FDA Blocks Use Of Monoclonal Antibody Treatment In Florida, State Fights Back

The Florida Department of Health announced Monday that the U.S. Food and Drug Administration (FDA) made an “abrupt decision to remove emergency use authorization for two monoclonal antibodies,” which effectively shut down treatment sites statewide.

The FDA said in its statement that it is removing the authorization because the treatments “are highly unlikely to be active against the omicron variant.”

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the Florida Health Department blasted in a press release. “To date, such evidence has not been provided by the United States Food and Drug Administration (FDA).”

“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 statement reads.

In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. 

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. 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.  

Back in September, Florida Governor Ron DeSantis (R) secured additional doses of the potentially lifesaving treatment despite the Biden administration taking control of the treatment and effectively reducing Florida’s necessary supply.

As highlighted by The Daily Wire, the Biden administration announced in September that they’d be rationing supply of the treatment, effectively cutting supply from COVID-positive Floridians:

As reported by Fortune, “Hospitals and other care providers will no longer be able to directly order monoclonal antibody therapies from distributors, according to a Sept. 13 update posted on the Department of Health and Human Services website.”

“Instead, the U.S. government will determine what quantity of the drugs to ship to each state and territory based on Covid-19 case numbers and use of the treatments locally. State health departments will then determine how to distribute the antibody therapies to hospitals and other sites, according to the HHS update,” the outlet added.

“Federal health officials plan to allocate specific amounts to each state under the new approach, in an effort to more evenly distribute the 150,000 doses that the government makes available each week,” Politico reported.

The move was made to apparently limit potential shortages elsewhere, though there aren’t any signs of a treatment shortage. The takeover was widely criticized and even deemed an act of “partisan payback” by Senator Marco Rubio (R-FL).

“Antibody treatments aren’t a substitute for vaccines. But they have prevented thousands of hospitalizations including in breakthrough cases,” Rubio posted to Twitter. “Now in a move that reeks of partisan payback against states like Florida, the Biden administration is rationing these treatments.”

Notably, the effective treatment has been far underutilized, as highlighted in a detailed report by The Daily Wire published in September. The White House, ironically, was widely criticized for not promoting the treatment and for reaching far fewer Americans than they should have mere weeks before Biden announced his move to take control of the treatment.

The FDA’s decision to removed emergency use authorization was blasted online.

“The FDA is trying to make it so that people in Florida die of Covid,” charged Mike Cernovich. “They’ll kill people to harm Republicans. Steel yourselves for the evil that is being unleashed.”

Original Article: https://www.dailywire.com/news/fda-blocks-florida-from-using-monoclonal-antibody-treatment-sites-shut-down-statewide?%3Futm_source=twitter&utm_medium=social&utm_campaign=dwtwitter