present.  Dr. Burnett pointed to Maryland, and Commissioner Miran, as examples for the ability of legislators to come together with outside experts to make  state-based decisions that would rightly choose the appropriate approach in response to complicated policy considerations of this type.

Tom Downey, a national expert and prominent regulatory attorney in Denver, Colorado, echoed the sentiments of Commissioner Miran and Dr. Burnett, in highlighting the opportunity Ohio has to create a robust regulatory scheme ahead of industry implementation. Mr. Downey’s extensive experience as a Colorado Regulator, Director, and in drafting the original policies and procedures for Denver’s  legalized cannabis licensing structure, were extremely timely as the Task Force considers the best possible approaches to regulate medicinal cannabis.  He advocated a system that would not impose overly restrictive barriers to entry, but that would be intensive enough only to support sophisticated operators.  Key considerations included a regulatory scheme that was not initially under-funded, and that did not over-tax medicinal cannabis thereby fueling the black market.  Mr. Downey addressed the challenges and concerns resulting from the lack of financial institutions willing to serve marijuana related businesses, and encouraged legislators to seek the expertise of outside experts to investigate solutions.  Finally, Jimmy Gould asked Mr. Downey to consider the present state of Colorado after full implementation of legalized medicinal cannabis.  Mr. Downey assured the Task Force that the fear of the imagined “horror stories” that might result from legalization had proven unfounded in Colorado, instead the economy was booming, tourism was up, and the state budget was being balanced on the strength of $135 million in taxes and fees collected in 2015 alone.

The Task Force also continued to hear touching, anecdotal evidence from patients who had received exemplary benefits of medicinal cannabis therapies. Scarlett Leisure testified with fourteen month-old daughter Savannah in her arms to the incredible impact cannabis oil treatments have had on Savannah’s “catastrophic form of intractable epilepsy” resulting from a deletion mutation of one of her X-chromosomes.  Savannah was forced to endure a ketogenic diet and four medications at a time, and was still having at least 5 tonic-clonic seizures a day (all requiring the use of oxygen).   With no functioning solution in sight, Scarlett took Savannah to Colorado and started cannabis oil therapy on her own.  It was a calculated risk, as there was no medical supervision available in Ohio, but as a result Savannah has only had 8 seizures in the last 5 months (where under the traditional treatments she was receiving, she would have had approximately 750 in that time-span.)  In rebuttal to this anecdotal evidence, Dr. Michael Privitera, MD of the University of Cincinnati (also President of the American Epilepsy Society) cautioned that more testing was necessary to assure this type of cannabis therapy was safe and truly effective.  In Dr. Privitera’s opinion, legalizing medicinal cannabis therapies without the Food and Drug Administration’s (“FDA”) approval was premature.  Dr. Privitera had professed to limit the scope of his testimony to the sphere of epilepsy, but as it veered into other treatment modalities and broader generalizations were made about other fields of medicine, Dr. Santin was there to rein him in, particularly in the area of physician autonomy and patient access.  Finally, Jimmy Gould asked Dr. Privitera to reflect on the testimony and experience of Scarlett and Savannah Leisure. The doctor did acknowledge the effectiveness of medicinal cannabis, and clarified that in his opinion more testing should be done.

Lastly, Jöelle Khouzam of Bricker & Eckler testified on behalf of the Ohio Manufacturers’ Association (“OMA”). While Ms. Khouzam presented many open questions her client had regarding employment-related issues, she was unable to address many of the regulatory solutions other states had devised to satisfy the challenges to employers that these questions presented.  The Task Force looked to Ms. Khouzam for data substantiating the depth of concern underlying the issues she presented for consideration, and unfortunately none was presented in her testimony.  To help clarify her position, Dr. Santin, Chris Stock, State Representative and physician, Dr. Steve Huffman (R-Tipp City), and Rep. Ramos all drew analogies to present employer-related issues with opioid medication in hopes of elucidating the OMA’s stance and the manner in which medicinal cannabis would create different and greater concerns.  While the responses failed to demonstrate the uniqueness medicinal cannabis presents employers, it did highlight that there are existing answers in both existing, state regulatory schemes and case law.

