MDMA and Psilocybin Are Approved as Medicines for the First Time

In a world first Australia has announced that it will officially recognize MDMA and psilocybin as medicines.

On February 3, Australia’s Therapeutic Goods Administration (TGA) – the government agency responsible for regulating medicines – announced that from July 1, 2023, licensed psychiatrists can prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD) psilocybin, the active ingredient in Magic mushrooms, for treatment-resistant depression. Because the TGA does not yet have to approve actual drugs containing MDMA or psilocybin, patients will first be given “unapproved” drugs containing those substances.

The decision came as a great surprise. At the end of December 2021, the same regulatory body decided against shutting down drugs for use in a medical context. “When I woke up, my email was completely inundated with people saying, ‘Did you hear what happened?’ I was shocked by the decision,” said Simon Ruffell, psychiatrist and senior research fellow at the University of Melbourne’s Psychae Institute.

Before advocates celebrate, experts warn that there are still many questions about how many people will actually have access to these treatments on July 1, and whether Australia has skipped the gun before collecting enough evidence to show how these treatments are effective can be imported and safely.

“I think it’s going to take a while to ramp up,” says Daniel Perkins, associate associate professor at Swinburne University’s Center for Mental Health and senior research fellow at the University of Melbourne. That’s wise, he says: let it open up gradually to see what’s working well and what’s not. “They probably did it that way on purpose.”

The road for a psychiatrist to get the all clear to distribute the drugs could be long and convoluted. First, psychiatrists must be licensed under Australia’s Authorized Prescriber Scheme, which means they are endorsed by a human research ethics committee and then the TGA. To do this, they must demonstrate that they can clinically justify the treatment regimen, that they will properly direct the treatment process and take appropriate measures to protect patients. The TGA still has to explain in detail what these measures look like in practice.

In addition, the TGA has yet to provide details of the minimum training standards required for psychiatrists to become authorized prescribers. This makes exactly how these treatments are prescribed ambiguous, considering the evidence base for their support is that patients are receiving therapy from trained professionals alongside the drugs themselves. Because of this — and because the TGA has put the onus on the psychiatrist to prove their prescribing practices are appropriate — therapy in conjunction with the drugs will likely be needed, says Rhys Cohen, who is a member of the non-executive advisory board of the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney and advises the medicinal cannabis industry.

And not every psychiatrist or psychologist can safely administer these types of therapies. Ruffell points out that people in established indigenous psychedelic practices around the world are trained to work with these types of substances for at least five to 10 years. “I think it would be a grave mistake to think that psychiatric and psychological qualifications are transferable to psychedelic substances without additional training.”