Breakthroughs Blog: NIH

GHTC responded to a request for information (RFI) on House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA)'s recently published framework that lays out the current challenges facing the National Institutes of Health (NIH) and makes recommendations for reform with the letter below, raising concerns that some of the recommendations could limit important and lifesaving work and urging that any reforms included in legislation to be thoroughly vetted to protect that work.Dear Chair McMorris Rodgers, As members of the global health advocacy community, thank you for your interest in optimizing the National Institutes of Health (NIH) and for the opportunity to provide input on the  Reforming the National Institutes of Health Framework for Discussion.We are pleased to share thoughts below on several specific proposals. However, given the significance of NIH to the health, security, and well-being of the American people and populations across the globe, it is critical to engage in a process that permits interactive discussion with and between different parties who can shed light on the day-to-day implications of these potential changes. Through this process, we can work together to identify opportunities to strengthen NIH in support of the goals and objectives of members of Congress from both sides of the aisle.    For this reason, we are deeply concerned that changes outlined in the framework have been incorporated into the Fiscal Year 2025 House Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill even before the deadline for comments on the proposal. Our concern is not that the calls for reform and increased transparency are without merit but rather that any reform included in legislation be thoroughly vetted to ensure that the important and lifesaving work of NIH is allowed to thrive.In the spirit of such a process, the following text provides specific input from the global health research community and advocates on several proposals included in the framework. The community’s apprehension centers on bifurcating the National Institute of Allergy and Infectious Diseases (NIAID); collapsing several institutes and centers, including the Fogarty International Center, into a single institute; and incorporating the Advanced Research Projects Agency for Health (ARPA-H) into an NIH institute. These actions will impose barriers, both administrative and scientific, for global health research and development that will affect NIH’s reputation as the global leader in biomedical sciences, a legacy that enhances the United States’ image on the international stage as a champion of global health innovation and a steward of global health diplomacy. NIAID is the world leader in global health research and development because its basic research expands our fundamental knowledge of antimicrobial resistance, HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. As COVID-19 variants continue to arise, the complex interactions between immunity and infectious threats have reached the public’s attention as never before. Antimicrobial resistance is another example of how the intertwined nature of infectious diseases and immunity requires constant collaboration between professionals from these fields. We are concerned that NIAID will not cleanly split in two as the LHHS report and House Committee on Energy & Commerce’s proposed framework posit. Rather, the split will disrupt the research helping us defeat the most deadly infectious disease threats—past, present, and future—at home and abroad. We are also concerned that grouping the Fogarty International Center (FIC) with topically unrelated and domestic-facing institutes into the Institute on Health Sciences Research would minimize the key role FIC plays in maintaining the United States’ global health security leadership role and advancing medical progress that benefits the American people and populations across the globe. FIC is a lesser-known but hugely consequential branch of NIH responsible for training a vast network of approximately 8,500 professionals from 132 countries in public health threat response. These trainees have gone on to hold high-ranking academic and government positions and have moved the needle on neglected and emerging infectious diseases, such as HIV/AIDS, COVID-19, Zika, and Ebola.  Rather than embedding FIC in another institute, we believe an important opportunity exists to strengthen this center to play an even more impactful role in advancing the health and security of Americans. We would welcome the opportunity to discuss options such as expanding FIC’s role to encompass strengthening clinical trial capacity and strategic partnerships in countries where capacity gaps pose risks and create tragic missed opportunities for faster medical progress. Finally, we believe that maintaining ARPA-H’s independent status is important for preserving its unique approach to high-risk, high-reward innovation as initially envisioned by Congress, which does not duplicate NIH’s critical role in basic and translational research.  