FDA Abruptly Halts Use Of Monoclonal Antibody Treatment In Florida

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?

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  1. Let’s Go Brandon and his corrupt Administration could care less about saving lives. They want people too die and the more the better because they believe that the cure for Climate Change is to de-populate the world.

  2. Once again Biden and company attacks our state of Florida in another attempt to hurt our great governor Ron DeSantis. This is the latest in a long line of attacks against our state and our Governor because the dems are scared to death of DeSantis becoming a presidential candidate. Of course DeSantis would be so much better as president than Biden and the left knows it and are doing their best to stop it. The dems cannot control Covid in any form it takes and they put out lies after lies trying to add booster on top of booster and none of them controls COVID. We were told if we got the two jabs we would be protected against the disease and then if we got the booster jab it would control Omicron but it didn’t and now they are developing a fourth jab in booster form to control Omicron.

  3. Why should the government have so much control over people who want to get monoclonal antibodies. Government can’t even stop people from securing and using illegal drugs. So why should they stop people from getting monoclonal antibody treatment and make it illegal to use.

    Government can inform and show data that monoclonal antibodies don’t work. They can even show data of death rate of people using monoclonal antibodies.

    Leave the final decision up to the individuals to use monoclonal antibodies or not. Look at illegal drugs, how effective has the government been to stop the use?

    Bottom line ….. leave it up to the individual’s choice.

  4. There is blood all over Bidens hands

  5. And the communists march on. They are so bold because they know they have plenty of “useful(useless) idiots” that believe in their B.S. After all, look how close the elections are.

  6. Horrendous and evil!
    Do as we say or we will let you die. Many did do as they said, but they are also being punished. Looks like they really prefer that all Americans die. 😔

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