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Australian Broadcasting Corporation: ‘Serious concerns’ over TGA’s decision making on landmark psilocybin, MDMA ruling

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The backlash was going to come and here it is..

Tania runs Mind Medicine Australia with her husband, Peter Hunt. Their organisation’s repeated attempts had been knocked back by the TGA.

As recently as October last year, the TGA ruled that there was insufficient evidence to down-schedule the drugs. But just months later, in February, it did a spectacular 180-degree turn and approved psychiatrists to use MDMA for PTSD and psilocybin for treatment-resistant depression.

That move divided the psychiatric community. It went against the advice from the peak bodies for doctors, psychiatrists and psychologists, respectively. And Background Briefing can reveal it went against the advice of the TGA’s own advisory committee.

“I have serious concerns about how that decision was reached,” a person involved in the deliberations told Background Briefing.

So, what caused the typically conservative TGA to change its mind, in a matter of months?

Push for change

Philanthropists Tania de Jong, an opera singer, and her husband Peter Hunt, a former investment banker, started Mind Medicine Australia in 2018, following a psychedelic therapy experience in Amsterdam in 2012 that they describe as life-changing.

The charity’s board includes The Ethics Centre boss Simon Longstaff, former Coalition trade minister Andrew Robb, and investment banker Nicholas Smedley, among others.

Mind Medicine Australia’s first application was rejected, following advice from the TGA’s advisory committee.

That committee met again in June last year to consider the organisation’s second, more conservative application. Background Briefing can reveal it still strongly opposed the down-scheduling.

Minutes from the meeting, obtained under freedom of information laws, reveal the committee’s reservations about listing the drugs as medicines.

“Members agreed that there was little additional evidence presented in this application … As such, the main barrier to down-scheduling psilocybine was therefore still a lack of established therapeutic value.

“Members expressed several concerns, including the broadness of the indication included in the proposal (treatment-resistant mental illness), the lack of phase III trials, and the problems associated with the translation from a clinical trial setting to clinical practice.

“The Committee agreed that the risk of diversion is low in a controlled medical environment, but noted that, contrary to the assertions of the applicant, there are significant risks of diversion at other points in the supply chain. In addition, not dispensing from a pharmacy would bypass the real-time prescription monitoring system, hence limiting oversight and governance.

“There remains no approved therapeutic product containing psilocybine anywhere in the world.”

The committee’s advice for MDMA echoed these concerns.

The committee also noted the Australian Medical Association’s continued opposition to the down-scheduling.

So it was little surprise that the secret TGA decision-maker known as “the delegate” made the interim decision in October to keep the drugs prohibited.

For most drugs, that would be the end of the story — TGA insiders told Background Briefing it’s uncommon for a final decision to diverge from the interim decision. But this time was different.

In the intervening months, Mind Medicine Australia doubled down on its campaign.

The group called for supporters to put in submissions opposing the TGA’s interim decision, and more than 3,000 heeded the call. That’s on top of the more than 13,000 public submissions the TGA had received before the interim decision.

The TGA delegate noted how few submissions came from actual psychiatrists or relevant organisations (submissions from the Royal Australian and New Zealand College of Psychiatrists and the Australian Psychological Society supported the interim decision not to down-schedule the drugs). The delegate said the submissions — largely corralled by MMA — were brief, and most failed to address any of the reservations expressed in its interim decision.

The TGA’s expert committee shared this view, advising the delegate that the submissions “did not identify any new or compelling evidence, and instead focused on emphasising human interest or philosophical points of view”.

Still, the delegate said the number of submissions was “a reasonable indicator of the scope and gravity of the issues … addressed in the application”.

The submission campaign was just the beginning.

Mind Medicine Australia engaged new lobbyists — Hawker Britton, known for their cosy relationships with the Labor government — who Peter says helped them “understand the dynamics of Canberra”.

The organisation then flew out Imperial College of London neuropsychopharmacologist David Nutt for a roadshow up and down the east coast. Professor Nutt’s world-leading research has made him something of a celebrity in psychedelic circles.

During a whirlwind tour sponsored by herbal tincture and organic chocolate brands, he addressed packed town halls in Byron Bay, Sydney, Canberra and Melbourne. Then there were the black-tie events with philanthropists and stakeholders at the Australian Clubs in Sydney and Melbourne.

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https://www.abc.net.au/news/2023-03-18/psychedelic-charity-accused-lobbying-tga-mdma-psilocybin/102103782



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Article: Early 2025 Empire State Psychedelic Policy Roundup

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Unique NY-Born Licensing Model for Therapeutic Psilocybin Use Gains Momentum in State Senate Amid Flurry of Psychedelic Bills Filed Across the US

(Albany, NY) As New York’s cannabis industry continues to turn a hefty profit in the earliest days of 2025 so far, many plant medicine community members both within and just beyond the cannabis industry have been steadily laying the groundwork for the next state-level drug policy reform movement rife with seemingly-incompatible, arguably-intertwined intersectional equity enhancement opportunities and profit margin maximization priorities at play: psychedelics.

For those unfamiliar, 2024 brought about a number of presumed-to-be momentum-stalling psychedelic setbacks – first with the FDA’s stunning rejection of a first-of-its-kind MDMA-Assisted Therapy Treatment developed by the Multidisciplinary Association of  Psychedelic Studies (MAPS) and their Public Benefit Corporation (PBC) spin-off Lykos Therapeutics. To compound public misperception of psychedelic policy reform efforts further, a much-discussed and deep-pocketed legal psychedelic therapy-personal possession and home cultivation decrim-focused psychedelic ballot campaign in Massachusetts failed spectacularly – leading some pundits – both pro-legalization and prohibitionists alike – to speculate that “the psychedelic renaissance” as it’s been called by some, had in fact stalled out at large.

