NIH Base Budget Increases by More Than $2 Billion; ARPA-H is Formally Established

President Joe Biden signed a fiscal year (FY) 2022 omnibus appropriations bill into law in March 2022 that includes full-year funding for all federal departments and agencies. Enactment of the bipartisan funding bill ended a drawn-out process that required four short-term funding bills, known as continuing resolutions (CRs), to keep the federal government open once the new fiscal year began on October 1, 2021.

The law appropriates $45 billion, an increase of $2.25 billion (5.3%), for the NIH base budget, and includes an increase of at least 3.4% for all NIH Institutes and Centers. As always, some of the new funding is set aside for specific purposes; for FY 2022, these include:

• a $289 million increase for research on Alzheimer’s disease and related dementias (for a total of $3.5 billion);
• a $104 million increase for research on HIV/AIDS (for a total of $3.2 billion);
• a $30 million increase for the Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative (for a total of $43.4 million);
• a $25 million increase for the development of a universal influenza vaccine (for a total of $245 million);
• a $15 million increase for research to combat antimicrobial resistance (for a total of $540 million); and,
• a $13.4 million increase for the Institutional Development Awards (IDeA) program (for a total of $410.5 million).

The new law also includes $1 billion (available for three years) to create President Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H). This falls well short of the president’s $6.5 billion request for the new agency, and below both the amount approved by the House in August ($3 billion) and the amount included in the Senate Labor, Health and Human Services, Education, and Related Agencies draft spending bill for FY 2022 in October ($2.4 billion). Shortly after the bill’s passage, Secretary of Health and Human Services (HHS) Xavier Becerra, J.D., officially transferred ARPA-H to NIH, a power given to him by the new law. Though the new agency will operate independently, the new ARPA-H Director, once appointed and confirmed, will report directly to Becerra. On May 25, Becerra announced ARPA-H’s formal establishment and named Adam H. Russell, D.Phil., the Acting Deputy Director. Dr. Russell is an anthropologist by training and worked as a Program Manager for both the Defense Advanced Research Projects Agency (DARPA), after which ARPA-H is modeled, and the Intelligence Advanced Research Projects Agency (IARPA).

CPA Chair Jensen Issues Statement

President Biden released his budget request for FY 2023 in late March. The president’s budget is an important statement of priorities that Congress takes into consideration when developing its own budget and appropriations bills. For FY 2023, the president recommends an extremely modest increase in the regular NIH budget of just $275 million (0.6%), less than the projected rate of biomedical research inflation (2.6%). This small proposed increase resulted in part from the fact that final appropriations bills for FY 2022 had not been enacted at the time that the budget was drafted; his request represented a 5.6% increase over the FY 2021 funding level used as the baseline at the time. Based on budget documents released by the Administration, this proposal would result in cuts to many NIH Institutes and Centers, including the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), and the National Institute on Aging (NIA).

While the budget includes a very small increase for core operations at NIH, it provides a sizeable increase for ARPA-H, increasing its funding from $1 billion to $5 billion. The president’s budget also includes a new proposal intended to prepare the nation for future pandemics and high consequence biological threats, allocating $81.7 billion (available for five years) in new mandatory funding (not subject to the annual appropriations process) to HHS to support these important goals. The funding is divided as follows (note: summaries of how dollars would be spent are from the FY 2023 HHS Budget-in-Brief):

• $40 billion for the Assistant Secretary of Preparedness and Response (ASPR) “to conduct advanced research and development of vaccines, therapeutics, and diagnostics for high priority viral families; scale up domestic manufacturing capacity for medical countermeasures; and expand the public health workforce.”
• $28 billion for the Centers for Disease Control and Prevention (CDC) “to invest in the public health system infrastructure, support international capabilities for vaccine preparedness and medical countermeasure development, enhance domestic and global disease surveillance, expand laboratory capacity, further develop a robust public health workforce, and strengthen public health data systems.”
• $12.1 billion for NIH for “research and development of vaccines, diagnostics, and therapeutics against high priority viral families, biosafety and biosecurity, and to expand laboratory capacity and clinical trial infrastructure.”
• $1.6 billion for Food and Drug Administration (FDA) “to expand and modernize regulatory capacity, information technology, and laboratory infrastructure to respond rapidly and effectively to any future pandemic or high consequence biological threat.”

The budget also allocates additional mandatory funding for pandemic preparedness activities to the U.S. Department of State and the U.S. Agency for International Development (USAID), as follows:

• $6.5 billion for the State Department and USAID “to make transformative investments in global health security and pandemic and other biological threat preparedness in support of national biodefense and pandemic preparedness goals. This funding will strengthen the global health workforce, advance research and development capacity, and increase health security financing to help prevent, detect, and respond to future COVID variants and other biological threats.” (summary from the State Department’s FY 2023 Congressional Justification)

CPA Chair Peter Jensen, M.D., issued a statement on April 12 which both acknowledges the president’s longtime support for NIH and biomedical research and expresses concern about the small, below-inflation increase proposed for the NIH base budget. It also asks Congress “to provide substantial funding to further support ARPA-H,” and “to fully fund the President’s request for mandatory funding for ongoing pandemic preparedness.” AAI looks forward to working with the White House and Congress to ensure that the NIH base budget receives robust increases even as important new initiatives, including ARPA-H, are being pursued.

CPA Chair Peter Jensen, M.D., recently submitted written testimony, on behalf of AAI, to the House and Senate Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittees, urging them to appropriate at least $49 billion (a $4 billion increase) for the NIH base budget to support its core operations in FY 2023. The testimony also reiterates the support of AAI for ARPA-H but cautions that any funding provided to the new entity should supplement, and not supplant, the NIH base budget.

