FDA Continues to Meddle with Covid-19 Treatments

Arabic man patient getting intramuscular shot against COVID-19 at clinic, african american woman doctor making injection in shoulder for young man, wearing protective face masks, copy space

On January 3rd, 2022, the Omicron Covid-19 set the US single-day Covid-19 case record by infecting over 1 million Americans. Although Omicron peaked quickly afterward, the Centers for Disease Control still estimates the variant caused nearly 525,000 new cases as of January 28th.

Thankfully, compared to other Covid variants, patients are much less likely to die or become hospitalized from an Omicron infection. However, Omicron’s transmutability has still resulted in a considerable amount of hospitalization. Sadly, children are more likely to be hospitalized with Omicron than other variants. Widespread cases burden US hospitals, many of which are reaching capacity and struggling to care for patients due to a shortage of healthcare workers.

Several major drug companies are racing to develop another Covid-19 vaccine for the Omicron variant. However, these vaccines have just begun their clinical trials. Further, Omicron’s ability to evade already-existing Covid-19 vaccines also indicates developing a vaccine for it could be exceptionally challenging.

Despite a clear need to find treatments quickly to combat rising cases and help patients avoid hospitalization, the Food and Drug Administration is curtailing such efforts.

The FDA recently released a statement indicating it limits the use of two monoclonal antibody treatments, bamlanivimab and etesevimab, because they are less effective in treating Omicron infections. As the statement explains:

“it’s highly unlikely that COVID-19 patients seeking care in the US at this time are infected with a variant other than Omicron, and these treatments are not authorized to be used at this time. This avoids 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”

At first, the agency’s decision seems reasonable. Omicron infections make up about 99 percent of new Covid infections, and more effective antibody treatments are available.

But several concerning issues arise when we consider the full ramifications of the FDA’s decision.

Even if Omicron cases compose 99.99 percent of all new cases, there would still be over 5000 new deadlier Delta Covid-19 variant cases each day. The FDA’s choice to limit bamlanivimab and etesevimab will make these treatments less available for patients. A recent government misstep to address Omicron outbreaks provides a telling example.

Nearly two months before the FDA’s decision, the Biden Administration began distributing fewer monoclonal treatments for the Delta variant because Omicron was quickly becoming the dominant strand. Hospitals quickly ran out of these treatments, and patients suffered. Texas and Florida (two of the five most populated states) especially struggled to treat patients because of the “sudden suspension of multiple monoclonal antibody therapy treatments.”

Limiting bamlanivimab and etesevimab treatments is another step in this wrong direction.

Further, the FDA placing limits on how to use Covid-19 treatments undermines efforts by physicians, drug developers, and other healthcare professionals to find the best ways to treat patients under challenging circumstances. As I’ve argued for the past two years, the FDA’s greatest successes in battling the pandemic have come from reducing its oversight and empowering healthcare professionals.

In my article published in the Independent Review, I note that Covid-19 testing availability and innovation increased substantially after the FDA began granting emergency use authorizations (EUAs) to allow drug developers to, “immediately use tests they developed and validated.” Less than three weeks after enacting this policy, over 100 kinds of Covid-19 tests became available.

Before the FDA began issuing EUAs, the CDC developed the only Covid-19 test approved by the FDA. These tests faced manufacturing issues and frequently gave false diagnoses, providing incorrect information to policymakers and politicians during the first U.S. Covid outbreaks. The tests eventually were removed from the market.

The FDA has also made errors in judgment regarding Covid-19 treatments.

Now hailed as the “standard of care” for all variants of Covid-19, remdesivir was twice denied FDA approval in clinical trials where it was used to treat Ebola and MERS. In October 2020, after widespread private efforts to grant experimental treatment to Covid patients, remdesivir became the first drug in decades to receive full FDA approval without undergoing its formal approval process.

New variants pose unique challenges. It’s unlikely Omicron will be the last one. When allowed to provide solutions, successes in battling Covid-19 have overwhelmingly come from the private sector. When the FDA and other agencies curtail private efforts, including limiting the use of existing and established treatments, we place our trust in less capable hands.