EF Supports Legal Efforts to Reschedule Psilocybin and Open Access for Therapeutic Use
The Etheridge Foundation has made a $20,000 grant to the National Psychedelics Association Foundation (NPA) Foundation in support of its advocacy to reschedule psilocybin, and open access for therapeutic use.
The NPA Foundation is a 501(c)(3) nonprofit committed to advancing equitable, safe, and evidence-based access to psychedelic-assisted care. Through advocacy, education, regulatory guidance, and member support, the NPAF works to build the infrastructure necessary for psychedelic therapies to operate responsibly within mainstream health systems.
Our grant supports the NPA Foundation’s Advocacy Program, directed by Kathryn Tucker, JD, which leads their legal effort to accelerate the federal rescheduling of psilocybin on the Controlled Substances Act (CSA).
Moving psilocybin from Schedule I to Schedule II of the CSA would remove significant legal, administrative, and institutional barriers to research and therapeutic use.
Rescheduling psilocybin would also allow for the integration of this medicine as a critical clinical tool in addiction treatment systems, including in the treatment of opioid use disorder (OUD). Access for those with life-threatening conditions could open even prior to FDA approval under Right to Try laws, under which the NPA has also been leading advocacy.
Benefits of the rescheduling of psilocybin would include:
● Enabling Integration with Standard Care: If regulatory risk is eliminated by rescheduling, addiction treatment programs can adopt psilocybin-assisted therapy as a complementary modality alongside medication treatment, psychotherapy, and community care.
● Facilitating More and Better Research: Under the current Schedule I status, research is burdened by licensing, restrictions, cost, and delay. Lower scheduling (e.g. Schedule II) unlocks the ability to run pragmatic, clinic-based trials in OUD populations with fewer administrative obstacles.
● Therapeutic Use: A lower schedule would allow widespread therapeutic use under medical supervision. This use would be possible even before FDA approval, under Right to Try laws, for people with life-threatening conditions, potentially including those whose OUD puts them at risk of fatal overdose.
● Lowering Liability and Stigma Barriers: Regulatory clarity removes the chilling effect on providers and institutions who might otherwise fear legal, accreditation, liability, or insurance repercussions.
In August 2025, as a result of the tenacious legal advocacy of Tucker and her team on behalf of her clients the AIMS Institute and Dr. Sunil Aggarwal, there was a landmark step towards rescheduling psilocybin.
The U.S. Drug Enforcement Administration (DEA) formally transmitted AIMS’ petition to reschedule psilocybin to the Department of Health and Human Services (HHS) / FDA for scientific review.
This hard won progress in the regulatory process reflects that psilocybin is now in formal, active regulatory review related to rescheduling.
However, without maintaining focus across the requirements of the regulatory process, the expected rescheduling outcome may not be actualized.
Continued legal oversight will be crucial to ensure that DEA and HHS / FDA strictly comply with the mandates under the Controlled Substances Act (CSA).
This includes:
● Monitoring deadlines, FOIA disclosures, and rulemaking procedures
● Filing petitions, briefs, and motions compelling more robust, timely and proper agency action
● Encouraging amicus briefs by stakeholders, and/or public comment on rescheduling, with important perspectives
● Holding agencies to statutory standards (e.g. the requirement for HHS to provide binding medical-scientific recommendations)
● Challenging any attempt to shortcut or backslide from full public process
The Etheridge Foundation champions the federal rescheduling of psilocybin and welcomes the opportunities it will open up for the advancement of clinical care and further research of this medicine.
The NPA Foundation’s Advocacy is supported by philanthropy – learn more at yournpa.org/blog.
