US FDA Announces OTC Monograph Drug User Fee Rates, Giving 45 Days For First Facility Payments
Executive Summary
The FDA says the new OTC monograph drug user-fee program (OMUFA) will provide additional resources needed to support the streamlined regulatory activities described by OTC drug reform legislation enacted in March 2020.
Entities that produce OTC monograph drug products will have 45 days to submit facility fees for fiscal 2021 following the US Food and Drug Administration’s expected publication of the fee schedule in the Federal Register on 29 December.
The agency issued a notice on 28 December that breaks down OTC monograph drug user-fee program (OMUFA) rates for the 1 October 2020-30 September 2021 period (see table).
The FDA announcement also lays out its methodology for determining facility rates.
Fiscal 2021 will be the FDA’s first year collecting facility fees from OTC drug manufacturers, both monograph drug facilities (MDFs) and contract manufacturing organizations (CMOs), which produce but do not sell OTC monograph drugs to wholesalers, retailers or consumers in the US.
The latter are responsible for paying a reduced fee – ie, two-thirds that assessed to MDFs – as established by sweeping OTC monograph reform legislation enacted in March 2020 as part of the Coronavirus Aid, Relief and Economic Security (CARES) Act. (Also see "US Pandemic Relief Package Delivers OTC Industry Regulatory Wishes, Supplement Business Hopes" - HBW Insight, 26 Mar, 2020.)
The announcement also includes tiered rates for OTC monograph order requests (OMORs). Under the CARES Act, Tier 2 OMORs may seek modifications to the drug facts labels of OTC monograph drugs, standardization of the concentration or dose of a specified finalized ingredient within a finalized monograph, or a change to ingredient nomenclature, among other asks specified by the law.
More costly Tier 1 OMORs are any not identified as Tier 2 – for example, requests to develop monographs for new ingredients or add new medical conditions to existing monographs. (Also see "OTC Monograph Reform Proposal Offers Two-Tier Approach" - HBW Insight, 30 May, 2017.)
The CARES Act granted the FDA authority to make OTC drug monograph changes with administrative orders rather than public notice-and-comment rulemakings; set timelines for agency decisions on industry proposals; and established a process for firms to appeal rejections.
“As with our other user fee programs, we anticipate that [OMUFA] will provide additional resources to help the agency conduct these important regulatory activities in a timelier manner and ultimately help provide the public with access to innovative OTC monograph drugs,” the FDA’s Center for Drug Research and Evaluation states in a 28 December newsletter.
The agency has indicated to Congress that it aims to hire 30 full-time equivalent staff in the first year of the overhauled OTC monograph program. (Also see "At US FDA, Adding ‘Effective’ Staff For Overhauled OTC Monograph Program ‘Really Takes Time’" - HBW Insight, 2 Sep, 2020.)
Manufacturers will find fee payment options and procedures explained in the notice.