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Food and Drug Administration Guidance Drives Racial Rationing of COVID Drugs

by Aaron Sibarium

InĀ New York, racial minorities are automatically eligible for scarce COVID-19 therapeutics, regardless of age or underlying conditions. InĀ Utah, “Latinx ethnicity” counts for more points than “congestive heart failure” in a patientā€™s “COVID-19 risk score”ā€”the stateā€™s framework for allocating monoclonal antibodies. And inĀ Minnesota, health officials have devised their own “ethical framework” that prioritizes black 18-year-olds over white 64-year-oldsā€”even though the latter are at much higher risk of severe disease.

These schemes have sparkedĀ widespread condemnationĀ of the state governments implementing them. But the idea to use race to determine drug eligibility wasnā€™t hatched in local health departments; it came directly from the federal Food and Drug Administration.

When the FDA issued its emergency use authorizations for monoclonal antibodies and oral antivirals, it authorized them only for “high risk” patientsā€”and issued guidance on what factors put patients at risk. One of those factors was race.

TheĀ FDA “fact sheet” for Sotrovimab, the only monoclonal antibody effective against the Omicron variant, states that “race or ethnicity” can “place individual patients at high risk for progression to severe COVID-19.” TheĀ fact sheet for Paxlovid, Pfizerā€™s new antiviral pill, uses the Centers for Disease Control and Preventionā€™s definition of “high risk,” which states that “systemic health and social inequities” have put minorities “at increased risk of getting sick and dying from COVID-19.”

The guidance sheets are nonbinding and do not require clinicians to racially allocate the drugs. But states have nonetheless relied on them to justify race-based triage…


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