Washington, DC Update

Posted 15 June 2022

ASTMH continues to advocate before Congress and the Biden administration. Letters that ASTMH led or joined include:
  • A letter from 100+ organizations urging a robust 302(b) allocation (funding level) for the Labor-HHS-Education Subcommittee to meet the very real research funding needs.

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House Appropriations Committee Releases FY2023 Markup Schedule
House Appropriations Committee Chair Rosa DeLauro (D-CT) announced the start of House Appropriations Committee consideration of these bills.  Subcommittee and full committee markups were expected to begin June 15 and conclude by June 30. Background: Federal government programs are funded through funding legislation called appropriations. Congress funds these programs through 12 funding bills. Each bill must be considered by the House and Senate Appropriations Committees and the full House and Senate; any differences between the House and Senate must be resolved; and finally, the bills go to the President individually or packaged together into one large bill.
COVID-19 Funding Stalemate Pushes White House to Divert Pandemic Response Funds to Vaccine Acquisition 
With COVID-19 funding stalled in Congress, and with no clear path forward in sight, the White House has said that it must cut more than $10 billion from areas of federal COVID-19 response — including testing, new vaccine research and development, and purchasing PPE — in order to be able to procure more vaccines and treatments.  “The administration has to act because Congress won’t,” the White House said in a statement. “These trade-offs we are being forced to make because of Congress will have serious consequences on the development of next-generation vaccines, therapeutics and diagnostics, domestic vaccine production capacity, stockpiling of PPE, and the procurement of tests and testing supplies for federally qualified and community health centers.”
House to Consider Revised ARPA-H Legislation the Week of June 20 to Keep Agency Independent of NIH, Overriding Recent HHS Decision
The House is expected to consider revised legislation the week of June 20 that would designate President Biden’s new biomedical research agency – Advanced Research Project Agency for Health (ARPA-H) – as an independent agency within the Department of Health and Human Services (HHS). The legislation, H.R. 5585, was sponsored by Energy & Commerce Health Subcommittee Chair Anna Eshoo (D-CA) and passed out of the full E&C committee on May 18 following a series of changes, including a requirement that the Senate confirm the ARPA-H director.
If passed, the legislation would override HHS Secretary Xavier Becerra’s announcement to house ARPA-H within the NIH. Eshoo previously criticized the move by Becerra, calling the decision an “opportunity squandered” and arguing that the Secretary had opted for “more of a bureaucratic structure than a transformational one.” Becerra recently appointed Adam Russell, former Chief Scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS), to serve as ARPA-H’s acting deputy director.
The Federal Register notice outlining the operationalization of ARPA-H affirms that the agency’s research activities will address global health concerns. Specifically, ARPA-H’s Health Equity, Dissemination, and Implementation Office will undertake “projects and initiatives to address and lessen health disparities in biomedical and health research within the United States and abroad.” The agency also seeks to advance health equity through its Health Equity, Dissemination, and Implementation Office, which will work “to ensure equity, diversity and inclusion in all aspects of ARPA-H’s work.”
BARDA Releases 2022-2026 Strategic Plan, Includes Objectives to Advance Global Health
The Biomedical Advanced Research and Development Authority (BARDA) released its new Five-Year Strategic Plan. BARDA is the agency that was created to fund advanced development medical countermeasures for biological, chemical, radiological and nuclear threats. Over time, BARDA has grown to include advanced development of Ebola, Zika and COVID-19 drugs and vaccines, as well as research for antimicrobial resistance. For the first time, BARDA’s strategic plan specifically reinforces BARDA’s commitment to addressing emerging infectious disease and developing medical countermeasures (MCMs) in limited and low healthcare-resource settings. 
Highlights include:
  • Establishing a new Emerging Infectious Diseases Division. 
  • Supporting advanced development and approval of therapeutics, including creating an antiviral repurposing program.  
  • Establishing a threat-agnostic program focused on therapeutics that address a broad range of pathogen families. 
  • Investing in vaccine platforms and developing at least one prototype vaccine for each virus family with pandemic potential. 
  • Accelerating emerging technologies that move testing closer to the patient and facilitate testing in limited healthcare resource settings. 
  • Expanding BARDA’s commitment to combating antimicrobial resistance, including seeking FDA approval of at least three novel antibacterials and developing at least one new diagnostic to inform appropriate antibiotic use. 
  • Expanding the Accelerator Network to capture early-stage innovation across the world and in underserved regions to promote pandemic preparedness.
  • Supporting the development and commercialization of alternative delivery technologies that will reduce the need for cold chain distribution and manufacturing of needles and syringes, with the goal of having at least one alternative vaccine delivery product FDA-approved and integrated into a vaccine. 
  • Expanding engagement with international stakeholders to ensure alignment on needs in the emerging infectious disease mission space. 
  • Focusing on developing low-cost, high performance MCMs, such as diagnostics and digital public health guidance tools, that can be used in low-acuity and limited healthcare resource settings, such as health centers and tribal facilities, nursing homes, physician’s offices, temporary testing centers and homes. 
  • Developing proven technologies for detection that address THE needs of rural, frontier, tribal and low-healthcare resourced communities – not just central commercial laboratories and large hospitals. 
  • BARDA Ventures will work with its nonprofit partner to establish a $500 million global health security fund. 
  • Establishing a new 10-year accelerator partnership that brings together new global partners to advance promising antibacterial products. 
Biden Administration Officials Continue to Testify on Capitol Hill Regarding Budget Requests, USAID Hearing Highlight
Over the past few weeks, Biden Administration officials have continued to testify before Congress regarding the FY 2023 budget requests for their agencies. During a hearing before the Senate Appropriations State and Foreign Operations Subcommittee, U.S. Agency for International Development (USAID) Administrator Samantha Power warned that current USAID-supported vaccination campaigns would cease in August without additional funding from Congress. Subcommittee Chair Chris Coons (D-DE) asked Powers about the U.S. International Development Finance Corporation’s role in building vaccine manufacturing capacity in Africa. In response, Powers said that building vaccine manufacturing capacity in Africa remains a priority, beyond COVID-19. Ranking Member Lindsey Graham (R-SC) expressed doubt that the vaccination rate in Africa could be increased and said that, therefore, the focus should pivot to therapeutics delivery. Powers rebutted his claim, asserting that neither therapeutics nor vaccines could be procured without impactful funding from Congress.