Washington Senate Bill 5263 proposes important psilocybin reforms but could go further 
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Washington Senate Bill 5263 proposes important psilocybin reforms but could go further 

The bill is a constructive proposal that lays the groundwork for the future adoption of a regulated marketplace for psilocybin in the state.

These public comments were submitted to the Washington House Health Care and Wellness Committee on March 23, 2023.

Dear Chairman Riccelli and Members of the Committee: 

On behalf of the Reason Foundation, thank you for accepting these comments and making them part of the public record. Reason Foundation is committed to ending the drug war and allowing discerning adults to safely and responsibly partake in substances they believe may enhance their lives. Decades of academic research combined with the emerging results of large-scale clinical trials have shown that psychedelic substances, used within many cultures since antiquity, may hold substantial value for improving mental health. 

Over the past few years, the U.S. Food and Drug Administration (FDA) has recognized psychedelic substances as “breakthrough therapies” for post-traumatic stress disorder (PTSD), major depressive disorder, and treatment-resistant depression. According to the FDA: “The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” This designation is reserved for the treatment of “serious or life-threatening conditions.”

Emerging evidence from clinical trials appears to validate the FDA’s designation of these substances as breakthrough therapies. In a trial of Methyl​enedioxy​methamphetamine (MDMA) to treat PTSD, two-thirds of patients no longer met the diagnostic criteria for PTSD 18 weeks after administration when combined with counseling sessions. In a psilocybin trial for treatment-resistant depression, 30% of patients achieved remission within three weeks of receiving a single dose and this remission persisted for at least 12 weeks. This is notable because treatment-resistant depression indicates that a patient has been unresponsive to at least two other forms of treatment. Psilocybin treatment combined with therapy has aided adults with alcohol use disorder to reduce alcohol consumption by more than half over 32 weeks from treatment.v Psilocybin treatment combined with cognitive behavioral therapy may also become the most effective known treatment for smoking cessation. An early trial has shown that therapy combined with two to three administrations of psilocybin allowed two-thirds of participants to successfully quit smoking and remain abstinent for an entire year.

Although the FDA appears poised to approve certain psychedelic therapies within the next few years, the process of pharmaceutical approval through the FDA is slow and costly. A study in the Journal of the American Medical Association reviewed drug approvals between 2009 and 2018 and estimated the average cost of bringing a pharmaceutical to market at $1.34 billion. Once the FDA grants market approval for a drug, pharmaceutical companies must recover their expenses and compensate providers of capital for the time and risk involved in drug development through their pricing schemes. This means FDA-approved medications, even if they become available, are likely to be more costly than naturally occurring alternatives.  

Washington can get ahead of this process by allowing for the cultivation, manufacturing, or possession of psychedelic substances within its own regulatory framework. In Oregon, voters approved Measure 109 in 2020, which enacted a state-regulated market for psilocybin services, including state licensing for the commercial manufacture and distribution of psilocybin products. That market is expected to go live later this year. State legalization sidesteps the uncertain timeline involved in federal approval of pharmaceuticals, allows states to tailor their policies, and could alleviate cost barriers for individuals seeking psychedelic therapy. 

Senate Bill 5263 is an important step in the right direction. It would establish a psilocybin advisory board, an interagency psilocybin work group, and a psilocybin task force within the health care authority. These agencies would collect research into the potential of psilocybin in treating mental health, discuss regulatory structures for clinical use and develop a comprehensive framework for a regulated psilocybin market. Oregon followed a similar approach in the two years following the approval of Measure 109 to prepare for the launch of its regulated marketplace. An earlier version of Senate Bill 5263 would have authorized the agencies to pursue their ultimate recommendations later and implement a regulated marketplace in Washington. The current version stops short of authorizing a marketplace. Section 8 of the bill would protect licensed medical professionals from censure for recommending psilocybin treatments but does not extend this protection to administering these treatments. 

Overall, Senate Bill 5263 is a constructive proposal that lays the groundwork for the future adoption of a regulated marketplace for psilocybin through a deliberative and public process.