Members of Congress request FDA establish toolkit for stopping spread of COVID-19

With the rise of Delta and Omicron variants of COVID-19, some previous interventions have become less effective in preventing spread of the pandemic.

The situation leaves patients who are vulnerable with limited options for treatment.

U.S Reps. A. Donald McEachin of Virginia and Dr. John Joyce of Pennsylvania led a bipartisan group of 12 Congress members in a letter encouraging Food and Drug Administration (FDA) Commissioner Robert M. Califf to ensure the nation has a broad toolkit available to manage variants, according to a press release.

“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 lawmakers wrote last week. “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.”

According to the press release, COVID-19 has had “a disproportionate impact” on racial and ethnic populations. The lawmakers request a more diverse range of therapeutics to help effectively prevent, treat and curb the spread of the virus.

The letter requests the FDA to clarify and consistently apply clinical standards for determining the efficacy of products as emerging variants are identified; clarify how applications for COVID-19 therapeutics are being prioritized for review; consider reducing the need for large safety databases at different doses for therapeutics with well-established safety profiles; and consider how flexibilities developed by the Center for Biologics Evaluation and Research for evaluating COVID-19 vaccines can be applied to the evaluation process for COVID-19 therapeutics at the Center for Drug Evaluation and Research.