Phillips Lytle Launches Psychedelics & Mental Health Therapies Practice
Among the first in the nation, Phillips Lytle’s Psychedelics Practice combines expertise in pharmaceutical science, FDA regulations and risk management to serve the legal needs of emerging bio-tech sectors
Buffalo, N.Y. – Phillips Lytle LLP announced the launch of its Psychedelics & Mental Health Therapies Practice, which is uniquely equipped to help pharmaceutical companies, research organizations and other stakeholders navigate the evolving legal and regulatory landscape related to the development, approval and use of psychedelic medications. Phillips Lytle Special Counsel Kyle W. Mack, who holds a doctorate in pharmacy, and Lisa L. Smith, a partner with the firm and co-leader of the firm’s Life Sciences & Health Effects Team, will lead the practice, bringing together scientist-attorneys and experienced litigators to support clients that are driving innovation in mental health treatments.
Phillips Lytle is a leader nationally and in New York State in forming a multidisciplinary practice to serve the psychedelics industry. The firm’s deep expertise in pharmaceutical sciences, FDA regulatory compliance and pharmaceutical product liability litigation and risk management enables it to address complex legal hurdles faced by stakeholders seeking to research, develop, invest in and bring-to-market psychedelic therapies.
“We are at the beginning of a revolution in how mental health conditions are medically treated. As research into the use of psychedelic therapies continues to expand and additional data demonstrate significant positive outcomes in the treatment of mental health conditions, the benefits that psychedelics offer will continue to gain acceptance and understanding across the medical community. Our multidisciplinary team is well prepared to serve clients in this evolving and exciting space,” Dr. Mack said.
“The number of companies seeking to bring FDA-approved psychedelic medications to the market has exploded in the last few years. Psychedelics present a new potential path to relief for patients who continue to struggle with mental health conditions despite conventional therapies. It also creates new opportunities for researchers, entrepreneurs, investors and pharmaceutical companies. With rapid change expected in state and federal laws and regulations governing the industry, we understood the urgency of launching a practice that provides sophisticated legal counsel bolstered by deep knowledge of science and the pace of innovation.”
Preliminary research shows that treatment with classical psychedelic compounds, such as psilocybin, LSD and DMT, the entactogen MDMA, and the dissociative ketamine, can be effective in treating certain mental health disorders including Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD), and Treatment Resistant Depression (TRD), when used in controlled clinical settings under the supervision of trained professionals. Study and development of these treatments remain challenging as psilocybin, MDMA, DMT and LSD are all listed as DEA Schedule I drugs. However, change appears imminent. In 2022, Oregon became the first state to legalize psilocybin-containing mushrooms for supervised adult administration, and state legislatures across the country, including New York State, are now considering bills related to regulated psychedelic treatments. Federally, the FDA also has granted “breakthrough therapy designation” for MDMA and psilocybin to expedite development and agency review. It is anticipated that MDMA will receive FDA approval for PTSD by the end of 2023, and that psilocybin approval will follow.
“Operating at the intersection of science, technology and the law, this new practice team has the skills necessary to guide the growth of this emerging industry,” said Ms. Smith. “Having served as national science counsel for a global pharmaceutical company for over 20 years, with a significant focus on medications for mental health conditions, we understand the challenges of navigating a constantly evolving regulatory environment while working to innovate and improve the treatments available to patients. In addition to global companies, our team of attorneys, who have doctorate degrees in pharmacy, chemistry and physiology, along with our in-house health care professionals and pharmaceutical scientists, will counsel drug developers, investors, entrepreneurs, hospitals, universities and research institutions.”
Joining Ms. Smith and Dr. Mack, the practice team will include Special Counsel George Hajduczok, Ph.D., Partner William P. Keefer, Partner Eric M. Kraus, Associate Joshua S. Wallace, Ph.D., Science Specialist Julia M. Markov, Pharm.D., as well as Partner Richard E. Honen (venture capital), Partner Amanda L. Lowe (health care/higher education) and Associate Mary-Jane R. Morley (emerging industries).
The firm’s Psychedelics & Mental Health Therapies Practice Team has an established track record in counseling companies, from startups to multinational corporations, in entity and venture formation, financing, commercialization, pre- and post-marketing strategies, regulatory approvals, compliance and enforcement, IRB protocols, clinical trial and informed consent matters, pharmacovigilance, licensing and product litigation.
Building on its work in the life sciences, cannabis and other innovative technologies, this latest entry into an emerging legal field marks another milestone for Phillips Lytle.