As we mentioned in previous posts here and here, the new program fee to be instituted as part of GDUFA II and how much you have to pay may be dictated by your diligence in participation in the program fee clean-up currently underway at FDA. This process is designed to identify affiliates of firms, so that there is only one program fee assessed per firm. According to Donal Parks, Director, User Fee Collection Staff at FDA, the clean-up process is underway, but only 9% of sponsors have provided FDA updates to the initial FDA listing of firms and the numbers of ANDAs they have listed.
FDA also requests that updates be sent in Excel files to facilitate the process of revising the list. Some firms have submitted screen shots, PDF documents, and narratives describing the affiliations. This information must be entered by hand and is not very efficient.
FDA also notes that, if the reported number of ANDAs on the list does not appear to be accurate, it may be because of an ANDA withdrawal request that has not yet been processed or missed. While Mr. Parks’ group will forward the information onto the appropriate Office for resolution, it may be faster to contact the appropriate office directly.
So, let’s get on it guys. The fee you save may be your own!