FDA Reissues OTC Monograph User Fees

As we reported previously, the U.S. Food and Drug Administration (FDA or Agency) caused a stir back in December when it announced fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) that failed to carve out companies producing OTC hand sanitizer to combat COVID-19. This decision was widely panned and deemed to be both inappropriate and against Congressional intent. The Department of Health and Human Services (HHS) quickly intervened and FDA’s notice regarding OTC user fee rates was withdrawn a mere two days after its publication.

After months of reconsideration, FDA on March 26, 2021 reissued new fee rates under OMUFA for fiscal year (FY) 2021. This time the Agency explicitly stated as follows:

Entities that registered with FDA during the Coronavirus disease 2019 (COVID-19) pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consists (or had consisted) of manufacturing OTC hand sanitizer products are not identified as OTC monograph drug facilities subject to OMUFA facility fees.

In addition, OTC monograph drug facilities that ceased OTC monograph drug activities, and updated their registration with FDA accordingly, prior to December 31, 2019 will also be exempt from FY 2021 facility fees.

Notably, due to this change in fee assessment, companies that are subject to the OMUFA facility fees will see an increase in their FY2021 facility fees compared to the previously announced fee rates. This is because FDA’s fee calculations rely, in part, on the total number of facilities engaged in OTC monograph drug manufacturing that will contribute to the collection of the Agency’s target revenue. Because certain hand sanitizer companies are now exempt, each remaining facility must pay more in order for FDA to achieve the aforementioned target revenue.

For FY 2021, the OMUFA facility fees are (1) $20,322 for OTC monograph drug facilities (MDFs), and (2) $13,548 for contract manufacturing organization (CMO) facilities. Payment on these fees will be due 45 days after the date of publication of this notice.

If any company needs help in dealing with FDA on user fee issues, the experienced FDA team at Buchanan Ingersoll & Rooney is here to help.