December 07, 2020

Health Law Daily Quotes Claudia Lewis on Key Developments from the FDA in 2020

2 min

On December 7, 2020, Claudia Lewis was quoted in Health Law Daily on key developments from the Food and Drug Administration (FDA) in 2020, including new drug regulations, nutrition label innovations, and the ongoing impact of COVID-19.

According to the article, the FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Board (VRBPAC) will meet in open session to discuss Emergency Use Authorizations (EUAs) for a number of COVID-19 vaccines. Pharmaceutical companies announced in November 2020 that preliminary results for their mRNA-based vaccines were over 90 percent effective at preventing COVID-19. Although the VRBPAC members provide advice to the agency, which may relate to the safety and effectiveness data submitted in the EUA request, the FDA makes the final decision on whether to authorize the vaccine for emergency use.

Beyond the logistics of producing enough doses of each vaccine is the concern over the public’s willingness to accept any new vaccine. Lewis states that more communication about the FDA’s evaluation process would be helpful. Lewis noted that the FDA and CDC have in place a comprehensive new vaccine approval process that generally mirrors that of new drug development. Lewis cautioned that while it is true that the FDA has “developed guidance and an EUA for vaccines that relax certain regulatory requirements, it is important to understand that the EUA is not a total removal of requirements.” Any COVID-19 EUA will still require a great deal of safety and efficacy evidence, including safety and efficacy results from a full-scale Phase 3 clinical trial.

Lewis further noted that because the vaccine developers are seeking FDA authorization under the agency’s EUA process instead of a traditional biologics license approval pathway, the FDA and Center for Disease Control and Prevention (CDC) should continue transparent messaging to explain the EUA process to the public.