The U.S. Food and Drug Administration (FDA) is continuing to support clinical research for cannabis and psychedelic drug development. On the heels of publishing its first draft guidance on clinical trials involving psychedelic drugs last year, the FDA acknowledged that there is scientific support for the use of cannabis as a medical treatment, and it joined the U.S. Department of Health and Human Services (HHS) in recommending that cannabis be moved from Schedule I to Schedule III.
The Current Regulatory Landscape for Cannabis and Psychedelics
At the state level, efforts to legalize cannabis—for both medical and recreational use—are already well underway. While cannabis remains fully illegal in many states, most states have now legalized medical cannabis in some form, and more than 20 states have legalized recreational use (within limits). The federal government has been much slower to act; and, despite the FDA and HHS’s recommendations, it remains up to the U.S. Drug Enforcement Administration (DEA) to decide whether cannabis should be moved to Schedule III absent congressional action.
Regarding psychedelics, the legal landscape is even less uniform. While states like Colorado and Oregon have made attempts to lead the way toward legalization, their efforts have faced setbacks, and they have not gained the same coast-to-coast traction as efforts to legalize cannabis. Yet, the FDA has made clear that it sees potential benefits—and it will be interesting to see what impacts clinical trials examining the therapeutic benefits of psychedelics have on both state and federal regulation in the future. The FDA’s pending review of MDMA-assisted therapy could provide key insight into how it intends to handle similar efforts as it receives more investigational new drug applications (INDs) using psychedelic drugs.
What Is Going to Happen Next?
With so much up in the air at such a pivotal time, for manufacturers, researchers, and healthcare providers (along with their patients), there is one fundamental question: What is going to happen next?
Here is what we think:
“Clinical research will explode if the DEA reschedules botanical cannabis from Schedule I to Schedule III,” says Mark Gardner, Directing Attorney. “There are many unfounded claims that researchers will want to vet, and moving cannabis to Schedule III will allow this to happen at pace.”
“The immediate future is the continuation of state regulation, including the roll out of Minnesota’s regulatory structure,” says David Graham, Senior Counsel. “Negotiating the patch work of state laws is the biggest challenge for new businesses. Rescheduling at the federal level would help, and would greatly increase the amount of research conducted—especially since funding will become significantly less risky.”
As David also explains, “Going forward, the FDA will almost certainly regulate cannabis and psychedelics within all of its areas of jurisdiction: drugs, devices, foods and cosmetics. We’re seeing this already with the FDA regulating edibles, lotions and other products that contain CBD and other components of cannabis.”
“The FDA will continue to regulate cannabis and psychedelics under its existing regulatory framework for drugs, devices, foods and cosmetics; but, as more states begin to legalize and more research is done, I think we can expect the FDA to explore new regulatory pathways and/or premarket approval processes that are unique to these products,” says Brynn Stanley, Associate Attorney. “This is already in the works for products made with cannabidiol (CBD), where the FDA has concluded that existing food and supplement regulations are not appropriate . In the meantime, manufacturers and firms should expect to comply with the FDA’s current regulations concerning research and marketing of cannabis or psychedelic-based products and all applicable state laws and regulations.
Key Takeaways for Researchers, Institutions and Manufacturers
As a manufacturer, researcher, or as the head of an institution seeking to delve into the world of cannabis or psychedelics, what does all of this mean for you? While the regulatory landscape is still far from clear, it is not as muddy as it once was. For the first time in history, we can see a fairly direct path forward, and there seems to be a sense of inevitability that cannabis and psychedelics will transition from federally prohibited to federally accepted—and perhaps even federally encouraged in the medical field.
For now, though, those seeking to research, develop, sell and use cannabis and psychedelics-derived products must continue to walk a fine line. Compliance remains both extremely important and extremely complicated.
