In March of this year, the Center for Drug Evaluation and Research (CDER) branch of the Food and Drug Administration (FDA) implemented a new fee under the OTC Monograph User Fee Program (OMUFA). The fee was required of all facilities that produced OTC monograph drugs during the 2020 calendar year, except for those who registered their hand sanitizer products after the declaration of the public health emergency in early 2020 and intended to market for only as long as the state of emergency was in place.
The due date for the OMUFA fee payment this year was set as May 10th, 45 days after the implementation of the new fee. Other drug user fees from CDER, like the Generic Drug User Fee, have long been applicable to certain categories of producers in the drug space, and those fees are owed on an annual schedule corresponding with the renewal season for facility registrations. Those drug user fee rates for the 2022 financial year are listed below.
PDUFA Application requiring clinic data $3,117,218
PDUFA Application not requiring clinic data $1,558,609
PDUFA Program fee $369,413
GDUFA ANDA $225,712
GDUFA DMF $74,952
GDUFA Large Program (20+ ANDAs) $1,536,856
GDUFA Medium Program (6-19 ANDAs) $614,742
GDUFA Small Program (5 or fewer ANDAs) $153,686
GDUFA Domestic API Facility $42,557
GDUFA Foreign API Facility $57,557
GDUFA Domestic FDF Facility $195,012
GDUFA Foreign FDF Facility $210,012
GDUFA Domestic CMO Facility $65,004
GDUFA Foreign CMO Facility $80,004
Unlike some of those fees, which are required for those who are planning a new or continued action for the upcoming fiscal year and must pay in order to proceed, the OMUFA fee is retroactive and will continue to be applied to all those who produced OTC monograph drugs in the previous year, unrelated to any plans for continuation. For the foreseeable future, it will also remain on a separate timeline from other fees and registration renewal season.
The OMUFA fee will next be due on June 1, 2022, at which time it will apply to OTC manufacturing facilities that operated in 2021. If you’re unsure as to whether you are responsible for paying the OMUFA fee, you can read more about the OMUFA fee here or contact us today.