Republican Florida Gov. Ronald DeSantis slammed the Biden administration Monday for ending its emergency use authorization of two major COVID-10 monoclonal antibody treatments.
The Food and Drug Administration announced earlier that day that it will permit the use of Lilly’s (bamlanivimab and etesevimab) treatment and Regeneron’s REGEN-COV (casirivimab and imdevimab) treatment only when a patient “is likely to have been infected with or exposed to a variant that is susceptible to these treatments.”
Referring to Centers for Disease Control and Prevention statistics indicating that omicron is the dominant COVID-19 strain in the United States, constituting 99 percent of cases nationwide as of Jan. 15, Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said that “data show these treatments are highly unlikely to be active against the omicron variant.”
Therefore, she said, “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,” Cavazonni said.
Because data shows these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the U.S., these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.
— U.S. FDA (@US_FDA) January 24, 2022
The FDA decided to restrict the monoclonal antibody treatments to prevent “exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant,” Cavazonni said.
The move is a revocation of a Trump-era emergency use authorization the agency implemented in November 2020 to fight the rising number of COVID-19 cases in the country.
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According to The New York Times, when a wave of delta variant cases hit hospitals across the nation last year, the treatments could prevent hospitalizations provided health care workers administered them in time.
However, the Times reported in December, once omicron struck, the treatments failed to work against the virus, prompting health care systems such as New York City’s to withdraw them.
“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,” the governor said.
“This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives,” he said. “There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”
Floridians have benefited from the state’s treatment sites and their access to treatment shouldn’t be denied based on the whims of a floundering president. https://t.co/Y5nmAV1LCs
— Ron DeSantis (@GovRonDeSantis) January 25, 2022
Florida Surgeon General Dr. Joseph Ladapo joined DeSantis in criticizing the FDA decision.
“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” Ladapo said.
“The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19,” he said. “Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”
SUPERCUT: Biden repeatedly promised to “shut down the virus.”
SPOILER ALERT: He failed.pic.twitter.com/Yhffn1GXls
— RNC Research (@RNCResearch) October 15, 2021
Appointments for more than 2,000 Floridians scheduled to take the antibody treatments were canceled in compliance with the updates to FDA guidelines, according to DeSantis’ office.
As a result of the @US_FDA‘s abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below. pic.twitter.com/RGeWTPwxCs
— Florida Dept. of Health (@HealthyFla) January 25, 2022
“Rather than giving Americans the option for various COVID treatments, the FDA and the Biden Administration issued their royal decree, taking away the very thing that is proven to reduce hospitalizations and save lives,” Florida Lt. Gov. Jeanette Nuñez said in a statement.
“Monoclonal antibody treatments like Regeneron have had a positive impact for thousands of Floridians,” she said. “For the CDC and FDA, which have been consistently inconsistent throughout the entire pandemic, to restrict treatment does nothing but put individuals at risk.”