Oregon moves ahead on legal psychedelic therapy rules
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Oregon moves ahead on legal psychedelic therapy rules

Many eyes will be fixed on Oregon over the next few years as it pioneers an approach to legal therapeutic psilocybin use that could become a model for other states.

In 2020, Oregon voters approved Measure 109, the ballot initiative which directs the Oregon Health Authority to establish a regulated market for psilocybin treatments.  Like marijuana, psilocybin is a Schedule I substance under the federal Controlled Substances Act. Thus, the substance is banned and the federal government officially recognizes no medical benefits from its use.  Also, like marijuana, a plethora of medical research has emerged revealing psilocybin’s substantial potential benefits regardless of federal bureaucrats’ official position.

Oregon, however, is poised to challenge federal hegemony on drug-related commerce that occurs within its own borders, just as it has done with marijuana.  The U.S. Supreme Court has taken a decidedly expansive view of the federal government’s powers to regulate purely intrastate commerce of federally controlled substances by leaning on the Filburn interpretation of the Interstate Commerce clause.  Nonetheless, the growth of commercial intrastate marijuana markets in Oregon and elsewhere has challenged the legitimacy of these powers.

But that is where the similarity stops. The psilocybin market envisioned by the Oregon initiative would in no way resemble the model used for commercial cannabis. The state has started drafting rules for its therapeutic psilocybin program. The Oregonian reports:

As Oregon prepares for a first-of-its-kind legal psychedelic mushroom program to be launched in 2023, the state’s newly created Oregon Psilocybin Services section of the Oregon Health Authority has released draft rules for that program.

Voters approved Measure 109 in November 2020, giving the state two years to set up the framework to regulate legal magic mushrooms in Oregon.

Researchers believe psilocybin could help treat depression, PTSD and addiction, and Oregon’s system would allow for consumption of the substance in a therapeutic setting for anyone 21 years or older. No prescription or diagnosis would be required to take part in the program.

The rules released last week are not complete and are not yet adopted, but they give a glimpse into what the program might look like. The draft rules deal with how training programs for those administering psilocybin will be evaluated and credentialed, what the psilocybin itself will be and how that substance will be tested.

In Oregon’s legal psilocybin market, customers will not simply be able to walk into a dispensary and purchase whatever psilocybin products they want for home use.  Instead, a person would need to set a series of appointments with a regulated treatment center and receive consulting on how psilocybin may be helpful in their lives. Advisors will also receive medical information from the patient to evaluate whether psilocybin might be dangerous for them or have harmful effects when combined with other medications they may be taking.

Although the initiative makes clear that psilocybin treatment centers will not be considered medical facilities from a legal standpoint, it points out:

“The United States Food and Drug Administration has: (a) Determined that preliminary clinical evidence indicates that psilocybin may demonstrate substantial improvement over available therapies for treatment-resistant depression; and (b) Granted a Breakthrough Therapy designation for a treatment that uses psilocybin as a therapy for such depression.”

Accordingly, recipients would need to participate in a preparation session to determine if they are a suitable fit for psilocybin therapy and then can schedule an administration session to receive the treatment at a later date.  Thereafter, recipients are advised to participate in an ‘integration session’ during which they discuss their experience during the administration session with a licensed professional and the ways in which they can apply any lessons learned.

This structure of treatment is highly similar to existing ketamine treatments that have been demonstrated to provide lasting relief from depression when administered under the right conditions.  The key difference is that ketamine treatment facilities are already available in multiple states because ketamine is a Schedule III substance that can be legally prescribed by a physician. 

The federal government controls physicians’ ability to prescribe substances and, although the FDA is expected to approve psilocybin treatments for depression (and potentially other conditions) in the near future, Oregon is getting ahead by licensing non-physicians who could recommend and administer psilocybin therapy.

The Oregon psilocybin market won’t necessarily be limited only to individuals with diagnosed mental health conditions, however.  The initiative says that access to psilocybin treatments cannot be limited to patients with ‘any particular medical condition,’ meaning that any individual can schedule a consultation to evaluate whether psilocybin therapy might be beneficial for them.

The state’s psilocybin therapy program is still a ways off from being operational—regulators were given two years to think through how the market should be set up.  The Oregon Health Authority is supposed to begin receiving applications for licensure by January 2023 and would then issue four different license types for different activities: manufacturing psilocybin products, testing those products, operating a treatment center, and facilitating psilocybin services. 

Interestingly, the state cannot require that facilitators—those who help guide recipients through a psilocybin administration session—hold any college degree, but facilitators must participate in state-directed training and pass state-administered examinations.

An advisory board is currently meeting to review available medical research into psilocybin and provide recommendations on aspects of the regulatory structure.  Toward the end of its work, this board is supposed to meet with the U.S. Attorney for Oregon to discuss federal enforcement policies in the hope that Oregon’s new regulated psilocybin market can be treated with the same prosecutorial discretion afforded to well-regulated state marijuana markets.

Many eyes will be fixed on Oregon over the next few years as it pioneers an approach to legal therapeutic psilocybin use that could become a model for other states.