Alice Mead

Alice P. Mead, J.D., LL.M.

Abstract Presenter

Ms. Mead received her Juris Doctor degree from University of Santa Clara School of Law and her Masters of Law degree from Yale. She served for twelve years as an in-house counsel to the California Medical Association (CMA), one of the largest state medical associations in the country. Prior to that time, Ms. Mead was a litigation associate at a global law firm and an Assistant Professor of Law at Arizona State University College of Law, where she taught courses in constitutional law. Since 1999 she has served as Vice President, U.S. Public Policy and Public Affairs, for Greenwich Biosciences, one of the first companies in the world to develop cannabis-derived medications as prescription products in adherence to modern scientific and regulatory standards for pharmaceutical products. She focuses on domestic and international drug control laws and policy issues.

Taking Cannabis-Derived Medications Through the FDA Approval Process

Securing approval from the Food and Drug Administration (FDA) is difficult for any investigational medication, but the challenges are even greater for products derived from botanical materials. In addition, there are additional hurdles and requirements for products containing substances that may affect the central nervous system (CNS). Strict control of the conditions of cultivation and harvest of the botanical starting material is the essential first step. Multiple quality control steps, specifications (agreed to by FDA), and batch-to-batch consistency are required at each point along the way as the botanical raw material moves through various stages into a finished drug product. Extensive toxicology and other safety testing (in animals and humans) is necessary. Robust clinical trials will assess safety, efficacy, and the effects of different doses. Since cannabis is classified in Schedule I of the Controlled Substances Act, special federal and state license and security requirements apply. Because cannabinoids have CNS activity, a full battery of abuse potential studies must be conducted. Upon FDA approval, a new cannabinoid product must be rescheduled under both state and federal law before it can be dispensed by pharmacies.