Bipartisan dozen in Congress urge FDA to pursue broad array of therapeutics for COVID-19 variants

In a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D. last month, 12 members of Congress pressed the regulator to guarantee a variety of therapeutics to ready the nation for further COVID-19 variants.

“We urge the FDA to ensure that the availability of multiple therapeutic (prevention and treatment) options for patients keeps pace with the emergency of COVID-19 variants,” the representatives wrote. “Hospitals are still seeing a high number of COVID-19 cases, and many communities are experiencing medium and high community levels of COVID-19. Due to the unpredictable nature of future variants, a diverse portfolio of products for both prevention and treatment against a wide range of variants is needed.”

Over the months and years since COVID-19 first broke out, variants such as Delta and Omicron, as well as subvariants, have posed renewed surges of cases and concerns for patient health and existing therapeutics’ capabilities. Indeed, some of the latter have been rendered less effective by these arrivals, limiting treatment in times of crisis. Worse, government reports have made it clear that COVID-19 disproportionately hit racial and ethnic minority populations – something a more diverse range of therapeutics might help stop.

In a report sponsored by the activist organization Black Coalition Against COVID and numerous medical and other associations earlier this year, even as case rates began to fall across the United States, the hospitalization rate for Black Americans held at more than double the overall rate: 65 per 100,000.

“Maintaining a library of multiple antibody therapies that can prevent and treat COVID-19 will increase the nation’s ability to respond quickly to new variants and prevent increases in hospitalizations and deaths,” the lawmakers wrote. “Our concern is that new variants are becoming dominant faster than current FDA emergency use authorization (EUA) processes and product deployment.”

To rectify this, they asked that the FDA define and apply clinical standards for determining the efficacy of products for use on new variants, explain how applications for COVID-19 therapeutics are being prioritized for review, and potentially reduce the need for large safety databases at different doses for therapeutics that have already been established safe and consider how flexibilities developed by the Center for Biologics Evaluation and Research for vaccines could be retooled for use on the evaluation process for COVID-19 therapeutics in turn.

Signatories to the letter included U.S. Reps. Jake Auchincloss (D-MA), Dr. Neal Dunn (R-FL), Tom O’Halleran (D-AZ), Larry Bucshon. (R-IN), Derek Kilmer (D-WA), Michael Burgess (R-TX), Kim Schrier (D-WA), Brett Guthrie (R-KY), Andrew Garbarino (R-NY), H. Morgan Griffith (R-VA), Mariannette Miller-Meeks (R-IA), and Fred Upton (R-MI).