AAI submits testimony annually to recommend the next year’s funding level for NIH. The testimony describes some exciting recent advances in immunology, which are identified by the AAI Public Policy Fellows. This year’s testimony explains some of the scientific successes and ongoing challenges associated with COVID-19, including a potential intranasal vaccine and a need for further research to understand and treat post-acute sequelae of SARS-CoV-2 (Long COVID). Other advances highlighted include the development of the first World Health Organization-recommended malaria vaccine, a new method that dramatically improves the efficacy of the Bacillus Calmette-Guerin (BCG) vaccine against tuberculosis in non-human primates, and the first KRAS inhibitor approved by the Food and Drug Administration (FDA) to treat a type of non-small cell lung cancer.

The Biden Administration is reportedly running out of funding for a wide range of activities crucial to controlling the COVID-19 pandemic, including diagnostic tests, monoclonal antibodies, antiviral drugs, and funds to continue crucial research. As a result, according to the AP, they have been forced to divert existing COVID-19 funding intended to support at-home rapid tests, personal protective equipment, and research and development, to further support the most immediate needs, including buying COVID-19 vaccine doses for the fall and purchasing a large supply of the oral antiviral treatment Paxlovid.

AAI is strongly advocating for additional supplemental funding to address critical pandemic needs. In April, CPA Chair Peter Jensen, M.D., sent a letter to key Congressional leaders urging them to appropriate at least $15.6 billion in additional supplemental funding to address these and other domestic and international pandemic priorities, including increasing global vaccination rates. This is the same level of funding that was originally included in the FY 2022 omnibus appropriations bill but was ultimately dropped due to a dispute over offsetting its cost.

Negotiations on supplemental COVID-19 funding have largely stalled in Congress. One possible path forward is a bipartisan bill that was announced by Senator Mitt Romney (R-UT) in April. This legislation would provide $10 billion in supplemental funding for domestic needs, including at least “$5 billion to research, develop, manufacture, produce, purchase, and administer therapeutics.” Unlike the AAI-supported proposal, it would not address international issues, including providing surge support to under-vaccinated countries through the U.S. Agency for International Development’s Global Vax program.

In mid-March, the 2021-2022 AAI Public Policy Fellows participated in a two-day virtual Capitol Hill Day program. The Fellows, accompanied by CPA Chair Peter Jensen, M.D., AAI Advocacy Programs Subcommittee Chair Gretchen Diehl, Ph.D. (AAI ’14), AAI Director of Public Policy and Government Affairs Lauren Gross, J.D., and AAI Senior Manager of Science Policy and Legislative Affairs, met with a total of 26 congressional offices by video or phone. They thanked Members of Congress and their staffs for their support for NIH and encouraged them to continue to invest robustly in the agency. The Fellows also advocated for funding for trainees and researchers whose work was negatively impacted by the pandemic and stressed the importance of continuing to provide additional funding to combat the COVID-19 pandemic.

As always, the Fellows received training throughout the fellowship year and in the hours leading up to Capitol Hill Day. The Fellows also met virtually with NIAID Principal Deputy Director Hugh Auchincloss, M.D., DFAAI (AAI ’83), to learn more about both NIH and NIAID. His well-received presentation focused largely on issues related to COVID-19. Dr. Auchincloss, a former CPA chair, received the AAI Public Affairs Recognition Award in 2015 in part for his outstanding support for the PPFP

December 14, 2021

The CPA sponsored two important and timely policy sessions at IMMUNOLOGY2022™, the AAI annual meeting that was held in Portland, Oregon, in early May. Both chaired by CPA Chair Peter Jensen, M.D., the sessions were: “ARPA-H: What You Need to Know and How it May Impact Federal Funding of Biomedical Research,” and “Vaccine Acceptance: Lessons from the Past and Tools for the Future.”

The ARPA-H session, which took place shortly after the legislation officially establishing ARPA-H had been enacted, featured three excellent presentations. The first speaker, NIH Acting Principal Deputy Director Tara Schwetz, Ph.D., provided detailed information about legislative and Administration efforts to create this bold new entity focused on use-driven high-risk, high-reward scientific research. Amy Jenkins, Ph.D., a Program Manager at the Defense Advanced Research Projects Agency (DARPA), the entity on which ARPA-H is based, described what she believes constitutes a good “ARPA” project. The final talk was given by Amanda Jamieson, Ph.D. (AAI ’15), an Associate Professor at Brown University, who shared her unique insights as an investigator who has received grant funding from both NIH and DARPA.

The vaccine acceptance session drew a large audience concerned about the problem of misinformation and disinformation and its deleterious impact on both public health, and trust in science. Richard Carpiano, Ph.D., M.P.H., Professor of Public Policy and the University of California, Riverside, gave a broad overview of the landscape, focusing on factors that drive people to vaccinate or not to vaccinate, and offering policy interventions that might address the problem. The audience was also pleased to hear from AAI Councilor Akiko Iwasaki, Ph.D. (AAI ’00), Sterling Professor of Immunobiology and of Molecular, Cellular and Developmental Biology at the Yale School of Medicine, who discussed specific types of misinformation and disinformation that has been spread during the COVID-19 pandemic and some of the ways that she and her colleagues have tried to counter these false claims. Dr. Iwasaki also talked more generally about how scientists can get involved in the public arena, including through some of the lessons she has learned through her robust presence on Twitter.

Both sessions were followed by lengthy question and answer periods. Recordings of these events will be made available to annual meeting attendees in the near future.