Lawmakers are clearing the way for use of the psychedelic mushroom compound psilocybin as a potential medical treatment, once a formulation is approved by the Food and Drug Administration.
Senate Bill 379 directs the state Board of Pharmacy to reschedule psilocybin consistent with the federal scheduling as soon as the FDA approves a formulation to be utilized in medical settings. The bill does not address decriminalization and is specified for a clinical setting, according to the bill’s sponsor Sen. Jennifer Boysko, D-Herndon.
Psychedelics, including psilocybin, are Schedule I substances, defined as drugs with no accepted medical use and a high potential for abuse, according to the FDA. Drugs with that schedule may not be prescribed, dispensed or administered.
Boysko introduced the bill as a potential solution to high veteran suicide rates, due to promising clinical studies toward treatment of mental health conditions with psilocybin. She believes if there is treatment available, it should be accessed.
“As someone who recently lost a dear person in my life to suicide, if we have a treatment available that could help, I think we should do it,” Boysko said.
The final vote on the bill passed unanimously and was not a partisan issue, according to Boysko.
Virginia had 678,149 veterans residing in the state in 2024, according to the U.S. Department of Veterans.
The Veterans of Foreign Wars Department of Virginia supported the bill. David Jones lobbied on behalf of the VFW Department of Virginia.
“The staggering numbers of veteran suicide demands that we urgently provide access to solutions that are approved at the FDA level, especally novel treatments like this,” Jones said.
Depression accounts for up to 9% of ambulatory military health network appointments. After deployments in Iraq or Afghanistan, military medical facilities saw diagnosed depression cases increase from 11.4% to 15%, according to a 2023 article published by the National Library of Medicine.
Psilocybin Treatment Could Soon be on Market
Compass Pathways, a biotechnology company, is in the late stages of a clinical trial for a synthetic psilocybin formulation called COMP360. The formulation is intended to treat resistant depression.
Researchers noted a reduction of depression symptoms in two trials where 25 milligrams of the treatment was administered. One trial had a 25% reduction, and another had a 39% reduction. The company says it is the largest trial ever undergone, with over 1,000 patients in Europe and North America, according to a February press release.
In February, the company said it finished a successful endpoint in its second phase 3 trials, and has requested a meeting with the FDA, according to the press release.
Veterans Seek Alternative Help for Depression
Various veteran groups have noted an interest in psychedelic-related and alternative treatments. Capital News Service previously reported veterans have paid out of pocket or gone abroad seeking alternative treatments.
Establishing a regulation to allow for psilocybin to be rescheduled once the FDA approves a form of it has been an ongoing effort since 2022. Lt. Gov. Ghazala Hashmi, a former Virginia senator, previously sponsored such legislation.
Hashmi stated in an email that it is time for the FDA to fully approve psilocybin-based medication to help with PTSD and treatment-resistant depression. She is pleased to see the passage of SB 379 and the identical House Bill 1347, and stated that the advanced legislative preparation will allow eventual access to the treatment without legal confusion.
“The research on the efficacy of psilocybin is compelling; under medical supervision, psilocybin has proven to be an effective and life-saving medication for many,” Hashmi stated. “The legislation now passed by the General Assembly allows Virginia to be prepared if and when the FDA approves psilocybin-based medication, and it enables Virginians to access the treatment legally and without delay.”
The FDA issued initial guidance on clinical trials with psychedelics in 2023, according to a press release. Oregon, Colorado and West Virginia have promoted legislation surrounding psilocybin. Colorado and Oregon have legalized usage of psilocybin mushrooms for recreational use.
If COMP360 is approved by the FDA, a federal rescheduling decision would be made. Then states would begin the process to allow the prescriptions for treatment.
Congress introduced the bipartisan-sponsored Innovative Therapies Centers of Excellence Act, which would designate five medical facilities within the Department of Veterans Affairs toward “innovative therapies,” including substances like MDMA, ketamine and psilocybin.
If you or someone you know needs help, the national suicide and crisis lifeline in the U.S. is available by calling or texting 988. There is also an online chat at 988lifeline.org
by Stef Anderson, VCU Capital News Service
Photo: Daniel Neuhaus
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