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US Regulators Propose New Rules for Cannabis-Based Medications

US Regulators Propose New Rules for Cannabis-Based Medications

For the first time, the US Drug Enforcement Administration (DEA) has proposed new rules that could make cannabis-based medications eligible for approval by the Food and Drug Administration (FDA). This move would significantly change the federal legal status of cannabis, shifting it from a Schedule I substance with “no accepted medical use” to a Schedule III substance, which is regulated as a medication.

The proposal has sparked debate among experts, with some questioning whether pharmaceutical companies will benefit from seeking FDA approval for cannabis-based drugs. According to Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego, the way legalization has occurred may discourage pharmaceutical companies from investing in cannabis research.

Grant notes that states have legalized cannabis, allowing it to be sold outside the federal regulatory system, making FDA approval less necessary. Jahan Marcu, author of “Cannabis Innovations,” agrees, stating that estimates suggest consumers already have millions of hemp- and cannabis-based products to choose from, making it difficult for drug companies to compete.

However, some pharmaceutical companies have already invested in medical cannabis research. In 2022, Pfizer acquired Arena Pharmaceuticals, which focuses on medical cannabis research. Dr. Peter Grinspoon, a physician and Harvard Medical School instructor, suggests that pharmaceutical companies may be motivated to join the cannabis industry as legalization gains momentum.

Despite the potential challenges, one company, Jazz Pharmaceuticals, has already had success with FDA-authorized Epidiolex, a pure form of CBD for rare seizures. The company is working to get the drug approved in other countries, including Japan.

The proposed rules have raised concerns that pharmaceutical companies may not fully understand the medical potential of cannabis if they do not invest in research. Grinspoon notes that the FDA approval process helps refine medications and make them more effective, potentially leading to more precise formulations of different cannabinoids.

While the proposed rules may not lead to a sudden wave of cannabis-derived drugs, they could pave the way for further research and development of cannabis-based medications.