FDA Yanks Notice of PDUFA Fee Increase for Fiscal 2022

The FDA abruptly withdrew a notice that was scheduled to be published in the Federal Register (FR) Tuesday, announcing a double-digit increase in the fees for drugmakers under the Prescription Drug User Fee Act.

The FDA pulled the notice “as the agency had concerns that mechanisms involved within the fee-setting process may not be well understood,” a spokesperson told FDAnews. “FDA is withdrawing the FR notice for now to help ensure understanding of these mechanisms among stakeholders.”

The agency plans to re-issue the notice “as soon as possible, but [does] not have a specific date at this time,” the spokesperson said.

The new rates, which would have gone into effect on Oct. 1, were to be almost $3.2 million for new drug applications requiring clinical data and almost $1.6 million for new drug applications not requiring clinical data. The current rates are $2.9 million and $1.4 million, respectively, so the proposed rates would have represented increases of 10 percent and 11 percent.