Florida shuts monoclonal antibody treatment sites after FDA sets new limits

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The Florida Department of Health announced that it is closing all monoclonal antibody treatment sites in the state after the U.S. Food and Drug Administration rescinded emergency-use authorizations for two particular treatments for COVID-19.

The FDA announced on Monday that it is no longer permitting the use of bamlanivimab and etesevimab (used together) as well as the combination of casirivimab and imdevimab known as REGEN-COV, or Regeneron.

“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 said in a statement.

The FDA said that since “data show these treatments are highly unlikely to be active against the omicron variant,” and because omicron is believed to account for more than 99% of current COVID-19 cases, the treatments are no longer authorized. It explained that this was meant to prevent side effects from treatments they do not believe will work.

“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” the FDA said.

Florida Deputy Secretary for Health Kenneth A. Scheppke went on the record saying that the state disagrees with the FDA’s decision, particularly regarding Regeneron, noting that it has not been supported by any clinical evidence provided by the FDA.

In a letter to leadership at the U.S. Department of Health and Human Services, Scheppke noted that Florida had ordered more than 30,000 doses of both Regeneron and the sotorovimab monoclonal antibody treatment (which remains permitted), but that HHS had not been responding to their requests for an update on the order.

“While we were hopeful to immediately connect on this timely and important issue, unfortunately, you were no longer able to accommodate our request for a call today and canceled,” Scheppke wrote. “We believe the decision to delay our meeting was made with the awareness that this would be announced. Rather than transparent communication from the federal government to states, decisions continue to be made through news cycles and this actively prevents states from making operational decisions that actively save lives.”

Gov. Ron DeSantis blasted the Biden administration for the decision.

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said in a statement. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”

HHS pushed back, with a spokesperson claiming that DeSantis is “more interested in promoting medicines that don’t work than urging people to take vaccines that do[.]”

In response, DeSantis press secretary Christina Pushaw slammed HHS for mischaracterizing the situation.

“Why doesn’t the HHS spokesperson understand that the majority of patients seeking monoclonal antibody treatment, like the majority of Floridians, ARE vaccinated?” she tweeted.