A Rhode Island decision to expand medical marijuana access has a worrying caveat for many in the CBD industry: Patients must first try an FDA-approved version of the drug.
That classification by the Food and Drug Administration is currently limited to Epidiolex, an epilepsy treatment made by United Kingdom-based pharmaceutical manufacturer GW Pharmaceuticals.
Rhode Island’s health department approved the use of MMJ to treat some patients with severe manifestations of autism spectrum disorder – after a group of parents filed a petition with the state requesting the change.
But first, patients would have to show that their physicians used an FDA-approved CBD treatment before recommending medical marijuana therapy.
“Doctors will be required to first try a new, FDA-approved cannabinoid medication,” agency spokesman Joseph Wendelken wrote to Hemp Industry Daily in an email.
The patients must also stop MMJ use if the doctors don’t see improvement.
Wendelken said the requirement to first try an FDA-approved version of CBD is “to ensure that patients are being treated safely.”
Epidiolex was approved for the treatment of epilepsy, not autism, though doctors can legally prescribe FDA-approved medications for other ailments.
Rhode Island had no estimate on the number of patients it believes will try MMJ for autism treatment, and the provision makes no mention of age restrictions for application.
“Our aim was to give parents and doctors this additional treatment option for this very specific patient population, while also ensuring that appropriate safeguards and protections are in place,” Wendelken wrote.
Epidiolex contains very low levels of THC, though its CBD is extracted from marijuana plants grown in the U.K.
GW Pharma has said Epidiolex will cost $32,500 a year, though it is not yet clear whether health insurers will cover the drug.