Washington, DC Update

Posted 14 August 2023

ASTMH continues to advocate before Congress and the Biden administration. Letters that ASTMH led or joined include:
  • Letter urging the Bureau of Consular Affairs at the Department of State to expedite B1 visa processing for applicants seeking to attend the ASTMH 2023 Annual Meeting.
  • Letter to House appropriations leadership expressing concern over proposed steep cuts to the State and Foreign Operations and Related Programs (SFOPS) budget and urging for robust funding for global health and humanitarian assistance programs within the International Affairs (150) account.

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FY24 Appropriations Process Continues
With Congressional members adjourned for the August recess, Congress must pass all 12 fiscal year (FY) 2024 appropriations (funding) bills by September 30 or approve a continuing resolution (CR) to extend spending negotiations—or else risk a government shutdown. The Senate Committee on Appropriations recently approved the FY24 Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill and accompanying report, as well as the State, Foreign Operations, and Related Programs (SFOPs) appropriations bill, accompanying report and amendments. The LHHS and SFOPS spending bills help fund global health R&D programs across the federal government, including programs at CDC, NIH and USAID. Similarly, the House released its LHHS bill (no report published yet) and SFOPS bill/report. Generally speaking, the Senate bills passed on a bipartisan basis are mostly aligned with President Biden’s budget request and reflect promises made in the debt ceiling deal, whereas the House bills passed on a partisan basis and seek to dramatically reduce spending below the debt ceiling. Below are initial funding levels proposed in the Senate and House SFOPS and LLHS bill. Please remember that these numbers are not final and ultimately reflect partisan, inter-caucus and chamber-specific priorities and disagreements.
 
Proposed Funding for Senate and House FY24 SFOPS and LHHS Bills
$ proposed funding in billions or millions (rounded)
“S” = Senate ; “H”= House ; “FY23” = FY23 Enacted Levels
  • NIH:  
    • S: $49.2b; H: $45.2b; FY23: $47.5b
  • NIAID:
    • S: $6.6b; H: $5.1b; FY23: $6.6b
  • Fogarty International Center:
    • S: $95.2m; H: $95.2m; FY23: $95.2m
  • CDC:
    • S: $9.2b; H: $7.6b; FY23: $9.2b
  • Center for Global Health:
    • S: $692.8m; H: $370.8m; FY23: $692.9m
  • National Center for Emerging and Zoonotic Infectious Diseases (NCEZID):
    • S: $750.8m; H: TBD; FY23: $750.8m
  • USAID:
    • S: $4.2b; H: $3.6b; FY23: $4.2b
  • Malaria Program:
    • S: $795m; H: $800m; FY23: $795m
  • Neglected Tropical Diseases Program:
    • S: $114.5m; H: 114.5m; FY23: 114.5m
NIH Announces New NIAID Director, Jeanne Marrazzo, MD  
NIH Acting Director Lawrence Tabak recently announced Dr. Jeanne Marrazzo as the new Director of NIAID, succeeding longtime director Dr. Anthony Fauci. Marrazzo is expected to assume her post in the early fall and will take over from Acting Director Dr. Hugh Auchincloss Jr. As Director of NAID, the second largest center at NIH, Dr. Marrazzo will oversee a budget of $6.3 billion. “Dr. Marrazzo brings a wealth of leadership experience from leading international clinical trials and translational research, managing a complex organizational budget that includes research funding and mentoring trainees in all stages of professional development,” Dr. Lawrence Tabak said in a statement. Currently, Dr. Marrazzo is the director of the Division of Infectious Diseases at the University of Alabama at Birmingham.
 
Biden Administration Launches New Pandemic Office, Taps Director, Maj. Gen. (ret.) Paul Friedrichs as Director
The White House recently launched the Office of Pandemic Preparedness and Response Policy (OPPR), a new office charged with “leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the United States.” OPPR will assume the responsibilities currently carried out by the COVID-19 Response Team and Mpox Team at the White House. Retired Maj. Gen. Paul Friedrichs will serve as the inaugural director of OPPR. Last month, Dr. Friedrichs joined the National Security Council as the senior health director for global health security and biodefense. He previously served as Joint Staff Surgeon at the Pentagon and the medical advisor to the Department of Defense (DoD) COVID-19 Task Force. As the new director of OPPR, Dr. Friedrich will oversee domestic biosecurity preparedness, help develop the next-generation of vaccines and ensure adequate supplies in the Strategic National Stockpile, among other important responsibilities.
 
