Navigating regulatory compliance is paramount for companies operating within the psychedelics space. Generally, these companies fall into two distinct categories: (1) companies seeking to operate in jurisdictions or municipalities that have decriminalized the sale and / or use of certain substances such as psilocybin (“decrim companies”); and (2) biotech companies developing naturally-occurring or synthetic molecules derived from or inspired by psychedelic compounds through the FDA drug development pathway with the objective of eventually obtaining FDA approval for their therapeutic drug product (“psychedelic biotech companies”). The legal environment surrounding decriminalized psychedelics is complex, with regulations varying significantly across the few municipalities or jurisdictions that permit these activities.
Regulatory Compliance
For psychedelic biotech companies, regulatory challenges typically encompass compliance with FDA regulations related to preclinical drug development, investigational new drug (IND) applications, and human clinical trial design and implementation. These steps are essential for generating the safety and efficacy data necessary for submitting a new drug application (NDA) to the FDA.
With regard to psychedelic biotech companies, the regulatory challenges typically encompass compliance with FDA regulations related to preclinical drug development in support of an investigational new drug (IND) application and, eventually, human clinical trial design and implementation as a company embarks on the generation of safety and efficacy data necessary for the submission of a new drug application (NDA) to FDA.
For companies operating in jurisdictions that have decriminalized the use of certain psychedelics, regulatory challenges often involve adhering to the specific regulations of the municipality, jurisdiction, or state that has decriminalized the substance. Additionally, these companies must navigate the interplay between local decriminalization regulations and federal regulations, which typically consider these substances as illicit, Schedule I drugs.
Services Provided
At Asebey Life Science Law, our FDA regulatory attorneys offer decades of combined experience in the biotechnology sector, which translates directly to the needs of psychedelic biotech companies. Our comprehensive services include FDA regulatory guidance, preparation for IND meetings, preparation of submissions to FDA, clinical trial design support, life science transactions such as capital raises, IP licensings, sponsored research agreements, material transfer agreements, cooperative research and development agreements (CRADAs), and patent portfolio strategy and management.
Additionally, our deep understanding of the legal landscape in decriminalized jurisdictions ensures that clients can confidently address the complexities of these new regulations. We assist our clients in obtaining necessary licenses, adhering to compliance standards, and responding to regulatory inquiries or actions. Our proactive approach helps clients mitigate risks and capitalize on opportunities within the rapidly evolving psychedelics sector, facilitating growth and innovation while maintaining strict adherence to the latest regulatory standards.