[1] Ted Bibart, and the Benesch team, will continue to provide detailed analysis and comprehensive coverage of Task Force meetings and on-going developments surrounding the issue.

Ohio’s Medical Marijuana Task Force Continues to Hear Testimony

By Jeff McCourt and Aaron Mendelsohn

Ohio’s Medical Marijuana Task Force (“Task Force”) continued to hear testimony on Thursday, February 25, 2016, as eleven individuals provided their thoughts related to medical cannabis in Ohio.  Most of the testimony was from proponents of medical cannabis, while one opponent, Captain Jeffrey Orr of the Trumbull County Sheriff’s Office, and one interested party, Dr. Anup Patel of Nationwide Children’s Hospital and The Ohio State University College of Medicine, offered alternative perspectives.

Dr. Patel’s testimony was of particular interest to the Task Force, as it lasted over forty-five minutes and included an open dialogue between Task Force members and Dr. Patel regarding his clinical studies using purified cannabidiol (CBD) compounds to treat severe epilepsy in children.  Dr.  Patel stated that the clinical studies he is leading at Nationwide Children’s Hospital are one of only two such studies sanctioned by the U.S. Food and Drug Administration (FDA) for CBD use to combat epilepsy in children.  Early indicators from his study suggest that CBD could reduce seizure frequency and has an adequate safety profile. Dr. Patel stressed that his research on the use of purified CBD extracts is different than that of “whole-plant” applications of medical cannabis, which he says have not received the same FDA review as CBD-only studies.  Dr. Patel’s research, along with others in the scientific community, seeks to determine the efficacy of purified CBD treatments (which contain none of the psychoactive ingredients in whole-plant medical cannabis), and Dr. Patel urged the Task Force to be cautious in crafting a legislative framework that legalizes anything without adequate scientific research to support its use.  Later testimony challenged some of Dr. Patel’s assertions, noting that the dearth of FDA sanctioned studies on whole-plant applications of medical cannabis is a direct result of the plant’s status as a Schedule I controlled substance under the Controlled Substances Act.

Of the evening’s proponent testimony, Dr. Michelle Price, a Dayton pharmacist, and Tamara Dietrich, of Scottsdale, Arizona’s Beacon Information Designs, provided particularly  interesting perspectives.  Dr. Price spoke at length about the historical use of medical cannabis in the US prior to its prohibition, the US Department of Health’s patent on medical cannabis, and some of the global research done on the endocannabinoid system.

Ms. Dietrich offered expertise regarding the need for a strong regulatory structure supported by information systems to track and maintain the entire medical cannabis system and infrastructure. Beacon Information Designs has done extensive research on this subject for the State of Arizona, and Ms. Dietrich provided the Task Force with much of this information, as well as offered her own opinions on which state regulatory structures have been successful.  For example, Ms. Dietrich spoke about her home state of Arizona’s lack of required testing, and the issues it has caused within the medical cannabis supply chain.   She also spoke about the perceived unfairness behind provisions of the Nevada medical cannabis law that only permit “homegrown” cannabis for patients who live twenty-five miles from a licensed dispensary.  Task Force member Lora Miller (Ohio Council of Retail Merchants) engaged Ms. Dietrich in dialogue regarding whether Ohio should have physician education requirements for recommending medical cannabis to patients, similar to laws in Maryland or New York.

