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

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...

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Bibliographic Details
Published in:Ethics & human research 2020-01, Vol.42 (1), p.2-13
Main Authors: Chapman, Carolyn Riley, Eckman, Jared, Bateman‐House, Alison S.
Format: Article
Language:English
Subjects:
Clinical trials
compassionate use
Drug testing
expanded access
FDA
FDA approval
Health care access
investigational drugs
IRB
right to try
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Summary: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.
ISSN:2578-2355
2578-2363
DOI:10.1002/eahr.500038