Food and Drug Administration Guidance Drives Racial Rationing of COVID Drugs

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

These schemes have sparked widespread condemnation of the state governments implementing them. But the idea to use race to determine drug eligibility wasn’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” patients—and issued guidance on what factors put patients at risk. One of those factors was race.

The 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.” The fact sheet for Paxlovid, Pfizer’s new antiviral pill, uses the Centers for Disease Control and Prevention’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.

“The FDA has acknowledged that in addition to certain underlying health conditions, race and ethnicity ‘may also place individual patients at high risk for progression to severe COVID-19,’” Minnesota’s plan reads. “FDA’s acknowledgment means that race and ethnicity alone, apart from other underlying health conditions, may be considered in determining eligibility for [monoclonal antibodies].”

Utah’s plan contains similar language. In a section on the “Ethical Justification for Using Race/Ethnicity in Patient Selection,” it notes that the FDA  “specifically states that race and ethnicity may be considered when identifying patients most likely to benefit from this lifesaving treatment.”

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Several legal experts told the Washington Free Beacon that the prioritization schemes amount to illegal race discrimination. “It’s certainly unconstitutional to use race in this way,” said David Bernstein, a professor of constitutional law at George Mason University.

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