A seismic shift in how we discuss mental health has occurred over the past few years. A willingness to engage in the topic beyond mere lip service at home, in our communities, and in our places of work is a testament to the profound progress that has been made in reducing the stigma associated with these conditions of Health and Human Services create a federal inter-agency task force to address issues of psychedelic use, therapy, and health care integration. Proposed pieces of legislation have been introduced to allow for psychedelic use under the federal Right to Try Act, and to amend the Controlled Substances Act to grant the U.S. Drug Enforcement Administration the ability to transfer Schedule I substances into Schedule II provided such substances have received either FDA Breakthrough Therapy designation or authorization for use in FDA’s expanded access program.
Finally, a bipartisan Congressional caucus entitled Psychedelics Advancing Clinical Treatments (“PACT”) was formed this past November to explore psychedelic research related to mental health conditions.
Medicinal psychedelics are coming to mainstream health care in the very near future. But the treatment protocols and clinical settings in which psychedelic care is delivered will be very different from any existing model in our health care system. Medical professionals and health care entities seeking to operate in this new medicinal psychedelics space should consider engaging legal counsel who possess not only a strong comprehension of the law, but also an in-depth understanding of the science behind these drugs and their medical applications. Kyle W. Mack, J.D., Pharm.D., is special counsel at Phillips Lytle, co-leader of the firm’s Psychedelics & Mental Health Therapies Practice Team and a member of the firm’s Life Sciences & Health Effects Practice Team. He can be reached at (716) 847-7068 or kmack@phillipslytle.com. in a relatively short amount of time. Equally as profound are efforts by clinicians, researchers, and state and federal legislators to find and implement new treatment options for mental health conditions. These efforts have been focused on an area of pharmacology that one might think strange or even absurd at first blush: psychedelics. Psilocybin (“magic mushrooms”), MDMA (“ecstasy,” “molly”), LSD (“acid”), and dimethyltryptamine (“DMT”) are all being researched as medications to treat a wide variety of mental health and substance use disorders. Why? Because clinical research has shown – and is continuing to show – that these compounds may have superior efficacy compared to existing FDA approved medications when combined with psychotherapy. In August 2017, the FDA granted Breakthrough Therapy designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). In 2018 and 2019, it granted Breakthrough Therapy designations to psilocybin for treatment-resistant depression and major depressive disorder, respectively. Breakthrough Therapy designation is a process designed to speed up the development and review of medications intended for the treatment of serious conditions. It is granted on the basis of preliminary clinical evidence indicating that the medication under investigation may have potential for superiority over approved therapies on at least one clinically significant endpoint. FDA approval of MDMA for PTSD is expected in 2024, with approvals for psilocybin to follow.
While drug sponsors pursue the FDA approval route, several states have taken initiatives to create their own state-regulated frameworks to bring psychedelic compounds to their residents in controlled settings. Oregon was the first to pass legislation providing for psilocybin treatment centers. Connecticut and Colorado have since passed their own measures. New York has two proposed Assembly bills (A8569a, A7928) and one proposed Senate bill (S3520) that would establish regulated systems for the medical administration of psychedelics for mental health conditions. A8569a was introduced by Buffalo native, Assemblyman Patrick Burke. These state initiatives across the country are occurring at a time when psychedelics are still classified as illegal narcotics under the federal Controlled Substances Act. But federal bipartisan support for the use of these compounds as medications appears strong. In the past year, members of Congress have requested that the U.S. Department
Our expertise in both law and science helps us look at the issues through a variety of lenses. That’s The Phillips Lytle Way. Count on our multifaceted Life Sciences & Health Effects Practice Team to provide you with deep knowledge wherever scientific and legal issues meet — from defending high-stakes product liability litigation to risk assessment and regulatory compliance. We understand the science behind the issues like few law firms can. Our team of experienced mass tort litigators, lawyer/scientists, scientific specialists, and skilled supporting professionals knows how to take data and developments and interpret them through business risk and litigation risk lenses. And we know how to communicate complex scientific issues to adversaries, regulatory bodies, judges, juries and stakeholders. Talk to us and learn why clients have focused in on Phillips Lytle.
Authors
By Kyle W. Mack, J.D., Pharm.D. Phillips Lytle LLP
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.
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)
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.
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.
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.