Biotech Representative Asks Legislature to Prepare for Possible FDA Approval of Synthetic Psilocybin
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Summary
Tess Butler of Compass Pathways requested that the committee adopt language to allow timely state rescheduling and patient access to COM‑360 (synthetic psilocybin) if the FDA approves and the DEA reschedules the product.
Tess Butler, associate director of government affairs for Compass Pathways, told the Senate Health & Welfare Committee the company is conducting Phase 3 clinical trials of COM‑360, a synthetic, pharmaceutical‑grade psilocybin compound being evaluated for treatment‑resistant depression and PTSD.
"We are asking for your help to ensure that patients have access to this innovative treatment in the event that it is FDA approved and rescheduled by the Drug Enforcement Administration," Butler said, summarizing the company's request that Vermont prepare statutory language to allow a prompt state rescheduling and prescribing pathway if federal authorities approve the medicine.
Butler noted the company has submitted draft language for regulatory change and cited prior Vermont precedent: the legislature added FDA‑approved cannabidiol drugs to the state's regulated drug list in 2018 to permit prescribing upon federal approval. Committee members said they have previously discussed psilocybin policy through study committees and that additional hearings and stakeholder input will be needed if the legislature is to act on rescheduling and access frameworks.
Butler left copies of submitted draft language and offered to follow up with staff and the Department of Health as the committee considers potential statutory changes.
