1. Has the TGA taken into consideration the increasing amount of research [showing benefits of use of psilocybin and MDMA in the treatment of mental illness, as per referenced publications]?
Yes. The TGA has considered research on the use of MDMA and psilocybin in the treatment of mental illness. The TGA decision maker (delegate) noted in the interim scheduling decision that there is emerging evidence of potential therapeutic benefit in the treatment of mental illnesses such as PTSD and depression, however the benefits and risks of such use are still currently under investigation in clinical trials.
The final decision has been deferred pending an independent expert review into the therapeutic value, risks and benefits of psilocybin and MDMA to public health. This will involve a review of the research, including research that has been published after the interim decision. The review will be considered by the Advisory Committee on Medicines Scheduling (ACMS) and the TGA decision maker before making a final decision.
2. Does the TGA recognise the potential benefits for sufferers of conditions such as post-traumatic stress disorder and clinical depression from psychedelic-assisted therapy?
As above, the TGA recognises that there is emerging evidence of potential therapeutic benefit in the treatment of mental illnesses such as PTSD and depression. As Schedule 9 substances, MDMA and psilocybin are currently limited to medical and scientific research, subject to regulatory controls. Clinical trials are considered the best way to assess the true benefits and risks of any new therapy. To date, the TGA has received notification of 4 clinical trials investigating the use of psilocybin in treating mental illness and 1 for MDMA.
In addition to clinical trials, doctors can legally access ‘unapproved’ medicines, which are not included in the Australian Register of Therapeutic Goods, on behalf of their patients through the Special Access Scheme (SAS) and the Authorised Prescriber Scheme. The TGA has approved a small number of applications through the SAS pathway, granting access to MDMA and psilocybin. However, state and territory legislation imposes additional requirements that must be satisfied prior to accessing these medicines.
3. On what date will the TGA be issuing its final decision on the rescheduling of substances for use in psychedelic-assisted therapy?
As above, the final decision has been deferred pending an independent expert review into the therapeutic value, risks, and benefits of psilocybin and MDMA for public health outcomes. The TGA decision maker intends to seek additional advice from the ACMS following the review. Amended timing on the scheduling process for these substances will be published on the TGA website following the completion of the independent review.