OTC Drug User Fees Halted – DHHS Withdraws FDA’s Notice

By: Jacqueline Chan

Pausing the Over-the-Counter (OTC) Monograph User Fee Program, the Department of Health and Human Services (DHHS) has withdrawn FDA’s December 29, 2020, Federal Register notice entitled Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021.  As discussed in our KKB Insight, FDA’s December 29th notice announced FY2021 fee rates for OTC monograph drug manufacturing facilities and submission of OTC monograph order requests.  According to DHHS, FDA lacked the delegated authority to issue the Notice.

DHHS has further ordered FDA to cease collection efforts related to the OTC Monograph User Fee Program until further action is announced.  DHHS indicates that it intends to provide the public with notice and opportunity for comment on FDA’s administration of the OTC Monograph User Fee Program.

So, OTC drug industry, stay tuned.