The federal government has finally broken its monopoly on growing cannabis for research. The Drug Enforcement Agency, the DEA, already gave its approval for two companies to harvest plants. For the last five decades, only the University of Mississippi has been growing with federal approval for reasons of study. Now, the DEA is authorizing more growers, clearly ending that too-long monopoly.
In May, several companies received conditional approval. Two of them, the Biopharmaceutical Research Company, or BRC, and Groff North America Hemplex, are already growing plants and harvesting them. They have official registration from the DEA. For now, they are growing for quality calibration and control. Soon, the DEA will be buying it and distributing it for drug development and clinical research.
Expansion of DEA Powers
Many in the field tout this development as necessary, with the DEA now implementing systems to supervise the production of cannabis. Not just any cannabis either. They aim to grow the very best research-grade, and on a scale never before seen. These steps, albeit incremental, are quietly building a federal cannabis industry, and all in response to advocates demanding legalization over the years.
For decades, health officials, advocates, and lawmakers have been trying to expand research. Federal supply has always been insufficient and low quality. Further, government-grown weed is not the same as that sold legally at stores. Plants do not share similar chemical profiles and are markedly different. Studies require the same as what people get when they search “weed delivery near me” in Google.
It is necessary for researchers to look at the cannabis that consumers are using. This will better understanding of the benefits and the risks countrywide. Back in November, President Joe Biden signed the Infrastructure Investment and Jobs Act, which gives researchers this access. Until then, having the DEA authorize more growers will provide the plants needed for this important study.
What the Future Holds
BRC harvested its first plants in November. It is currently growing its second batch of crops, all with DEA license. The same is true for Groff, which just finished its first harvest last week under a very similar agreement. For Groff, this first harvest is an opportunity to establish its genetics, start growing plants, and prove its value to the DEA, much the same as any other substance.
According to Frank Haughton, CEO at Groff, “That is where we are at. It was really proving the concept, getting it there, and now creating a pathway to hopefully becoming a sort of domestic supplier as approval by the Food and Drug Administration goes through after these experiments are done.” Lofty ambitions? Indeed. A cannabis delivery network for research projects will also be necessary.
Scientists also lauded the DEA for increasing annual quotas for production of Schedule 1 substances, including cannabis and some psychedelics. According to the DEA, its only interest is in promoting study. It says its decision to increase production quotas is due directly to increased demand among researchers, as well as the need to provide support in the development of effective medications.
What about Psilocybin?
With the DEA now taking steps to authorize research-grade weed, Congress is now pushing too for the agency to allow the use of psilocybin for terminally ill patients. At least, for now, as an investigational therapy, for study, without having to worry about federal persecution. Recently, Rep. Earl Blumenauer (D-OR), circulated a Dear Colleague letter in Congress.
The letter notes that certain federal and state right-to-try, RTT; laws exist already and should make it easier for certain patients to access the psychedelic. This is especially important now that it shows early promise in ongoing clinical trials. However, despite this evidence, the DEA still denies access. In March, a Washington State doctor filed a lawsuit against the DEA for its refusal.
The doctor wanted federal guidance on using psilocybin mushrooms to treat terminally ill patients. Instead, the DEA told him there was no legal avenue for him to do so lawfully. The lawsuit is now before the U.S. Court of Appeals for the Ninth Circuit. It heard oral arguments for the case back in September. The state’s Office of the Attorney General joined the plaintiff in support of legal access to psilocybin.
In argument, the DEA used lack of jurisdiction to ask the court to dismiss the lawsuit. Despite this, the DEA is supportive of a proposal by the White House to streamline the research of Schedule I substances, particularly weed and some psychedelics. More importantly, the Biden administration aims to align research requirements for both Schedule I and Schedule II substances.
Other Important Activities
However, lawmakers and scientists have been very consistent in pointing out issues with the current rules. Studying Schedule I substances has been near impossible, so excessively burdensome that they limit crucial research. Then separately, back in August, a court of federal appeals dismissed a petition that would require the DEA to relook at the scheduling of cannabis under the Controlled Substances Act.
This will likely be necessary anyway, as pointed out by one judge. The concurring opinion is that the agency will need to consider major policy changes nevertheless. The current classification is dishonest, as it misinterprets the therapeutic value of cannabis. Meanwhile, hemp businesses selling delta-8 THC received a DEA boost recently. The agency clarified that the substance remains uncontrolled at this time.