STATEWIDE — Late Monday, the Food and Drug Administration announced that it was rescinding COVID-19 treatment authorization for Regeneron and Eli Lilly monoclonal antibody treatments, saying they are ineffective against the omicron variant.
Florida Gov. Ron DeSantis immediately condemned the move, calling it a "haphazard decision," and demanded the Biden administration reverse course.
What You Need To Know
- FDA says that treatments are highly unlikely to be effective against the omicron variant
- Gov. Ron DeSantis is demanding the Biden administration reverse the FDA's decision
- White House says the governor is fighting for a treatment that doesn't work
- ABOVE: Watch governor's remarks during Tuesday public appearance
- Where to get a no-cost COVID test in Central Florida
In response to DeSantis' comments, White House Press Secretary Jen Psaki pointed out that Florida has been given 71,000 monoclonal antibody treatment doses that are still cleared for use.
"Let's just take a step back here just to realize how crazy this is a little bit," she said during a press conference Tuesday. "To be clear, what the FDA is making clear is that these treatments — the ones that they are fighting over, that the (Florida) governor is fighting over — do not work against omicron, and they have side effects.
"That is what the scientists are saying."
The trouble started Monday night when the FDA put out a statement regarding the two monoclonal antibody treatments, saying data shows they are highly unlikely to be effective against the omicron variant, resulting in "unauthorized use in any U.S. states, territories, and jurisdictions at this time."
The announcement by the FDA resulted in the closing of many monoclonal antibody treatment centers throughout Florida, the state Department of Health announced.
DeSantis' response was swift and condemned 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,” DeSantis said in a statement. “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.”
According to the FDA, monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments no longer working against certain variants such as omicron.
The FDA stated that COVID-19 patients seeking care are likely infected with the omicron variant, citing CDC data that estimates omicron accounts for more than 99% of U.S. cases as of Jan. 15.
In rare occasions, patients exposed to these certain treatments have experienced side effects such as reactions to the injection site or allergic reactions, "which can be potentially serious."
COVID treatments still available for those seeking care are Paxlovid, sotrovimab, remdesivir, and molnupiravir. According to the FDA, those treatments continue to be authorized for use and are expected to work against the omicron variant.
Speaking in Wakulla County on Tuesday, DeSantis reiterated his opposition. He called the decision reckless and argued that even if the treatment is only partially effective against omicron, people should still be allowed to get it.
The state’s surgeon general also spoke out against 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,” 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'.”
#New this morning on @MyNews13, I’m in Seminole County where a recently opened #MonoclonalTreatment site will be forced to close after the @US_FDA’s decision to revise authorization. A new limit on the #COVID19 outpatient treatment effectively closes all these centers as of today pic.twitter.com/3BiM6Tm81j— Ashleigh Mills (@AshleighMNews) January 25, 2022
Psaki argued that Regeneron and Eli Lilly treatments just don't work against omicron — which scientists say accounts for nearly all COVID-19 cases in the U.S. right now — and questioned why anyone would continue to push for them when other treatments are available.
"We've seen, unfortunately, from the beginning in our pandemic response, a range of steps or pushes that have been made through social media platforms — unfortunately from the mouths of elected officials — advocating for things that don't work, even when we know things do work," she said. "Injecting disinfectant, promoting other pseudoscience, sowing doubt on the effectiveness of vaccines and boosters, and now promoting treatments that don't work.
"We know what works: vaccines and boosters. We have a range of doses of things that do work in treatments, and we're providing those to Florida."
Florida Department of Health officials say that those who had appointments to get Regeneron or Eli Lilly monoclonal antibody treatments have been contacted regarding the cancellations and encourage Floridians to contact their health-care provider if they have tested positive for COVID-19.
Seminole County responds to announcement
In a press release on Tuesday, Allan Harris, Seminole County's chief administrator and emergency manager, stated, "After information from the FDA was received (Monday), True Health transferred all appointments from Regeneron to the Strovimab antibody treatment. The facility will remain open (Tuesday) treating persons with COVID-19."
The county's Monoclonal Antibody Infusion Center has a partnership with True Health, and it is located Five Points Complex at 4240 North U.S. Highway 17-92, Sanford, explained Harris.
Harris also mentioned in the press release that other private medical centers and hospitals are continuing to use the monoclonal antibody treatment with other approved methods.
"Community Paramedicine programs offered through the Seminole County Fire Department is also ready to provide monoclonal antibody infusion treatment inside assisted living facilities and nursing homes. Only state-operated facilities have closed (Tuesday)," he stated.