Captain Orr’s opponent testimony began with him holding two bags of police-seized cannabis representing the two maximum weights for the two lowest misdemeanor criminal charges for possession of cannabis in Ohio.  The gesture grabbed the Task Force’s attention, and at times Captain Orr’s testimony took the tone of a cross examination as Task Force member Chris Stock (Markovits, Stock & DeMarco) probed Captain Orr regarding his proffered knowledge of an increased black market for cannabis in states that have recreation cannabis use.  After a repeated line of questioning by Mr. Stock, Captain Orr admitted to having never visited or raided dispensaries in any of these states but stated that he had worked with law enforcement joint-task forces in those states to bolster his testimony.

Of all the proponent testimonies, the most impactful may have come from the night’s last, as Patrick Rogers of Dayton limped to the podium to offer his heart wrenching story.  As a young cancer survivor, Mr. Rogers discussed how he traded being cancer free for a life of bone disease and other various painful afflictions that he said was caused by his cancer radiation treatments. He articulately spoke on how his personal use of medical cannabis has allowed him to walk relatively pain free, maintain a 40 hour a week job, and be a productive, tax paying citizen of Ohio.  Without access to medical cannabis, Mr. Rogers said he would be unable to move and provide for his family, and urged the Task Force to permit legal home grown medical cannabis.

The Task Force is off the week of February 29, but will resume with its final three sessions on Thursday, March 10 at 7 p.m., Thursday, March 17 at 3 p.m., and Thursday, March 31 at 3 p.m..

The Benesch team will continue to provide detailed analysis and comprehensive coverage of Task Force meetings and on-going developments surrounding the issue.

The Proponent Testimony Goes Unrefuted As Renowned Physician Dr. Sue Sisley Highlights The Testimony Of Ten Witnesses Before The Medical Marijuana Task Force

By Ted Bibart, Legislative Analyst[1]

Thursday, February 17, 2016, was the first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”), which heard a full complement of testimony, all in support of legalizing medical cannabis. The Task Force, chaired by State Representative, and physician, Dr. Steve Huffman (R-Tipp City) in the absence of Rep. Kirk Schuring (R-Canton), announced it was by mere coincidence that all ten witnesses would offer proponent testimony and that no witnesses had scheduled to come forward against medical cannabis.  With three Task Force meetings in the books, it is safe to say that while the lack of opposition testimony is certainly not intentional on the part of the Task Force, it is certainly not a mere coincidence in the face of mounting evidence substantiating the medicinal value of cannabis and its beneficial uses to Ohio patients in need.  After carefully scrutinizing over 3.5 hours of testimony, as well as subsequent, individual discussions with Task Force members and witnesses alike, the following represents the most salient points and analysis from the medical testimony offered at the third Task Force meeting.

Two well-respected medical doctors came forward to offer their proponent testimony. Dr.  Matt Noyes, M.D., an orthopedic surgeon from northeast Ohio, testified in support of the many medical uses for cannabis in post-operative care.  Dr. Noyes attested to the many patients who do not want to take narcotics in recovery from the surgical procedures he regularly performs, as well as the corresponding benefits, and reduced morbidity, of cannabis treatments.  Support for this course of treatment comes both from cannabis’s medicinal value in reducing symptoms resulting from acute pain, as well as its anti-tumoral and anti-inflammatory properties.  Dr. Noyes called for a robust regulatory scheme beyond what was historically utilized in California, and stated that the major universities and medical institutions Ohio is renowned for should be allowed to excel in the medical research that would surely uncover additional medicinal benefits of herbal cannabis and its chemical compounds.  The regulatory questions continued to pile up from the Task Force members as Larry Moliterno (Ohio Alliance of Recovery Providers), Dr. Brian Santin, Jimmy Gould (Responsible Ohio), Matt Lutz (Muskingum County Sheriff), and  Lora Miller (Ohio Council of Retail Merchants) all asked Dr. Noyes specific policy questions that the doctor could not fully address.  While Dr. Noyes could fully opine on the medicinal value of cannabis, he readily admitted his lack of expertise as to the appropriate regulatory response.

