The Varieties of State-Level Psychedelic Policy: Part 1

Plus: The Federal Inter-Agency Task Force on Psychedelics & The 800-Pound Gorilla

For several months, I have been mulling over and working on this concept of East & West Coast approaches to state-level psychedelic policy.

It has appeared in several newsletters (here, here, here) and has prompted some positive feedback.

I think it is a helpful way to categorize the handful of state-level frameworks that have been introduced and/or passed into state law, and I want to flesh it out further.

My goal is to help would-be operators, therapists, and other professionals consider the differences in these state policies.

For example, suppose you are a therapist. What framework—i.e., Supported Adult Use as in Oregon or state-funded Expanded Access Programs as in Connecticut—represents the more conducive environment for delivering psychedelic-assisted therapy for you? And what training and credentialing might you need to participate?

You might pack up the car and head out to Oregon only to later realize that Connecticut’s framework is more conducive to the environment in which you want to practice. The preliminary details of the various policy reform measures are instructive for such stakeholders.

Cannabis 2.0?

Many will see this patchwork of state-by-state reform as cannabis 2.0, given the similarities to implementing access frameworks for federally illegal substances.

Cannabis is a state-regulated natural product market with oversight of growth & manufacturing, product testing, and retail sales.

However, several critical differences between cannabis and psychedelics force the authors of state-level psychedelic legislation and ballot initiatives to consider tradeoffs that will yield markedly different policy products.

Relevant Recent Developments

Last week saw several developments that help frame the tradeoffs in the design of state-level psychedelic policy:

1. The ColoradoSecretary of State’s office approved the Natural Medicine Health Act (NMHA) to appear on November’s ballot. If passed, it will decriminalize several psychedelic plant medicines and implement a ‘supervised access’ commercial framework. This is an example of the West Coast approach.

2. The DEA withdrew a proposal to add five tryptamines to the schedule I substance list, a very welcomed but unexpected outcome.

3. As we covered last week, US Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act. It would allow patients with life-threatening illnesses access to Schedule I substances such as MDMA and psilocybin before FDA approval through the Right to Try Act.

4. A companion letter of support for the Right to Try Clarification Act from retired Marine Lieutenant General Martin R. Steele—head of the Veteran Mental Health Leadership Coalition (VMHLC) and CEO of the non-profit policy group Reason for Hope—indicates there is more federal legislation to come (emphasis added):

“The Right to Try Clarification Act is the first in a series of forthcoming bills that VMHLC plans to lead as part of our fight to prevent suicide and deaths of despair – not only for Veterans – but for all Americans – through increased access to safe and affordable psychedelic-assisted therapy…

Indeed, we have been leading an ambitious initiative to streamline the regulatory infrastructure for MDMA- and psilocybin-assisted therapy through advocating for the establishment of an interagency task force within the Department of Health and Human Services, which is meant to issue guidelines that assist states in addressing the complex clinical, regulatory, and public policy issues necessary for the ‘real-world’ deployment of these treatments.

These four developments highlight a paradox I have been thinking about and trying to make sense of regarding state-level psychedelic policy.

The 800-Pound Gorilla

First, to understand nearly all of the business, philanthropic and strategic objectives underway in the psychedelic field—including state-level policies—you have to understand who the 800-pound Gorilla is.

It’s the Controlled Substances Act (CSA).

Every business, from drug development to therapist training to foreign retreat, would operate differently if not for the CSA. Every local measure, including state and municipal decriminalization/legalization schemes, is developed in the CSA's shadow. Even in the case of patents, perhaps the most contentious issue in the field, the animating force is the CSA.

The developments of last week—the DEA backing away from scheduling five psychedelic tryptamines, the prospect of an inter-agency task force for psychedelics, and the inclusion of Schedule I substances in the Right to Try Act—these all simultaneously highlight the burden of the CSA and are perhaps small, progressive blows against it.

Equally, a state-level policy such as Colorado’s recently approved ballot measure also highlights the burden and absurdity of the CSA. But despite its novelty and progressive approach, I am not sure such a policy moves the needle.

Interestingly, I had the exact opposite opinion only a few weeks ago!

In the first post about East & West Coast Psychedelic Policy from May, I noted:

“While the more conservative East Coast approach could streamline the adoption within the healthcare systems, it is the West Coast approach that could ultimately lead to radical changes in drug policy; therefore, both are valuable.”

This is the beauty and the frustration of analyzing this field with such detail; my perspectives and opinions change—as the saying goes, “the more I know, the less I understand.”

But let me try to hash out the differences between these two approaches as I see them now.

East & West Coast Psychedelic Policy

Broadly speaking, the most developed state-level psychedelic policy frameworks can be divided along the stereotypical East Coast—West Coast dichotomy.

The East Coast ethos is codified by prestige, tradition, and legacy institutions, while West Coast boasts innovation, experimentation, and novelty.

West Coast Model

Western states like Oregon and Colorado are pioneering commercial legalization efforts that include state-regulated growing, manufacturing, and consumption in licensed healing centers.

