TGA announces final decision: MDMA and psilocybin will not be rescheduled

In October, Cosmos reported on the pending decision from Australia’s drug regulator on the potential rescheduling of psilocybin and MDMA from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Medicines) of the Poisons Standard.

The shift would see these treatments move beyond their current use solely in restricted clinical trials to broader applications in the treatment of a range of psychiatric disorders.

At the time the article was written, the Therapeutic Goods Administration (TGA) had received 453 supportive submissions for MDMA and 575 for psilocybin, and 11 opposed for each. A growing body of experts was pushing strongly to have the two treatments down-scheduled.

Earlier this week, the TGA announced its final decision: MDMA and psilocybin will not be rescheduled for use as medicines at this time.

This will be a blow to those who have been advocating for the substances’ inclusion as controlled medicines, citing evidence of safety and efficacy for a range of clinical treatments. However, a number of researchers have welcomed the news.

Citing research published by Dr Martin Williams, Executive Director of Psychedelic Research In Science & Medicine (PRISM Ltd), and colleagues, the TGA announcement notes that any changes to the scheduling of MDMA and psilocybin must be done with the current Australian clinical context in mind, ensuring that Australia’s medical community is adequately equipped with expertise in both administration and ethical use.

Williams has subsequently expressed his support for the announcement, noting that this decision reflects insufficient evidence rather than any identified safety concerns.

“While excellent late-phase clinical research is ongoing around the world, and the results so far have been very promising, we agree that the standards of evidence required for formal approval and implementation still need to be met,” Williams says.

He reiterates that the decision doesn’t mark the end of the road for the drugs in a clinical setting, but simply ensures research continues to work towards establishing safe practices.

“Australian research needs to be conducted to ensure successful implementation in the local environment, to engage our medical community, and to pave the way towards appropriate training and accreditation of Australian mental health professionals in this game-changing area of mental health practice,” he says.

Fellow PRISM director Dr Stephen Bright agreed with this position, stating that rescheduling at this time would be “premature given there is still no accredited training in Australia”.

“My concern was that the application for rescheduling, as submitted, did not go far enough to ensure adequate clinical governance for the use of these powerful therapeutic drugs,” says Bright.

“Without an established and integrated system of clinical governance for the provision of psychedelics, rescheduling alone may open the door to unsafe and unethical practices. Appropriate training in this novel and paradigm-changing approach is still broadly lacking, even among mental health professionals.”

“At PRISM Ltd, our focus remains on completing the research we are engaged in that will put Australia in a better position to make these drugs medicines.”