As a governor-appointed member of the Maryland Cannabis Public Health Advisory Council, many of my colleagues have asked for my thoughts on what will happen next with the rescheduling of cannabis from Schedule I to Schedule III in the Controlled Substance Act (CSA). As a physician who integrates medical cannabis into my patients’ treatments, I do welcome this change as an important step forward, but the journey is far from over.
The Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and the Department of Justice now (DOJ) all agree that cannabis has accepted medical use. Therefore, it cannot remain a Schedule I substance, which by definition states there is no accepted medical use. Last month, DOJ proposed a new rule that would reclassify the drug as one with “moderate to low potential for physical and psychological dependence,” such as ketamine, anabolic steroids and testosterone. This is a milestone that medical professionals and patients have been striving toward for over 50 years.
But while rescheduling may validate my patients’ experiences utilizing cannabis as a “medicine,” it is not technically a medicine under U.S. law. A change in cannabis’ classification alone won’t change that fact.
Only FDA-approved drugs are considered “medicine” in the United States. Last year, the FDA issued clinical research draft guidance for the cannabis industry and pointed product developers to their 2004 “Guidance for Botanical Drug Development” protocols to develop cannabis medicines. However, this avenue for drug approval was not designed for complex herbal medications like Cannabis, which contains hundreds of active compounds. In fact, only two drugs have been approved using the FDA’s botanical protocols; both were single compound formulations extracted from plants and neither was cannabis derived.
This roadblock and the prohibition of cannabis is what pushed patient advocates toward states for protections and legal access in the first place. State medical programs have always operated outside federal laws, and they will continue to do so even if cannabis is rescheduled. Rescheduling cannabis will not make the cannabis my patients currently obtain federally legal nor will accessing these products require a prescription.
After rescheduling, my patients will still obtain their medical cannabis outside federally regulated systems, unable to access it affordably through insurance. Interstate travel will remain problematic, and patients in states without medical cannabis laws will still lack access. Consistency, safety and quality issues with medical cannabis products will persist, a crucial problem for treating serious conditions. Cannabis will still be prohibited for my patients requiring inpatient hospice services or hospitalization after surgery.
Rescheduling will not address the safety concerns I have for my patients accessing cannabinoid products from the unregulated hemp market. Nor will it give FDA the regulatory pathway they need to regulate these products “legalized” through the 2018 farm bill. That means my patients will continue to have access to potentially dangerous “hemp-derived” cannabinoid products without knowing if they contain synthesized compounds, pesticides, contaminants or residual solvents.
While the rescheduling process is moving forward, Congress is currently debating amendments to the Hemp Authorization Act in the farm bill, aimed to close “loopholes” that created this market of unregulated hemp-derived cannabinoid products. This will not address the needs of patients who are forced to utilize these products because they live in the wrong ZIP code or they are seeking cannabis products no longer available now in adult-use markets.
That is why I am urging Congress to scrap these piecemeal approaches to medical cannabis policy reform and take a comprehensive approach that would eliminate the need for loop-holes and integrate cannabis into our health care systems like the Medical Cannabis and Cannabinoid Control Act being proposed by Americans for Safe Access (ASA).
ASA proposes the creation of a new schedule for cannabis and cannabinoids, calling it Schedule VI, and a new agency under HHS — the Office of Medical Cannabis and Cannabinoid Control (OMC) — to oversee the new schedule. The OMC would coordinate state and federal medical cannabis laws, and enforce national safety and quality standards for medical cannabis products, benefiting patients and allowing for meaningful reproducible quality research that can then lead to clinical guidelines for treatment.
Congressional leadership is needed to ensure that all patients in the United States will have access to medical cannabis regardless of where they live. It will help ensure they have employment, housing and health care rights. A Schedule VI designation would remove federal penalties for medical cannabis possession and would bring the U.S. into compliance with the U.N. Commission on Narcotic Drugs, which already recognizes cannabis’ therapeutic values.
While rescheduling cannabis is progress, it doesn’t solve the critical issues of accessibility, affordability and safety for patients. Establishing a new Schedule VI and an Office of Medical Cannabis and Cannabinoid Control is essential to creating a coherent, patient-focused cannabis policy. Our patients’ health and well-being must be the priority in federal cannabis policy reform; my patients deserve more from Congress.
Dr. Leigh Vinocur (info@ananda-medical.com) is a board-certified emergency physician with a master’s degree in medical cannabis science and therapeutics. She chairs the provider education committee on the Maryland Cannabis Public Health Advisory Council and has a monthly column, “Ask Dr. Leigh” in the Hearst publication GreenState.com, where she answers readers’ questions related to medical cannabis.