Yet, Dr. Sue Sisley, M.D., an acclaimed Arizona physician practicing for 20 years in internal medicine and psychiatry, possessed the requisite firsthand experience to address the full range of medical and regulatory questions. Dr. Sisley’s comprehensive expert testimony was grounded in her experience as principal investigator for the only FDA-approved controlled trial studying whole-plant inhalation therapy for combat veterans with chronic, treatment resistant Post Traumatic Stress Disorder (“PTSD”).  Dr. Sisley is the foremost national expert in medical cannabis, having worked with legislatures in Nevada, Maryland, Arizona, Washington, Hawaii, Utah, Minnesota, New York, Vermont, and Washington D.C. in considering not only the medicinal benefits of cannabis, but the best regulatory solutions serving patients in need.

Dr. Sisley presented voluminous amounts of testimonial and documentary evidence submitted into the Task Force record.  Her overwhelming medical expertise in the area, and the persuasiveness of the scientific evidence she provided, allowed the Task Force members to fluidly move the conversation toward Dr. Sisley’s credentialed, personal experience with state regulatory responses to legalized medical cannabis.  Dr. Sisley answered one of the Task Force’s most burning questions, by pointing out that Arizona’s success since 2010 in regulating cannabis has limited its use to medicinal purposes and not allowed it to veer into recreational use.  Dr. Sisley also pointed out that Arizona’s law was passed by general election through a ballot initiative, which decreases the legislative ability to revise the law, and resulted in challenges such as a lack of laboratory testing requirements.  On the other hand, states like Maryland have passed, through their general assemblies, superior laws that have far more robust regulatory schemes including elements such as access to whole-plant materials, self-titration, lab testing, and packaging standards.

The regulatory questions soon dominated the conversation, as Rep. Huffman was particularly interested in how proactive legislation could positively impact further scientific studies. Rep. Huffman himself pointed out the successful trials in Europe and the fact that current research has moved beyond Phase I clinical trials focusing on safety, and into the more advanced Phase II trials focusing more on the range of beneficial uses. Dr. Sisley concurred and detailed how the current federal position is inhibiting the FDA-approved studies and it would be at least three more years before peer-reviewed studies would be published.

Former Ohio Attorney General Betty Montgomery inquired as to the best regulatory approach to cultivation, processing, and distribution, to which Dr. Sisley has intimate, practical knowledge based on the extensive reach of her practice in Arizona. She recommended the vertically integrated licensing system utilized in Arizona which effectively manages, through extensive regulation, over 60 grow-sites, 90 dispensaries, over 500 “caregivers” (who are designated by patients to help assist in the administration of the medical cannabis), and home growing for patients who qualify.

Mr. Gould inquired as to which states have the best and worst medical cannabis laws. Dr. Sisley is uniquely positioned to answer the question due to her involvement in the legislative process of the states in question, responding that Minnesota and Utah have particularly ineffective laws because the regulatory schemes inhibit patient access to cannabis treatment. Therefore, Minnesota only has approximately 1000 patients with access to the medicine, and the black market continues to thrive.  Furthermore, Utah patients have virtually no effective means of access and as a result simply cross the border to Colorado to obtain cannabis for medicinal use. What’s more, Utah’s ineffective legislative response continues to keep the state at or near the top of the highest rate of opiate overdoses in the nation.

One of the Task Force members then pressed Dr. Sisley on the large percentage of patients who use medical cannabis for chronic pain, asserting that those patients are abusing the system for recreational purposes. Dr. Sisley acknowledged that while that may be the case in isolated circumstances, just as it is in other treatment modalities, confirmed studies have shown that in the 23 states that allow medicinal cannabis, opiate overdose rates are down 25%.  Furthermore, there is not a single documented case of medical or recreational cannabis overdose.  As in every intersection between medical care and regulatory oversight, physician integrity must be relied upon as the first defense.  Furthermore, in the medical cannabis states which have robust regulatory schemes, there is no evidence that state medical boards and patient advocate groups are not effectively responding to the challenges presented.