The agency, authorized in 2022, has not been in place long enough to evaluate federal investment in this new model. Its efforts to reverse blindness, dramatically increase the precision of tumor removal, and overcome challenges with broad significance should be given the time they need to succeed or fail. Had Congress abandoned the Defense Advanced Research Projects Agency in its first years of operation, GPS could be a matter of science fiction, not everyday use. ARPA-H has the potential to bring new scientific thought and processes to a field marked by tradition—minimizing its role risks the United States falling behind our geopolitical rivals in health innovation during an age of rapidly evolving technologies. We believe it is in the nation’s interests to put ARPA-H’s muscle toward addressing health threats within and (currently) outside our borders. Again, Chair McMorris Rodgers, we share your commitment to strengthening NIH and believe that thoughtful, bipartisan reforms, supported by thorough discussion and vetting, are key to achieving this goal. We write to advocate for robust funding and a structural, operational, and policy infrastructure that best supports fast-paced scientific, medical, and public health progress. NIH is an asset that serves US interests and contributes in profoundly important ways to the health and well-being of all around the world. We urge that congressional efforts to optimize NIH take place on a bipartisan and bicameral basis and that only changes that have been carefully vetted through a thorough, interactive, and cross-sector process are considered. Thank you for your consideration,Alex LongUS Policy & Advocacy OfficerGlobal Health Technologies Coalition (GHTC)E: along@ghtcoalition.org 

How we got hereSince the earliest days of the House Republicans’ current position in the majority, health agencies like the US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) have been called to testify multiple times before the House Committee on Energy and Commerce (E&C). E&C has used its power as the authorizing committee for domestic health agencies to hold hearings, issue subpoenas, and file reports on what Republican lawmakers perceive as failures of—and a lack of transparency of—public health agencies. More recently, in the committee, there has been a crescendo of opposition to NIH’s status quo—often focused on the work of the National Institute of Allergy and Infectious Diseases (NIAID) and its staff.With that in mind, GHTC and the global health community were prepared for either new legislation or reform plans targeting NIH. Sure enough, E&C, under the leadership of Chair Cathy McMorris Rodgers (R-WA), released a proposal in June to overhaul NIH by restructuring the agency and redirecting the mission of the institutes back to what House Republicans believe should be NIH’s focus. The proposal was outlined in a report and further explained in an op-ed coauthored by E&C Chair Rodgers and Robert Aderholdt (R-AL), Chair of the Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations Subcommittee, which oversees NIH funding, signaling Chair Aderholdt’s support of the proposed framework.Later that month, the House’s fiscal year 2025 (FY25) LHHS bill was released, incorporating the newly proposed NIH framework. Rather than go through the typical process of advancing authorizing legislation, House Republicans attempted to put into effect a new NIH structure through the appropriations process. This process signaled House Republicans’ serious intent to reform NIH, even though there is little likelihood that these currently partisan priorities would ever be enacted in the final version of the LHHS bill since the Democrat-controlled Senate and White House must pass it.The frameworkThe proposed framework takes several key Republican talking points and applies them to NIH’s structure, mission, and processes. These broad buckets of change have implications across the entire NIH system, notwithstanding other new rules concerning how many grants a principal investigator can hold and how much overhead research organizations can claim. Here is a quick walk-through:Structure: The framework takes the 27 institutes of NIH and the (currently independent) Advanced Research Projects Agency for Health (ARPA-H) and consolidates them into 15 new institutes. This consolidation reflects a key Republican talking point that health agencies have gotten too large and cumbersome to effectively collaborate internally, which takes them further away from the core missions of the institution.Mission: The framework proposal persistently condemns demographic- and disease-based research and urges a focus on “the whole individual and all populations across the entire lifespan” instead.  Processes: One issue E&C Republicans have been laser focused on is accountability and transparency concerning what and who NIH funds. The framework proposes a heightened degree of oversight on grants and a stricter set of rules for NIH leadership.Of course, proposals to reform and make a more efficient agency are not without merit, but the context in which they were proposed has left some in the advocacy community with many questions. For example, before the pandemic, on the Hill, NIH generally received bipartisan support for its work and typically unquestioned budgetary increases to maintain its status as the global leader in biomedical research. However, since the pandemic, these issues of NIH consolidation, reconsidering demographic-based research, and heightened transparency have been targeted for what is seen by the advocacy community as a political issue, fueled by the fallout from COVID-19.Global health and the frameworkWhen it comes to the global health implications of the proposal, the issues are vast but also