OTC User Fee Rates – Is This a Classic Pay-for-Delay?

A Federal Register notice published on March 26, 2021 announced the Over-the-Counter (OTC) Monograph User Fee rates for the Agency’s newest UFA, OMUFA, 2021.  There are two types of user fees; one is for facilities of firms that manufacture and distribute OTC products (monograph drug facilities (MDFs)) and the other is for a subset of facilities, contract manufacturing facilities that manufacture for another party but do not sell or distribute OTC products, which will pay two-thirds of what the MDFs will.  The other type of fee is for the submission of an Over-the-Counter Monograph Order Request (OMOR), which is broken down into two buckets: Tier 1, requests that seek an administrative order to establish a new monograph ingredient, new use, or new combinations of ingredients, and Tier 2, which is the default for anything that does not fall into Tier 1.  The exception is that no fees will be charged for a Tier 2 request seeking a change in labeling of the drug facts portion of the label or other safety aspect of labeling, including warnings or contraindications.

The Federal Register notice can be found here.  The rates are provided in the chart below.

                                        OTC USER FEE SCHEDULE FOR FY 2021

As we move into the new UFA, there will be no goal dates for the first three years of the implementation and, based on current thinking, it does not look like many aspects of the program will be operational until FY 2022.  You can learn more about the new program in a webinar that provides an overview of nonprescription drugs, Over-the-Counter (OTC) monograph reform, and how the FDA identifies and evaluates safety issues (here).