The FDA published its first arrears list for failure to pay FY 2021 Over-the-Counter Monograph User Fee Act (OMUFA) facility fees. Invoices were emailed on June 25, 2021 for fees not paid by the May 10, 2021 due date. And, holy smokes, there are almost 500 firms on the arrears list. Twenty‑eight are contract manufacturing organizations (CMOs) and the rest are monograph drug facilities (MDFs).
OMUFA program fees were established and required under section 744M of the FD&C Act, as added by the Coronavirus Aid, Relief, and Economic Security Act. The current 2021 yearly fee is $20,322 for MDFs and $13,548 for CMOs. The Agency states that “[i]f a facility does not pay the annual facility fee within 20 calendar days of the due date, the Agency will place the facility on a publicly available arrears list, and all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded under section 502(ff) of the FD&C Act. Additionally, OMORs and meeting requests related to OMORs will not be accepted from persons, or their affiliate(s) in arrears (see section 744M(e) of the FD&C Act).” (An OMOR is an OTC Monograph Order Request, which requests either the addition of a new ingredient as an OTC product or a new condition of use for an existing ingredient under the new OTC program.)
The FDA strongly suggests that all OTC manufacturers and distributors review the arrears list (here) and be certain that your fee has been paid in order to avoid potential regulatory actions, such as seizure of your products as misbranded and/or other potential regulatory actions. Remember, like the IRS, if you owe money to the government, they know where to find you and how to make your life difficult. After the due date, if you did not pay, you have an outstanding obligation to the government.
To read more about the new OTC program, click here.