The FDA has sent a “Dear Colleague” letter (here) to NDA holders to get ready for the start of FY 2021 on October 1, when the program fees (previously called “product fees” in previous iterations of PDUFA) will be due for each product (up to 5 in each application) marketed by the application holder. The letter indicates that FDA will announce the FY 21 program fee sometime in August.
Get ready now to review the drug and biologic products lists sent to you by the Agency, as well as, those listed in the Orange Book for accuracy. Any discrepancies should be noted and provided to FDA with an explanation of why a product should be removed or correcting the lists when a product is missing. All products that have been withdrawn from sale should have updates submitted to FDA by June 1, 2020. Failure to take action to do so may result in a product being included on the FY 2021 invoice. If the marketing status of a product changes after June 30, 2020, you may be eligible for a refund if notice of the change is made to the application by September 30, 2020. After that date, the obligation will be incurred and the fee for the product no longer marketed must be paid.
The process is further outlined in the letter and with all that is going on with the COVID 19 pandemic, firms should take a breath and review these lists and the Orange Book carefully, or your firm’s bean counters might visit your desk to create a new orifice in your body.
