The Australian government has rescheduled the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder (PTSD) and treat-resistant depression.
The substances aren’t being legalized for broad use, but by placing them in Schedule 8 for therapeutic use under the country’s drug code, psychiatrists who meet the required standards will be able to prescribe the psychedelics. The drugs will remain in the stricter Schedule 9 for unauthorized use.
“The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” Australia’s Therapeutic Goods Administration (TGA) said in a notice on Friday.
“It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting” starting on July 1, it said. “However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.”
“The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.
There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses.”
This is precisely the type of administrative action that advocates in the U.S. have hoped to see, especially given the Food and Drug Administration’s (FDA) designation of psilocybin and MDMA as breakthrough therapies.
“Australia’s policy change is one that every country should consider: suffering people, regardless of nationality, need more opportunities to access novel treatments,” Rick Doblin, executive director of the U.S.-based Multidisciplinary Association for Psychedelic Studies, said in a press release. “We hope that this announcement will encourage more international discussion and collaboration towards access to psychedelic therapies and comprehensive drug policy reform.”
California State Sen. Scott Wiener (D), who has sponsored legislation to legalize possession of certain psychedelics, called the Australian development “fantastic news.”
In the U.S. the Drug Enforcement Administration (DEA) last year again rejected a petition to reschedule psilocybin and a doctor’s request for a federal waiver to obtain and administer the psychedelic to terminally ill patients, prompting a new set of legal challenges in federal court.
Sunil Aggarwal, a Washington State-based palliative care specialist, has been fighting DEA for psilocybin access for over a year. But the agency has denied his petition to place the substance in a lower drug schedule, as well as the doctor’s waiver request under federal “Right to Try” (RTT) law.
Matt Zorn, an attorney on that case, said in a blog post that the process by which the Australian reform happened is “exactly what we are seeking to do” in the case against the DEA.
“The only thing I want to emphasize is how this happened. An applicant petitioned the government to reschedule psilocybin and MDMA in June 2022. The application presented evidence supporting moving psilocybin and MDMA to Schedule 8 — medicines that are legally available with strict legal controls. Months ago, the Australian government made an interim decision not to reschedule either. Thousands of people participated. You can read the responses. Most opposed the interim decision. Today (in Australia), the government reversed course and allowed unapproved MDMA and psilocybin to be used in treatment under severe restrictions.”
DEA has also faced increased political pressure from bipartisan lawmakers, who took an extra step to provide additional congressional clarification, filing companion bills in the House and Senate last session to reaffirm that the scope of RTT policy should include Schedule I drugs like psilocybin.
The legislation would make a technical amendment to the text of the existing statute, with the primary purpose of clarifying—in the face of DEA objections—that RTT policy as signed into law by former President Donald Trump already means that patients with terminal health conditions can obtain and use investigational drugs that have undergone clinical trials, even if they’re Schedule I controlled substances.
The bills were filed about six months after bipartisan members of Congress sent a letter, led by Rep. Earl Blumenauer (D-OR), requesting that DEA allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.
Last year, Sens. Cory Booker (D-NJ) and Brian Schatz (D-HI) separately pushed top federal officials to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.
Booker posted a video in October where he talked about how psychedelics like psilocybin are strictly controlled under federal law as Schedule I drugs, which places “a lot of limitations” on them.
“But at the same time, we’re having massive breakthroughs in a lot of the research,” he said, noting psilocybin and MDMA specifically “are showing incredible results for helping people with PTSD, with trauma, even with anxiety and depression.” (Full Story)