Cannabis: FDA Guidance

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter at Darshan Talks or the show's website at Darshantalks.com. Darshan: A really important discussion to be had is about the role of cannabis and drug development in the context of cannabis. As we all know, there is already a product that uses naturally occurring cannabis, or at least components of it, which is Epidiolex by GW pharma, by Greenwich pharma. However, the fact is that there are more and more companies that are interested in doing this, and there's always been this overarching problem about the FDA and the federal government not encouraging research in the cannabis area. To change that, companies have always accused the FDA of hiding the ball if you will. The FDA took a long overdue step of putting out a guidance on how to actually do research in the context of cannabis. They put out a guidance called cannabis and cannabis derived compounds, quality considerations for clinical research guidance for industry. Darshan: The key portion of this is the idea of how they start by defining a drug. According to the FDA, a drug is any product that is intended to diagnose, cure, mitigate, prevent or treat a disease, or any product other than food intended to affect the structure and any function of the body. Now, the key reason this is interesting is because the FDA takes this position and therefore renders a lot of the state approved or state eligible cannabis... So the products that are available because each state says that as long as you meet these criteria, we're going to allow you to make drug-like claims. Suddenly those are rendered drugs under the definition of the federal food, drugs, and cosmetics act. And it's not suddenly, it's always been the case, but the FDA is sort of putting it down again. Darshan: In 2018, there was the farm bill, which changed how cannabis is treated on the controlled substances act. So essentially what they came up with, and they said, that there's a new definition of hemp, which includes cannabis and derivatives or extracts of cannabis with no more than 0.3% by dry weight of the compound of Delta-9-THC. So the bill removed hemp from the definition of marijuana provided in section 102 of the controlled substances act, which means that hemp is no longer a controlled substance under federal law. Darshan: So essentially now you've got to think about hemp and you've got to think about marijuana. Marijuana is still technically a regulated under the controlled substances act, but hemp has been pulled out from under it. And you qualify for hemp only if you have no more than 0.3% by dry weight of THC in it. The key component and the key question that companies have asked over and over and over again is, "Where do we get the cannabis?" For the most part sponsors, including sponsored investigators are required to meet all FDA requirements to conduct human clinical trials, regardless of the source of cannabis or any other botanical product under studying the trial. Darshan: NIDA, which is a National Institute of Drug Abuse, drug supply program provided the only domestic federally legal source of cannabis for clinical research. So cannabis for this drug supply program was grown under contract by the University of Mississippi at the National Center for Natural Products, natural products research. But the 2018 farm bill changes that, essentially saying that under the 2018 farm bill, hemp may be produced as a source of cannabis and cannabis derived compounds for drug development if they do not contain Delta-9-THC at more than 0.3% by dry weight. And this gives sponsors and investigators new options that do not involve NIDA.