FDA more than doubles Orphan designation revocations overnight, analyst notes

A decision by the US Food and Drug Administration to revoke designation of a drug (or a biological product) as an orphan drug is a rare event, notes Kurt Karst writing on US law firm Hyman, Phelps & McNamara’s FDA Law Blog.

Until recently, we were aware of only three orphan drug designation revocations in the 30-plus year history of the Orphan Drug Act. That number more than doubled in April 2016 when the FDA revoked four orphan drug designations for various drugs for the treatment of hypertension in pediatric patients.

Prior to April 2016, we were aware of only three orphan drug designation revocations.  In each of these three cases, orphan drug designation was revoked because the FDA determined that the drug “had not been eligible for orphan drug designation at the time of submission of the request.”