Florida Gov. Ron DeSantis is “hopping mad” over the U.S. Food and Drug Administration’s (FDA) decision to effectively pull emergency use authorization of monoclonal antibody treatments and has vowed to “fight back.”
On Jan. 25, more than 2,000 Floridians woke up to emails and text messages telling them their appointments to receive monoclonal therapies were canceled due to the FDA’s decision, the governor’s office reported.
This brought ire from the governor and prompted him to speak out.
“Without a shred of clinical data to support this action [President Joe] Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said in a press statement.
“There are real world implications to Biden’s medical authoritarianism—American’s access to treatments is now subject to the whims of a failing president.”
He said in a press conference on Jan. 25 that “this is not how you help people.”
“The government is going above and beyond to deny access to people,” DeSantis continued. “Now [patients] are being told that it would be illegal for a provider to give it to them—all based off one observational non-peer reviewed study.”
In his statement he demanded that the Biden administration reverse its “reckless decision” to revoke EUA for Regeneron and Eli Lilly monoclonal antibody treatments.
Monoclonal antibodies are described by the FDA as “laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2.”
SARS-CoV-2 is another name for the CCP (Chinese Communist Party) virus, which causes COVID-19.
The FDA, citing a National Institutes of Health panel, which in turn cited two non-peer reviewed papers, said two of the monoclonal antibody treatments do not work against Omicron, a recently-emerged variant of the virus.
The FDA’s announcement included estimated data from the Centers for Disease Control and Prevention that the Omicron variant is responsible for more than 99 percent of the cases in the United States.
“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,” the statement from the FDA said.
The statement went on to say that withdrawing the treatments would avoid “exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the Omicron variant.”
The federal government had contracted to purchase the monoclonal treatments. In the contract it bars other entities such as hospitals and doctor’s offices as well as states from purchasing in what DeSantis has called the government’s “cornering the market” on the treatment.
In the 2021 state budget DeSantis set aside $1 billion to go towards purchasing COVID-19 treatments, personal protective equipment, and any other related expenses associated with the pandemic.
The FDA suggested other therapies such as paxlovid, sotrovimab, remdesivir, and molnupiravir.
According to the drug administration, these treatments are authorized and approved to treat patients with mild to moderate COVID-19 symptoms who are at high risk for “progression to severe disease” and who may end up hospitalized or dead.
It also advises the “authorized treatments are not a substitute for vaccination” and boosters are “recommended.”
“Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death,” the FDA website went on to say.
However, DeSantis said the majority of people infected with the Omicron variant are vaccinated.
“Yet they’re still infected and many of them are high risk—they’re pulling the rug out from under people on a single, non-peer reviewed, non-clinical study.”
The state’s Surgeon General Dr. Joe Ladapo said the FDA’s action came “without advance warning.”
“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,” Ladapo said in a press release.
Ladapo went on to say that the FDA has “failed to adequately provide the United States with adequate treatment options for COVID-19.
“Now they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus,’” he said.
The governor’s office said it believed the “abrupt” decision by the Biden administration was made with unsupported clinical data to support “such a decision.”
DeSantis believes the decision made by the administration was “deliberate,” as the announcement was made via a press release.
“They had months and months and months to stockpile this, and they chose not to do it,” DeSantis said at the press conference. “I think part of it is there’s politics at place.
He added, “… part of it is they don’t have enough treatments to go around—they realize that it would look very bad to be able to admit they so instead they are saying this is revoked.”
“This prevents states and health care providers from making real-time operational decisions that save lives,” DeSantis said.
The governor went on to say that during the pandemic that scientist and researchers from across the United States have “worked hard to bring treatments that are both safe and effective.”
One of these treatments has been monoclonal antibodies,” he said. “This treatment has saved thousands of lives in Florida and across our nation.”