The Psilocybin Rescheduling Petition
The Drug Enforcement Administration (DEA) is under renewed pressure to move forward with the rescheduling of psilocybin, a compound found in certain psychedelic mushrooms. The push comes from a petition originally filed by Dr. Sunil Aggarwal of the AIMS Institute, who has been seeking access to psilocybin for terminally ill patients receiving palliative care since at least 2020. His efforts began under state and federal right‑to‑try (RTT) statutes before a formal request was submitted to the DEA in 2022, asking that psilocybin be shifted from Schedule I to Schedule II of the Controlled Substances Act (CSA).
The petition’s path has been anything but straightforward. After an initial denial by the DEA, Dr. Aggarwal’s team pursued appeals and court hearings. In August 2025 the matter was referred to the Department of Health and Human Services (HHS) for further review. Since that referral, the agencies have not issued any updates on the petition’s status, despite multiple inquiries from counsel representing the petitioner.
FDA Review and Breakthrough Therapy Status
Attorney Shane Pennington of Blank Rome LLP, who represents Dr. Aggarwal, pointed out that the Food and Drug Administration (FDA) – an agency within HHS – has already conducted a thorough scientific evaluation of psilocybin. This review culminated in the FDA granting breakthrough therapy designation to the investigational psychedelic on two separate occasions. According to Pennington, “the vast majority of the relevant evidence, data, and scientific literature” has already been examined, making the continued delay in the DEA’s review perplexing.
Further underscoring the federal interest in psilocybin research, the FDA has recently awarded national priority review vouchers to two companies advancing psilocybin‑based therapies. These vouchers are intended to accelerate the development and approval process for treatments that address serious unmet medical needs.
Executive Order and Psychedelic Medicine Access
A significant development that has intensified the call for action is an executive order signed by President Donald Trump last month. The order explicitly directs federal agencies to streamline the rescheduling process for psychedelic substances that show promise in clinical research. It states that the administration’s policy is “to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.”
While the order emphasizes substances that have completed Phase 3 trials, its language also signals an intent to fast‑track agency action for investigational drugs with demonstrable clinical value and breakthrough status. HHS Secretary Robert F. Kennedy Jr., speaking at the signing ceremony, reiterated that the department will “accelerate research, approval and access to new mental health treatments, including psychedelic therapies.” He added that the administration is eager to establish a clear pathway for patients to receive psychedelic‑based care.
In his letter to Daniel Aguilar of the Justice Department’s Civil Division, Pennington concluded that, in light of the FDA’s prior review, the breakthrough therapy designations, and the executive order’s directives, there appears to be little left to analyze before a recommendation on Dr. Aggarwal’s rescheduling petition can be made. He urged prompt action to avoid further unnecessary delays.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Hemp Gazette does not provide medical recommendations, diagnoses, or treatment plans. Always consult a qualified healthcare practitioner before making any decisions regarding your health or any medical condition. Statements concerning the therapeutic uses of hemp, cannabis, or cannabinoid-derived products have not been evaluated by Australia’s Therapeutic Goods Administration (TGA). Medicinal cannabis products in Australia are accessed via prescription pathways under TGA regulation.
