September 4, 2018, Vol 320, No. 9, Pages 849-948
Promoting Patient Interests in Implementing the Federal Right to Try Act
Holly Fernandez Lynch, JD, MBE; Patricia J. Zettler, JD; Ameet Sarpatwari, JD, PhD
JAMA. 2018;320(9):869-870. doi:10.1001/jama.2018.9880
This Viewpoint reviews provisions of the US Right to Try Act, which allows patients with life-threatening conditions access to investigational drugs without FDA approval, and calls for clarifications around patient and drug eligibility, reporting requirements, and differences from the FDA’s Expanded Access program to minimize potential harms from the law.