Final GDUFA Guidance Clarifies Penalties for Unpaid User Fees

Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017.

Sponsors that are delinquent on user fees will be charged interest at a rate determined by the Treasury Department, the document said. In addition, an annual penalty of six percent of the amount due will be assessed to invoices delinquent for more than 90 days, according to the guidance.

The final guidance comes more than three years after the FDA released a revised draft version. It clarifies the penalties for delinquent user fees, resubmissions, refunds, deadlines and exemptions. Additionally, the document strikes three sections from the draft version that covered self-identification, the review of generic drug submissions and inspection provisions. Those topics will be covered in a separate final guidance, the FDA said.