Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors
Year: 2015
Type: article
Abstract: Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval access to an investigational drug can be provided to a group of patients. Although an EAP is a regulated program, the decision to authorize an EAP is the responsibility of the biopharmaceutical sponsor. Because of the significant impact an EAP can have on current patients, drug development, and future patients, we propose that a sponsor's decision must be based not only on regulatory criteria but also on ethical and practical considerations regarding implementation of an EAP. Such an approach will help ensure that decisions and plans uphold ethical precepts such as fairness, promoting good, and minimizing risk of harm.
Authors: Mitchell Klopfenstein, Luann E. Van Campen, Timothy Garnett
Institution: Eli Lilly (United States)
Language: English
Subfield: Issues, ethics and legal aspects
Field: Nursing
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,090
Funder: Eli Lilly and Company
OpenAlex ID: W2156490363