The Food and Drug Administration (FDA) made a sudden change recently which blocks the ability for people to seek highly effective alternative treatments against COVID-19.
According to the Florida Department of Health, 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.”
This is not the first attempt by the federal government to restrict Florida’s access to the lifesaving alternative treatment. Back in September, Florida Governor Ron DeSantis secured additional doses of treatment despite the Biden administration taking control of the distribution of it and making it nearly impossible for states to get their hands on it.
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 Florida Senator Marco Rubio.
“Antibody treatments … 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.”
The White House has even been criticized for not promoting the usage of this highly effective treatment – with many pointing out that after Biden seized control of it far fewer Americans were able to access it.
The FDA’s recent 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.”
Author: Joseph Maven