The number of requests for designation of orphan drugs has increased steadily over the past five years. FDA has approximately 200 requests for designation of orphan drugs that are pending review: Commissioner Scott Gottlieb has committed to clearing the backlog within 90 days and responding to all new requests for designation within 90 days reception, according to an Orphan Drug Modernization Plan, during his testimony before a Senate subcommittee. (Press release of 06/29/2017)