The FDA launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative in 2020 to strengthen our response to the COVID-19 pandemic and improve our resiliency for future public health emergencies. To help achieve these goals, we asked an independent, non-government organization to conduct an objective review of the FDA’s pandemic response, inventory our accomplishments and activities, and identify future opportunities for consideration. The independent organization interviewed FDA leadership, conducted listening sessions with external stakeholder groups, and collaborated with subject matter experts on the FDA staff to produce the summary report.

"We have a responsibility to learn from our actions to focus on what we can—and must—do better for the future. Our experience so far has taught us that transparency and continuous improvement are the essential drivers of a successful response."

- Commissioner of Food and Drugs Stephen M. Hahn, M.D.

- Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D.

U.S. Food and Drug Administration

January 13, 2021

As part of our commitment to openness and transparency, we are making this report public. The report consists of an Executive Summary and detailed Technical Report summarizing the FDA’s progress and potential actions to consider going forward. While the report is not a to-do list, the FDA will carefully review the recommendations while taking into account our current statutory authorities and available resources.

Our response to the COVID-19 pandemic is constantly evolving. Our workforce remains deeply involved and committed to the pandemic response. We will evaluate the ideas in the PREPP Initiative summary report, along with other considerations, to continue adapting our approach to the COVID-19 response and to build future resilience.