FDA Approves CBD-Based Drug

Today the US Food & Drug Administration announced approval of the first legal cannabis-based drug. The drug, GW Pharmaceuticals’ Epidiolex, which will be prescribed to treat severe seizures caused by Dravet syndrome and Lennox-Gastaut syndrome, will be offered in liquid form and will not contain any THC, which is the psychoactive part of the plant. FDA Commissioner Scott Gottlieb warned the public should not read too much into this. “This is an important medical advance,” he said. “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.”

The FDA ordered that Epidiolex be removed from Schedule 1 status as a very dangerous drug under the Controlled Substances Act (CSA) and be considered legal nationwide subject to a medical prescription. Actions like these may assist the efforts of those behind a constitutional challenge to the CSA as it relates to cannabis. Part of their argument for descheduling cannabis is that its medical benefits have been demonstrated, therefore it cannot be continued as a Schedule 1 drug, since they must have no discernible medical benefit (such as heroin or LSD). While the case was dismissed on largely procedural grounds, the plaintiffs have appealed the decision.

Many in the cannabis industry report feeling a sense of forward momentum towards easing of federal restrictions on cannabis, with multiple bills pending in Congress to deschedule cannabis or implement “states rights” to ban federal enforcement against state legal actors. The Senate Majority Leader also has introduced a bill to legalize industrial hemp, and a majority of Americans now favor legalization according to recent polls. It appears this FDA move is another meaningful step towards control of cannabis regulation moving more to the states.

 

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