Washington, DC Update

Posted 12 September 2022

ASTMH continues to advocate before Congress and the Biden administration. Letters that ASTMH led or joined include:
  • A letter urging Congressional leadership to meet the September 30 FY23 appropriations deadline
  • A letter urging President Biden to use all resources necessary to address the monkeypox virus (MPV) outbreak in the U.S.
  • A letter urging Congressional leadership to pass the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act)
  • A letter urging the Senate Committee on Commerce, Science and Transportation to promptly consider Dr. Arati Prabhakar for Director of the White House Office of Science and Technology Policy (OSTP)

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Draft Senate FY23 Spending Bills Signal Overall Increase for Global Health R&D Compared to FY22
The Senate Appropriations Committee released all 12 draft spending bills for fiscal year 2023 (FY23) and accompanying explanatory text that directs federal agencies on how funding should be used. This includes the State, Foreign Operations, and Related Programs (SFOPS for USAID and PMI) and Labor, Health and Human Services, Education, and Related Agencies (LHHS for NIH and CDC) spending bills.  The proposed Senate funding for these programs is lower than the current House package but the spending levels are still, generally, above fiscal year 2022 (FY22) amounts.
Remember: these bills are not yet final and currently only reflect Democratic policy priorities. Below are several highlights from the FY23 Senate SFOPs and LHHS bills:
Proposed Funding for Senate FY23 SFOPs and LHHS Bills
+proposed funding increase in billions or millions/percent increase compared to final FY22 Senate Budget (rounded)
  • NIH: : +3b/7%
    • NIAID: +127m/2%
    • Fogarty International Center: +2.7m/3%
  • CDC:  +2b/24%
    • Center for Global Health: +114m/18%
    •  National Center for Emerging and Zoonotic Infectious Diseases (NCEZID): +100.5m/15%
  • USAID:  +259.5m/7%
    • Malaria Program: +25m/3%
    • NTD Program: +7m/6%
FY23 Appropriations Stall, Setting the Stage for Stopgap Bill to Keep Federal Government Open
So far, the House has only passed six of the 12 annual appropriations bills. No vote has been scheduled on the six outstanding bills, including the LHHS and SFOPs bills that impact global health R&D programs at USAID, NIH and CDC. Unlike the House, the Senate has not even held committee votes on the proposed appropriations bills. Senate Appropriations Committee Chair Patrick Leahy (D-VT) elected to forego committee markups (the legislative process that allows a bill to be debated and amended before being brought to the full Senate floor for approval) for the draft spending bills due to disagreements with Senate Republicans over top-line spending levels.
Given these circumstances, it is almost certain that Congress will not be able reach an agreement on a FY23 spending package by the September 30 deadline. As a result, House and Senate leadership are currently exploring a short-term funding bill— known as a continuing resolution (CR) — to keep the federal government open through December 16. This means that the FY23 spending bills are likely to not be finalized for another few months.
The Senate Commerce Committee Votes to Advance Next OSTP Director
The Senate Committee on Commerce, Science, and Transportation voted to advance the confirmation of Dr. Arati Prabhakar to be the Director of the White House Office of Science and Technology Policy (OSTP). “Dr. Prabhakar is supremely qualified, having previously served as Director for both NIST and DARPA. Her proven leadership and accomplishments at these agencies will be of great service to the OSTP,” said Committee Chairwoman Maria Cantwell (D-WA). Prabhakar’s nomination received widespread support and is currently before the full Senate.
House Passes NDAA, Includes Global Health Security Amendment
The House approved the 2023 National Defense Authorization Act (NDAA) — the annual
“must pass” bill that authorizes defense spending — in a 329-101 vote. The final $840 billion bill included an amendment by Rep. Gerald Connolly’s (D-VA) that would bolster federal investment in global health security. It is important to note that this provision may be removed in final NDAA negotiations between the House and Senate.
New U.S. Global Malaria Coordinator Appointed
Dr. David Walton was appointed by President Biden as the new U.S, Global Malaria Coordinator of the President’s Malaria Initiative. Dr. Walton has over 20 years of experience working in global health and a strong track record of fighting disease outbreaks around the world, including the 2010 cholera outbreak in Haiti and the 2014 Ebola outbreak in in Sierra Leone. ASTMH looks forward to welcoming Dr. Walton to the Annual Meeting in Seattle.
Dr. Fauci to Retire from Government After Decades-Long Career in Public Health
Dr. Anthony Fauci, Director, NIAID and Chief Medical Advisor to President Biden, announced that he will be stepping down this December. Dr. Fauci intends to use his experience to “continue to advance science and public health” and “inspire and mentor the next generation of scientific leaders.”
White House Hosts Summit on the Future of COVID-19 Vaccines
Federal health officials, scientists and vaccine manufactures convened at the White House to discuss a new generation of vaccines to protect against coronavirus and related variants. During the summit, NIAID Director Fauci voiced his support for “two pillars” of the next generation of vaccines: the development of a pan-coronavirus vaccine to help curb the proliferation of variants and a nasal vaccine that can be inhaled instead of injected. Other notable government officials in attendance included Dr. Ashish Jha, White House COVID-19 Response Coordinator; Alondra Nelson, Acting Director of OSTP; and David Kessler, Chief Science Officer of COVID Response. 
