Access & Advocacy
Psychedelic Policy Updates
*updated July 2024*
In America, psychedelics continue to be federally illegal Schedule I substances. However, a number of states and cities have passed laws that locally make various psychedelics legal or decriminalized.
FDA | The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to psilocybin/psilocin, MDMA, and LSD. This designation is intended to expedite the development and review of drugs that treat serious conditions, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. In August, the FDA denied Lykos Therapeutics’ submission for MDMA-Assisted Therapy for PTSD. Lykos will need to conduct another Phase 3 trial and then resubmit their application for review. This process likely will take 3 years or longer.
Wins/Progress
Oregon
For more than a year, Oregon has been offering facilitated psilocybin sessions at Service Centers. More than 3,500 people have experienced facilitated psilocybin in Oregon, which is a larger number than all the US psychedelic clinical trial participants over the past 20 years combined. Unfortunately, the treatment is expensive (prices range from $1,000 to $3,500 per session) and is not covered by health insurance.
Colorado
In 2022, Colorado voters decided that natural psychedelics would be decriminalized (possessing, growing, sharing, using is legal) and they are creating a facilitated psilocybin program that is very similar to the program in Oregon, with some key improvements to hopefully increase quality of care and reduce costs. The rules are being finalized now and the program is expected to launch at the start of 2025.
Utah
The Republican legislature passed a bill creating a pilot program for tightly regulated medical access to psilocybin and MDMA. The Republican Governor allowed the bill to become law and the pilot program is now up and running.
Indiana
The Republican Governor signed a bill from the Republican legislature that funds psilocybin research in the state focused on veterans and first responders. Seven conditions are listed for study, including chronic pain and migraines.
Maryland
Legislature created a Task Force on Responsible Use of Natural Psychedelic Substances. The Task Force will make recommendations for “broad, equitable, and affordable access to psychedelic substances” and to “transition from criminalizing conduct involving natural psychedelic substances.”
Massachusetts
The November ballot will include an initiative allowing adults 21 and older to legally possess, grow and share certain amounts of natural psychedelics. Initiative also creates service centers and will require trained facilitators.
New York
Chair of the Assembly Health Committee introduced a bill (A10375) to create a personal psilocybin permit system that allows adult use of psilocybin for health and wellness purposes. Adults must complete a health screening and take a psilocybin safety education course to acquire a permit. Permits will authorize adults to purchase, grow, possess, and independently engage in regulated use of psilocybin.
New Jersey
Legislative committees held hearings and passed amendments on a bill that will create legal therapeutic access to facilitated psilocybin.
Canada
Health Canada recently approved the first Special Access Program (SAP) request to allow a cluster headache patient to legally use psilocybin. This first approval opens the door for doctors to request SAP access for others living with cluster headache in Canada. Unfortunately, the process is not simple. If you know of anyone with cluster headache in Canada who wants to apply through SAP for legal access to psilocybin, please connect them with PPA.
Losses/Roadblocks
California
Legislature failed to pass multiple bills that would have expanded access to facilitated psilocybin medicine.
Arizona
Governor vetoed a bill that would have created legal Psilocybin Service Centers.