The U.S. Food and Drug Administration has introduced new draft guidance that could speed up drug approvals for oral CBD medications.
Last week, the federal agency said it’s opening up a public forum to take feedback from industry researchers to support abbreviated new drug applications for cannabidiol solutions.
To accelerate approvals, the FDA said companies can request a waiver of an in vivo bioequivalence study, which is normally used by the agency to test whether a proposed pharmaceutical drug is the same as a product on the market.
That means a drug company, if it meets certain requirements, wouldn’t have to undergo the same rigid approval process as Epidiolex, the CBD epilepsy medication produced by GW Pharmaceuticals (Nasdaq: GWPH) that was approved two years ago by the FDA.
If the draft guidance moves forward, companies looking to produce generic versions of 100 milligram CBD solutions similar to Epidiolex would have to follow specific rules to bypass the bioequivalence study. The new CBD solution would have to be derived from hemp, contain 0.1 per cent THC or less, “and contain no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”
Applicants need to prove they used accepted rigorous analytical methods to determine the CBD medication contains only hemp.
“Due to the many cultivars within this species, identification and authentication of plant species should be conducted at the cultivar level if the potential cultivar will be used as a natural source,” the FDA said.
Companies will also have to follow good harvesting procedures to ensure batch-to-batch consistency is high.
The public comment period for the FDA’s draft guidance will stay open until Nov. 23.
The federal agency recently closed a separate public forum for draft guidelines on cannabis-related clinical research and developing drugs containing hemp-derived compounds.
While the FDA is cautiously moving to open up the market for CBD-based drugs, industry stakeholders are still awaiting guidelines for a wider variety of CBD products like infused supplements, food and drink.
Major Canadian cannabis firm Canopy Growth Corp. (TSX: WEED), which recently launched a CBD line in the U.S. with Martha Stewart, expects the FDA to soon come up a with a solution for the industry.
The company has also hedged its bets by lobbying federal lawmakers on Capitol Hill who could veto the FDA and provide a legislative solution for CBD through its classification as a dietary supplement.
Earlier this month, a pair of U.S. House Representatives introduced a bipartisan bill to allow CBD and other hemp-derived products to be sold as dietary supplements.
The legislation, sponsored by Democrat Kurt Schrader and Republican Morgan Griffith, is part of the ongoing effort to clear up confusion on hemp and its derivatives since both were legalized under the 2018 Farm Bill.
“Hemp was historically an important crop for Virginia farmers, and dietary supplements made from it do not possess dangerous addictive qualities,” Griffith said in a statement. “Nevertheless, the current state of regulation creates confusion about its legal uses. I joined this bipartisan bill to provide certainty for hemp farmers that their crop may find legal uses.”
If the U.S. government issues regulations in a reasonable timeframe, cannabis market trackers at Brightfield Group estimate the country’s CBD market could reach US$16.8 billion by 2025.
Top image via Deposit Photos