Finally, Dr. Santin asked a particularly poignant question of Dr. Sisley (paraphrased here): removing the social stigma of cannabis and its propaganda reflected in the history over the last century, what is your medical opinion as to its proper schedule classification? Dr. Sisley, in step with every physician who has testified before the Task Force (as well as comments made by physician and Task Force member Rep. Huffman), opined that the current classification of cannabis as a Schedule I drug with no medicinal value is “absurd.”  Dr. Sisley pointed out that it is the Drug Enforcement Agency (“DEA”) and not doctors who decide that classification.  With the medical side-effects so benign, even with the inhalation of plant-based treatments as recognized by the FDA allowance of the current trials administered by Dr. Sisley, and addiction levels no higher than that of caffeine, the current federal schedule is neither supported by hard science nor sound policy.

The proponent medical testimony, yet to be refuted before the Task Force, has now framed the discourse not by how valuable medical cannabis is in treating a whole range of illnesses, but by how best to regulate its use. The perspectives on a robust regulatory scheme that are emerging paint an optimistic picture for those Ohio patients in need.  Similarly, the optimism for the emerging markets in support of the industry, and its regulatory framework, are just as well-founded.

[1] Ted Bibart, and the Benesch team, will continue to provide detailed analysis and comprehensive coverage of Task Force meetings and on-going developments surrounding the issue.

Local Government Officials And Patient Advocates Alike Line Up To Offer Proponent Testimony At The First Evening Session Of The Medical Marijuana Task Force

By Ted Bibart, Legislative Analyst[1]

The first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”) didn’t conclude until after 10.30 p.m., but the testimony was provocative and the questions illuminating. While our separate post focuses on the poignant medical testimony provided, and its intersection with regulatory solutions, this piece focuses on the most relevant anecdotal testimony provided by local government officials, as well as patient advocates whose personal insights provided a unique glimpse into the needs of Ohio citizens who could benefit from medical cannabis.

Blue Ash City Councilman Robert Ryan was the first of two local government officials to testify in favor of legalizing medical cannabis. As a retired aerospace systems engineer with a career in satellite and propulsion design, as well as a three-time cancer survivor and leader of the Ohio Patient Network (“OPN”), Ryan has extensive knowledge on both the medicinal value of cannabis and state regulatory solutions.  In fact, before returning to Ohio, Ryan was author of the Maryland Republican party’s medical cannabis resolutions that paved the way for an early medical marijuana bill signed by Maryland’s Governor.  After hearing his personal testimony regarding his use of medical cannabis to overcome his cancer symptoms, the Task Force was very interested in Ryan’s opinions as to the best legislative response to allowing Ohio in need access to cannabis.  Dr. Brian Santin in support of Ryan’s opinion as to the appropriateness of self-titration in dosing medical cannabis, drew a useful analogy to insulin self-management by diabetic patients.

Later, Franklin County Municipal Court Judge Ted Barrows testified in support of medical cannabis legalization. While Judge Barrows was more than willing to profess his belief that cannabis should be legalized beyond its medical uses, and managed, controlled, dispensed, and taxed similarly to alcohol, the Task Force limited his testimony to medicinal cannabis and Barrow’s professional opinion as to the immediate need for legislative action.  Judge Barrows captured clearly a theme often professed from Task Force members, and at the root of the committee’s purpose, which is to deeply contemplate legislative action before another ballot initiative goes before Ohio voters this November.  According to Judge Barrows, the main legal opposition to Issue 3, which failed to legalize both recreational and medicinal cannabis, was a constitutional amendment creating a state sanctioned oligopoly.  Therefore, legalizing medicinal cannabis through the state legislature would be the most appropriate and measured response to meeting the needs of Ohioans and crippling the black market.

