The Food and Drug Administration (FDA) is introducing new draft guidance to speed up the approval process for oral CBD medications.
The FDA said researchers who wish to submit abbreviated new drug applications (ANDAs) for CBD products can, under certain conditions, request a waiver of an in vivo bioequivalence study. This waiver is used for potential new drugs that are largely the same as an existing authorized medication on the market.
The FDA’s move comes more than two years since the agency approved its first marijuana derived medication. The 100 milligram solution, Epidolex, was manufactured by GW Pharmaceuticals and underwent a lengthy approval process before being given the green light.
If the FDA’s draft guidance comes into force, other drug companies developing oral CBD medications could bypass some of the requirements met by GW Pharmaceuticals in producing Epidolex, which is used to treat rare, severe forms of epilepsy. To skip the in vivo bioequivalence study step, the proposed CBD medication must derive from hemp, contain no more than 0.1 percent THC and “contain no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”
The draft guidance stipulates researchers must demonstrate CBD medication is derived from hemp using “appropriate analytical methods” such as DNA bar-coding and macroscopic or microscopic analysis. The draft guidance also states the hemp must be collected using “established good agricultural and collection practices (GACPs)” to ensure consistency across research investigations.
The FDA’s move is the latest in a series of proposed changes to hemp regulations brought forward by lawmakers and federal agencies since hemp was legalized across the US through the 2018 Farm Bill. The FDA has been busy over the past year crafting streamlined CBD regulations that would see the marijuana-derived compound classed as a dietary supplement, with a separate public comment period on this topic closing recently. Meanwhile, lawmakers introduced a bill that would legally define CBD as a dietary supplement, since the FDA’s process to do so could take years without legislative action.
In a separate move, the FDA announced a virtual public meeting in November on gender and sex differences in CBD’s use and responses.
While the FDA’s action on CBD regulations is perhaps not as comprehensive as marijuana reform advocates may have hoped for since the 2018 Farm Bill and Epidolex’s approval, it’s nonetheless striking that a federal agency is working at all to facilitate the production and marketing of drugs derived from the marijuana plant while it remains federally prohibited. The FDA put its new draft guidance on the approval process for oral CBD medications up for public comments until November 23.