TGA seeks input on MDMA, psilocybin downschedule


depression mental health anxiety population

The TGA has decided to seek further advice in relation to psilocybin and MDMA and their therapeutic use

The TGA says this will include “an independent expert review into the therapeutic value, risks and benefits to public health outcomes for these substances as well as seeking additional advice from the Advisory Committee on Medicines Scheduling following the review”.

It says its final decision will no longer be made on April 22, and stakeholders will be advised of an amended timeline following the review.

On February 3 2021, it had announced an interim decision not to amend the current Poisons Standard in relation to MDMA and psilocybin.

Mind Medicine Australia, an organisation which seeks to expand treatments available for mental illness, had applied to have the two substances rescheduled, as part of therapy in medically controlled environments, from S9 to S8 of the Poisons Standard.

It welcomed the move by the TGA to seek further input.

“We are delighted with this development because we have become increasingly concerned about the process to date and the quality of the arguments that were used by the Delegate to justify rejecting our applications at the interim stage,” said its chairman, Peter Hunt.

“We have the ridiculous situation in Australia where the TGA is authorising applying medical practitioners to use these medicines as part of therapy in medically controlled environments for patients suffering from treatment resistant PTSD and treatment resistant depression but the wrongful scheduling of these medicines in Schedule 9 of the Poisons Standard is preventing these medical practitioners from obtaining the consents of the State and Territory Governments where the treatment would be carried out.”

Last month the AJP reported that the latest Global Drug Survey showed that among 110,000 respondents from around the world (10% from Australia), 6,500 were exploring self-treatment with psychedelics.

RMIT University’s Dr Monica Barratt, who led the survey’s Australian arm, said the findings showed that people are already using psychedelics as a DIY mental health treatment.

“As Australia awaits the progress of clinical trials of these substances for mental health conditions, we need to recognise the demand for them is increasing and this demand may end up being filled outside of the medical setting,” Dr Barratt said.

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