Compassionate Use: An Analysis of the Ethical Frameworks of Expanded Access Programs

Expanded Access Programs allow severely ill patients with no alternative treatment options immediate access to FDA-unapproved investigational new drugs outside of clinical trials. Also referred to as compassionate use, EAPs are meant to create fair medical access for those in extreme need of the treatment. Unfortunately, due to inconsistent application and variations in modern interpretation of medical responsibility, EAPs fail to embody fairness, resulting in ethical inefficiencies in its implementation.