For those of you who read my blog post on September 13, 2017 (here), the new fee structure for NDA and certain BLAs may have come as quite a shock, especially if you don’t normally play in that sandbox. Well, apparently a lot of folks must have had questions too, as FDA just published a draft guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017: Guidance for Industry.”
It fully explains the new fee structure as to be derived 20% from application submissions and 80% from the program fees. (Remember that the program fees are what were previously termed product fees under previous iterations of PDUFA). See my blog post cited above for the actual fees and a further discussion of how the fees are to work.
Before you freak out – there will still be small business waivers, and orphan drug application waivers, and a couple of previous waiver provisions. But the big news is that the same process for assessing program (product) fees will be in place. That is, if there is a duplicate of your drug (duplicates are further defined in the guidance document) approved as a generic, then there is no program fee if there is at least one generic in the active section of the Orange Book (OB). So, breathe easier, you new drug holders, it is not as bad as you may have thought. And remember that there will be a maximum of 5 program (product) fees assessed per application. I can see a lot of functional scores being added to tableted products over the next year!
Fess will be assessed for applications at the time of submission, but eligible program fees will be due on October 1 each fiscal year unless your product is withdrawn or in the discontinued list and no longer marketed. The guidance gives specific advice on requesting listing in the discontinued section of the OB. Failure to provide appropriate notice and to the appropriate OB staff could result in a fee being owed if the removal from the active list is not made in time, so pay attention to that section of the guidance document.
In addition, there are some changes in the way the FDA is defining strength for certain biologic parenteral products under PDUFA VI to make them consistent with the way the FDA defines them for NDA parenteral products.
The guidance also discusses the user fees and the impact of refuse-to-file actions, provides information on payment information and the impact of failure to pay fees, as well as appeal procedures and refunds.
Like you didn’t have enough to do already, the FDA is burying you in guidance documents – maybe they think it will eat up enough of your time to delay application submission! Just kidding! Keep the guides by your bedside and if you can’t fall asleep start reading – I guarantee you’ll be in la-la land before page 5! Night night!