technically speculative, solely based on what we know from E&C and House Republicans’ past comments on the future of NIH and their stance on infectious disease research in the wake of the COVID-19 pandemic. The potential implications are as follows:NIAIDOne of the most intriguing developments is the splitting of NIAID, the world’s largest funder of global health research and development (R&D), into the National Institute of Infectious Diseases (NIID) and the National Institute of the Immune System and Arthritis. This fracturing of NIAID is seen as a direct response to the scrutiny that NIAID and its previous director, Dr. Anthony Fauci, have faced for the institute’s infectious disease work. While there may be good arguments for having an institute expressly focused on infectious diseases, this move also has the appearance of utilizing legislative powers and abilities to purposefully single out a critical line of work in global health at NIH, thus making it more susceptible to political pressures and perhaps more vulnerable to cuts in appropriations. This raises natural questions around process—why use this process at this time versus a more vetted and strategic process and why now.Additionally, the schism may disrupt the immunity and infectious disease research conducted at NIAID. Research into pathogens with pandemic potential, neglected diseases, vaccines, antimicrobial resistance, and even long COVID are all issues that intertwine with infectious disease work and work on the immune system. This break in the institute might disrupt or complicate ongoing efforts to combat important disease threats at home and abroad.If this piece of the framework were to be enacted in any way, NIAID advocates would have to take a closer look at the division of resources at the two new institutes to better understand how the work will be distributed and how the research will be financially impacted. From there, advocates will have to work with congressional colleagues to ensure that the infectious disease work at NIID remains independent but is conducted safely through consultation with researchers and advocacy organizations.FICIn the restructuring proposal, the Fogarty International Center (FIC) is lumped together with unrelated and domestic-facing institutes into the National Institute on Health Sciences Research. FIC acts as the global health focal point at NIH and has trained a vast network of around 8,500 professionals from 132 countries in public health threat response, many of whom have gone on to hold high-ranking academic and government positions. By placing FIC with unrelated institutes under the umbrella of “Health Sciences Research,” Congress would minimize its position in global health leadership and would mischaracterize FIC’s core mission and value added to the NIH ecosystem.If these changes were enacted, the onus would be on the advocacy community to make sure FIC is seen as an integral player in the US global health apparatus and to US global health security. In the 2018 President’s Budget Request and the FY25 House LHHS appropriations amendments process, there have been proposals to zero out FIC, leaving advocates understandably on alert for this potential restructuring.ARPA-HAs was alluded to before, in the framework, ARPA-H is moved under NIH’s leadership and merged with other institutes into a new National Institute on Innovation and Advanced Research rather than serving as an independent incubator for next-generation research. If ARPA-H begins operating under NIH’s topline appropriation, this would likely lead to a shrinking budget for ARPA-H—as was seen in the House’s FY25 LHHS bill.These cuts should be a warning sign to any research that exists outside the US-facing work ARPA-H is set to conduct. ARPA-H’s recently built-out Office of International Affairs and potential for global reach will likely be diminished as available resources dry up because of NIH’s primarily domestic mandate and competition for budgets.If the framework were to be enacted and ARPA-H did fall under NIH’s jurisdiction, global health advocates would need to strengthen their messages on ARPA-H's potential for global health research and needed funding. The next-generation innovation the advocacy community hopes to see out of this new agency is only possible if the appropriators sustain past funding levels, even if it rests within a restructured NIH.Going forwardGHTC wants to see a strengthened and streamlined NIH and agrees that improvements can be made to structures and systems, provided that the ultimate goal is to have an empowered, strategically structured, and well-resourced NIH. That way, the institutes can take on the global health R&D demands and challenges of the future that will result in greater innovation for vaccines, therapeutics, and diagnostics.In the wake of the release of this proposal, GHTC is focused on advocating for strengthening NIH’s global health R&D capacity and working with congressional colleagues on a path forward for NIH that reforms what can be improved and doubles down on what is already working. The global health impacts of NIH’s work are expansive, but in the framework, they are less obvious and require a closer look at the current political landscape and how global health-related issues are divided up at NIH.GHTC is hopeful that our colleagues on and off the Hill will work together to strengthen NIH’s global health impact.