Right-to-try is the latest topic addressed in the ASCO in Action podcast series. ASCO CEO Dr. Clifford Hudis recently interviewed ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky to examine RTT legislation—now enacted as federal law—and discuss the Food and Drug Administration’s (FDA) expanded access program.
Both RTT and expanded access aim to provide very ill patients with access to investigational therapies outside of clinical trials. The main difference between the two is that FDA provides important patient protections in the expanded access program.
Dr. Schilsky clarifies that under expanded access patients benefit from important FDA safeguards including guidance for physicians on critical aspects of patient care, such as appropriate dosing and managing side effects, as doctors likely have no clinical experience with the investigational drug a patient might receive.
The term itself gives patients a sense of false hope, says Dr. Schilsky. “Right-to-try is a catchy phrase, but it doesn’t actually provide patients with the right to try anything. It provides patients with the right to ask for a drug.”
Stay tuned to ASCO in Action for the latest updates in cancer policy and practice.