USA – What happened with FDA’s OTC monograph user fee notice?

Just before the New Year, the US Food and Drug Administration (FDA) published a notice in the Federal Register announcing the fee rates it will collect for its Over-the-Counter (OTC) Monograph Drug user fee program (OMUFA) in FY2021, as it did earlier in the year for its other user fee programs.

The seemingly innocuous act proved controversial for its potential impact on liquor distillers who stepped in to manufacture hand sanitizers amid the COVID-19 pandemic and touched off a dispute with the Department of Health and Human Services (HHS) over FDA’s delegated authorities that led to the notice being withdrawn days later…