First of all, what’s a “schedule”? The Controlled Substances Act (CSA) classifies substances on five schedules. The choice of schedule is, in theory at least, based upon the substance’s medical use, potential for abuse, and its safety or dependence liability. In practice, the scheduling appears to be guided less by science and more by politics, interest groups (especially pharma), and the Drug Enforcement Agency’s (DEA’s) obstinance.

 

 

 

 

 

 

It doesn’t make sense that substances shown to have therapeutic value continue to be listed in Schedule I. Yet the U.S. government, including the Food and Drug Administration (FDA) – which is in charge of protecting the nation’s public health using accurate, science-based information – treat cannabis and psilocybin as extremely dangerous and not useful as medicine. 

 

However, drug policy reform is increasingly becoming a hot topic in Washington, D.C. and now the President is using some of his authority to prompt changes with cannabis’ federal status (and, as we explain in the last section of this bulletin, Congress is working on changes to psilocybin’s federal status). This past October, President Biden announced 3 steps he’s taking to end the country’s “failed approach” to cannabis criminalization and imprisonment. He pardoned federal simple possession offenses, urged Governors to issue corresponding state pardons, and ordered an expeditious review of how cannabis is scheduled under federal law. We suggest reading Biden’s full statement in full due to the historical significance.

 

Here are a few snippets:

“As I often said during my campaign for President, no one should be in jail just for using or possessing marijuana. Sending people to prison for possessing marijuana has upended too many lives and incarcerated people for conduct that many states no longer prohibit. Criminal records for marijuana possession have also imposed needless barriers to employment, housing, and educational opportunities. And while white and Black and brown people use marijuana at similar rates, Black and brown people have been arrested, prosecuted, and convicted at disproportionate rates. 

 

Three months after that statement, here’s where descheduling or rescheduling stands: 

The federal government is reviewing cannabis’ scheduling. Xavier Becerra, head of the U.S. Department of Health and Human Services (HHS) and former California Attorney General, recently said that the federal government won’t use “20th century modalities and ways of thinking to drive what we do if we have evidence that tells us we go a different direction.” Shortly after President Biden’s announcement, Becerra tweeted: “Looking forward to working with Attorney General Garland to answer @POTUS’ call to action to review how marijuana is scheduled under federal law.”

 

Two additional things to know about that: 

 

Also keep in mind that “rescheduling” could bring the cannabis industry under FDA regulation of medicines, perhaps handing it to the pharmaceutical industry and locking many existing operators completely out. This is expected if cannabis goes to Schedule II, as President Biden has indicated in the past, but may be less of a risk in the lower schedules. On the other hand, “descheduling” without a federal law in place (e.g., MORE Act, CAOA, States Reform Act) would solidify the current policy framework of state-by-state regulation or prohibition.  

 

…and cannabis may not be the only substance the DEA has to reexamine….

 

This past November, Senators Booker (D-NJ) and Paul (R-KY) introduced the Breakthrough Therapies Act, to prompt reconsideration of MDMA and psilocybin, which are currently classified as Schedule I drugs. The Breakthrough Therapies Act would reclassify from Schedule I to II the substances themselves (i.e., psilocybin) rather than the drug product (i.e., a particular formulation of psilocybin). The bill would also reduce burdens that impede research and development of drugs that have the potential to help many, but which are inappropriately classified as Schedule I. In doing so, it could provide a pathway for such therapies to roll out through FDA-approved Expanded Access pilot programs. 

 

In other research news, H.R. 8454, a.k.a. the Medical Marijuana and Cannabidiol Research Expansion Act, passed the Senate, House, and was signed into law by President Biden on December 2, 2022. The bill will allow certain registered entities (such as universities, practitioners, and manufacturers) to manufacture, distribute, dispense, or possess marijuana or cannabidiol (CBD) for medical research purposes. In addition, HHS will be required, in coordination with the National Institutes of Health and relevant federal agencies, to report on the therapeutic potential of marijuana and on possible public safety or health risks. 

 

Congress is also pushing cannabis and psychedelic therapies for service members. The proposed National Defense Authorization Act (NDAA) language instructs the Secretary of Defense to study the “feasibility and advisability of conducting a study on the use of certain pharmacologic or potential plant-based therapies as alternatives to prescription opioids for the treatment of PTSD, TBI, or chronic pain” by March 1, 2023. This is an evolving situation and the NDAA could be voted on any day, with or without drug policy reforms. Keep an eye on the news if this is a topic of interest to you.  

 

The November announcement by Reps. Lou Correa (D-CA) and Jack Bergman (R-MI) that they are creating and co-chairing the Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus to “focus on exploring psychedelic research to alleviate the U.S. mental health crisis.” The significance of the caucus is separate from the CSA scheduling conversations; its goals center around awareness, funding, and barriers to research rather than psychedelics’ legal or commercial status.

 

And, finally, we mention the interagency Federal Task Force, which was announced last July through a letter from Miriam E. Delphine-Rittmon, Assistant Secretary for Mental Health and Substance Abuse (SAMHSA), to Rep. Madeleine Dean (D-PA). The Federal Task Force would lead a public-private partnership as the “use of psychedelic medicines will require a broad-spectrum interdisciplinary stakeholder approach to effectively tackle the complexity of the issues” associated with FDA approval of MDMA and psilocybin assisted-therapies. We’ve heard rumblings of the Task Force being renamed to a Working Group, and mixed feedback on whether the Federal Task Force/Working Group is being convened, who’s tapped, and all sorts of whispers, but nothing official. We’ll be keeping our ear close to the ground and report back. Keep an eye out for additional updates. 

 

Stepping into 2023, we are curious about what’s next for the cannabis and psychedelics ecosystems. The types of developments we talked about in this month’s bulletin remind us of the progress made and the steps that are underway. Just a decade ago, the idea that the federal government would consider rescheduling or decriminalizing cannabis and psilocybin seemed far-fetched to many. Now there are concrete proposals at the highest level of government and increasing support from the public. That being said, it all depends on Congress’s ability and appetite to deal with these long overdue reforms. We can’t wait to see what the year will bring.