New Michigan Bill Would Legalize Psychedelic Mushrooms For People With PTSD

Newly introduced legislation in Michigan would clear the way for people with post-traumatic stress disorder (PTSD) to legally possess and use psychedelic mushrooms.

Sponsored by Rep. Mike McFall (D), HB 5980 would legalize possession of up to two ounces of “a substance that contains psilocybin” provided a person is 18 or older and has a medical record “that demonstrates the individual has a diagnosis of post-traumatic stress disorder.” The change would also apply to substances containing psilocin, another psychoactive chemical found in mushrooms.

In addition to the weight limit, the proposal allows possession “only for personal use.” And unlike more regulated psychedelics programs, such as Oregon’s therapeutic psilocybin program, the Michigan measure doesn’t contemplate licensing an industry to produce and dispense psychedelics.

However, the proposal does state that qualified individuals would be “not in violation of” laws barring the creation, manufacture, possession or use of psilocybin and psilocin.

McFall’s new bill, HB 5980, was filed on Thursday with co-sponsors Reps. Dylan Wegela and Kimberly Edwards, both Democrats. It’s been referred to the House Criminal Justice Committee, though it hasn’t yet been scheduled for a hearing.

Late last year, McFall indicated his support for the reform on social media, saying he was working to decriminalize psychedelics for PTSD patients in the state.

I'm with Texas Congressman @DanCrenshawTX on this one. Never thought I'd be saying that. I'm currently working to decriminalize #Psilocybin for Michiganders with #PTSD.https://t.co/Elstwt94R7

— Mike McFall (@VoteMcFall) December 16, 2023

Already at least five municipalities in Michigan have acted at the lower level to end criminal enforcement of laws against psychedelics. Most recently, in January, the Ypsilanti City Council unanimously passed a resolution to deprioritize enforcement of laws against psychedelic substances and express support for a statewide bill to legalize certain entheogenic plants and fungi.

That measure, much like those adopted by other localities in the state, specifically says that it is not intended to legalize the commercial sale of psychedelics. Rather, it makes the arrest and investigation of people for psychedelics-related activities such as possession and cultivation “the lowest law enforcement priority” for the city.

Other Michigan municipal governments that have moved to decriminalize psychedelics include Detroit, Ann Arbor, Ferndale and Hazel Park.

Not all Michigan cities to consider a decriminalization proposal have adopted it, however. Last May, the East Lansing City Council narrowly rejected a similar resolution, with the mayor and city attorney voicing concerns about possible legal ramifications.

In 2021, Grand Rapids, lawmakers approved a resolution supporting the decriminalization of a wide range of psychedelics. That measure, however, disappointed activists because it didn’t actually change any city enforcement practices and merely expressed support for future reforms.

In 2022, a group of activists failed to qualify a psychedelics legalization initiative for the ballot, saying they would refocus their efforts on the 2024 election.

Meanwhile, in August, Michigan lawmakers sent a letter to Congress, the U.S. Department of Defense and Department of Veterans Affairs (VA) urging them to prioritize research and investment in psychedelics and other “non-technology treatment options” to address psychological trauma from military service.

Also in August, the head of the National Institutes of Health (NIH) said there’s “growing evidence” that psilocybin could represent a novel therapy option in the treatment of substance misuse, depression, anxiety and other mental health conditions.

While NIH Director Monica Bertagnolli cautioned that the agency is not advising people to use the psychedelic for recreational purposes, initial studies looking into its therapeutic potential have shown promising results, she said, especially as it concerns increasing plasticity in the brain that could help address major mental health disorders.

Psilocybin “comes with health risks and isn’t recommended for recreational use,” she said. But “there’s growing evidence that—under the right conditions—its effects on the brain might be harnessed in the future to help treat substance use disorders or mental illnesses.”

Like the top NIH official, National Institute on Drug Abuse (NIDA) Director Nora Volkow said last year that there is emerging evidence that psychedelics carry “significant potential” as therapeutic treatments for certain mental health conditions, and it’s a topic of “great interest” for researchers.

Meanwhile, the U.S. House of Representatives recently approved amendments to a large-scale spending bill that would authorize VA doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.

The Senate Appropriations Committee also recently passed report language for appropriations legislation conveying concerns about restrictions on marijuana and psychedelics research imposed by current prohibition.

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FDA Expert Committee Will Review MDMA-Assisted Therapy For PTSD Next Month

The Food and Drug Administration (FDA) is taking the next step in its historic review of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), scheduling a meeting next month where an expert committee will examine the evidence behind the application.