Nicole Scholten with Ohio Families CANN (“OFC”) spoke on behalf of her own 12 year old daughter Lucy, and other Ohio families of children who could benefit from the verifiable, medicinal benefits of cannabis. Lucy suffers intractable epilepsy (meaning that it is drug resistant), enduring an average of 100 seizures a day.  According to Mrs. Scholten, no current treatment has eased the frequency or duration of her daughter’s seizure, an experience shared by roughly 1 million of the 3 million Americans with epilepsy.

As Scholten discussed the anecdotal evidence for Ohio families being forced to move to other states to seek medicinal cannabis therapy for their children, it was former Ohio Attorney General Betty Montgomery who first waded into the policy waters, away from the medical benefits of cannabis and into regulatory solutions allowing Ohio patients access to this much needed treatment. Montgomery was interested in Scholten’s opinion as to how to regulate medical cannabis to avoid its spread into recreational uses.  Dr. Santin then joined Montgomery’s regulatory inquiries by asking about OFC’s collective experiences in the realm of doctor-patient relationships and dispensary protocols.  Scholten provided her best anecdotal testimony from personal experience and that of other OFC families, but it is clear the ongoing regulatory questions of the Task Force will require comparative, statutory analysis from a policy perspective.

Patients, such as John Precup, and patient caregivers, such as Jean Taddie, testified as to the struggles of those in need of medical cannabis in the absence of responsible legislative action. Melissa Durkee provided heart wrenching testimony regarding her son Noah who is tortured by a treatment resistant form of Tourette’s Syndrome that has proven unresponsive to the 15 medications they have trialed to date. Mrs. Durkee testified that a dose of medical cannabis would reduce his tics and stabilize him enough to provide a vastly improved quality of life, as supported by the evidence of other patients in legal states using medical cannabis to treat this condition.

The testimony of all these witnesses, in conjunction with the scientific evidence presented by two respected medical doctors (including the foremost national expert on medical cannabis Dr. Sue Sisley, M.D. of Arizona), consistently advanced the discussion toward the regulatory framework necessary to support effective and controlled administration of medical cannabis to Ohioans in need. The questions of the Task Force clearly reflect a holistic approach to the policy implications at play with a focus on what is best for all of Ohio’s citizens.

[1] Ted Bibart, and the Benesch team, will continue to provide detailed analysis and comprehensive coverage of Task Force meetings and on-going developments surrounding the issue.

The Information Sharing Has Begun: First Testimony Offered Before The Medical Marijuana Task Force

By Ted Bibart, Legislative Analyst

The Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”) reconvened at the state capitol on Thursday, February 11, 2016, and once again members of Benesch were in attendance. The Task Force heard its first testimony regarding the medicinal value of cannabis, and the discussion was lively and well-informed.

The Task Force diligently quarantined the conversation to the medicinal virtues of cannabis, but regulatory considerations were ever-present in both the testimony and lines of inquiry from Task Force committee members. As the medical evidence in favor of the medicinal qualities of cannabis, and the corresponding benefits for Ohio patients in need, went uncontroverted, the Task Force often found itself willingly considering questions beyond the medical risks and rewards of cannabis-based treatments, and into perspectives related to a prospective regulatory scheme.

First, the National Multiple Sclerosis Society (“MS Society”) offered testimony, through its representative Holly Pendell, in hopes that the Task Force “will result in meaningful and responsible legislation allowing patients in need of cannabis, access in a safe and responsible manner.” The testimony came as part of the MS Society’s support of legalization of medicinal cannabis at both the state and federal level.  The MS Society has arrived at its position in support of legalized medical cannabis on the strength of numerous studies, “including one published in the American Academy of Neurology in March, 2014, ‘Summary of evidence: Complementary and alternative medicine in multiple sclerosis’” which showed medical cannabis “may lessen patient-reported MS symptoms.”  In fielding questions from the panel, Ms. Pendell made clear the synthetic forms of the chemical compounds in cannabis already approved by the Federal Drug Administration (“FDA”) were not sufficient, and the MS Society sought greater autonomy for patients and doctors in choosing medical cannabis treatment options.

