Views 559
Citations 0
Comment & Response
September 22/29, 2015

FDA Expanded Access Programs for Experimental Medicines

Author Affiliations
  • 1Consultant on Public Health Policy and Regulatory Affairs, National Institutes of Health, Chevy Chase, Maryland

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(12):1296. doi:10.1001/jama.2015.9725

To the Editor Dr Rosenblatt and Mr Kuhlik1 listed a number of important principles and challenges in the provision of investigational drugs under the expanded access programs (EAPs) of the US Food and Drug Administration (FDA). The authors identified fairness as a foundational principle. They articulated society’s interest in prioritizing efforts to demonstrate safety and efficacy so drugs can be approved quickly and become widely available as well as the need to respond quickly and equitably to desperate requests by patients for compassionate access. However, they did not identify informational barriers as challenges that must be addressed if there is to be true fairness for patients who might benefit from expanded access.

First Page Preview View Large
First page PDF preview
First page PDF preview