In response to a long pending rescheduling request, the Drug Enforcement Administration has requested in writing that federal health officials perform a medical and scientific review of psilocybin.
The DEA initially denied advocates’ request for a review of psilocybin. However, it forwarded last week the request that psilocybin be moved to Schedule II of Controlled Substances Act.
This transmittal was made on August 11, following a legal battle between DEA, the petitioners and Washington State doctor Sunil Aggarwal. Aggarwal had sought to have psilocybin administered for his end-of life care patients.
The U.S. Court of Appeals for the Ninth Circuit rejected separate arguments from lawyers for Aggarwal and his clinic, the Advanced Integrated Medical Science (AIMS) Institute, in February—ruling that the Drug Enforcement Administration (DEA) provided a reasonable explanation in denying the doctor’s request for review.
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 laws.
The federal appeals court’s ruling from last October, while technically going against DEA in theory, did not refer the rescheduling application to FDA for their review. This was requested by the lawyer for the doctor.
The DEA now has taken a major step forward in the rescheduling of psychedelic medicines for those with severe mental illnesses. This request was sent to HHS under the leadership of Secretary Robert F. Kennedy Jr.
AIMS argues that, given FDA’s previous designation of psilocybin a “breakthrough drug,” as well as the “abundance of clinical trial results” supporting rescheduling, “HHS/FDA are in a position to provide DEA with an evaluation and scheduling recommendations before sending it back to DEA for the formal rulemaking required to reschedule.”
AIM’s legal team has issued a media alert that states: “Patients who face death from terminal illnesses and Veterans facing suicide risk due to PTSD are among the groups benefiting from rescheduling.” As soon as the psilocybin is removed from Schedule I, Right to Try access will be available to these groups.
Leaders in the federal agencies of this administration, such as HHS Sec. Robert F. Kennedy Jr. and FDA commissioner Marty Makary and VA Commisssioner Doug Collins have publicly stated their intent to provide access to psychoactive therapies. This includes US Health and Human Services sec.
Aggarwal wrote in a Facebook post that, “it took us about 3.5 years to get this far.”
The man said: “Here’s to a quick review, and smooth sailing going forward.”
Aggarwal filed a lawsuit after DEA denied his 2020 rescheduling application. And in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.
In August last year, the panel heard oral argument in this case. The lawyers for Aggarwal & AIMS said that RTT law should allow the use of psilocybin & other controlled substances. But attorneys for DEA contended in an April filing that the federal RTT law, signed into law in 2018 by President Donald Trump, “does not provide any exemptions” from CSA restrictions.
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In the meantime, a judge ruled recently against Utah county and state officials who were pursuing a religious group in Provo City that used psychedelic mushroom as sacrament.
This comes about three months after U.S. District Judge Jill N. Parrish granted Singularism’s motion for a temporary injunction and ordered police to return psilocybin that was seized last year as part of a raid at its spiritual center.
The Trump administration, while HHS examines the rescheduling of psilocybin to Schedule III under the CSA, is also examining a separate proposal that would move cannabis into this schedule. There are mixed views in MAGA circles regarding the reform. However, last week the President said that an imminent decision would be taken.
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