FDA Advises The Consideration Of Race When Giving Out COVID-19 Drugs

UNITED STATES - NOVEMBER 9 - The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)

The Food and Drug Administration has stated that they want health care providers to pay heavy consideration to a patient’s race when making the decision as to whether or not to administer COVID-19 drugs to them, as reported by the group in a newly released fact sheet.

This fact sheet from the FDA that talks about the emergency use of authorization of the drug sotrovimab for the treatment of moderate COVID-19 cases listed conditions that place certain people at much higher risk for deteriorating into a more severe COVID-19 case.

As part of these conditions listed is being over the age of 65, diabetes, pregnancy, cardiovascular disease, chronic lung diseases, or neurodevelopmental disorders like cerebral palsy, claimed the agency.

“Race or ethnicity” could also be a factor for being at higher risk for severe COVID-19 as well, read the fact sheet.

“Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above,” said FDA officials.

The FDA is currently not the only government agency to order health care workers to factor in a person’s race when considering the distribution of COVID-19 care.

Currently, at least three states –New York, Minnesota, and Utah– have put forth similar documents at a state level talking about considering race as a possible indicator of a person’s risk for severe COVID.

Back in December, the health department of New York put forth a document that states that only COVID-19 patients who met certain criteria were able to get monoclonal antibodies and oral antiviral treatment. The race of the patients was listed as one of the deciding factors that lead to an increase in a person’s risk for severe illness and should be considered at all times.

“Non-white race or Hispanic/Latino ethnicity should be considered a risk factor, as longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19,” stated the New York health department as part of its official guidance.

Health officials out in Utah, however, use a point system as a way to determine a COVID-19 patient’s “risk score” when determining whether to treat the patient with a monoclonal antibody treatment.

Being of “Non-White race or Hispanic/Latinx ethnicity” lends two points to a patient’s risk score, which holds the same weight on the score as when a patient has a “highest-risk comorbidity” like diabetes, obesity, or being severely immunocompromised.

“Risk factors for hospitalization and mortality are now well-recognized and include age, cumulative comorbidities, male gender, shortness of breath, and importantly, but for reasons not well-understood, non-white race/ethnicity,” stated the state guidelines on treating with monoclonal antibody treatments in Utah.

The health department of Minnesota cited the FDA as part of its state guidance by saying that health care providers may consider “whether a patient has heightened risk of progression to severe COVID-19 associated with race and ethnicity” when figuring out a patient’s eligibility for monoclonal antibodies.

 

 

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