"Compassionate Use" and the Law on Unapproved COVID-19 Drugs

President Trump has touted experimental drugs approved for other uses, like malaria and lupus, as a potential treatment for COVID-19. What is the law when it comes to accessing unapproved medicines in a time of crisis?  The Food and Drug Administration (FDA) in the U.S. regulates the process of new drug approvals and allows “compassionate use” in certain circumstances under a program called Expanded Access. Professor Glenn Cohen explains the FDA’s process and how it applies to experimental COVID-19 treatments.

 

  Professor Glenn Cohen of Harvard Law School is one of the world's leading experts on the intersection of bioethics and the law, as well as health law. He is the faculty director of Harvard Law's Petrie-Flom Center.