FDA faces criticism after restricting COVID antibody treatments

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Critics express fury after the Food and Drug Administration revised emergency use authorizations for Regeneron and Eli Lilly’s COVID-19 antibody treatments to limit their use, saying the drugs are unlikely to work against the variant of the Omicron coronavirus.

Florida Governor Ron DeSantis, who opened processing centers to distribute the antibodies, criticized the decision, saying the FDA acted “without any clinical data to support its decision.”

Following the FDA’s decision on Monday, Florida said it was forced to close all of its treatment centers and cancel thousands of appointments, and DeSantis lashed out at President Joe Biden over of this decision.

“There are real implications in Biden’s medical authoritarianism — Americans’ access to treatment is now subject to the whims of a failing president,” DeSantis said in a statement.

The FDA noted in its decision Monday that Omicron accounts for more than 99% of infections in the United States, making it “highly unlikely” that the antibodies will help people currently seeking treatment.

The agency said restricting their use would also eliminate unnecessary drug side effects from ineffective treatment, including allergic reactions.

Both treatments are still effective against Delta, but the CDC now estimates that Delta accounts for only 0.5% of new cases in the country.

A closed monoclonal treatment site is seen in Miami on Tuesday after the FDA revoked emergency use authorization for monoclonal antibody treatments Regeneron and Eli Lilly

The FDA has restricted COVID-19 antibody treatments (above) from Regeneron and Eli Lilly to limit their use, saying the drugs are unlikely to work against Omicron

The FDA has restricted COVID-19 antibody treatments (above) from Regeneron and Eli Lilly to limit their use, saying the drugs are unlikely to work against Omicron

Florida Governor Ron DeSantis, who opened treatment centers to distribute the antibodies, criticized President Joe Biden's decision, calling it a

Biden

Florida Governor Ron DeSantis (left), who opened treatment centers to distribute the antibodies, criticized President Joe Biden’s decision, calling it ‘medical authoritarianism’

Some critics have accused the FDA of trying to restrict treatment options to coerce people into getting vaccinated.

“This is about Biden and his admin pulling back a treatment that helps force people to get vaccinated,” one person tweeted.

“I just saw that the FDA withdrew emergency approval for monoclonal antibodies Regeneron and Eli Lilly. What are they doing? Try to kill us?’ another wrote.

“Okay, so now the government is actually saying we want people to die. There is still some delta floating around. To take away [emergency use authorization] is stupid,” wrote another.

The FDA said Monday that the two antibody treatments are not currently cleared for use in US states or territories, but may be cleared in some areas if they work against potential new variants.

Doctors have alternative therapies to fight early cases of COVID-19, including two new antiviral pills from Pfizer and Merck, but both are rare.

An antibody drug from GlaxoSmithKline (GSK) that remains effective is also in short supply.

Last month, the US government suspended distribution of Regeneron and Lilly treatments and said the shutdown would continue until new data emerged on their effectiveness against Omicron.

Both drugs are lab-made versions of virus-blocking antibodies. They are intended to prevent serious illness and death by delivering concentrated doses of one or two antibodies early in an infection.

Then-President Donald Trump received the antibody combination from Regeneron after testing positive for the coronavirus in 2020.

GSK and Vir Biotech are ramping up production of their alternative antibody drug, sotrovimab, to help meet growing demand in the United States.

The FDA has also expanded its approval for the use of remdesivir, a COVID-19 antiviral drug from Gilead Sciences, to treat non-hospitalized patients ages 12 and older.

“The FDA is committed to continuing to review emerging data on all COVID-19 therapies related to the potential impact of variants and to further revise approvals, as appropriate, to ensure that healthcare providers have an effective arsenal of treatments for patients,” the agency said in a statement.

But the announcement, which came in a press release without warning, drew criticism from Florida officials as “abrupt” and poorly supported.

“Rather than give Americans the option of various COVID treatments, the FDA and the Biden administration have issued their royal decree, removing what is proven to reduce hospitalizations and save lives,” the lieutenant governor said. of Florida, Jeanette Nuñez, in a statement.

“Monoclonal antibody treatments like Regeneron have had a positive impact on thousands of Floridians,” she added.

Florida closed all of its treatment sites, like the one seen above in Miami on Tuesday

Florida closed all of its treatment sites, like the one seen above in Miami on Tuesday

DeSantis has been heavily promoting antibody drugs as an integral part of his administration's COVID-19 response, setting up infusion sites (above) across the state.

DeSantis has been heavily promoting antibody drugs as an integral part of his administration’s COVID-19 response, setting up infusion sites (above) across the state.

“For the CDC and FDA, which have been consistently inconsistent throughout the pandemic, restricting treatment only puts individuals at risk.”

DeSantis has heavily promoted antibody drugs as an integral part of his administration’s COVID-19 response, creating infusion sites and praising them at press conferences, while opposing mandates for vaccination and other public health measures. Texas Governor Greg Abbott has also launched state-sponsored infusion sites.

The drugs are not a substitute for vaccination and are generally reserved for the most vulnerable, including the elderly, transplant recipients, and people with heart disease and diabetes.

Since early January, the US government has shipped enough doses of the two antibodies to treat more than 300,000 patients.

Regeneron and Lilly previously announced that they were developing new antibodies targeting omicron.

The move comes days after regulators expanded the use of remdesivir – the first drug approved for COVID-19 – to treat more patients.

On Friday, the FDA expanded the antiviral’s approval to include adults and children with early COVID-19 who are at high risk of ending up in hospital. Remdesivir was previously limited to hospitalized patients.

An influential group of federal experts had previously recommended using the infused drug to try to avoid hospitalization. The same National Institutes of Health panel guidelines recommend against continued use of Lilly and Regeneron antibodies due to their reduced effectiveness against omicron.

Still, many hospitals will face challenges in accelerating remdesivir treatments.

The drug requires three consecutive IV infusions over three days, when used for outpatients. This cumbersome process will not be an option for many overcapacity hospitals facing staff shortages.

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