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…
Pharmalot: What is a navigator supposed to do?
Bateman-House: That’s still being decided. There are a number of options on the table. It could be a portal to get information on expanded access, to follow up a request for a medicine, or to follow up to see if a medicine was clinically helpful or not. It may also tabulate requests so we can have data.
