FDA Compassionate-Use Plan May Be Band-Aid

In response to patient demands for access to unapproved medicines, the US Food and Drug Administration and the Reagan-Udall Foundation, an independent, nonprofit created by Congress to help the agency accomplish its work, will hold a public meeting next week to create a navigator. What is a navigator? An online tool that would help patients and doctors find drugs that quality for an FDA program called expanded access, or compassionate use. These are drugs not currently approved, but are being tested and may be suitable to help someone who has a fatal illness. The notion seems helpful, but Alison Bateman-House, a bioethicist and public health researcher at the New York University Langone Medical Center, believes the navigator would be a Band-Aid. We asked her to explain.

 

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