PsychedeLinks – February 17, 2023

There’s been chatter coming from Colorado this week that lawmakers will move forward this session with legislation restricting the Natural Medicine Health Act (“NMHA”). The NMHA is a rather broad act with a decriminalization element allowing personal use, possession, cultivation, and adult sharing of five psychedelic medicines (psilocybin, psilocin, mescaline (excluding peyote), DMT, and iboga), and a regulated element allowing adult consumption at state-licensed healing centers. At a Boulder town hall meeting on February 13, 2023, Colorado Senator Steve Fenberg confirmed the Colorado legislature will consider specific limitations on cultivation, possession, and transportation restrictions for the decriminalization component of the NMHA. Other groups in Colorado are lobbying for local jurisdiction approval of cultivation and healing centers. Colorado is home to a growing and vibrant community of advocates and activists who are working tirelessly to ensure the healing potential of these medicines is fully realized. “In the months before the election, psilocybin advocates who supported decriminalization before commercialization voiced concerns that legislators would water down the hard-won ‘personal use’ provisions. It appears those fears have just been substantiated. It would be paternalistic and antidemocratic for legislators to defy constituents by substantially modifying the law at this point,” says Matt Brockmeier, Of Counsel Attorney at Emerge Law Group.

“The Therapeutic Goods Administration announced on Friday that, from July, approved psychiatrists would be able to prescribe MDMA (ecstasy) for post-traumatic stress disorder and psilocybin (found in magic mushrooms) for treatment-resistant depression. The move makes Australia the first country in the world to officially recognize psychedelics as medicines. Psychiatrists will need to get approval by a human research ethics committee, then approval under the TGA’s authorized prescriber scheme. To get those approvals they must demonstrate their training, robust patient selection and evidence-based treatment protocols, as well as patient monitoring. They must also satisfy governance and reporting criteria. Because there are are currently no approved Australian substances, the psychiatrist would also have to apply for a license to import them.”

“In Nov. 2022, the U.S. nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it had completed a second phase-three trial on MDMA as a treatment for PTSD—a step widely seen as the last hurdle to clear before applying for approval from the U.S. Food and Drug Administration (FDA). Rick Doblin, MAPS’ founder and executive director, says his group is preparing to apply for FDA approval based on those data. If all goes well, he says, the drug could be approved as soon as 2024. Australia’s approval of these drugs, Doblin says, may only expedite the approval process in the U.S. A representative for the FDA did not respond to TIME’s request for comment before press time. But in a May 2022 letter first published by the Intercept, a U.S. Department of Health and Human Services official wrote that FDA approval of MDMA and psilocybin was ‘anticipated’ within ‘approximately 24 months.’”

“Arizona lawmakers have approved a bill in committee to promote research into the medical potential of psilocybin mushrooms for a variety of conditions, which could inform future reforms to more broadly allow access to psychedelic-assisted therapy. The proposal is focused on psilocybin research, providing $30 million in grants over the course of three years for scientists to study the impact of the psychedelic on 13 different conditions such as post-traumatic stress disorder (PTSD), depression, anxiety, long COVID symptoms and substance misuse disorder. The research grants would be appropriated for phase I, II and III clinical trials that are “capable of being approved by the United States Food and Drug Administration (FDA) to evaluate the effects of whole mushroom psilocybin” for the designated conditions. A “Psilocybin Research Advisory Council” would be established under the Department of Health Services (DHS), tasked with establishing eligibility criteria for grant recipients, overseeing applications and making “recommendations to the governor, the speaker of the House of Representatives, the president of the Senate and the department on psychedelic-assisted therapy based on current federal and state research policy.”

“A lawmaker is paring down her plan to decriminalize magic mushrooms in Utah for patients suffering from certain conditions. Senate Bill 200, sponsored by Sen. Luz Escamilla (D-Salt Lake City), now aims to create a pilot program for patients to use psilocybin. She hopes that change might move it across the finish line. Escamilla’s plan would allow patients suffering from depression, anxiety, PTSD, or those on hospice care to use psilocybin. But it would cap the number of patients at 5,000. ‘This will be under a lot of control,’ said Escamilla. Her bill would also impose an end date to the pilot program so the Legislature can review it.”