Federal Agencies Leverage Whole-of-Government Response to Monkeypox Outbreak in U.S.
As the U.S. leads the world in confirmed monkeypox virus (MPV) cases, HHS Secretary Xavier Becerra declared the monkeypox virus (MPV) a Public Health Emergency in the United States.  The rare designation followed President Biden’s naming of Robert Fenton to serve as White House National Monkeypox Response Coordinator and Dr. Demetre Daskalakis as his deputy. The pair will lead the Administration’s strategy and operations to combat the current monkeypox outbreak, including equitably increasing the availability of tests, vaccinations and treatments.
Researchers at NIH are finalizing a study that aims to expand the nation’s supply of the Jynneos vaccine — the only FDA-approved vaccine to help prevent MPV. Known as “fractional dosing” or “dose sparing,” the plan would test if splitting a one-dose vial of Jynneos into five doses would provide adequate protection against the virus. The FDA is also reviewing a similar vaccine approach that could lead to a fivefold increase in the U.S. supply of Jynneos.
OSTP released of a new set of research priorities that aim to address key questions, objectives and investigations to help inform U.S. monkeypox outbreak response. The new research focus came on the heels of a joint-letter signed by 21 countries, including the United States, and a group of Chief Scientific Advisors of the European Commission calling for the scholarly publishing community to provide immediate access to research that has the potential to accelerate the global monkeypox response.
CDC Launches Major Restructuring  
CDC Director Dr. Rochelle Walensky announced that the public health agency will undergo a series of massive structural and cultural changes. The restructuring follows the results of two performance reviews of the agency conducted in response to the COVID-19 pandemic, as well as the emergence of the monkeypox virus outbreak in the United States. Director Walensky stated that the CDC must refocus itself on public health needs, respond much faster to emergencies and outbreaks of disease, and provide information in a way that ordinary people and state and local health authorities can understand and put to use.
Changes will include, but are not limited to, a new executive council that will help guide budget decisions with a “bias toward public health impact,” a new equity office, improved public communications and streamlined public health guidance, altering employee reward systems to better align with “public health action,” and measures to accelerate the publishing of data and other key scientific findings. Dr. Walensky also plans to seek additional authority for the CDC from Congress and the Biden Administration to improve data collection, staffing and resource distribution during public health emergencies. 
Biden Administration Reorganizes HHS to Boost Pandemic Preparedness 
The Biden Administration intends to make the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS its own operating division. Under the reorganization, ASPR will become a peer institution to other independent HHS divisions, namely the CDC and FDA. “This change allows ASPR to mobilize a coordinated national response more quickly and stably during future disasters and emergencies while equipping us with greater hiring and contracting capabilities,” ASPR Assistant Secretary Dawn O’Connell wrote in an internal memo. The reorganization is expected to be phased in over the next two years. Critics of the reorganization warn that the change could undercut CDC response efforts, but the public health agency has publicly backed the new plan calling ASPR a critical partner in addressing public health threats.
White House Releases Inaugural Pandemic Preparedness Report
The Biden Administration recently released its first progress report on the implementation of the American Pandemic Preparedness Plan (AP3). The 32-page report highlights the need for sustained federal investment in vaccines, therapeutics, and other diagnostic tools beyond COVID-19, warning that there is a high likelihood of future pandemics. The report also calls for strong top-down leadership with clear decision-making authority.
White House Pushes for Open-Access to Federally Funded Research by 2025
The Office of Science and Technology Policy  instructed federal agencies to make any taxpayer-funded research immediately available to the public without an embargo or cost. The new requirement takes effect by the end of 2025 and eliminates an existing rule that permits an optional 12-month paywall before releasing government-funded research. The new guidance aligns with President Biden’s long-time support of open access for federally-funded research to accelerate scientific discovery. The publishing industry was quick to respond,  citing concerns that the major policy shift could upend business models of scientific journals. 
President Biden Taps Dr. Renee Wegrzyn to Lead ARPA-H
President Biden recently appointed Dr. Renee Wegrzyn to serve as the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H), a new biomedical research agency created by the president in March 2022 to accelerate health and biomedical breakthroughs. Dr. Wegrzyn previously worked at the Defense Advanced Research Projects Agency (DARPA) and Intelligence Advanced Research Projects Activity (IARPA), two institutions that originally inspired the creation of ARPA-H. “ARPA-H will create the transformative and collaborative space that is required to support the next generation of moonshots for health,” Dr. Wegrzyn said.