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Oversight of Right‐to‐Try and Expanded Access Requests for Off‐Trial Access to Investigational Drugs

Carolyn Riley Chapman

Faculty affiliate of the Division of Medical Ethics in the Department of Population Health in the NYU School of Medicine at NYU Langone Health

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Jared Eckman

Worked on this article as an intern in the Division of Medical Ethics in the Department of Population Health at NYU School of Medicine at NYU Langone Health and is currently pursuing an MD as well as an MA in bioethics at Emory School of Medicine

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Alison S. Bateman‐House

Assistant professor in the Division of Medical Ethics in the Department of Population Health in the NYU School of Medicine at NYU Langone Health

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First published: 22 January 2020

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ABSTRACT

For decades, the U.S. Food and Drug Administration (FDA) has provided an “expanded access” pathway that allows patients who meet qualifying conditions to gain access outside a clinical trial to an investigational medical product being tested to see if it is safe and effective for a specific use. The Right to Try (RTT) Act, enacted in 2018, created a second mechanism for off‐trial, or non‐trial, access to investigational drugs. In contrast to the expanded access pathway, the federal RTT pathway does not require the involvement of the FDA or an institutional review board (IRB). Given that physicians, drug manufacturers, and medical institutions now have a choice whether to assist individual patients through the expanded access or the federal RTT pathway, we review the differences between these options and discuss the benefits and burdens of IRB involvement in requests to access interventions through the pathways. We also suggest ways in which IRB oversight may be further improved.

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