Deputy U.S. Global Malaria Coordinator Rick Steketee, MD, MPH, FASTMH, Retires
After more than 40 years of service to the global malaria community, longstanding ASTMH member Dr. Rick Steketee has announced he will retire from the President’s Malaria Initiative (PMI) at the end of August. As Deputy Global Malaria Coordinator for the past five years, Dr. Steketee was instrumental to helping maintain malaria services during the COVID-19 pandemic, advancing the impact of the new malaria vaccine and developing PMI’s Strategy 2021-2026: End Malaria Faster. His efforts have helped save an estimated 11.7 million lives and prevent more than 2 billion malaria cases since 2000. More information on his many contributions to malaria eradication can be found here.

State Department Launches New Global Health Bureau, Ambassador Dr. Nkengasong to Lead  
The U.S. State Department recently launched the Bureau of Global Heath Security and Diplomacy (GHSD). The new bureau will lead and coordinate the Department’s work on strengthening global health security to prevent, detect and respond to infectious diseases. The new bureau will also lead and coordinate the President’s Emergency Plan for AIDS Relief (PEPFAR) and will be led by Dr. John Nkengasong, who currently serves as the U.S. U.S. Global AIDS Coordinator and will deliver the opening keynote at the Annual Meeting in Chicago on October 18. In a statement, Secretary of State Antony Blinken said GHSD will “seamlessly integrate global health security as a core component of U.S. national security and foreign policy, underscoring the Department of State’s commitment to advancing human health worldwide.”

HHS Formally Halts Funding to Wuhan Institute of Virology 
The Department of Health and Human Services recently suspended federal funding to the Wuhan Institute of Virology (WIV) and proposed a possible long-term federal funding ban, finding that WIV “lacks the present responsibility to participate in United States Federal Government procurement and non-procurement programs.” The move follows a monthlong review by the Biden Administration due to WIV’s repeated failure to provide requested documentation regarding the lab’s biosafety protocols and security measures to NIH. According to the memo, HHS stated “immediate action is necessary to protect the public interest.” The memo cites nearly 30 different examples of how WIV failed to comply with NIH’s requests for information and states that the agency’s conclusion that WIV research likely violated biosafety protocols of the NIH is “undisputed.” The WIV has 30 days to respond to the notice.
 
HHS Seeks Public Comment on Scientific Integrity Policy
The Department of Health and Human Services recently issued a request for public comment on its draft Scientific Integrity Policy. The draft policy includes provisions related to preventing political interference, ensuring independent review of scientific activities, facilitating the free flow of scientific information, barring suppression or delay of scientific findings for non-scientific reasons, forbidding censorship or alteration of scientific findings and protecting against retaliation. Comments are due by September 1.  
 
PAHPA Reauthorization Advances Toward Reauthorization
Lawmakers have recently made crucial progress on the fourth reauthorization of the must-pass Pandemic and All-Hazards Preparedness Act (PAHPA), set to expire September 30. PAHPA is the legislation that determines the operations of the Biomedical Advanced Research and Development Authority, which funded and developed with industry partners many of the tools used to fight COVID-19, Zika and Ebola. On the Senate side, the Senate Health, Education, Labor & Pensions (HELP) Committee voted 17-3 to advance the chamber’s version of the bill out of committee. The bill reauthorizes the FDA’s medical countermeasures (MCM) priority review voucher (PRV) program until 2028 in exchange for a new study that delinks R&D incentives from the price of drugs. The bill also expressly directs BARDA to develop innovative medical countermeasures to protect against pathogens with pandemic potential. The committee also approved two amendments. The first amendment, proposed by Sen. John Hickenlooper (D-CO), would establish an emerging pathogen preparedness program at the FDA. The second, proposed by Sens. Ted Budd (R-NC) and Maggie Hassan (D-NH), would help strengthen the Strategic National Stockpile.
 
