US FDA Commissioner Scott Gottlieb is defending the accelerated approval pathway in response to payors who have balked at covering high-priced products cleared under what they perceive to be a lower regulatory standard than the traditional approval process.
Speaking during the National Organization for Rare Disorders’ “Rare Summit” on Oct. 17, Gottlieb acknowledged “some instances” in which payors have limited reimbursement of a newly approved drug, in part...