USA – FDA increases OTC monograph facility fees in reissued notice

Following a dispute with the Department of Health and Human Services (HSS) that resulted in its initial notice being withdrawn, the US Food and Drug Administration (FDA) on Thursday reissued its notice announcing fee rates for its newly created over-the-counter (OTC) monograph drug user fee program (OMFUA) for FY2021.
 
FDA initially issued the notice on 29 December, but it was quickly withdrawn by HHS over public outcry against FDA’s plans to collect user fees from companies such as liquor distilleries that stepped in to manufacture hand sanitizers under the agency’s temporary enforcement policy during the COVID-19 pandemic. (RELATED: What happened with FDA’s OTC monograph user fee notice?Regulatory Focus 7 January 2021).
 
“Following FDA’s issuance of the initial OMUFA user fee notice, the FDA determined that certain hand sanitizer producers — those which registered with FDA during the COVID-19 public health emergency (PHE) solely to produce hand sanitizer products during the COVID-19 PHE — would not be required to pay OMUFA facility fees,” said Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research…