Another UFA – sounds like the noise an animal cartoon character might make. It is, however, no laughing matter. “On March 27, 2020, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security Act, which authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests.” The FDA is terming this new UFA as the OTC Monograph User Fee Act (OMUFA) and, today, in the Federal Register Notice (here), the Agency announced the fee structure for the new program. While the concept of revising the OTC monograph review process is not new, it looks like it is full steam ahead now that the OMUFA fees have been announced. There will be an FDA seminar on the new system in January.
The fees will support FDA activities in reviewing facilities, providing advice, and reviewing new OTC monograph order requests through the collections of the following: “1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC monograph order requests.”
“FDA will assess and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. A full facility fee will be assessed to each qualifying person that owns a facility identified as an MDF (see section 744M(a)(1)(A) of the FD&C Act), and a reduced facility fee of two-thirds will be assessed to each qualifying person that owns a facility identified as a CMO facility (see section 744M(a)(1)(B)(ii) of the FD&C Act).” In addition, for FY 2021, the FDA will collect fees from firms that submit an OTC monograph order request (OMOR). There are two classification of OMOR, a Tier 1 ($500,000) (usually for the addition of new or innovative ingredients as an OTC) and Tier 2 ($100,000) (for other, more minor, changes to products). See here for an overview of the new OTC program. The FY 2021 facility fee for a monograph drug facility (MDF) will be $14,060 and for a contract manufacturing organization (CMO) the fee will be $9,373. The OMOR is a one-time fee, like the application fees for other UFAs, and the facility fee will be due yearly. The fees will be due forty-five days from the official date of publication of the FR notice, which is scheduled to be published tomorrow, December 29, 2020.
The notice states that “Under the statute, a facility fee will not be assessed if the identified OTC monograph drug facility: (1) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and (2) has updated its eDRLS registration to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act). As the applicable fiscal year for fee-setting under this notice is FY 2021, the year immediately preceding the applicable fiscal year is FY 2020. December of FY 2020 is December 2019. Thus, a FY 2021 facility fee will not be assessed with respect to an OTC monograph drug facility that, prior to December 31, 2019, had ceased all activities related to OTC monograph drugs and updated its eDRLS registration to that effect.” In addition, facility fees will not be charged to manufacturers of the active pharmaceutical ingredient that is use in an OTC product nor will a facility that merely packages two or more finished products in an outer overwrap or packages for further sale. Further, these fees do not apply to firms marketing OTC products under an approved NDA or ANDA.
Be sure to fully understand how the program works and what is needed for you to request additions or revisions to OTC products to comply with the user fee requirements.