DeSantis vows to fight feds on monoclonal shutdown

All monoclonal antibody sites in Florida are now closed after the U.S. Food and Drug Administration narrowed its emergency use authorization, eliminating treatments “unlikely to be active against the omicron variant.”

“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” the Florida Department of Health announced in a statement. 

On Monday Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, explained the federal agency’s move to limit the use of bamlanivimab and etesevimab (taken together) and REGEN-COV. 

“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” she said in a statement. “Their use [is] limited to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.” 

The decision met with swift condemnation from Florida Gov. Ron DeSantis, who championed the use of monoclonal antibody treatments last year to help quell the delta variant surge. At a press conference Tuesday morning DeSantis told reporters the state would “fight back against this” with potential legal action and by touting the stories of those successfully treated with monoclonal antibodies.

“Let them tell their story,” he said, adding that even if the treatment helps 25 percent of the time it’s worth having it available.

The governor’s morning comments came on the heels of a sharply worded statement released Monday night.

“Floridians have benefited from the state’s treatment sites and their access to treatment shouldn’t be denied,” he said, calling on the administration to “reverse its sudden and reckless decision to revoke emergency use authorization (EUA) for Regeneron and Eli Lilly monoclonal antibody treatments.”

Alachua County opened a monoclonal treatment site at Fellowship Church in High Springs in August and served about 130 patients a day during the delta variant surge. Gilchrist County added a site two months later. By November those local sites were closed and treatment was referred to local hospitals and clinics, but the state re-opened some locations during the omicron surge. 

In September, the Biden administration announced it would be handing control of the monoclonal antibody supply chain to the Department of Health and Human Services (HHS) instead of letting individual sites order the supply needed. The change resulted in Florida receiving fewer doses, which DeSantis blasted as unfair to the state.

The most recent COVID-19 data show case numbers are dropping, but local hospitalizations are still on the rise.