RE: Psilocybin Rescheduling Petition, Dr. Sunil Aggarwal, AIMS Institute
Dear Assistant Administrator Prevoznik:
This is in further follow up to your letter to Dr. Sunil Aggarwal of the AIMS Institute, dated February 3, 2025, addressing our February 2, 2022 petition to transfer psilocybin from schedule I to schedule II of the Controlled Substances Act.
Pursuant to the invitation in your February 3, 2025 letter to provide additional information regarding psilocybin’s clinical safety and efficacy that supports our petition, we forwarded some of the more significant studies
confirming the medical efficacy and safety of psilocybin by letter dated March 3, 2025. We now submit an additional pertinent study showing the efficacy and safety of psilocybin assisted therapy for patients with cancer published in June 2025 in a leading medical journal: Agrawal et al, Long-term benefits of single-dose psilocybin in depressed patients with cancer, Cancer (June 16, 2025) (copy attached). We also bring to your attention the fact that New Zealand has recently acknowledged and operationalized currently accepted medical use of psilocybin with severe restrictions. https://www.health.govt.nz/news/new-zealand-psychiatrist-granted-approval-to-prescribe-psilocybin; https://www.beehive.govt.nz/release/government-expands-access-melatonin-and-psilocybin. We would appreciate your including this additional information in the materials in support of the petition to be considered by the United States Department of Health and Human Services (“HHS”).
Dr. Aggarwal continues to provide care to patients with advanced and terminal cancer who could benefit greatly from psilocybin assisted therapy, enabling them to experience a more peaceful dying process; the reality for patients with progressive disease is that they do not have much time left. Consideration of, and action on, our petition is urgent. The science supports movement to schedule II; such placement will enable access under Right to Try laws, which contemplate early access to promising new drugs for those with life-threatening conditions, including Dr. Aggarwal’s patients. It would also enable access by veterans experiencing life-threatening PTSD, which often precipitates suicide.
We appreciate your efforts to respect the reality such patients face and move this matter forward as promptly as possible. We previously requested that you inform us when you transmit our petition to HHS. We have received no response from you to this request, leaving us in the dark as to the status of our petition. If we do not hear from you by July 31, 2025, we intend to file a Freedom of Information Act request seeking all information bearing on what has been done with the petition since remand in October 2023.
Respectfully submitted,
Kathryn L. Tucker
Counsel to Dr. Sunil Aggarwal and the AIMS Institute
206-595-0097
Let us know what you think