ISCT 2021 | Anticipating a crackdown on unproven cell-based therapies

Following the development of the US FDA’s regenerative medicine policy framework in 2017, the agency outlined its intent to exercise enforcement discretion for certain regenerative medicine products, giving manufacturers time to submit investigational new drug (IND) and premarket approval applications. With this discretionary period coming to an end, Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, considers how the this might affect the direct-to-consumer marketing of unproven cell-based therapies in the US and the positive impact this could have on the regulation of unproven therapies worldwide. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.