The ‘Oregon Model’ regulates the production and testing of psilocybin mushrooms. Unlike cannabis, consumption of psilocybin products will only occur at licensed facilities in a format called ‘supported adult use’ or ‘supported access,’ which means that a facilitator is present for the duration of the psychedelic experience. In other words, psilocybin products will not leave the facility, and all journeying takes place on-site.

In Colorado, the NMHA includes a commercial ‘supported adult use’ framework like Oregon but goes further to decriminalize possession, consumption, cultivation, and sharing of psilocybin, ibogaine, mescaline (not derived from peyote), DMT, and psilocin for adults 21 and older, without an explicit possession limit.

In other words, the ‘Colorado Model’ is the ‘Oregon Model’ plus decriminalization.

Another ballot initiative in Colorado, Initiative 61, is also in play but has yet to supply sufficient signatures to the Secretary of State. If it does appear on the November ballot, this measure would decriminalize the possession, consumption, cultivation, and gifting of several psychedelic plant medicines in the state and does not include a commercial framework.

Finally, there is California’s Bill 519, which is still up for a vote in the state legislature and is scheduled for a committee hearing on August 3rd.

Unlike Oregon and Colorado, Bill 519 is strictly a decriminalization effort without any commercial framework. Like Colorado’s Initiative 61, it would decriminalize several psychedelic substances but goes further by decriminalizing synthetic compounds such as LSD and MDMA as well as several naturally occurring plant medicines.

So, as you can see, these West Coast models follow in the footsteps of state cannabis reform and fly in the face of federal law.

East Coast Model

In contrast, the seemingly more reserved East Coast approaches seek to work within the previously established frameworks erected by the federal institutions, such as investigator-initiated clinical trials, Expanded Access Programs, and possibly the Right to Try Act.

East Coast models are structured to use state funds to develop research programs and subsidize access to what we might call ‘research-based-treatment’ for groups with high rates of mental illness, such as veterans and frontline healthcare workers.

For example, Maryland passed a bill that created the Post-Traumatic Stress Disorder and Traumatic Brain Injury Alternative Therapies Fund, intended “to provide “cost-free” access to psychedelics like psilocybin, MDMA and ketamine for military veterans suffering from post-traumatic stress disorder (PTSD) and traumatic brain injury”¹

The Connecticut Psychedelic Treatment Program offers more detail at this point and will establish treatment centers to provide MDMA-AT and Psilocybin-AT through Expanded Access Programs:

“Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.”

More broadly, such programs aim to establish the infrastructure necessary for the post-FDA approval world by training healthcare professionals, collecting outcomes data, all while enabling early access to veterans and other groups that experience high rates of mental illness.

Integrating psychedelic medicine is far more complex than introducing a new drug or device. Instead, it may demand an overhaul of conventional mental health treatment approaches.

Therefore, if states, which stand to benefit from improvements in mental health treatment, take on the cost and burden of establishing clinical and administrative infrastructure, they would help streamline the adoption of psychedelic medicine.

Now, with the possibility of a federal Inter-Agency Task Force on Psychedelic Medicines and Therapies intended to help states onboard psychedelic medicines, I wonder if state legislators will be swayed to go in the direction of the East Coast Model.

Below is an excerpt from a letter from several members of Congress to Xavier Becerra, the Secretary of Health and Human Services, about the proposal of the said inter-agency task force:

“Establishing national guidelines through this collaborative process, to be published in the federal register, would significantly ease the burden on individual states attempting to address the myriad of complex issues. Moreover, published national guidelines would be the most effective mechanism in establishing good standards of practice, including provider training, credentialing, state licensure, dispensing, safe and ethical use monitoring, etc. States will be able to then reference these national guidelines when implementing their own frameworks that meet their needs and requirements, with support and federal funding through SAMHSA block grants.”

The Tension

So there are two flavors of state-level psychedelic policy emerging, one that seeks to follow more closely in the footsteps of cannabis through local legalization of suppliers, distributors, and licensed facilitators and healing centers.

The other seeks to leverage state funding to set up the infrastructure for the forthcoming wave of FDA-approved medications and enable “cost-free” ‘research-based access’ for specific populations.

Basically, I am coming to view the East Coast Model as preparation for a new treatment paradigm within ‘the system’ while the West Coast Model seeks to break from ‘the system’ entirely.

Therefore, if we do see a federal agency to assist states in onboarding psychedelic medicine, does the East Coast Model lend itself to integrating with forthcoming federal assistance, and states that go the West Coast route end up at a disadvantage by operating outside of this federal orbit?

As I noted above, the more I dive into these things, the less beholden I am to any prior convictions about the right path forward or predictions about how this will all unfold.

I hope readers find this framework useful, and of course, I am always eager for feedback, so if I missed anything or you see things differently, I would love to hear from you.

1. https://www.marijuanamoment.net/maryland-bill-to-fund-psychedelics-research-and-access-for-veterans-takes-effect-without-governors-signature/