SummaryWhen life sciences companies consider whether to allow compassionate use—access to unapproved investigational treatments outside of clinical trials—there are no easy answers. Brenda Huneycutt gleans insight from Arthur Caplan, PhD, and Alison Bateman-House, PhD, from the New York University Langone Medical Center Division of Medical Ethics on some of the many questions that life sciences companies should ask themselves before implementing a compassionate use policy.
While compassionate use may help some patients, it may harm others and granting access can also put FDA approval at risk. In this complex and evolving environment, life sciences companies need to create compassionate use policies and develop ways to allow appropriate access to their investigational treatments while managing the inherent risk in doing so.
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