On November 21, 2016 we issued an important alert (here) relative to the FDA activities regarding the proposed GDUFA II Program Fees and the responsibility of industry to review the list and provide feedback to FDA relative to its accuracy and whether there was an affiliate relationship among entities listed. This so-called “cleanup” activity will enable firms to avoid paying multiple program fees and will also enable the FDA to obtain the information necessary to establish the appropriate fees for the three tiers of applicants, which are those those with 20 or more ANDAs, those with between 6-19 ANDAs, and those with 5 or fewer ANDAs. As explained in the blog post referenced above, failure to participate and conduct an accurate review could result in multiple program fees being assessed to the same firm unnecessarily and, once the obligation is assessed, sis not known whether it can be eliminated.
It is important to note the timeline as outlined in the presentation by Donald Parks, Director, and Gisa Perez, Branch Chief, Generics of the Division of User Fee Management and Budget Formulation. As you probably notice, this is a tentative timeline and while anything that is not today seems like its months away, as we all know, time has a way of sneaking up on you. The timeline is important because FDA must publish the FY 2018 Fees in August of 2017. This process will allow a second bite at the apple when FDA publishes its updated list in June 2017 based on initial feedback from individual firms (just in case you missed something).
FDA provides additional instructions and recommendations for proceeding with the cleanup activity here. In addition, the first spreadsheet can be accessed from the above link. In its announcement of the availability of the first list, the Agency outlies the goals of the process as follows:
Under GDUFA II, it is anticipated that affiliated companies will be grouped together and counted as a single entity for purposes of assessing the program fee. The term “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.
To enable timely invoicing of FY 2018 GDUFA Fees, FDA has begun an inventory of all approved ANDAs, and has assembled a spreadsheet that lists all ANDA holders and the number of ANDAs associated with each entity. The current spreadsheet and instructions on how to use the list are available for download below.
FDA is seeking general feedback on whether the information in this spreadsheet is accurate and complete. FDA is particularly interested in information that could be relevant to assessing whether two or more companies that are currently listed separately are considered to be affiliated for purposes of assessing the anticipated program fee.
After receiving feedback and comments about this list, FDA anticipates making a revised spreadsheet available. FDA plans to seek comment on the revised spreadsheet before compiling the final information that will be used as the basis for determining and assessing FY 2018 program fees.
An old professor of mine defined time as follows:
“Time is what keeps one darn thing after another from becoming every damn thing at once.” So get started now before time plays that nasty trick on you!