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[FDA News] The FDA has established the OTC (Over-the-Counter) Drug Monograph Facility User Fee rates for Fiscal Year (FY) 2024, and they have increased!

Date: 3/28/2024

otc drug user fee

FDA has announced the OTC (Over-the-Counter) Drug Monograph Facility User Fee rates for Fiscal Year (FY) 2024, and they've increased! Section 744M of the FD&C Act authorizes FDA to collect facility fees from qualifying owners of OTC monograph drug facilities, as well as fees from submitters of qualifying OTC Monograph order requests (OMORs).

For FY 2024, facility fees are due on June 3, 2024. There are two types of fees: one for OTC manufacturing drug facilities (MDF) and another for contract manufacturing organization (CMO) facilities. The fees have increased compared to previous fiscal years:

  • MDF: $34,166 for FY 2024 (compared to $26,153 for FY 2023)

  • CMO: $22,777 for FY 2024 (compared to $17,435 for FY 2023)

This significant increase reflects the rising costs of operating in the OTC monograph market. While some may reminisce about the days when government functions were funded differently, the reality is that the user fee model is here to stay. Critics argue that it makes the FDA too cozy with industry, but until Congress decides otherwise, it's unlikely to change. Ultimately, consumers bear these costs through higher product prices or taxes, making it an unavoidable reality.

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