GDUFA Launch Pains: Facility List Fluctuations, Back-Due Backlog Fees
FDA still has backlog fees in arrears more than two months past the payment deadline, but cannot forcibly withdraw the applications; facility listings also change consistently because industry can update them as needed.
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Industry avoided application supplement fees by using CBE submissions instead, forcing FDA to change its estimates and sending generic drug user fees higher.
About 24% of facility fees and 20% of all fees are outstanding, but industry officials also want to measure success through FDA hiring and communication.
FDA’s Office of Generic Drugs was at the start of a turnaround: $299 million in new user fees to clear a big ANDA backlog and fund overseas inspections, an elevated status within the Center for Drugs and a brand-new director to steer the ship. But there have been some bumps in GDUFA implementation, and OGD’s new director, Gregory Geba, has abruptly left the agency. What next for FDA’s generic drug oversight?