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) announced on Monday that FDA’s Psychopharmacologic Drugs Advisory Committee will meet on June 4 to review the results of its clinical trials for the psychedelic-assisted therapy.

Not only will this be the first time in 25 years since FDA has reviewed a new PTSD treatment option, it’s the first time in history that the agency has taken up a new drug application for a psychedelic substance.

Amy Emerson, CEO of Lykos Therapeutics, said it is a “significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy.”

“We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD,” she said.

FDA’s expert panel will look at an extensive body of research that includes two randomized, double-blind, placebo-controlled Phase 3 studies that looked at the safety and efficacy of MDMA-assisted therapy.

Today, we announced the first FDA Advisory Committee meeting for #PTSD in 25 years will be held on Tuesday June 4 to review our investigational therapy. Read more on this milestone here: https://t.co/v6LNsSB8R6pic.twitter.com/D2ZCMThjKz

— Lykos Therapeutics (@Lykos_PBC) May 6, 2024

The committee review will take place about four months after FDA accepted the MDMA new drug application and granted it a priority status.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.

FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.

Last year, FDA released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.

Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that assign psychedelics-specific codes to collect data on the novel therapies.

Meanwhile, a separate study by researchers at New York University’s Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that pairing MDMA with either psilocybin or LSD helped people overcome the “challenging experiences” associated with use of psilocybin or LSD alone.

In 2022, the Biden administration said it was “actively exploring” the possibility of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.

Bipartisan congressional lawmakers asked the U.S. Department of Veterans Affairs (VA) last month to produce a plan to begin providing MDMA-assisted therapy for veterans as soon as the psychedelic is approved by FDA.

Also, proposed changes to federal workforce drug testing guidelines that are currently being reviewed by officials would remove screening for MDMA—which has only rarely appeared in workers’ urine samples during recent years—and add testing for fentanyl, a substance that’s become far more widespread in unregulated drug markets over the past decade.

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FDA Grants Priority Review Of MDMA-Assisted Therapy For PTSD, Psychedelics Drug Development Company Says

The Food and Drug Administration (FDA) has agreed to review MDMA-assisted therapy as a potential treatment option for post-traumatic stress disorder (PTSD), and the application has been granted priority status, according to the psychedelics-focused drug development company that’s leading the effort.

About two months after Lykos Therapeutics (formerly MAPS Public Benefit Corporation) submitted the new drug application (NDA) for MDMA in combination with psychotherapy, FDA granted it priority review last week and has set a target date for determination by August 11, the company announced on Friday.

If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with talk therapy and other supportive services.

“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” Lykos CEO Amy Emerson said in a press release. “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”

#BREAKING: We are proud to announce the @FDA acceptance and priority review of our new drug application (NDA) filing for our investigational therapy for post-traumatic stress disorder #PTSD in adults. Learn more: https://t.co/WbvgbygG1Spic.twitter.com/v1eHp7XXuQ

— Lykos Therapeutics (formerly MAPS PBC) (@Lykos_PBC) February 9, 2024

Lykos, which was founded as a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) but last month accepted new investors in conjunction with its name change, provided FDA with copious scientific data derived from multiple clinical trials that supported the efficacy of MDMA as a therapeutic for moderate and severe PTSD.

MAPS published the results of a recent Phase 3 trial in the journal Nature last September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”

FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.

MAPS President Rick Doblin said in a press release that the organization is “celebrating the therapists and subjects who participated in the Phase 2 and Phase 3 studies and the team at Lykos Therapeutics on the historic accomplishment they have achieved.”

“We hope that potential FDA approval of MDMA-assisted therapy for PTSD is only the first of many psychedelic-assisted therapies that become available by prescription,” he said.

The review that’s now underway is expected to be completed within six months given the expedited application status. That’s four months earlier than a standard NDA review.

An FDA representative told Marijuana Moment on Monday that the agency is “generally unable to discuss existing or potential applications,” citing “confidential commercial information.”

Last year, FDA released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.

Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that assign psychedelics-specific codes to collect data on the novel therapies.

Meanwhile, a separate study by researchers at New York University’s Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that pairing MDMA with either psilocybin or LSD helped people overcome the “challenging experiences” associated with use of psilocybin or LSD alone.

In 2022, the Biden administration said it was “actively exploring” the possibility of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.

In California, meanwhile, Gov. Gavin Newsom (D) signed a bill last October that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled.

Last February, Australia legalized MDMA and psilocybin for use by prescription.

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Photo courtesy of Pretty Drugthings on Unsplash.