FDA Guidance on Antibodies Seen as Rationing Treatment by Race

Encouraged by the Biden administration, several states and municipalities are adopting policies that give preference to non-white patients in receiving potentially lifesaving treatments for COVID-19, including scarce monoclonal antibody infusions.

Health officials in Utah, New York City, and, initially, Minnesota developed race-based ranking systems after a key federal agency issued guidance documents citing race and ethnicity as factors in allocating therapies.

The U.S. Food and Drug Administration (FDA) “fact sheet” for emergency use authorization (EUA) of GlaxoSmithKline’s Sotrovimab, currently the only monoclonal antibody treatment effective against the Omicron variant, states “race or ethnicity” can “place individual patients at high risk for progression to severe COVID-19.”

Legal Challenges

Now, entities that embraced racial formulas for dispensing coronavirus treatments are facing serious legal challenges.

On January 17, Minnesota, which had specifically cited the FDA’s fact sheet’s language on race and ethnicity in determining eligibility for monoclonal antibodies, removed race as a preferential factor in receiving treatment. The move came after the state was threatened by a lawsuit from the America First Legal Foundation, which said Minnesota’s policies violated several federal statutes.

Similarly, SSM Health, a Catholic hospital chain with 23 hospitals spread across Illinois, Missouri, Oklahoma, and Wisconsin, abandoned its race-based ranking system after the Wisconsin Institute for Law & Liberty threatened a lawsuit.

Determining the Intent

Some medical conditions are more prevalent among particular minorities and that deserves consideration, but it is unlikely this is what motivates the Biden administration’s push for preferential treatment, says Merrill Matthews, Ph.D., resident scholar at the Texas-based Institute for Policy Innovation.

“The FDA’s statement highlights medical conditions that ‘may place adults and pediatric patients … at higher risk of progression to COVID-19,’ said Matthews. “Among those conditions is sickle cell disease, which primarily affects blacks. But some racial minorities also tend to have a higher incidence of obesity, diabetes, and hypertension, all of which are on the FDA list. If the FDA is saying that certain races and ethnicities are more likely to have those comorbidities and so should be given higher priority in receiving Sotrovimab, that may well represent appropriate medical rationing.

“But the Biden administration may not deserve a generous interpretation,” said Matthews.  “For example, Biden’s American Rescue Plan included $4 billion in debt relief for ‘farmers of color,’ as a form of restitution for past discriminatory lending practices. The courts blocked that effort. If the FDA’s underlying motive in its guidance is a form of restitution for what we might call ‘patients of color,’ then it not only violates the constitution, it violates good medical practice.”