John Schroyer
Long-awaited federal guidance on cannabis clinical drug trials for humans has finally arrived.
The guidance document from the U.S. Food and Drug Administration follows the 2018 federal legalization of hemp via that year’s federal farm bill, which removed cannabis with less than 0.3% THC by dry weight from the list of controlled substances.
The move could dramatically accelerate the value of the CBD industry, which has been waiting on the guidance, and it could also help the industry back up some of the health claims various companies have made, which got them warning letters from the agency.
“This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds,” the agency wrote.
The guidance is intended for the modern cannabis industry as many companies embark on the development of FDA-approved cannabis drugs for various medical ailments, an accomplishment thus far only achieved by GW Pharma with its drug Epidiolex.
Now, however, the FDA has made a number of clarifications, including that drugs made from hemp can be sourced from places other than the University of Mississippi, where the National Institute on Drug Abuse has been growing the only federally approved marijuana for research purposes.
The new guidance also gives researchers ways to calculate the THC differences between “hemp” and “marijuana” so as to not accidentally run afoul of federal rules.
But, the agency said, it reserves the right to mandate certain “quality” levels of cannabis used for clinical trials.
It also delivered a host of publications for reference material that could be useful for researchers and companies engaged in R&D and emphasized that industry insiders should be prepared to “show that they can consistently manufacture a quality product.”
“In each phase of clinical investigation, sponsors must submit sufficient information to demonstrate the identity, quality, purity, and potency or strength of the investigational drug,” the FDA wrote in its guidance.
