Washington State has formally approved a very limited psilocybin therapy program. On May 9, Governor Jay Inslee (D) signed into law a bill to allow treatment of veterans with trauma and other conditions. Psilocybin still won’t be available to the general public for any purpose.
Senators Jesse Salomon (D) and Liz Lovelett (D) sponsored Senate Bill 5263, which the legislature with overwhelming bipartisan support. But the bill was serverely watered down in the process, and lawmakers axed a model that would have allowed all adults to receive the psilocybin for therapeutic purposes. Sen. Salomon previously told Filter that removing that provision was a necessary compromise to get more lawmakers—especially conservatives—on board.
The bill states that the clinic must offer only services “through pathways approved by the FDA.” This seemingly creates a big problem.
In its final form, the bill calls for the establishment of a psilocybin therapy pilot program by January 1, 2025. It will be housed at the University of Washington, and employ doctors and nurses to administer the drug. Only military veterans or first responders qualify, and they can seek treatment for post-traumatic stress disorder, substance use disorder or other mental health conditions.
But the bill states that the clinic must offer only services “through pathways approved by the federal Food and Drug Administration (FDA).” This seemingly creates a big problem—psilocybin is not currently approved by the FDA for any condition, and is a federal Schedule I controlled substance. When previously asked by Filter, Salomon did not clarify exactly how Washington would address this.
One potential workaround could be through the FDA’s “expanded access” program. This is an FDA rule that allows patients with a life-threatening illness to receive a non-approved experimental medicine “when no comparable or satisfactory alternative therapy options are available.” The program is inherently very restrictive, and a realistic pathway for only a tiny fraction of the millions of people who may want these treatments. It is also not covered by health insurance. It’s possible that the FDA could grant expanded access to psilocybin for a pilot like this one—but that’s speculative at this point.
Psilocybin is currently being studied as a treatment for depression in clinical trials. COMPASS Pathways is currently in the third and final phase of human trials. Usona Institute is also researching psilocybin for major depressive disorder, and conducting Phase 2 trials.
According to Marijuana Moment, Inslee also vetoed some of the provisions when the bill reached his desk. The version that lawmakers passed would have created a “psilocybin advisory board,” “interagency psilocybin work group” and “psilocybin task force.” But Inslee cut the first two, leaving just the task force. Inslee also removed language giving responsibilities for regulating and researching psilocybin to the Departments of Health and Agriculture and the Liquor and Cannabis Board.
It’s hard to know how much real-world impact these cuts will have. Perhaps Inslee just felt Washington didn’t need to fund three different commissions to study psilocybin. On the other hand, the psilocybin work group, which he killed, would have “[developed] a comprehensive regulatory framework for a regulated psilocybin system”—so it’s possible that removing it could slow down efforts to fully legalize in the future. But no commission would guarantee broader legalization, which ultimately can only happen if lawmakers approve a bill or voters approve a ballot measure.
The psilocybin task force, which survived the cuts, will include members from the Liquor and Cannabis Board and the state health department. The latter will also appoint experts in public health, disability rights, two psychologists, two mental health counselors, two physicians and a pharmacologist. Other members will include a veteran, an Indigenous psilocybin practitioner, a cannabis industry representative, an LGBTQ advocate, and up to two members “with lived experience of utilizing psilocybin.” The governor and legislature have no role in appointing or approving members.
Can it, as Sen. Salomon believes, open the door for broader, more inclusive reforms down the line?
The task force will first meet on June 30. It will review clinical trials and other scientific evidence on psilocybin, discuss possible regulations for medicinal use, and consider other issues including diversity of access, public safety and health. It must report to the governor and legislature by December 1, after which plans and rules for the program will be developed further.
Gov. Inslee’s signature on this bill is meaningful, but still a small step. This pilot—even assuming the difficulties regarding FDA approval are overcome—is very restrictive, meaning millions of Washington who may wish to access psilocybin for therapeutic reasons or pleasure will still be legally prevented from doing so.
Will it remain so, or can it, as Sen. Salomon believes, open the door for broader, more inclusive reforms down the line? That will depend perhaps on recorded outcomes from the pilot and wider research, but certainly on advocates continuing to persuade voters and pressure politicians.
Photograph via Washington Senate Democrats