Legislation aimed at loosening federal oversight of state right-to-try laws is gaining momentum on Capitol Hill. Bills in the House and Senate would allow patients with cancer or other serious illness to request access to experimental therapies that are not yet approved by the Food and Drug Administration (FDA). We believe the proposed legislation raises significant ethical issues and could be detrimental to patients. The FDA should not be sidestepped or circumvented. It serves to protect Americans, including critically ill patients and their families, from the potential harms of untested drugs.