FDA Orphan Products Office to Focus on Clearing Backlog

To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first.

The agency’s plan, released Thursday, also includes implementing a new, streamlined template for reviewing orphan designations, and a CDER-CBER pilot project to conduct preliminary evaluations in a subset of applications, with the Office of Orphan Products Development performing secondary reviews.

In addition, the plan says the FDA will “minimize discretionary work,” such as non-designation and non-grant-specific assignments and analytical work, to lighten the load for all other reviewers — as well as limiting outreach activities to projects deemed the most meaningful.