Australia has made waves by rescheduling MDMA and psilocybin, essentially legalizing the drugs for narrow medical uses. It’s a big step when countries like the United States and United Kingdom have yet to reclassify these psychedelics. But as Australia allows limited access to treat severe mental health conditions, other governments will surely be watching.
On February 3, Australia’s Therapeutic Goods Administration (TGA, similar to the US Food and Drug Administration) announced that from July 1, specially authorized psychiatrists can prescribe medicines containing MDMA, for post traumatic stress disorder (PTSD); and psilocybin, for treatment-resistant depression. “These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” it stated.
Some Australian drug policy reform advocates have been praising the move. The Royal Australian and New Zealand College of Psychiatrists also “cautiously welcomed” the decision, according to the Guardian. “So this is a baby step in the right direction and what it does is allow us to do things in an appropriately safe way for everyone … and if necessary take a step back as well,” said Vinay Lakra, president of the college.
The TGA won’t allow any doctor to prescribe these drugs. To be eligible, psychiatrists must apply through an “Authorised Prescriber Scheme,” subject to approval by a human research ethics committee. The government is partially reclassifying the drugs to Australia’s Schedule 8, as “Controlled Drugs,” legal for these narrow medical uses; but they will remain in Schedule 9 as “Prohibited Substances” for other uses. So there’ll be no retail sales—and even psychiatrists can’t prescribe the psychedelics for other conditions.
But the TGA did not actually approve any specific medication, and there’s no brand-name MDMA pill or psilocybin formulation hitting the market. Instead, the law will allow prescribers to access unapproved versions of the drugs if there’s no approved alternative. Doctors will have to inform patients of the risks (and benefits) of using such an unapproved drug, and report outcomes to the TGA.
Australia’s decision, by permitting prescribing without requiring a research component, goes significantly further than the US, and should mean access for more patients in need.
It sounds similar on paper to the US policy of “compassionate use” or “expanded access,” which allows doctors to prescribe an unapproved treatment if a patient’s life is at risk and there is good evidence it can help. But there are some big differences.
“Expanded access is treated like a research program,” Matthew Zorn, an attorney and partner at Yetter Coleman, told Filter. Zorn coauthored a 2022 petition to the DEA to shift psilocybin from the most restricted federal category, Schedule I, to the less restricted Schedule II to make it easier to research.
In the US, he explained, “because MDMA and psilocybin are Schedule I drugs, expanded access is effectively research access, but all the other hurdles remain in place, which isn’t true if it’s moved to Schedule II.”
So Australia’s decision, by permitting prescribing without requiring a research component, goes significantly further than the US, and should mean access for more patients in need.
Why is this happening now? The answer is found mainly in the the current state of research. MDMA and psilocybin studies are moving rapidly toward proving their medical benefits. Trials of MDMA for PTSD, ongoing for years, have advanced to the final stage, and researchers will file an application for FDA approval for medical use in the first half of this year. Clinical trials of psilocybin for treatment-resistant depression are also entering the final stage, Phase 3. These will run through 2025 before psilocybin, too, could be FDA-approved for medical use. (Meanwhile Oregon and Colorado have already legalized non-pharmaceutical, therapeutic use.)
Still, some researchers are concerned about how the TGA chose to move forward on this.
Regulators in Australia will be well aware of these developments. They’ll have considered both the near-certainty that these drugs will come to market internationally, and the compassionate grounds for giving patients access ahead of the curve.
Still, some researchers are concerned about how the TGA chose to move forward on this.
Dr. Susan Rossell PhD, a psychology professor at Swinburne University in Melbourne, is leading Australia’s largest clinical trial of psilocybin for treatment-resistant depression, now entering Phase 3. She told Filter that the TGA’s move is “premature” and possibly “detrimental” because it hasn’t clearly defined what safety guardrails will be in place for doctors and patients.
“Who’s going to be an accredited physician?” she asked. “They haven’t even decided on the guidelines. What is going to be an accredited therapy? No one’s decided, there are no guidelines. The significance of it is, it can actually put us back years because this hasn’t been thought through properly.”
“The literature today has got absolutely so many holes that the decision is too early,” she continued. “There is no long-term data; the longest anyone’s been followed up is six months. There’s no data or discussion on adverse events, which are really quite substantial—I know this from running my own work.”
Despite Dr. Rossell’s concerns over accreditation and safety provisions, she does welcome how rescheduling the drugs will facilitate continued study.
“I concede it does make things a little easier in terms of research, heaps less paperwork for my team,” she said. “The administrative costs will be reduced for doing the research. On that point I’m quite happy.”
While such debates continue, Australia’s decision is undoubtedly a major one—particularly in light of other countries’ inaction. In the US broader medical access to these drugs outside clinical trials remains blocked, despite legislation that seemed to enable it.
“The goal is to alleviate suffering.”
In 2018, President Donald Trump signed the Right to Try Act—giving access to unapproved drugs, which are actively being studied in clinical trials, to patients who are not participating in studies but have life-threatening illnesses.
But the Drug Enforcement Administration (DEA) has refused to allow this to include to marijuana, psilocybin or MDMA—all of which are being studied as treatments and arguably qualify. Because of that, the Senate has introduced a bill which would clarify that yes, this law applies even to Schedule I drugs.
“It is therapy, the goal of it is not [just] to learn more about MDMA or psilocybin,” Sunil Aggarwal, MD, co-director of the Advanced Integrative Medical Science Institute, told Filter. Dr. Aggarwal headed up the petition to have the DEA reschedule these drugs. “The goal is to alleviate the suffering of individuals who have maladies and give them therapy.”
Photograph of psychedelic-assisted therapy being conducted in a UK trial, courtesy of AWAKN Life Sciences