FDA blasts ANDA Citizen's Petitions

FDA said Citizen's Petitions requesting specific action on ANDA and 505(b)(2) NDAs for a specific drug often "do not raise valid scientific issues and are intended primarily to delay the approval of competing drug products." Responding to such petitions by the statutory deadline takes "substantial resources," and requires prioritization above potentially more serious petitions addressing public health and safety concerns. The comments came in the agency's annual report to Congress on the 505(q) statute, which allows FDA to delay an ANDA or 505(b)(2) approval only in response to a written petition that causes FDA to determine there could be a threat to public health. ...