Florida Shuts Down Monoclonal Antibody Site After FDA Says Treatment is Useless Against Omicron
22:30 GMT 25.01.2022 (Updated: 13:28 GMT 06.08.2022)
© REUTERS / Andrew Kelly
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Florida’s Republican Governor Ron DeSantis has sparred repeatedly with federal officials and Democratic local government figures over pandemic mitigation practices, including mask mandates, vaccines, and now an antibody therapy treatment.
On Monday, the US Food and Drug Administration (FDA) withdraw authorization in most cases for use of two different monoclonal antibody treatments for COVID-19: bamlanivimab and etesevimab, which are used together, and the combination of casirivimab and imdevimab known as REGEN-COV, or Regeneron.
“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 US states, territories, and jurisdictions at this time,” the federal regulator said. “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 said the reason behind the restriction was to avoid exposing patients to the drugs’ side-effects, which according to a fact sheet by the maker, which is also called Regeneron, can include “brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.”
However, the FDA added that other therapies, including Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir, have retained their use authorization because they have been proven to be effective against the Omicron variant of SARS-CoV-2, the virus that causes COVID-19.
Monoclonal antibody treatments are lab-made proteins that help the immune systems of infected persons jump-start their defense against the illness by providing them with the blueprint for antibodies needed to fight the virus off. However, they have to be administered at a hospital or clinic. Recently, oral antiviral pills have been approved, which are likely to be more effective than antibody therapy and can be taken at home.
DeSantis’ administration was not pleased with the move.
In a letter to the FDA obtained by Fox News, Florida Deputy Secretary for Health Kenneth Scheppke said the Florida government disagrees with the agency’s decision, saying he believed the Health and Human Services Department’s delay of an update on 30,000 doses of the two treatments ordered by Florida had been done with knowledge of the forthcoming update.
"We believe the decision to delay our meeting was made with the awareness that this would be announced. Rather than transparent communication from the federal government to states, decisions continue to be made through news cycles and this actively prevents states from making operational decisions that actively save lives,” Scheppke wrote.
The governor took a swing at the Biden administration too:
"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."
In response, DHHS spokesperson for Covid issues, Ian Sams, tweeted out: “Why is Gov. DeSantis more interested in promoting medicines that don’t work than urging people to take vaccines that do?”
Why is Gov. DeSantis more interested in promoting medicines that don’t work than urging people to take vaccines that do? https://t.co/qHt9BTKWA6
— Ian Sams (@IanSams) January 25, 2022
While the FDA might not have sent along research justifying their position, recent studies vindicate their conclusion, and Regeneron itself conceded last month that the antibodies the treatment helps the patient’s body produce to fight off a SARS-CoV-2 infection “have diminished potency versus Omicron.”
In September 2021, DeSantis accused DHHS of seizing the state’s monoclonal antibody treatments after the department restructured distribution of the drug to be more equitable among US states. The Sunshine State became the center of the Delta variant-driven outbreak in the US in the summer of 2021 after DeSantis spent months fighting mask mandates and demonizing COVID-19 vaccines during the federal government’s rollout of its mass vaccination campaign.
The fact that Ron DeSantis is selling “Don't Fauci My Florida” koozies on his campaign website while the state leads the nation in new COVID cases and deaths tells you everything you need to know about him. pic.twitter.com/pThrTUMWqI
— Andrew Weinstein (@Weinsteinlaw) July 12, 2021
After DeSantis threatened to pull funding from schools that require their students to wear masks in class, the US Department of Education said it would consider taking Florida and Texas, another state pursuing similar policies, to court over civil rights violations.
