By NCL Director of Health Policy Jeanette Contreras

As the United States enters the third wave of COVID-19, low-income and minority communities hit hardest by the virus continue to disproportionately lack access to testing. The pandemic is shining a spotlight on the underlying health disparities that have long persisted within these medically underserved communities. Racial and ethnic minorities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death from COVID-19. This is due largely to the prevalence of chronic conditions such as diabetes, asthma, heart disease, and chronic obstructive pulmonary disease (COPD).

In addition, racial and ethnic minorities make up a significant portion of the low-wage essential workers on farms, in grocery stores and warehouses, and in truck shipping. The essential workforce is composed of  64 percent women and 41.2 percent people of color. This translates to a higher risk of exposure to the virus among minorities because their employment involves interacting with the general public or co-workers in an unsafe environment. According to an August 2020 report from the U.S. Department of Health and Human Services (HHS), Hispanic/Latino persons were the largest demographic living in counties identified as coronavirus hotspots (3.5 million persons), followed by Black/African American persons (2 million).

HHS released a comprehensive strategy to address the lack of access to COVID-19 testing in vulnerable communities, which included expanded testing at federally qualified health centers (FQHCs) and partnerships with retail pharmacies. However, the very social determinants of health that these communities face, such as lack of transportation, child care, and paid sick leave, create significant barriers to getting to a community health clinic or a drive-through testing site. Despite higher demand in minority communities, there are fewer testing sites available to them when compared to access in predominantly white, more affluent areas. Researchers of the COVID Tracking Project found that zip codes with white populations of 75 percent had significantly more testing sites per capita than zip codes that were 75 percent minority.

Though adequate testing is only one of the prongs in confronting the pandemic, followed by contact tracing and isolation, it provides critical data needed to provide resources in the communities hardest hit by this pandemic. The World Health Organization (WHO) recommends conducting around 10–30 tests per confirmed case as a general benchmark–less than 5 percent positivity rate suggests the pandemic is under control. The U.S. currently has a positivity rate of 6 percent, and many states are not testing at a rate needed to contain the spread. Further adding to the disproportionate burden, there is no federal guidance for routine testing of essential workers. To provide adequate testing in low-income and minority communities, we need to address the underlying social determinants of health that place them at greater risk.

By NCL Director of Health Policy Jeanette Contreras

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration (FDA). The FDA is charged with ensuring the safety, efficacy, and security of the drugs, biologic products, and medical devices needed to treat and prevent the spread of COVID-19. The agency has undergone scrutiny from the scientific community for issuing Emergency Use Authorization (EUA) for COVID-19 treatments and diagnostics that appeared to be politically motivated.

On August 23, the FDA issued an EUA for the use of an investigational convalescent plasma to treat patients with COVID-19, touting it as yet another achievement in the Administration’s fight against the pandemic. After just two days of backlash from the scientific community, FDA Commissioner Dr. Stephen Hahn, took to Twitter to concede his mistake, admitting that the criticism was justified. Commissioner Hahn stated that the EUA is not the final FDA approval and that the agency would revoke authorization if needed. Criticism included former FDA Commissioners who stand by randomized clinical trial as the gold standard for evidence-based medicine.

This renowned round of criticism has come not long after the FDA provided EUA for hydroxychloroquine in March which it revoked in July after further review proved that it lacked efficacy.

The Federal Food, Drug, and Cosmetic Act provides the FDA Commissioner with the authority to issue EUAs for unapproved medical products or unapproved uses of medical products in response to a public health emergency, such as the current pandemic. An EUA can be revoked when new evidence emerges and the risk no longer outweighs the benefit of the unapproved use of a drug or product, yet the Trump Administration claimed that it was revoked due to political reasons.

Since February, when the Department of Health and Human Services (HHS) declared the pandemic a public health emergency, the FDA has exercised its authority to issue hundreds of EUAs for diagnostic tests, personal protective equipment, ventilators, and other medical devices to combat COVID-19. In August alone, the FDA revoked EUAs for over 100 diagnostic tests, including antibody and rapid tests. The FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a drug, treatment, or product.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments, testing products, and safety recommendations. After witnessing the media controversy over EUAs for hydroxychloroquine and convalescent plasma, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs for political gain. The FDA, now more than ever, needs to reestablish public trust as it proceeds to fast track the approval of a COVID-19 vaccine.