The Honorable Shalanda D. Young
Director, Office of Management and Budget
United States Office of Management and Budget
725 17th Street, NW
Washington, DC 20503
RE: Inclusion of Funding for FDA’s Emerging Pathogens Preparedness Program in FY 2025 Budget of the United States Government
Dear Director Young,
With the specter of the COVID-19 pandemic’s worst months only recently passed and the threat of novel future epidemics increasing,¹ we write to you to request your inclusion of the FDA’s proposed Emerging Pathogens Preparedness Program in President Biden’s FY 2025 budget. This letter reflects our recommendations sent to Secretary Becerra in September in the form of a letter of support co-signed by 14 organizations, included as an addendum here.
Located within the FDA’s Center for Biologics Evaluation and Research (CBER), the Emerging Pathogens Preparedness Program would provide a crucial expansion of CBER’s regulatory capacity to support agencies and sponsors developing medical countermeasures (MCMs) during the interpandemic period and provide rapid product review once a biothreat is identified.
At present, no FDA center has a team of reviewers dedicated to MCM development, as was made apparent during the COVID-19 pandemic. The unprecedented number of Emergency Use Authorization requests during this period put immense pressure on FDA infrastructure and staff, leading to reviewer burnout and a backlog of other crucial medical products – demonstrating a clear need for additional FDA resources to sustainably execute its mandate to protect the nation from emerging threats. Funding the Emerging Pathogens Preparedness Program would address this need by providing a hub for building pandemic-specific regulatory expertise across the products for which CBER is responsible. The program could also be key to the success of the Biden-Harris Administration’s Project NextGen by accelerating the review of its vaccines on a timeline similar to the original COVID-19 vaccines.
Regulatory preparedness is not only essential from a public health perspective but also enormously valuable from a fiscal one: an International Monetary Fund working paper has calculated that the COVID-19 vaccine development campaign would have been paid for itself if it shortened the pandemic by merely 12 hours.² Thus, almost any reduction in a pandemic’s duration will render biosecurity investment retrospectively inexpensive. The Emerging Pathogens Preparedness Program, in particular, would be remarkably cost-effective, as we estimate a $15 million funding level would alone be sufficient to increase review efforts within CBER to address “known and unknown biological threats or pathogens”³ and align with the priorities the Biden-Harris Administration has laid out for the White House’s Office of Pandemic Preparedness and Response Policy.
On the eve of the first COVID-19 vaccines’ three-year anniversary, we must draw on the remarkable feats of science and governance that led to those lifesaving doses to ensure our future security. Investing in increased FDA readiness through the Emerging Pathogens Preparedness Program would be a cost-effective means of developing the capacity and resources necessary to be better prepared for the next pandemic, and we therefore express our strong support for the funding of this program in the FY 2025 budget.
The Honorable Patty Murray, Chair, Senate Committee on Appropriations
The Honorable Susan Collins, Ranking Member, Senate Committee on Appropriations
The Honorable Kay Granger, Chair, House Committee on Appropriations
The Honorable Rosa DeLauro, Ranking Member, House Committee on Appropriations
1. Marani, M., et al. (2021). Intensity and frequency of extreme novel epidemics. PNAS, 118(35).
2. Baker, J., Chaudhuri, A., & Kremer, M. (2021). Accelerating Vaccinations. Finance & Development, 58(1).
3. The White House (2023). FACT SHEET: White House Launches Office of Pandemic Preparedness and Response Policy.