JACKSONVILLE, Fla. – Gov. Ron DeSantis, who heavily promoted the use of Regeneron’s monoclonal antibody treatment as a part of his administration’s COVID-19 response, sharply criticized the Biden administration on Tuesday after the Food and Drug Administration announced it had revoked the treatment’s emergency use authorization.
The Florida Department of Health was left with no choice but to shut down all state-run monoclonal antibody treatment sites until further notice, including two sites in Jacksonville: the Southside Senior Center and the Joseph Lee Center in Brentwood.
DeSantis expressed his frustration with the FDA’s decision during a news conference Tuesday in Crawfordville to announce a new state literacy initiative.
“It’s really a reckless decision to be able to take this option away from patients when we’ve had the site set up, we’ve had this distributed to different medical groups or hospitals,” DeSantis said. “So we’re gonna fight back against this because this is just wrong. This is not the way you know that you help people.”
A sign on the Southside Senior Center site Tuesday explaining the closure read, “The Biden Administration has removed the ability for any state to administer Regen-Cov or BAM-ETE monoclonal antibody treatments. As a result, this site is closed.” It advises visitors to call 911 if they are experiencing severe symptoms, to contact their health care provider for COVID-19 treatment options and to call the FDA for information on why the antibody treatments were halted.
During the news conference, DeSantis said the data the FDA based its decision on came from a single study.
“They are relying on revoking this and pulling the rug out from under people, on a single, non-peer-reviewed, non-clinical study that was actually done by a consultant for a rival company to the other two monoclonal antibody treatments,” DeSantis said. “Our view is people have a right to access these treatments and to revoke it on this basis is just fundamentally wrong, and we’re going to fight back.”
During an interview on “The Morning Show” on Tuesday, Dr. Mohammed Reza, infectious disease specialist at CAN Community Health, explained why the FDA might have been willing to base its decision on a lab study, rather than waiting for clinical data.
“A lot quicker data comes available through the laboratory studies, and then we have to look for clinical data as time goes on,” Reza said. “But that may take months. In the meantime, we in medicine want to do no harm. So if we’re seeing that it’s not working in the laboratory setting, giving it to people may not be effective. So clinical data should follow, but at this point, it doesn’t look like it’s effective against this variant.”
The FDA said restricting the use of monoclonal antibody treatments will eliminate unnecessary side effects, including allergic reactions. The agency said there is a chance if the drugs are proven effective, it could reauthorize them.
“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the state health department said after the FDA decision was announced Monday.
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
White House Press Secretary Jen Psaki addressed DeSantis’ comments during her daily news conference on Tuesday.
“They are still advocating for treatments that don’t work. 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 have things that do work. Injecting disinfectant, promoting pseudo-science, sewing doubt on the effectiveness of vaccines and boosters. And now promoting treatments that don’t work,” Psaki said. “We know what works, vaccines and boosters. We have a range of doses of things that do work in treatments, and we are providing those to Florida.”
Psaki said the federal government has provided 71,000 doses of anti-virals to Florida, along with 34,000 additional treatments that do work against omicron sent to the state last week.
“We’ve approached COVID treatments like filling a medicine cabinet. We’re not relying on one type, one brand or treatment. We’ve invested in and continue to buy a variety of monoclonal antibodies, pre-exposure prevention therapies and oral anti-virals,” Psaki said. “What the FDA is making clear is these treatments, the ones they’re fighting over, that the governor is fighting over, do not work against omicron, and they have side effects. That’s what the scientists are saying.”
DeSantis said any chance of helping patients is better than no chance at all and claimed that anecdotally, Florida has seen COVID-19 patients respond in the last month to Regeneron treatments.
“Maybe you do a clinical trial, and it’ll show it’s less effective than against delta. That may be the case. But we have patients who have benefited. That’s just the fact,” DeSantis said.
Florida had just recently opened new Regeneron sites around the state, including the one on the Southside, after securing 15,000 doses of the treatments, following weeks of back-and-forth with the federal government.
“This was kind of sudden. I mean, they had said different things about it, but this was a really sudden shift, and I think it caught a lot of people by surprise,” DeSantis said. “I think there’s politics at play, but I think part of it is I just don’t think they have enough treatments to go around. And I think they realize that and I think it would look very bad to be able to admit that. So instead they’re saying this is revoked.”
DeSantis said his administration will consider the possibility of a lawsuit.
“I mean, the fact of the matter is, if you look at how the FDA has handled a lot of this stuff, whether there’s legal cause of action or not, I think it leaves a lot of Americans kind of scratching their head with some of this,” DeSantis said.
The Associated Press contributed to this report.