Dr Winlo said faster progress could have been made in studying the effectiveness of the two drugs if TGA had reduced its classification to Schedule 8.
“However, the way forward is now clear: Researchers, innovators and government must work together to gather the evidence that TGA expects to see,” he said.
“If we do it right, rescheduling will be back on the agenda. “
Mind Medicine Australia chairman Peter Hunt said they were “bitterly disappointed” by the TGA decision.
“Australia has missed a tremendous opportunity to help people with treatment-resistant PTSD and treatment-resistant depression and to become a world leader in this field,” he said.
“In our opinion, the medical use of psilocybin and MDMA in medical environments controlled by trained professionals should fall under Schedule 8 of the Poison Control Standard.
“This is a point of view shared by the many researchers and physicians who have supported our rescheduling requests.
“There are so many people with treatment-resistant depression and treatment-resistant PTSD in Australia who will be desperate for this decision.
“It leaves them little hope. “
However, Stephen Bright, Edith Cowan University professor of drug addiction, said that although late phase clinical research around the world has shown promising results, the standards of evidence required for formal approval have yet to be met.
“My concern was that the reprogramming request, as submitted, did not go far enough to ensure adequate clinical governance for the use of these potent therapeutic drugs,” said Dr Bright, who is also the founding member of nonprofit psychedelic research. PRISM group.
“Without an established and integrated system of clinical governance for the delivery of psychedelics, reprogramming alone can open the door to unsafe and unethical practices.
“Appropriate training for this innovative and paradigm-shifting approach is still largely lacking, even among mental health professionals. “
In its published decision, the TGA raised similar concerns regarding the use of MDMA and psilocybin in clinical settings, but concluded that both showed promise only when administered in closely monitored clinically settings. and with intensive professional support.
He said both drugs carry a high risk of both acute and long-term effects if abused or misused.
The TGA said the drugs remaining in Schedule 9 meant that a high level of control could be maintained through prohibition of access and supply to minimize the risk of abuse or diversion into illicit activities. .
“The reduction could be further considered if there was more evidence of the therapeutic value of these clinical trials,” the statement said.
“There are still arrangements for clinical trials with the approval of Commonwealth and / or State or Territory health authorities, with the potential to obtain additional evidence that may inform future requests for psilocybin reduction. and MDMA. “