GDUFA II Fee Structure Modifies Revenue Model to ‘Predictable’ Annual Dues

The FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency’s generics program starting in fiscal 2018.

In a summary of the GDUFA II fee structure, the FDA says it reached an agreement with industry on a user fee structure and target revenue of $493.6 million annually, which is roughly $170 million more than the agency expects to receive in FY 2017.

The proposed fee structure will have to be approved by Congress in the reauthorization of GDUFA II, which is expected to take effect once the current version of the five-year authorization expires in September 2017.