(The Center Square) — The Food and Drug Administration announced Monday evening that effective immediately, certain monoclonal antibodies would no longer be available to states and health care providers, saying they are ineffective against the omicron variant.
Within a few hours, Florida Gov. Ron DeSantis blasted the decision, calling it “reckless, abrupt, unilateral,” and an “indefensible edict.”
In the FDA’s announcement to “Limit the Use of Certain Monoclonal Antibodies to Treat COVID-19 due to the Omicron Variant,” it states, “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.”
DeSantis is demanding the Biden administration reverse “its sudden and reckless decision to revoke emergency use authorization (EUA) for Regeneron and Eli Lilly monoclonal antibody treatments.” The FDA’s decision Monday, he says, will prevent access to life-saving treatments for Floridians and all Americans.
“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,” DeSantis said. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism — Americans’ access to treatments is now subject to the whims of a failing president.”
The FDA says that based on Centers for Disease Control and Prevention data, “the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time.”
DeSantis says the FDA’s decision was made without clinical data to support it.
The FDA argues it’s based on decisions made by an NIH COVID-19 Treatment Guidelines Panel, “an independent panel of national experts,” who recently “recommended against the use of bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) because of markedly reduced activity against the omicron variant and because real-time testing to identify rare, non-omicron variants is not routinely available.”
The FDA says there are several other therapies that can be used instead, including Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir, which “are expected to work against the omicron variant, and are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.”
Over the last two years, scientists and researchers nationwide “worked hard to bring us treatments that are both safe and effective,” DeSantis said. “One of these treatments has been monoclonal antibodies. This treatment has saved thousands of lives in Florida and across our nation.”
“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,” Florida Surgeon General Dr. Joseph Ladapo said. “The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.'”
As a result of the administration’s decision, appointments for more than 2,000 Floridians scheduled to receive the monoclonal treatments were canceled on Tuesday.