Previously in a blog post on November 21, 2016 (here) and again in a post on December 8, 2016 (here), we outlined the proposed GDUFA II program fee and the need to review the FDA spreadsheet in order to assure that affiliate firms are properly identified such that only one program fee is assessed in each fiscal year. Today, in a Federal Register notice (here), FDA again reminds firms to review its spreadsheet (which can be found here).
The Federal Register Notice describes that “[T]he proposed legislation defines the term “affiliate” in the same way it was defined in GDUFA. An “affiliate” is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has the power to control, both of the business entities.” In anticipation of the passage of GDUFA II legislation and the institution of the program fee, FDA is asking for comments on the accuracy of the spreadsheet and any other relevant information regarding the affiliate status of firms listed separately. Once FDA receives feedback on the accuracy of the spreadsheet, they will publish a revised list for further comment and examination. The timelines were stated in one of the previous blog posts but, as noted before, firms should take action in sufficient time for FDA to accurately revise the spreadsheet and list of ANDAs and applicant holders.
FDA’s message is clear – GET TO IT!