The Drug Enforcement Administration (DEA) is facing renewed calls to expedite the psilocybin rescheduling process, specifically concerning a petition filed by Dr. Sunil Aggarwal of the AIMS Institute. This push follows an executive order signed by President Donald Trump aimed at streamlining access to psychedelic medicines for therapeutic use. Attorney Shane Pennington of Blank Rome LLP, representing Dr. Aggarwal, recently sent a letter to the U.S. Department of Justice’s Civil Division, highlighting years of delays in the petition’s review, according to a report by Marijuana Moment.
The Psilocybin Rescheduling Petition
Dr. Aggarwal’s efforts to obtain psilocybin for terminally ill patients in palliative care date back to at least 2020, initially under state and federal right-to-try (RTT) laws. A formal petition was filed with the DEA in 2022, requesting that psilocybin be reclassified from Schedule I to Schedule II of the Controlled Substances Act (CSA). The petition’s journey has involved:
- An initial denial by the DEA.
- Subsequent appeals and court hearings.
- Referral of the rescheduling petition to the Department of Health and Human Services (HHS) in August 2025.
Since the HHS transmittal in August 2025, the agencies have provided no further information regarding the petition’s status, despite multiple inquiries, as noted in Pennington’s letter to Daniel Aguilar of the Justice Department.
FDA Review and Breakthrough Therapy Status
Pennington emphasized that the Food and Drug Administration (FDA), operating under HHS, has already conducted extensive scientific data reviews on psilocybin. This review led to the FDA twice granting breakthrough therapy status to the investigational psychedelic drug. Pennington stated that “thorough and careful scrutiny has already occurred,” making the continued delays in the petition’s review “perplexing.” He argued that the FDA’s examination of “the vast majority of the relevant evidence, data, and scientific literature” for breakthrough designations should expedite a resolution.
Furthermore, the FDA has recently awarded national priority review vouchers to two companies researching psilocybin, indicating the agency’s strengthened commitment to the scientific understanding of the substance.
Executive Order and Psychedelic Medicine Access
A significant development since the petition’s referral to HHS is President Trump’s executive order, signed last month, which explicitly directs the streamlining of psychedelic substance rescheduling. The order acknowledges the potential of psychedelic substances, including psilocybin, in clinical studies for serious mental illnesses. It states, “It is the policy of my Administration 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.”
Pennington highlighted that while the executive order primarily refers to substances that have completed Phase 3 clinical trials, its clear intent is to fast-track agency action for investigational drugs with evidence of clinical value and breakthrough status. HHS Secretary Robert F. Kennedy, Jr. reiterated this sentiment at the executive order signing event, stating that the department “will accelerate research, approval and access to new mental health treatments, including psychedelic therapies.” Kennedy also indicated the administration’s eagerness to establish a pathway for psychedelic therapy access.
Given these developments, Pennington concluded his letter by stating, “In light of these developments, it is unclear what further analysis could possibly be necessary to make a recommendation on Dr. Aggarwal’s rescheduling petition,” urging prompt action from the Justice Department.
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.
