With the new Over-the-Counter (OTC) Monograph Reform came new facility fees (see our blog posts here and here, and FDA’s announcement here), and with new fees comes the new Arrears List. Facility fees under the OTC Monograph User Fee Act (OMUFA) were due for the first time on May 10, 2021, for fiscal year (FY) 2021. On June 14, 2021, FDA published the OMUFA Facility Arrears List which is a list of registered facilities that are required to pay the FY2021 annual facility fee, but have failed to do so. The list includes several hundred facilities running over 70 pages. Given that this is the first year the fees have been assessed, it is not surprising that the list is long. It likely contains some facilities that ceased operations prior to the applicability of the facility fee, and may also include some facilities that were registered as new manufacturers because they were used solely for the production of hand sanitizer under FDA’s temporary policy for manufacturing hand sanitizers in response to the COVID-19 pandemic. As FDA explained when it reissued the OMUFA facility fees following the withdrawal of the original publication of fees, these facilities would not be required to pay OMUFA fees.
As with the arrears lists for other user fee programs, (possible) embarrassment is not the only consequence that accompanies appearing on the Arrears List. Under section 502(ff) of the Food, Drug, and Cosmetic Act, a drug that is manufactured at a facility for which required OMUFA fees have not been paid is deemed misbranded.
On the same day it released the Arrears List, FDA also published on its website a series of Qs & As, “Other OMUFA Fee-Related Questions”. These cover how to pay an overdue fee, whom to contact to correct an error in the listing, and how to request a refund for a fee paid in error. They also clarify that, unlike some other user fee programs, there are no waivers or exemptions for OMUFA fees (although FDA is not assessing OMUFA facility fees for the aforementioned hand sanitizer facilities).