FDA Effort to Charge Distillers for Making Hand Sanitizer Blocked
As COVID-19 cases began surging in March, distilleries started making hand sanitizer by switching their alcohol production to antiseptic, undrinkable alcohol and giving away bottles to members of their communities.
The efforts rose after the country faced a shortage in hand sanitizer as shoppers panic bought hand soap, cleaning wipes and other sanitation products.
The CARES Act enacted in March included a non-prescription drug policy, making distilleries producing hand sanitizer “over-the-counter drug monograph facilities.” The CARES Act also established these facilities must pay user fees under the over the counter monograph drug user fee program.
The fees impacting distillers are a $14,060 Monograph Drug Facility Fee and $9,373 Contract Manufacturing Organization Facility Fee due on Feb. 12.
The resulting uproar got noticed at HHS headquarters:
…the Department of Health and Human Services appeared to have struck down the FDA fees. “Small businesses who stepped up to fight COVID-19 should be applauded by their government, not taxed for doing so,” HHS chief of staff Brian Harrison said in a statement posted on Twitter.
“I’m pleased to announce we have directed FDA to cease enforcement of these arbitrary, surprise user fees,” he said. “Happy New Year, distilleries, and cheers to you for helping keep us safe!”
It’s a small victory for common sense. And a sad reminder that some in government are more devoted to their rules than the public good.