The Food and Drug Administration wants health care providers to consider a patient’s race when deciding whether to administer COVID-19 drugs to them, the agency said in a fact sheet.
An FDA fact sheet discussing the emergency use authorization of the drug sotrovimab for treatment of mild to moderate COVID-19 cases listed conditions that place people at higher risk for developing severe COVID-19.
Among the conditions listed is being 65 or older, pregnancy, diabetes, chronic lung diseases, cardiovascular disease, or neurodevelopmental disorders like cerebral palsy, the agency wrote.
“Race or ethnicity” may also put someone at higher risk for severe COVID-19, too, the fact sheet added.
“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,” the FDA stated.
The FDA is not the only government entity to direct health care providers to factor in someone’s race in distributing COVID-19 care.
At least three states — New York, Minnesota, and Utah — have released similar guidance at the state level about considering race as an indicator of the risk of severe COVID.
In December, the New York health department released guidance saying that only COVID-19 patients who met certain criteria were eligible to receive monoclonal antibodies and oral antiviral treatment. Race was listed as one of the factors that increases a person’s risk for severe illness and should be taken into account.
“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,” New York’s health department stated in official guidance.
Utah health officials use a point system to calculate a COVID-19 patient’s “risk score” to determine whether to administer monoclonal antibody treatment.
Being of “Non-White race or Hispanic/Latinx ethnicity” bumps a patient’s risk score up two points, the same amount the score is raised when a patient has a “highest-risk comorbidity” such as 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,” reads Utah’s state guidelines on administering monoclonal antibody treatment.
The Minnesota health department cited the FDA in state guidance saying health care providers may consider “whether a patient has heightened risk of progression to severe COVID-19 associated with race and ethnicity” when determining eligibility for monoclonal antibodies.
The Centers for Disease Control and Prevention has echoed the FDA, saying “COVID-19 has unequally affected many racial and ethnic minority groups, putting them more at risk of getting sick and dying from COVID-19.”
The new FDA guidelines were met with criticism from Dr. Ben Carson, a retired neurosurgeon and former Housing and Urban Development secretary in the Trump administration. Carson said the guidance reminded him of the racial discrimination he endured as a child.
“Here we are trying to bring it back. It’s unbelievable,” Carson said on Fox News.