Dear Majority Leader Schumer, Senators Booker and Wyden:

The below signed stakeholders are collectively parties that have an interest in or work with medical cannabis. We are committed to ensuring qualified physicians administer sound medical cannabis advice, that patients have access to high-quality, safe cannabis medicines, and that appropriate regulatory oversight is implemented to protect the integrity and value of cannabis medicine.

We have joined together in this letter to provide comments in response to the Cannabis Administration and Opportunity Act, Discussion Draft (the ‘Draft’).

To read the pdf version of this article, click here.

We appreciate the excitement and opportunity in designing federal oversight for the cannabis plant. The Draft has been touted as legislation that would address the social harms from the plant being a scheduled substance, yet the Draft wholly failed to address medical cannabis and the needs and rights of medical cannabis patients.

We view health care and access to medicines as a critical means to the preservation of care, and every person, regardless of race or background, should have access to both medical cannabis products and healthcare professionals who are trained in the medical applications of cannabis.

We offer the following concepts for your consideration on how to appropriately address medical cannabis to ensure all patients have uninterrupted access to cannabis medicine.

Conceptually and from a macro perspective, we propose a distinct regulatory pathway for medical cannabis. A pathway that coexists yet is independent of recreational cannabis and the conventional pharmaceutical paradigm. We believe this can absolutely be achieved and will improve patient care without compromising patient access or safety. More specifically, the infrastructure of this pathway would include:

Use of a Prescription

• Medical cannabis should be prescribed via a prescription that is issued by a cannabis specialist or qualified physician to effectuate a treatment plan. A prescription for medical cannabis should bear significant resemblance to any other prescription written by a physician. Prescriptions serve to hold physicians accountable in their role in a patient’s health, and just as important, provide patients adequate information on and instructions of use for the cannabis medicine to improve patient outcomes.

• While acknowledging the depth of the existing research on medical applications, ACS supports the continuation of timely, efficient and patient centric research. Discoveries from these efforts will further refine the accuracy in prescribing medical cannabis for multiple medical conditions.

• Of supreme importance, dispensing agents and companies must be required to fill this prescription as written without alteration or “up-selling”. The use of a prescription serves as a harm reduction measure by preventing the derailment of the treatment plan by the medication seller and also by instructing patients on the most effective and safest way to use their cannabis medicine.

Harmonized National Standards

These standards would serve as a federal baseline for states and product developers to look to that would ensure consistency and appropriate controls, again to ultimately serve the patient’s interests. The standards would include:

• standards for medical claims, advertising and the labeling of medical products; this must include a national moratorium on salespersons (aka budtenders) giving medical advice to any purchaser, whether purchasing via medical or recreational markets.

• appropriate evidence-based standards unique to cannabis medicine. The Draft presently subjects medical cannabis products to the FDA pharmaceutical approval pathways, one with no account for the progress made and existing cannabis medicines developed under the state medical cannabis programs. This leap would be catastrophic for patient access and may unnecessarily delay continued access to medical cannabis products, especially for communities with limited means. The medical cannabis pathway, as proposed in these comments, would require the FDA to acknowledge a specific cannabis pathway for botanical and derivative products with appropriate controls to ensure quality, safety and efficacy.

• standards for the cultivation, harvest, manufacture and laboratory testing practices designed uniquely for cannabis medicine. There are standard-setting organizations that have done much of this work, such as the Patient Focused Certification (PFC) program at Americans for Safe Access, AOAC International, and the American Herbal Pharmacopoeia, all of which can be utilized to streamline this process.

Patients Can Travel with Medicine

Patients must be allowed to travel with their cannabis medication, including by air, within all U.S. states and territories, and use their medicine in same. All states must recognize a valid medical cannabis prescription (currently, an ‘order’ or ‘recommendation’) just as states do with other conventional medications.

Bridge Federal Oversight with State-Regulated Medical Cannabis Programs

The state-operated medical cannabis programs are currently serving millions of patients and these highly operational medical programs must be taken into account in designing federal oversight. Patients have been denied access to the cannabis plant for decades and the state initiatives corrected course by implementing robust programs to meet patient needs. The state medical cannabis programs are not without room for improvement – particularly around requiring and maintaining the sanctity of treatment plans; however, federal oversight should take into account and work with the state medical cannabis programs to best serve patients.

Data and Technologies

The availability of patient data is vast, and with appropriate controls and transparency – to the benefit of the patient and research efforts – these data can be invaluable. Federal oversight should be forward- thinking in how best to capture and utilize real-time data on the use of cannabis medicine to accelerate positive patient outcomes. Technologies that are available today are revolutionizing how to deliver care, track outcomes, and be more responsive in real-time.

Data is a currency and that holds value for the patient, a clinical practice, and for research purposes. At a minimum, federal oversight should have built-in mechanisms to allow a nimbleness to take advantage of modern data and technological advancements.

Conclusion

The above highlights key parameters to include in any federal oversight proposals or cannabis-related legislative packages. The cornerstones of a medical cannabis framework, as outlined in these comments, are designed for the preservation of care of current and future patients that use cannabis medicine. The role of cannabis as a valuable medicine and the importance of qualified medical professional guidance cannot be overlooked in any federal cannabis reform.

We hope you understand the pointed tone of this letter. The gravity of proposing a descheduling of the cannabis plant without proper consideration for the medical pathway will create great vulnerabilities and uncertainties for the millions of patients that rely on medical cannabis. We appreciate the opportunity to provide these comments in response to the Discussion Draft and are eager to have conversations to more fully discuss the above concepts and concerns.

Sincerely,

Debbie Churgai, Executive Director, Americans for Safe Access

Dr. Jordan Tishler, President, Association of Cannabinoid Specialists

Please see comments submitted independently by Association of Cannabinoid Specialists below for additional information.

Legislative Priorities

As Congress works to advance comprehensive cannabis reform, the Association of Cannabis Specialists (ACS) advocates to ensure patients will have access to appropriate medical care and high quality, safe cannabis medicine. Patients have been denied access for decades and modern-day access remains insufficient to meet their needs. With a true appreciation for the infrastructure of the various state medical models and a deep expertise in the benefits and shortcomings of the current state systems, ACS offers the following foundational considerations for federal legislation.

The use of prescriptions in administering the medicine and appropriate national standards are top priorities for ACS. The broader implications from these requirements prove many.

Use of PRESCRIPTIONS

By requiring practitioners to write a prescription for medical cannabis, the physician is held to account on their role in the patient’s health. The use of prescriptions also further secures two distinct regulatory pathways for cannabis. Medical cannabis and recreational use should remain separate to ensure patients have access to qualified medical practitioners, and cannabis medicine is subject to strict quality controls.

Establish HARMONIZED NATIONAL STANDARDS

Of most concern is the necessity for appropriate controls on medical claims, which can be achieved through national harmonized standards. To build greater integrity into a national medical cannabis system, limitations must be placed on medical claims made about products available in both the medical and recreational systems. Harmonized standards would also benefit other areas within the cannabis industry; however, ACS is most concerned with standards for medical claims and the labeling of medical products.

Additional Important Considerations

Patients must be allowed to travel throughout the U.S. with their medicine; hence, all states must recognize a medical cannabis prescription (currently, an ‘order’ or ‘recommendation’) that was issued
in compliance with a state regulation just as states do with other conventional medications.

Systematic data tracking of usage, patient conditions, and patient outcomes. This requirement starts with the physician tracking data within their respective practice, and graduates to anonymized national data for research and trend detection.