FDA Blocks Florida From Using COVID Antibody Treatment

16

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?

16 Comments
  1. Old goat says

    FDA is going to kill tens of thousands by withholding treatments necessary for treatments

    1. Old goat says

      treatment, I meant

  2. AL says

    There is no way the FDA or any other govt body could reasonably determine that the treatments such as monoclonal antibodies, are “highly unlikely” to be active against the omicron variant. Have we become a communist country? Is anyone comfortable with politicians making medical decisions?

  3. DONAT ROBICHAUD says

    Oh! there must be a lot less money in the cure than in the vaccines that doesn’t work. !

  4. Pat says

    Be sure CORRUPT DEMONCRAPS *****DON’T *****GET ANY TREATMENTS. THEY DESERVE *****NOTHING*****🖕🏻

  5. David says

    Can’t Governor Desantis order these needed medications from Canada or elsewhere and override the FDA and Biden?!

  6. David says

    Is it possible Governor Desantis could order these medical supplies from Canada or other countries without the consent of Biden or the FDA?!

  7. rlNhnMKTAUiFdJ says

    rLacIMHdJWEP

  8. Brad Miller says

    Does America have any balls I’m not a patriot or belong to any organization I’m an old man that has paid into these pricks all my life its time to put the boot to these folks lets go for two years of Service then kick them out and you can’t live in DC and be a lobbyist after your term.

  9. tEdNxZia says

    ZEIhKOgW

  10. Kathleen says

    I was sent to get monoclonal antibodies by my doctor in Fort Worth, TX, but 36 hrs later, I was told there is nothing available for me! Are they removing the antibody treatments from Texas, too? Just wondering ?

  11. DCVbpcBmdL says

    ZumRWSNs

  12. oeLzGgZdAryVfCt says

    AXFRMLlOZf

  13. FWPgNXKnkiYwolxS says

    NYKnHqVk

  14. KOqUtdNi says

    tGnvagRebK

  15. QvPmAkMrKNboB says

    OoYJRCmE

Leave A Reply

Your email address will not be published.