Mental health and substance abuse disorders are receiving increased attention both medically and culturally. This ongoing destigmatization has triggered a renaissance in the evaluation and application of psychedelics, including psilocybin, LSD, DMT, MDMA and ketamine in the treatment of such conditions. Phillips Lytle has a deep and broad knowledge of the regulatory and legal issues related to approval, marketing and use of medications to treat mental health conditions, having served as national science counsel for a global pharmaceutical company for over twenty years.
Psychedelics are emerging as potentially life-changing treatments for disorders such as depression and posttraumatic stress disorder (PTSD). As psychedelics move towards legalization, the psychedelics industry presents great opportunities for innovative entrepreneurs and investors, health care professionals and patients. But with state and federal laws poised for rapid change, the emerging legal and regulatory landscape in which stakeholders must operate requires sophisticated and experienced legal counsel.
We have decades of experience providing guidance to life sciences companies, from startups to multinational pharmaceutical companies, on all issues affecting the lifecycle of a medication and its clinical use. Our multidisciplinary team of attorneys (with doctorate degrees in pharmacy, chemistry and physiology), health care professionals and pharmaceutical scientists has deep industry knowledge. We counsel FORTUNE 100 pharmaceutical companies as well as pharmaceutical developers, private equity investors, entrepreneurs, hospitals, universities and research institutions.
As national science counsel for a global pharmaceutical company, our team worked with leading mental health and medical experts for over two decades to present the scientific, legal and factual information necessary to successfully defend an antidepressant medication in thousands of cases against claims that: (1) preclinical studies, clinical trials and post-marketing safety surveillance were improperly designed and/or interpreted; (2) the medication’s labeling and warnings were improper; and (3) plaintiffs had suffered adverse health effects. Our work in the mental health and medical treatment space also includes our representation of hospitals, behavioral health facilities and opioid addiction treatment clinics. Additionally, members of our team have continuously served on the board of directors of a mental health advocacy nonprofit in New York State for over two decades.
Our multidisciplinary team has an established track record in counseling companies and investors 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, as well as other areas. We are highly experienced in effectively communicating scientific, medical and legal issues to achieve our clients’ goals in complex and sometimes controversial industries.