The Drug Enforcement Administration (DEA) is being put on notice—again—over prolonged delays in processing a petition to reschedule psilocybin from a doctor who wants to use it to treat terminally ill patients, with an updated reminder that President Donald Trump has now made clear his administration’s intent to streamline psychedelic medicine access.
In a letter sent to an appellate staffer with the Justice Department’s civil division on Wednesday, an attorney representing Sunil Aggarwal of the AIMS Institute laid out the years-long timeline since a petition was first filed with DEA in 2022 requesting that psilocybin be moved from Schedule I to Schedule II of the Controlled Substances Act (CSA).
Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal right-to-try (RTT) laws.
However, after a dizzying back-and-forth that involved an initial DEA denial of the rescheduling petition, appeals, court hearings and DOJ’s forwarding of the rescheduling petition to the Department of Health and Human Services (HHS) in August 2025, the agency went silent.
“We have had no information about the status of the petition since that time, despite a series of inquiries,” attorney Shane Pennington of the law firm Blank Rome LLP wrote in the letter to Daniel Aguilar of the U.S. Department of Justice’s Civil Division on Wednesday.
He added that the Food and Drug Administration (FDA) under HHS has already extensively reviewed relevant scientific data into psilocybin that should, in theory, expedite a resolution in Aggarwal’s petition case.
The FDA review ultimately resulted in the agency twice granting breakthrough therapy status to the investigational psychedelic drug, so “it is clear that thorough and careful scrutiny has already occurred,” Pennington said. That makes DOJ’s explanation about the continued petition review delays all the more “perplexing.”
“FDA necessarily examined the vast majority of the relevant evidence, data, and scientific literature before it granted multiple Breakthrough designations to psilocybin,” he said. “Any additional data and evidence since that time is consistent with all the prior data and evidence and has been in hands of HHS and FDA since the transmittal from DEA in August of 2025.”
What has changed since that time, however, is the fact that the president signed an executive order last month “directing that rescheduling of psychedelic substances be streamlined,” while recognizing that psychedelic substances such as psilocybin “show potential in clinical studies to address serious mental illnesses for patients.”
The letter continues to quote from Trump’s order:
“Indeed, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific psychedelic drugs, and there are numerous products currently in the clinical trial pipeline for review of safety and efficacy. 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.”
“The EO explicitly addresses ‘timely rescheduling,’ and while that section of the EO refers to substances which have completed Phase 3 clinical trials, the intent of the President is clear: investigational drugs with proven value in clinical trials, and which have been granted Breakthrough status, ought be fast tracked for agency action to begin to open access to those in need,” Pennington said.
The attorney also noted that FDA “recently granted national priority review vouchers to two companies studying psilocybin to accelerate their path through the drug-approval process,” and so it stands to reason that the agency’s “commitment to its view of the science and data on psilocybin has only strengthened since DEA referred the petition to HHS in August of last year.”
“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,” the letter concludes. “Please review this history, and urge your client to promptly move forward.”
To Pennington’s point about the administration’s position on psychedelics, HHS Sec. Robert F. Kennedy, Jr. said at last month’s executive order signing event that under the president’s order, his department “will accelerate research, approval and access to new mental health treatments, including psychedelic therapies.”
“We’re taking this decision, this decisive step, to confront one of the most urgent public health challenges facing our nation, the mental health crisis,” he said. “This executive order will remove legal impediments that block American researchers, scientists, physicians and clinicians from properly studying these medicines and, where appropriate, establishing protocols for their safe therapeutic use.”
Kennedy also said recently that the Trump administration is “very anxious” to create a pathway for access to psychedelics therapy and that top officials across federal agencies want to “get it out to the public as quickly as possible.”
Read the attorney’s psilocybin rescheduling letter to DOJ below:
