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And So It Begins: FDA Approves Epidiolex (CBD)

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And So It Begins: FDA Approves Epidiolex (CBD)

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Today the US Food & Drug Administration has approved the first cannabis-based medicine for prescription by physicians nationwide.

GW Pharmaceuticals’ Epidiolex is an oral solution of cannabidiol (CBD) that has been approved for treatment of two rare epileptic conditions known as Lennox-Gastaut syndrome and Dravet syndrome. You may remember the latter as the disease suffered by Charlotte Figi, the little girl in Dr. Sanjay Gupta’s first CNN documentary on medical marijuana who nearly eliminated her seizures by using cannabis oil.

Epidiolex won’t immediately be available to patients, because as FDA states (despite what CBD oil sellers will tell you), “Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance.”

But that will be changing. According to Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals that will sell the product, “Epidiolex must be rescheduled from its current Schedule I… expected to occur within 90 days.”

Legal Epidiolex may spell doom for the current sellers of CBD products, who often falsely market their products as “legal in all fifty states.” FDA Commissioner Scott Gottlieb in a statement explained that, “we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”

However, those states that have passed laws allowing for the possession of CBD oil would still protect patients who possess those non-approved products from state prosecution. It is unlikely the feds would spend resources prosecuting patients, but highly likely they’d make the effort to prosecute manufacturers and sellers in order to protect GW Pharma’s market for Epidiolex.

FDA’s guidance on use of Epidiolex contains some questionable claims. “As is true for all drugs that treat epilepsy,” FDA warns, “the most serious risks include thoughts about suicide….”

While it is wonderful that the US government has finally recognized a naturally-occurring component of cannabis as medicine (synthetic THC has been recognized for years), the pharmaceuticalization of cannabis threatens to return the power of healing to the health-care / insurance / pharmaceutical-industrial complex and out of the backyards and closet grows. If there are FDA-approved, federally-legal, insurance-covered cannabinoid medications on the shelf, how long before some more conservative states decide that there’s no need for these home-grown medical marijuana programs?

Patients, if you want to continue to enjoy growing your own medicine, you can no longer depend on that happening in a strictly medical marijuana program. Only legalization for all adults with guaranteed home grow rights will protect a patient’s right to treat themselves.

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