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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The public hearing on cannabis and cannabis-derivative products also included calls for Good Manufacturing Practices to be imposed.
FDA Road To Decision On Expanding CBD Uses Starts With Weighing Impact On Existing And Future Use As Drug
At public hearing, FDA officials starting with acting Commissioner Sharpless emphasized CBD is approved only as a drug and deciding on allowing its use in any other type of FDA-regulated product will be done with potential impact on drug development foremost in agency's thinking. Also apparent from questions 12-member panel of FDA officials asked was a potential regulatory pathway for clearing hemp and CBD as dietary ingredients will require resolving concerns about the substances' dose or concentration levels and establishing ingredient identity standards.
Legal dispute between FDA and Pharmanex decided in 1999 could be precedent for using hemp-derived ingredients including CBD in supplements, even though CBD already has been authorized for clinical drug evaluation and for use in a drug, says attorney Miriam Guggenheim.