The Australian Government’s Therapeutic Goods Administration (TGA) has announced that authorised psychiatrists will be allowed to prescribe drugs containing psilocybine and MDMA for certain mental health conditions, starting from 1 July this year.
The TGA has limited its authorisation of MDMA to the treatment of certain cases of treatment-resistant depression, and pysilocilbine to treat post traumatic stress disorder.
Psychiatrists who are approved under the Authorised Prescriber Scheme, which requires a doctor’s application be scrutinised and approved by a human research ethics committee, will be able to prescribe the drugs.
The TGA’s decision will mean that in these cases, psilocybin and MDMA will be listed as Schedule 8, ‘Controlled Substances’ under the Poisons Standard. In all other circumstances, the drugs will remain Schedule 9 ‘Prohibited Substances’.
Before making its decision, the TGA received applications to reclassify the drugs in the Poisons Standard, in addition to 6,000 submissions in a public consultation and a report by an expert panel regarding the proposed changes.
In its report, the TGA said that “registered psychiatrists have the training and expertise to diagnose and appropriately treat those conditions for which there is emerging evidence for the use of the Substances.”