Gottlieb: Epidiolex Approval Covers One Specific Cannabidiol Medication, Not Marijuana
The approval for the GW Pharmaceuticals drug covers the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two forms of rare and severe childhood epilepsy – the US agency was quick to clarify what the approval did not cover, chiefly marijuana.
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Rise in state-legalized marijuana helped pushed FDA to recommend more lenient regulation of the substance, easing pathway to prescription drug approval, but those same state markets may pose a challenge for commercialization of an Rx botanical if DEA follows through on rescheduling.
Research targeting botanicals generally, as well as cannabis, as potential APIs is increasing, a factor in CDER’s publication of cannabis trials guidance, the FDA’s Norman Birenbaum says in an interview.
FDA is formally asking Congress to weigh in on the best approach to regulate CBD in consumer products. That provides another target for legislative attention that may mean that FDA’s core drug regulatory activities stay comfortably out of the spotlight.