USA – PREPP initiative: FDA’s COVID-19 response and the path forward

The US Food and Drug Administration (FDA) has adapted in its response to the COVID-19 pandemic, from increasing transparency of its risk-benefit analyses for emergency use authorizations (EUAs) to providing guidance on vaccine development, according to a summary report of the agency’s COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.

The report catalogues the agency’s work during the pandemic, noting that it has published and revised more than 65 industry guidance documents related to COVID-19, reviewed more than 2,300 EUA requests and issued over 600 EUAs, and reviewed and conducted inspection activities related to nearly 400 therapeutic candidates.

The report, which was prepared by an external third party with input from FDA staff and stakeholder groups, also provides several recommendations for how to continue or expand the current regulatory flexibility beyond the public health emergency.

But the report’s recommendations are not a “to-do” list, FDA Commissioner Stephen M. Hahn, MD, and FDA deputy commissioner for medical and scientific affairs Anand Shah, MD, said in a statement.

“The agency will need to carefully consider the relevance and implementation feasibility associated with the ideas as it decides the appropriate courses of action in the continually evolving COVID-19 response and recovery,” they wrote