Next, local business owner Andy Joseph of Apeks Supercritical, a manufacturer of botanical oil extraction equipment located in Johnstown, Ohio, presented a wide range of educated testimony on the subject.  With $12 million in revenues, 95% of which is generated by the legal cannabis industries across 20 states, Apeks was named by Columbus Business First magazine as #2 on its list of “Fast 50” companies in the state.  The Task Force allowed Mr. Joseph’s testimony to stray away from the virtues of medicinal cannabis and into the virtues of a robust regulatory scheme that promotes a healthy, stable medical cannabis industry in service of Ohio patients in need.  Topics such as testing, taxation, licensing, and product types were explored at length.  Here, State Representative Dan Ramos (D-Lorain) astutely inquired as to whether, and to what extent, the legislature should define and limit eligible conditions for treatment.  Mr. Joseph advocated for broad physician autonomy, as part of his over-all opinion as to what makes for an effective state regulatory scheme.

Next, Carlis McDerment testified on behalf of Law Enforcement Against Prohibition (“LEAP”), a national organization of “former and active police officers, prosecutors, judges and other law enforcement professionals.” Mr. McDerment was born and raised in Columbus, and is a former Fairfield County Deputy Sheriff with 11 years of law enforcement experience.  LEAP speaks out against the failed “war on drugs” in an effort to reduce the harms associated with the illegal market place.  The Task Force sharpened the focus of the discussion away from legalization of all drugs and to the value medical cannabis.  Here, McDerment spoke to his experience as a law enforcement officer and the benefits of “allowing patients to use medical marijuana in place of opiate painkillers,” also highlighting the toll prohibition of medical cannabis takes on the criminal justice system.

Next, Dr. David Ellison, owner and president of the Cincinnati Wellness Center, testified as to his extensive, and self-taught, knowledge of the medicinal qualities of cannabis and the industrial usefulness of hemp. Dr. Ellison lamented the current federal designation of cannabis as a Schedule 1 drug (above cocaine – a Schedule 2 drug), a perspective shared openly by Task Force member State Representative, and physician, Dr. Steve Huffman (R-Tipp City).  Dr. Ellison went on to describe how the “risk profile” of medical cannabis is actually lower than that of aspirin.  Rep. Huffman went on to have an extensive dialogue, and line of questioning, related to conceivable medical management practices of medicinal cannabis, similar to the standards of care already in place for prescription drugs such as Vicodin.  The Task Force was invigorated by Dr. Ellison’s testimony with additional questions coming from Dr. Brian Santin, Betty Montgomery, Jimmy Gould, and Linda Hondros.  Rep. Ramos asked a particularly elucidating question of Dr. Ellison to compare the addiction profiles of medical cannabis versus any prescription drug in the opiate classification.  Dr. Ellison resoundingly opined that medical cannabis has a far lower incidence or consequence of addiction than any opiate.

Finally, poignant testimony came from the last three witnesses scheduled to testify. First, attorney and former Air Force serviceman Michael Brice Keller testified to his personal experience using cannabis in treatment of his PTSD symptoms that resulted from his service in combat.  Lastly, Corrine Gasper and Nancy Vincent both spoke on behalf of their loved ones who were killed in traffic accidents by individuals allegedly under the influence of marijuana.  The Task Force was obviously moved by the personal stories of all three, and the fullness of its responsibilities in addressing this question on behalf of all citizens of Ohio.

Benesch will continue to have an extensive presence before the Task Force, with a keen eye toward the development of underlying policy initiatives and concerns. While the current focus of the Task Force seems to be in step with its stated goal of information gathering as to the medicinal virtues of cannabis, the statutory and regulatory considerations are always flowing below the surface and invariably percolate to the top of both the testimony and questions from the Task Force.  Benesch will be there to monitor these trends, with a forward-looking view to legislative solutions and emerging markets.