Questions remain around the safety of psychedelic therapy

The Therapeutic Goods Administration (TGA) reclassified the drugs in late 2022.

In an article, several leading academics claimed that the TGA had yielded to pressure from lobby groups to increase access to experimental treatments.

"There are many questions regarding the precise details of this change that remain unanswered. Until these are adequately addressed, we cannot, in good conscience, support this move," they wrote.

The authors claimed the TGA did not consult researchers and clinicians with experience in psilocybin-assisted psychotherapy before reclassifying the drug.

However, the TGA said the process for changes to MDMA and psilocybin access was not rushed nor influenced by lobby groups or media interest.

"The assertion that the TGA did not consult with Australian researchers and clinicians is incorrect," it said.

Cognitive neuropsychologist Susan Rossell said she was concerned with the lobbying associated with psychedelics..

"This is the first time I know of in history that lobbying rather than science has got an intervention to the market," she said.

"We are in a desperate state in terms of the mental health of the Australian population, and I think that's where we need to be careful.

"Just because we're desperate doesn't mean we should rush to market with something that hasn't had all the safety elements checked out."

Despite a growing body of evidence, psychedelic-assisted therapies are in their infancy. Advocates say they are necessary with mental health problems on the rise.

However, the hype and promise around these drugs may encourage people to view psychedelic treatments as a first line of response, according to University of NSW professor of psychiatry Colleen Loo.

"My main concern is that the public understand that while the TGA has down-scheduled these drugs we don't have the usual level of evidence of effectiveness and safety that we would have before these drugs are made publicly available," she said.

"If you think that things aren't working for you make sure first of all to go and consult a psychiatrist before you jump to something like psychedelic assisted psychotherapy."

Advocacy group Mind Medicine Australia lobbied extensively to have the drugs reclassified and is supplying psilocybin and MDMA at no cost for some clinical trials.

"The TGA felt the safety profile shown in trials alongside the efficacy that has been shown was enough to approve them within the confines of this program," Mind Medicine executive officer Scott Edwards said.

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The TGA said the drugs are approved only for people with treatment-resistant depression and post-traumatic stress disorder and are to be used in conjunction with psychotherapy.