Editor’s Note: This article is part of a Health Affairs Forefront series on Racism and Health, published in conjunction with the February issue of Health Affairs Journal. Read other posts in the series on the Racism and Health landing page.

The U.S. Food and Drug Administration has faced backlash after recommending that clinicians use race and ethnicity, among other factors, to guide allocation and use of novel monoclonal antibodies for COVID-19 treatment. These guidelines are similar to recommendations from health departments in states like New York, Utah, and Minnesota to prioritize high-risk individuals who are elderly, pregnant, immunocompromised, have medical comorbidities, and are non-White for access to scarcely available COVID-19 medications like nirmatrelvir/ritonavir (Paxlovid) and molnupiravir. As clinicians and researchers who have studied and witnessed firsthand the unequal trajectory of this pandemic from the very beginning, we want to counter this pushback with an evidence-based perspective.

Explicitly race-based guidelines have marred the historical and current practice of medicine. Even today, race-based medicine exacerbates delays in access to timely treatment, inequitable rationing of ventilators, and widening chronic disease disparities.

While race-based guidelines that harm patients should be dismantled, we believe the FDA and state health department decisions to consider race have noble intentions: to advance equitable access to care and redress the impacts of racism, rather than worsen disparities with “colorblind” policies.

Inequitable Access To Novel Therapeutics

In stark contrast to recent false claims (which have since been debunked) that White patients are being denied access to monoclonal antibodies like sotrovimab based on their race, new national data from the Centers for Disease Control have revealed wide disparities in the use of outpatient monoclonal antibody treatment among patients with Hispanic ethnicity and Asian, Black, and Other race. Unequal access to novel treatments is certainly not unique to COVID-19, with access barriers extending from clinical trials to biases in clinical decision-making to ‘pharmacy deserts’ in disinvested neighborhoods.

We are deeply concerned that ongoing inequitable therapeutic access will only widen disproportionate hospitalization and death rates among Black, Hispanic, Indigenous, and some Asian populations. With COVID-19 treatment guidelines rapidly evolving in the Omicron variant era, current evidence suggests sotrovimab, Paxlovid, and molnupiravir can prevent hospitalizations and deaths. As such, racial equity considerations within resource allocation frameworks are not just the right thing to do to redress injustice. They will also help reduce the spread and severity of COVID-19 across our country.

Clarifying Public Health Messaging On Race-Conscious Guidelines

Entities establishing COVID-19 treatment allocation guidelines must pursue clearer messaging.

The color of one’s skin does not increase one’s risk of COVID-19 infection or severity. However, the downstream consequences of interpersonal, institutional, and structural racism certainly do.

Since racism, not race, is the causal driver, race-conscious guidelines should emphasize that race is an imprecise social and political invention with no biological or genetic basis; name systemic health and social inequalities as root causes of racial disparities; and frame prioritization as both a moral imperative to mitigate inequities and a public health imperative to slow disease spread. Race-conscious allocation, just like allocation prioritizing people who are pregnant, immunocompromised, or have chronic medical conditions, will ensure medications are distributed to individuals and communities in greatest need.

Our call to action is simple: State and federal policymakers must be intentional about advancing pharmacoequity. Guidelines should clearly indicate that race is being used as a proxy for racism (i.e., as a “risk marker”). Unlike the FDA’s guidance, which failed to explain any reasoning for inclusion of race, the New York Department of Health’s prioritization framework handled this nuance well, justifying consideration because “longstanding systemic health and social inequities have contributed to an increased risk of severe illness and death from COVID-19.”

Legal And Policy Considerations To Move Past Pushback

Equitable allocation efforts may continue to meet resistance. After threats of legal action, state health departments in Minnesota and Utah recently dropped race as a factor in rationing monoclonal antibody infusions—a frustrating reversal of a policy intended to promote equity. While an individual-level race criterion falls in murkier legal territory, ethicists and legal scholars have emphasized that place-based or population-level allocations which prioritize minoritized groups de facto through geographic vulnerability indices, appropriate age standardization, and targeted investments in disadvantaged areas are more universally viewed as ethical and lawful. Place-based equity approaches also have  widespread, bipartisan public support compared to race-based prioritization, offering policymakers a politically feasible alternative to equitably distribute therapeutics using neighborhood characteristics or clinic patient populations. But, such approaches should be selected cautiously; for example, the CDC’s Social Vulnerability Index, which includes area-level racial and ethnic composition alongside 14 other indicators, has been demonstrated as a more equitable prioritization scheme than the race-free Area Deprivation Index.

Though legal threats may persist, policymakers should strongly consider how policies which appear race-neutral at face value often lead to disparate impact. For example, purportedly “equal” age-based thresholds for COVID-19 vaccination failed to recognize the disproportionately younger age distribution of Black, Indigenous, and Hispanic populations. This failure led experts to call for race-conscious age cutoffs which echo  approaches in Canada and Australia to prioritize Indigenous communities. Need-blind strategies are unpopular across the political spectrum among U.S. adults, yet guidelines for vaccine allocation and free test distribution have repeatedly overlooked equity considerations.

Moreover, because they perpetuate disparate treatment and impact, colorblind approaches may be prone to their own set of constitutional, Title VI and Affordable Care Act Section 1557 legal vulnerabilities. Race-conscious schemas which mitigate disparate impacts should be viewed as well-aligned with civil rights law, if lawmakers indeed consider it a “compelling government interest” to prevent racially disparate premature deaths. This is also where the Office for Civil Rights within the federal Department of Health and Human Services could come in. Under Section 1557, HHS OCR already has authority to set forth affirmative obligations for covered entities to collect and report sociodemographic data and perform compliance reviews ensuring entities are preventing inequitable impacts by race. However, because HHS OCR is chronically understaffed while managing hefty responsibilities — including enforcement of Health Insurance Portability and Accountability Act compliance — operationalizing Section 1557 and other civil rights laws for disparate impact claims against facially race-neutral policies remains a challenge. Although the agency has offered ample public examples of prohibited discrimination in health care with respect to sex, disability, and national origin, similar resources have not yet been dedicated to addressing racial discrimination.

While pharmacoequity remains a crucial goal, we must also remember that COVID-19 therapeutics are just one tool within a broad arsenal of flexible policy levers. Increasing vaccination uptake mitigates racial and ethnic inequities in hospitalization and death and should remain our primary focus. In the short-term, immediate evidence-based interventions like equitable and timely access to free testing and paid medical leave, intentional vaccination outreach, distribution of high-filtration masks, and implementation of indoor mask mandates during surges can help keep our schools and small businesses open. And, addressing structural factors which contribute to COVID-19 spread through eviction moratoria, prison and jail decarceration, and interventions to promote food and economic security can similarly flatten the curve by protecting our most vulnerable neighbors.

An Opportunity To Prioritize Equity

State and federal agencies have made challenging decisions and navigated tradeoffs throughout this pandemic. Clarity in public health messaging and operationalization of foundational civil rights laws may be necessary to bolster current allocation schemes for COVID-19 therapeutics and more. We hope stakeholders across the country continue to recognize scarce resource allocation as an opportunity to intentionally prioritize equity over colorblindness.

Authors’ Note:

This essay expresses the authors’ personal viewpoints rather than that of their affiliated employers or institutions.