Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors

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...

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Bibliographic Details
Published in:Therapeutic innovation & regulatory science 2015-05, Vol.49 (3), p.352-358
Main Authors: Klopfenstein, Mitchell, Van Campen, Luann E., Garnett, Timothy
Format: Article
Language:English
Subjects:
Authorship
Clinical trials
Corporate sponsorship
Decision making
Drug Safety and Pharmacovigilance
Drugs
Ethics
Ethics Special Section
Ethics Special Section: Analytical Report
Pharmaceutical industry
Pharmacotherapy
Pharmacy
Regulatory approval
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Summary: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.
ISSN:2168-4790
2168-4804
DOI:10.1177/2168479015578154