- Australia’s Therapeutic Goods Administration has rejected applications to reschedule psilocybin and MDMA as controlled medicines.
- In interim decisions handed down on February 3, the regulator said the current classifications of psilocybin and MDMA as prohibited substances remained appropriate.
- The charity behind the applications to reschedule the drugs, Mind Medicine Australia, said the regulator’s decisions lacked evidence and were made based on prejudice.
A bid to allow Australian patients suffering from treatment-resistant mental health illnesses such as depression, post-traumatic stress disorder (PTSD), and substance abuse access to psilocybin and MDMA has been rejected by the country’s Therapeutic Goods Administration (TGA). Registered charity Mind Medicine Australia (MMA) lodged applications seeking the rescheduling of psilocybin and MDMA under Australia’s Poisons Standard from prohibited substances to controlled medicines in July 2020. In interim decisions on the applications published by the TGA on February 3, the regulator said the current classifications of psilocybin and MDMA both remained appropriate. Final decisions will be handed down in April.
Rescheduling Psilocybin and MDMA ‘Premature’ says Therapeutic Goods Administration
In relation to its interim decision concerning psilocybin, the TGA said to down-schedule the drug to a controlled medicine would be premature. The regulator flagged concerns over toxicity particularly in relation to multi-drug toxicity, the risk of misuse, and a lack of information about the medium and long-term effects of psilocybin-assisted psychotherapy. “There remain many unknown factors and side effects, especially in the long term. The risks of developing psychosis, especially in vulnerable populations, must be established in a clinical trial setting,” the TGA said.
However, the regulator did not rule out allowing psilocybin-assisted psychotherapy in the future. “Psilocybin-assisted psychotherapy may eventually prove to be safe and efficacious, but the evidence does not yet suggest this. It will take years to develop a curriculum and accredited training process for psychiatrists. To protect public health and prevent misuse, psilocybin should not be down-scheduled until all necessary safeguards have been established and implemented,” the TGA said.
In relation to its decision not to reschedule MDMA, the TGA also raised concerns over a lack of research on the drug’s effects and optimal dosages. “There are significant benefits to waiting for the results of clinical trials. MDMA-assisted psychotherapy may prove to be safe and efficacious, but the evidence does not yet suggest this especially for conditions outside of PTSD,” the regulator said.
Interim Decisions to be Contested by Mind Medicine Australia
Second-round submissions on the interim decisions can be made to the TGA by parties who have already commented on the applications until March 4, with the regulator’s final decisions to be published on April 22. In a statement on February 3, MMA said it would be contesting the TGA’s decisions.
In the statement, MMA chairman Peter Hunt said while the TGA’s rulings were disappointing it was important to remember they were only interim decisions. “We believe the reasons given by the secretary to justify his interim decisions contain a number of significant errors and omissions and we will be working hard over the next few weeks to draw these to his attention in our final submissions. In the absence of evidence, many of the statements amount to nothing more than prejudice,” Hunt said.
MMA board member Simon Longstaff said past prejudices should not be allowed to deny relief in the present. “If these medicines are safe and effective when applied in a clinical environment, as current research suggests, then Australian governments have an obligation to make them available,” Longstaff said.
