Originally Published In Buffalo Business First

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

Contact

https://phillipslytle.com/people/lisa-l-smith/