March 05, 2021

Health Law Daily Quotes Claudia Lewis on the FDA’s Emergency Use Authorization Process

2 min

On March 5, 2021, Claudia Lewis was quoted in Health Law Daily on the Food and Drug Administration’s (FDA) authority over vaccines in the United States, from development to approval, and how its oversight authority has been affected by the use of emergency use authorizations (EUAs) during the COVID-19 pandemic.

According to the article, the FDA’s emergency use authorization is an obscure, expedited approval pathway that facilitates the availability and use of medical countermeasures, including vaccines, during a public health emergency. Lewis commented that "EUAs have been issued for specific products, such as individual drugs, tests, or other therapeutic products, seemingly on case-by-case bases." However, she noted that "the unprecedented scope of the COVID-19 pandemic has led the agency to issue both product-specific EUAs (such as the ones covering the current set of COVID-19 vaccines and drugs) and ‘umbrella’ EUAs for various types of medical products, such as face masks and other PPE."

Lewis added that she expected once the COVID-19 pandemic has substantially passed, the FDA will begin "moderating EUAs and shift to regulating any covered products under its ordinary regulations." For instance, the FDA may determine some EUAs are no longer needed and "will consult with companies distributing products under a revoked EUA to evaluate product disposal options."

Lewis further noted that within the medical device context, there has been increased "scrutiny over counterfeit products entering the PPE supply chain," resulting in the FDA warning numerous firms against issuing "registration certificates," which imply that the agency has reviewed or approved a product. Lewis said that it was not hard to imagine counterfeit issues occurring under drugs and biologics EUAs and that "agency messaging is key in making clear that counterfeiting drugs or vaccines is highly unlikely given the agency’s strict requirements under its EUA authority."