12 September 2017 - Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them. 

Moreover, the agency pledged to never allow a backlog of these designations to accumulate again.

At that same time, I said that we may pursue other policies that we believe would enable us to better advance the goals of the Orphan Drug Act. All of these commitments were part of a new Orphan Drug Modernization Plan that we announced on 29 June.

I’m pleased to update you on our progress in meeting each of these objectives.

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