In the House, the Energy & Commerce (E&C) Committee recently voted 28-23 to advance PAHPA along partisan lines, undermining the historic bipartisan tradition of the reauthorization. Committee disagreements have centered around how drug shortages would be addressed via PAHPA, leading E&C Democrats to introduce their own version of PAHPA right before the July 19 markup. Despite E&C Democrats’ requests, FDA-related provisions were ultimately left out of the bill, as well as several other Democratic priorities, such as provisions to strengthen the CDC and increased funding for preparedness programs like the Strategic National Stockpile. Both chambers’ bills still must be reconciled into a single, final bill for passage by the House and the Senate. With August recess and the September 30 deadline rapidly approaching, expect PAHPA to be a top legislative priority once Congress returns.
 
End TB Now Passes Out of House Committee
The End TB Now Act of 2023 (H.R.1776) recently passed out of the House Foreign Affairs Committee by a unanimous bipartisan vote. The bill will help strengthen U.S. and international TB response and further scale up prevention, diagnosis, treatment and control efforts of TB. The House bill needs support in order to brought to the floor for full consideration. In the Senate, the companion bill was filed as an amendment to the FY24 National Defense Authorization Act (NDAA), but ultimately was not included in the final bill.
 
House Republicans Introduce Bill to Dismantle USAID; Unlikely to Gain Traction But…  
Representatives Matt Gaetz (R-FL), Andy Biggs (R-AZ), Eli Crane (R-AZ), Paul Gosar (R-AZ), Marjorie Taylor Greene (R-GA) and Anna Paulina Luna (R-FL) recently introduced a bill (H.R.5108) that would abolish USAID. While the bill has no political feasibility, given strong bipartisan support for the agency, it does signal a growing desire by far-right members of the House GOP to attack federal public and global health-related programs.

Senate HELP Committee Holds Hearings on Antimicrobial Resistance
In July, the Senate HELP Committee held a hearing titled Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine. Hearing witnesses included  Michael Apley, Professor at Kansas State University; Dr. Helen Boucher, Dean and Professor at Tufts University School of Medicine; Melanie Lawrence, healthcare advocate; and Christine Miller, President and CEO at Melinta Therapeutics. Committee members and witnesses broadly emphasized the growing threat of antimicrobial resistance (AMR) on global health and the importance of increased development of antibiotics to address superbugs. Specifically, both committee members and witnesses highlighted the impact of public-private partnerships in developing new antimicrobials, including BARDA’s Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). Throughout the hearing and leading up to the hearing, committee members voiced strong support for advancing the bipartisan and bicameral Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act.
 
E&C Asks GAO to Assess Gain-of-Function Research
House Energy and Commerce Committee (E&C) Republicans sent a letter to the Government Accountability Office (GAO) Comptroller General Gene Dodaro requesting an examination of the risks and benefits of gain-of-function research involving pathogens with pandemic potential. The letter also asks the GAO to gather more information on how agencies are defining “gain-of-function” research across the federal government. The letter seeks to build on the committee’s ongoing investigation efforts of “high-risk” research. The committee has repeatedly called on the Biden Administration to declassify information related to the origins of the pandemic and the U.S. government’s role in funding “risky virus research,” including at the Wuhan Institute of Virology.

E&C Investigates Administration’s Biosafety Practices and NIH Reappointments
House Energy and Commerce Committee Republicans continue to press the Biden Administration on its biosafety practices. In June, E&C Republican leaders sent a letter to NIH Acting Director Dr. Lawrence Tabak inquiring how biosafety practices are implemented and prioritized at NIH laboratories. Additionally, House E&C Republicans concluded their investigation of leadership vacancies at the NIH, which initially began in March 2022. In a letter to HHS Secretary Xavier Becerra, E&C Republicans argue that the secretary failed to lawfully reappoint 14 NIH Institute and Center (IC) Directors— including former National Institutes of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci—violating the 21st Century Cures Act and calling into question the legality of billions of dollars in taxpayer funding to the agency. Committee Ranking Member Frank Pallone, Jr. (D-NJ) has publicly rebuked the findings of the investigation, calling the assertions unfounded and based on flawed legal analysis.
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