Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, provides an overview of the current landscape of direct-to-consumer marketing of unproven cell-based therapies in the United States. As the FDA’s enforcement discretionary period comes to an end, Dr Levine hopes to see an increased level of enforcement activity toward stem cell clinics operating outside of FDA guidelines and formal regulatory processes. He also highlights the impact of the COVID-19 pandemic, which saw an increase in the spread of health misinformation and the marketing of unproven cell-based interventions for COVID-19, resulting in enforcement action from the FDA. Finally, Dr Levine expresses his concerns surrounding the unregulated and premature growth of speculative commercial cell banking services. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.
Aaron Levine’s work on ethical and policy issues related to cell therapy and cell manufacturing is supported, in part, by the U.S. National Science Foundation under Grant No. EEC-1648035. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the interviewee(s) and do not necessarily reflect the views of the National Science Foundation.