ACS Comment to DEA Rescheduling Rule

Drug Enforcement Agency

The Association of Cannabinoid Specialists (ACS) is an international non-profit organization of physicians and other health professionals specializing in using cannabis or cannabinoids, as appropriate, for the care and treatment of patients suffering from a range of debilitating conditions such as cancer, Crohn’s disease, AIDS, multiple sclerosis, Parkinson’s disease, epilepsy, autism, and post-traumatic stress disorder, and patients with terminal illnesses.

We have unique training and expertise in the endocannabinoid system and the appropriate use of cannabinoids for specific medical purposes.

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Medical Professionals on the Forefront of Cannabinoid Medicine

As medical professionals dedicated to the safety, well-being, and relief from suffering of our patients, we welcome the Drug Enforcement Administration’s (DEA) proposal to reschedule marijuana to Schedule III. We believe rescheduling is a long overdue first step on the path we must take to align federal policy with scientific evidence and state laws and realize the promise of evidence-based cannabinoid medicine for American patients.

Accepted Medical Use of Cannabis

We strongly support the findings of the Department of Health and Human Services (HHS) that marijuana has a currently accepted medical use (CAMU),[1] which are consistent with our own years of professional experience advising and successfully treating patients needing cannabis as medicine.

Department of Health and Human Services

We urge DEA to consider the substantial scientific and medical expertise HHS brings to its evaluation of the preclinical, clinical, and epidemiological data that support the CAMU finding, and HHS’s lead role within the federal government in fostering sound science and improving public health and safety.

Fostering Research and Development

ACS values and advocates for rigorous scientific investigation of the therapeutic potential of all cannabinoids and other cannabis derivatives to improve public health and ensure that patients have access to a broader array of treatment alternatives.

We care for patients for whom current pharmaceutical products have proved inadequate to combat debilitating diseases and painful conditions, and for whom a particular cannabinoid formulation and dosage is a lifeline to maintaining daily function. We seek a science-based medical and regulatory environment in the U.S. that incentivizes research and development of cannabis-derived compounds.

Cannabis research

We urge DEA to clarify, in the final rule, that the procedures applicable to Schedule III, IV, and V in 21 U.S.C. § 823(e) will govern marijuana manufacturing registrations upon rescheduling so as to lower the current barriers to research and spur greater public and private investment into researching the endocannabinoid system, the biochemistry of cannabis, and the sound development of more precise medications based on this research.

It is crucial that Americans coping with the burden of disease and disabling conditions have access to scientifically informed, holistic, and person-centered cannabinoid medicine as part of a comprehensive plan of care.

We urge DEA to finalize the rescheduling of cannabis. It is our hope this will provide an opportunity to engage medical dispensaries, patients, and clinicians in developing and adhering to plans of care that reduce risk, maximize the benefits of cannabinoid-based medicine, and improve patient outcomes.

Moving toward a Prescription Model

State-licensed medical practitioners currently can only recommend, not prescribe cannabinoid products for their patients, except in the limited case of plant-derived cannabidiol and certain synthetic cannabinoids.[2] We appreciate that clinical trials with a botanical product present unique challenges and will take time and the investment of substantial resources.

In the meantime, however, it is important that today’s medical cannabis patients have access to the specific cannabis formulations, dosages, routes of administration they need.

The current state-licensed dispensary model has developed because of the longstanding gulf between state and federal law concerning marijuana. While prescriptions continue to be required for FDA-approved drugs (including controlled substances), we recommend that DEA consider ways to afford medical cannabis patients health, safety and regulatory oversight protections similar to those available to patients to whom Schedule III drugs are routinely dispensed by pharmacies as prescribed by a medical practitioner.

Dispensary

For example, a cannabis recommendation submitted to a medical cannabis dispensary should include, as with a prescription for an FDA-approved drug, date of issue, patient-identifying information, clinician-identifying information, cannabis product name (and possible alternatives if the product specified is not available at the dispensary), relative amounts of THC and other major or minor cannabinoids, dosing instructions, quantity limits, limits on refills, and prescriber signature.

Dispensaries Must Fill Prescriptions as Written

Similarly, dispensaries should be accountable for and limited to filling these prescriptions as written. Regulatory recognition of the need for a prescription process paralleling the pharmacy model, in this context, would help ensure that cannabis-derived products are recommended, administered, and dispensed for a legitimate medical purpose in the usual course of a practitioner’s professional practice, as we progress toward integrating cannabis medicine with conventional medicine.

The ACS appreciates the opportunity to provide the above comments and recommendations. We would be pleased to answer any questions you may have. Please contact Jordan Tishler, MD.

Sincerely,

Jordan Tishler, MD

President, Association of Cannabinoid Specialists

Harvard Medical School


[1] See generally “HHS, Basis for the Recommendation to Reschedule Marijuana to Schedule III of the Controlled Substances Act” (Aug. 29, 2023), https://www.dea.gov/sites/default/files/2024-05/2016-17954-HHS.pdf.

[2] Cesamet (nabilone, a synthetic cannabinoid similar to tetrahydro cannabidiol or THC), Epidiolex (a plant-derived cannabidiol), and Marinol (dronabilone, a synthetic THC), have been approved by the U.S. Food and Drug Administration (FDA) for certain indications.