The departmenton New Year's Eve to reverse those fees, saying that they punished do-gooders and that FDA levied the fees without securing approval from the secretary. FDA allies have complained that the move undermines the agency's ability to collect user fees and fund its public health agenda."The legal logic here is amazing," Alec Gaffney of AgencyIQ wrote in a
, analyzing the notice. "Basically, HHS wants to argue that despite the fact that distillers are making an OTC drug in accordance with an FDA monograph, they aren't *really* drugmakers because that's not how the public sees them." Gaffney predicted that despite the "factually tortured" notice, the distilleries would end up avoiding user fees."There was a burning issue on Dec. 31, take care of the bills," a senior HHS official told PULSE, noting that distilleries were still on the hook for additional fees into 2021. "We knew we'd have to come back and address these lingering issues to ensure the protections continue as the pandemic did.
The resulting notice, drawn from conversations with advocates for the distillery industry, is also intended to protect businesses if they want to keep making sanitizer. "If a [public health emergency] for Covid exists, you're going to be protected," the official added.
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