After Colorado enacted a right-to-try law in May 2014, Eva Feldman, MD, PhD, director of the program for neurology research and discovery at the University of Michigan, began receiving phone calls and emails from people in Colorado with amyotrophic lateral sclerosis (ALS). The state’s new law allowed patients with terminal illnesses to petition drug manufacturers for investigational drugs and therapies without seeking Food and Drug Administration (FDA) expanded access (compassionate use) approval first. The ALS patients were inquiring if they could undergo the experimental stem cell therapy procedure for which Feldman and her team were conducting clinical trials (NCT01730716, NCT02058732) at the university.
Jacob JA. Questions of Safety and Fairness Raised as Right-to-Try Movement Gains Steam. JAMA. 2015;314(8):758-760. doi:10.1001/jama.2015.7691