FDA moves to clear Orphan request backlog, streamline responses

On Thursday, FDA unveiled its Orphan Drug Modernization Plan, which is designed to fulfill FDA Commissioner Scott Gottlieb’s goal to eliminate backlogged Orphan Drug designation requests and accelerate review of new requests. The plan commits FDA to completing review of all requests older than 120 days by September 21 and responding to all subsequent requests within 90 days of receipt.

The plan will establish a “SWAT team" of senior reviewers to focus on backlogged requests and will roll out a streamlined Orphan Drug Designation Review Template for more consistent and efficient review...