Gov. Ron DeSantis is demanding the Biden Administration reverse its decision to revoke emergency use authorization for Regeneron and Eli Lilly monoclonal antibody treatments to combat the effects of COVID-19.
On Monday, Jan. 24, the U.S. Food and Drug Administration revised the authorizations, disallowing providers to administer these treatments in most cases.
“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,” the FDA reported on its website.
“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,” the statement continued. “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 had initially approved use of REGEN-COV for certain adults and older pediatric patients on Nov. 21, 2020, and the Eli Lilly treatments on Feb. 9, 2021, for the same populations.
As a result of Monday’s announcement, the Florida Department of Health closed all monoclonal antibody sites, including those in Duval County, until further notice. The governor’s office reported that more than 2,000 appointments to receive these treatments were canceled Tuesday, Jan. 25, in the state of Florida.
In a statement on the governor’s website, DeSantis took the Biden Administration to task for the decision.
“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,” said DeSantis. “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.”
“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,” said the state’s surgeon general, Dr. Joseph Ladapo. “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.’”
According to the FDA, the revision of authorizations “avoids exposing patients to side effects, such as injection site reactions or allergic reactions.”
The FDA statement cites the existence of other approved therapies that are expected to work against the omicron variant.
