By now we all know that the fee structure for NDAs and BLAs has changed with the passage of PDUFA VI. We know that now there are only application fees and “program fees” (program fees are the same as previously assessed product fees). The FDA issued a final guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017” today which explains the fundamental issues associated with the new fee structure such as
- how fees are to be assessed
- when fees are assessed and due
- what waiver provisions are still in place and which are no longer available
- definitions of prescriptions drug products
- effect of failure to pay fees
- payment information and procedures
- fee waiver provisions, reductions, refund requests and appeals
The guidance answers many of the questions that have been raised regarding the new PDUFA VI fee structure and provides a clear description of how the Agency is interpreting such issues as fee exceptions for products that are the same as another product, impact of moving product to the discontinued section of the Orange Book and timing to assure a program fee is not assessed, maximum program fees that can be assessed per application among other important issues.
This is a must read for any NDA or BLA sponsor. The full guidance can be found here.