Fortunately for the plant medicine community, those naysayers were largely wrong, as in January 2025 alone, a record-breaking 38 psychedelics-related bills were filed in 14 states across the country. Here in New York, prominent psychedelic policy reform advocates have gained serious traction within the state’s legislature, especially after a recent lobbying day at the state Capitol.

Led by the increasingly diverse coalition known as New Yorkers for Mental Health Alternatives and backed by a growing bipartisan interest in alternative mental health treatments, New York’s burgeoning intersectional community of psychedelic activists and legal experts recently gathered in Albany to rally support for two proposed bills aimed at expanding access to psychedelics for therapeutic and personal use.

Avery Stempel NYMHA

“Our 2025 New York State Capitol Lobby Day was a huge success,” said Avery Stempel, co-founder of New Yorkers for Mental Health Alternatives (NYMHA) and founder of Collar City Mushrooms. “Advocates, doctors, and lawyers from Brooklyn to Buffalo traveled to Albany to participate. We had individual meetings with 10 senators and assembly members and talked to many more in the hall while they passed by our tables. There is a lot of energy gathering around the New York bills, and we are hopeful that we will be making some serious traction this year.”

At the forefront of the legislative push is Assembly Bill A2142, introduced by Assemblywoman Amy Paulin (D) alongside four co-sponsors. The bill would create a state-supervised program allowing licensed facilitators, including health and social care professionals, to administer psilocybin-assisted therapy to eligible patients. The measure mirrors a growing movement across the country, following in the footsteps of states like Oregon and Colorado, which have already established legal frameworks for psychedelic-assisted treatment.

A second measure, House Bill 628, introduced by Assemblymember Linda Rosenthal (D) with eight co-sponsors, takes a broader approach. If passed, the legislation would legalize the adult possession and use of several plant- and fungus-based hallucinogens, including psilocybin, mescaline, DMT, ibogaine, and psilocin. The bill is currently under review by the state’s public health committee and, if advanced, would require approval from Governor Kathy Hochul (D) to become law.

Momentum for these reforms received a boost with the recent filing of Senate Bill S5303 by State Senator Julia Salazar (D). The measure serves as a companion bill to A2142, signaling increased legislative interest in the possibility of a hearing on psychedelic policy in Albany later this year. According to NYMHA leaders, this marks a critical step in New York’s efforts to bring psychedelic-assisted therapy into the mainstream.

Jonah Martindale, Rick Doblin, Gina Giorgio

“We are seeing that in the last few years, there has been a shift in the popularity of alternative treatments for the worsening mental health crisis, such as psychedelics,” said Jonah Martindale, a New York City resident, NYMHA coalition member, and advocate with Students for Sensible Drug Policy (SSDP). “The openness of various politicians across the political spectrum for these bills seems to reflect that. Now is the time to keep building momentum.”

Supporters of the bills argue that psychedelic-assisted therapy has the potential to revolutionize mental health care, offering new hope for individuals suffering from treatment-resistant conditions such as PTSD, depression, and substance use disorders. Medical research and clinical trials have shown promising results in recent years, prompting lawmakers in various states to reconsider their stance on these substances.

However, despite the growing enthusiasm, challenges remain. Critics have raised concerns about public safety, regulatory oversight, and the potential for misuse. Law enforcement officials and some health professionals caution that broader legalization could lead to unintended consequences, particularly if access to psychedelics is not accompanied by rigorous safety protocols.

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Early 2025 Empire State Psychedelic Policy Roundup

 



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Linked In Post – Jon Dennis, Psychedelic Lawyer: Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce ( 18 Feb 2025)

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Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce. The bill would require low-income and other taxpayers to subsidize regulated access that is cost-prohibitive for many, while continuing to criminalize the same activities outside of the regulated marketplace.

For context, Oregon’s regulated system was promised to be self-funded by licensing fees and sales taxes, but the program needed a $3.1MM bailout in 2023, and the program is now seeking an additional $3.5MM bailout from the legislature. This is despite already-exorbitant licensing fees, including a $2,000 annual fee for facilitators. (By contrast, the annual fee for an Oregon law license is $683; the annual fee for medical doctors is $702.)

Taxing residents for the administration of a costly access program, while criminalizing affordable access outside the program, is problematic–particularly in Washington where local governments representing 14% of the entire population have already called on state lawmakers to decriminalize psilocybin and other plant-based psychedelic substances. Washington lawmakers must do better and not ignore the socio-economic and criminal justice impacts of a regulated-only access program.



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Alert: We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

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Dear Interested Parties:

 

We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

 

This week, we wanted to share some logistical information about the application process.

 

We encourage you to submit your application online, and there will be instructions on how to submit applications on the Natural Medicine Division website.

However, based on stakeholder feedback, we will be opening up limited appointment slots for in-person assistance at our Lakewood office starting on Friday, Jan. 10, 2025. At this time, Fridays will be the only day that we will be offering in-person natural medicine licensing application assistance. We will be open from 9 a.m. to noon and 1 p.m. to 4 p.m. for in-person Friday appointments.

We are finalizing the applications and will be sharing those prior to our application process coming online. You can always check out our Public Resources folder to find information and compliance tools.

As always, please reach out to us at [email protected].us if you have any questions.

 

Stay tuned!

The Natural Medicine Division



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