FDA Sets OTC Drug Monograph Facility User Fee Rates for Fiscal Year (FY) 2024 and They Are UP! 

Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes the FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC Monograph order requests(OMORs).  OMOR fee rates for Fiscal Year (FY) 2024 were published on September 12, 2023 (see blog post here ). We have been waiting for the facility fees to be announced since September and now, some  six months later, we have our answer! 

“Under Section 744M(a)(1) of the FD&C Act, “Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility.”  For purposes of FY 2024 facility fees, that time period is January 1, 2023 through December 31, 2023.” (see footnote 2 in the FR notice here announcing the FY 2024 fees).  The facility fee is paid once a year and the FY 2024 payments are due on June 3, 2024.  

There are two types of fees for OTC monograph manufacturing facilities: 

• “An OTC manufacturing drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug (see section 744L(10) of the FD&C Act); and   
• A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States (see section 744L(2) of the FD&C Act).” 

The OTC Monograph Facility Fees for FY 2024 are presented in the table below along with the past three fiscal year fees. 

As you can plainly see, the cost of doing business in the OTC monograph market space, like everything else, is going up.  The FY 2024 facility fee takes the biggest jump since it was initiated.  

Many yearn for the good ol’ days when appropriated funds paid for functions of the government. But those days are seen only in the rear-view mirror and, unless Congress breaks from the user fee model that many critics claim makes FDA too cozy with industry, don’t expect relief any time soon.  We all know that consumers eventually wind up paying for these functions through increased product costs or taxes anyway so there is no escaping the inevitable, unfortunately.