Doctor Seeking To Reschedule Psilocybin To Treat Dying Patients Demands DEA Update After Agency Agreed To Initiate Federal Review

Attorneys for a doctor seeking to reschedule psilocybin so he can
administer it to terminally ill patients are demanding an update from the
Drug Enforcement Administration (DEA), which previously agreed to submit a
request for a scientific review of the psychedelic from the U.S. Department
of Health and Human Services (HHS).

In a letter to Thoman Prevoznik, assistant administrator of DEA’s Diversion
Control Division, attorney Kathryn Tucker said that advocates “appreciate”
that the agency was “gathering necessary data to transmit to [HHS] with a
request for a scientific and medical evaluation and scheduling
recommendation for psilocybin” in response to their rescheduling petition.

“Of course, psilocybin has achieved breakthrough therapy designation for
treatment resistant depression in 2018 and major depressive disorder in
2019 and is in Phase III clinical trials at the Food and Drug
Administration (FDA),” the letter said.

But the lawyers want to know if DEA has followed through on its commitment
and incorporated updated research they provided “confirming the medical
efficacy and safety of psilocybin.”

“Can you advise if the transmittal has occurred and if we can offer further
assistance in moving this important matter forward?” Tucker—who is
representing the Washington State-based doctor Sunil Aggarwal of the AIMS
Institute—asked.

“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,”
the letter says, adding that he hopes moving psilocybin from Schedule I to
Schedule II under the Controlled Substances Act (CSA) “will enable access
pursuant to Right to Try laws, which contemplate early access to promising
new drugs for those with life-threatening conditions.”

“We appreciate your efforts to respect the reality such patients face and
move this matter forward as promptly as possible,” it concludes.

News that DEA agreed to submit a request for an HHS review and scheduling
recommendation for psilocybin largely flew under the radar, and it’s a
notable development considering that the agency previously rejected a
rescheduling petition from Aggarwal, kicking off a years-long legal battle.

The U.S. Court of Appeals for the Ninth Circuit in February rejected
Aggarwal’s challenge to that denial, with the panel affirming that DEA
provided a reasonable explanation in denying the doctor’s request.

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.

When DEA rebuffed that request, Aggarwal sued. 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.

The latest Ninth Circuit ruling resulted from Aggarwal’s responses to that
ruling. In February 2022, the doctor filed a formal petition with DEA to
reschedule psilocybin from Schedule I to Schedule II—the denial of which
was a reviewable action. He also applied for a regulatory waiver to obtain
psilocybin.

DEA denied Aggarwal’s petition in September 2022 and rejected the waiver
request the next month. The doctor’s Ninth Circuit case challenged both
decisions.

The panel heard oral arguments in the case in August of last year. Lawyers
for Aggarwal and AIMS argued that RTT laws should open a path to legal use
of psilocybin and 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.

Aggarwal and AIMS have spent years pursuing various legal and regulatory
pathways to allow the clinic to use psilocybin in palliative care. The
clinic has presented DEA with multiple proposals to legally cultivate or
otherwise obtain psilocybin to treat patients under RTT. The agency has
denied them all.

Colorado Governor Signs Marijuana And Psychedelics Bills Into Law

*Photo courtesy of Dick Culbert.*

The post Doctor Seeking To Reschedule Psilocybin To Treat Dying Patients
Demands DEA Update After Agency Agreed To Initiate Federal Review appeared
first on Marijuana Moment.