Health Equity and Access to COVID-19 Treatments Available through Emergency Use Authorizations

Journal of Racial and Ethnic Health Disparities https://doi.org/10.1007/s40615-024-02094-x Health Equity and Access to COVID‑19 Treatments Available through Emergency Use Authorizations Candon Johnson1 · Carolyn Wolff2 · Jing Xu3 · On behalf of the N3C consortium Received: 1 April 2024 / Revised: 8 July 2024 / Accepted: 10 July 2024 This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2024 Abstract Understanding and evaluating equity in access to care is a critical component to ensuring health equity for all individuals. During the COVID-19 pandemic, the U.S. Food and Drug Administration made unprecedented use of its regulatory authority by authorizing the use of unapproved products through Emergency Use Authorizations (EUAs). We use data from the U.S. National COVID Cohort Collaborative (N3C) to understand how access to therapeutic products authorized under EUAs has varied across COVID-19 patients and over time. We find that Black patients were more likely to receive early EUA drugs while White patients were more likely to receive monoclonal antibodies. Male patients were more likely to receive any EUA drug than Female patients. Patients in Metropolitan areas were more likely to receive EUA drugs than patients in other regions. Additionally, differences in the rates of exposure to EUA drugs by gender, rural-urban classification, and length of stay decreased over time while differences by race and ethnicity have generally persisted. Our project identifies inequities in the rate of access to EUA drugs across patient groups that can inform policy makers in future planning and decision making. Keywords COVID-19 · Health Equity · Racial Health Disparities · Emergency Use Authorizations MSC 62P25 Introduction In order to achieve health equity for all individuals, we need a better understanding of the heterogeneous impacts of health policies across diverse populations. Understanding how access to health care may vary across the United States is a critical component of this goal. Prior to the COVID-19 pandemic, the overall trend in access to care was improving for minority and disadvantaged groups, although significant disparities by race, ethnicity, household income, and location of residence remained [1]. While it is yet to be determined how the overall COVID-19 pandemic may have impacted these general trends, Alcendor (2020) finds * Candon Johnson 1 Food and Drug Administration, Office of the Commissioner, Silver Spring, MD, USA 2 Federal Trade Commission, Bureau of Economics, Washington, DC, USA 3 Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA that communities of color and other underserved populations living with limited access to social services have been particularly hard hit by the pandemic and continue to be among the most vulnerable [2]. A key public health measure used during the COVID-19 pandemic was the authorization of medical products under FDA’s Emergency Use Authorization (EUA) authority. While FDA made unprecedented use of this authority during the pandemic to help expedite the availability of medical products and strengthen the public health protections,3 it is currently unknown what impact it has had on health equity in the United States. In an effort to shed light in this area, we examine the health equity associated with access to drugs authorized under the FDA EUA authority during the COVID-19 pandemic. The EUA authority allows FDA to authorize unapproved medical products or unapproved uses of previously approved medical products to be used in an emergency. On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there was a public health emergency involving the SARS-CoV-2 virus, which causes the COVID-19 illness. That determination provided the basis for justifying Vol.:(0123456789) Journal of Racial and Ethnic Health Disparities 1/18/2020 Chloroquine phosphate or hydroxychloroquine sulfate Veklury (Remdesivir) 9/9/2020 6/23/2021 11/3/2021 4/25/2022 5/1/2020 4/16/2021 11/9/2020 Baricinib (Olumiant) 11/19/2020 REGEN-COV (Casirivimab and Imdevimab) 11/21/2020 Bamlanivimab and Etesevimab 1/24/2022 1/24/2022 2/9/2021 Sotrovimab 4/5/2022 5/26/2021 Actemra (Tocilizumab) 6/24/2021 Evusheld (Tixagevimab co-packaged with cilgavimab) 12/8/2021 Paxlovid (Nirmatrelvir/Ritonivir) 12/22/2021 Lagevrio (Molnupiravir) 12/23/2021 Bebtelovimab EUA without a revocaon/ terminaon 9/7/2022 6/15/2020 Bamlanivimab EUA with a revocaon/ terminaon 3/23/2022 3/28/2020 2/11/2022 Jan-20 Mar-20 Jun-20 Sep-20 Dec-20 Mar-21 Jun-21 Sep-21 Dec-21 Mar-22 Jun-22 Sep-22 Date Fig. 1  Drugs Authorized under an EUA for COVID-19 the authorization of emergency use of medical products during the COVID-19 pandemic [4]. FDA has since used the EUA authority to authorize numerous vaccines, therapeutic products, and medical devices to combat the COVID-19 pandemic. By analyzing how access to drugs authorized under the EUA authority for COVID-19 has varied across diverse patient populations, our work contributes to the broader, expanding literature on health equity. Previous studies in this area have tended to focus on differences across race and ethnicity using a convenience sample of patients or examining a subset of the drugs authorized for COVID-19 [5, 6]. Our study expands the literature in three ways. First, we use data from the National COVID Cohort Collaborate (N3C), the largest open U.S. database of patient electronic health records representing more than 15 million patients observed between January 2020 and September 2022 [7]. Second, we include in our analysis all drugs ever authorized under an EUA for COVID-19. Third, we seek to identify the presence and size of any possible differences in the use of these drugs for COVID-19 patients across a variety of demographic factors such as race, ethnicity, age, gender, and rural-urban classification, including how these differences changed over time throughout the pandemic. Our findings suggest disparities in EUA use during the COVID-19 pandemic and highlight the need for future research to incorporate a comprehensive set of controls for confounding factors to further understand the causes of the disparities shown. Data and Methodology We first use the FDA’s website to identify drugs authorized for COVID-19 under an EUA as of September 2022. The website maintains lists of drugs with current EUAs and terminated or revoked EUAs [8]. Using these lists, we collect the drug name, the date of first EUA issuance, and the date of termination or revocation of the EUA if applicable. Each drug is listed in Fig. 1 with the date of first EUA issuance and the date of termination or revocation if applicable.1 We use data from the N3C to identify patients who received EUA drugs authorized for COVID-19 [7]. The N3C is the largest collection of COVID-19 data from electronic (...truncated)