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The US Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority, has awarded $176 million to Moderna to support the continued development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concerns about the spread of bird flu cases in dairy cows across the United States continue to rise. Moderna's bird flu vaccine candidate is in very early-stage testing and uses the same mRNA technology as its COVID-19 vaccine. The new funding could support a late-stage trial of the vaccine candidate as early as next year if early study results continue to be positive. The vaccine could also be quickly redirected to target another form of influenza if a different threat emerges.A research team has developed a test that will help measure the persistence of HIV in people affected by viral strains found predominantly in Africa, which are greatly understudied, helping to fill a major gap in HIV research. Most HIV studies have focused on the strains circulating in Western countries, predominantly by men who have sex with men affected by subtype B, with much fewer studies examining strains circulating in Africa, where women are disproportionately affected. The new laboratory test allows researchers to determine whether following antiretroviral treatment there is any intact viral DNA capable of producing new viruses if antiretroviral treatment is interrupted. The test is already being used to study long-term viral persistence in Uganda and could be a vital tool in the search for an HIV cure that could target and eliminate this intact DNA reservoir.Last week, the US National Institutes of Health (NIH) announced the launch of a Phase 1 trial testing a nasal vaccine against COVID-19, the first trial conducted by NIH’s National Institute for Allergy and Infectious Diseases as part of Project NextGen, a US government initiative designed to advance the development of next-generation COVID-19 vaccines. In preclinical nonhuman primate studies, the candidate, MPV/S-2P, elicited a strong systemic immune response, as well as mucosal immunity, which plays an important role in controlling respiratory virus replication. Next-generation vaccines, including nasal vaccines, are a key tool needed to reduce COVID-19 infections and transmission as new variants of the virus continue to emerge.

Nearly six months into fiscal year 2024 (FY24), the US government has finally agreed upon a budget for the remaining six months. Nevertheless, March brings with it a new appropriations cycle forcibly run in parallel with the last. With the release of the President’s Budget Request (PBR) for fiscal year 2025 (FY25) and ongoing meetings with appropriations staff, the prospects for future US spending on global health research and development (R&D) are coming into focus, with both good and bad on the horizon.FY24 spending package: A mixed bag for global health R&D This year’s appropriations process was certainly one for the history books in that it was historically difficult—largely due to partisan divisions and threats to the House speakership. But on March 22, moments before a partial government shutdown was set to go into effect, a six-bill “minibus” was voted through by the House of Representatives and the Senate and later signed into law, which will keep the government operational until September 30. This second spending package included funding bills for Labor, Health and Human Services, Education, and Related Agencies (LHHS); State, Foreign Operations, and Related Programs (SFOPS); and Defense, which are a mixed bag for funding for global health R&D.LHHSThe LHHS bill, which covers funding for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA), included some welcome increases to agencies and programs that support global health research alongside overall stagnant funding.Out of the three agencies, BARDA, which focuses on the R&D of countermeasures against emerging health threats, received the largest increase in funding with a $65 million (6.8 percent) boost over fiscal year 2023 (FY23) levels, bringing its total budget to $1.015 billion. The CDC, America’s lead public health agency, and NIH, the primary agency responsible for biomedical health research, witnessed marginal adjustments, with their budget lines most relevant to global health R&D remaining largely static. Notably, CDC's National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) received a $9.5 million (1.27 percent) boost, which will help bolster crucial surveillance initiatives such as the Advanced Molecular Detection program.  Additionally, the minibus also included complimentary directives, known as report language, which were championed by GHTC, that reinforce the importance of global health and neglected disease research taking place at CDC and NIH. It also included important language encouraging BARDA to consider the needs of people living in low-resource settings in its R&D funding decisions and directing the agency to provide more transparent and regular reporting on its investments and allocate at least $10 million of its budget to create a new Disease X medical countermeasures program to develop tools against viral families with pandemic potential.SFOPSThe SFOPS bill covers global health work undertaken by the US Agency for International Development (USAID) and the US Department of State (State). Unfortunately, the FY24 spending package included a significant cut of $530.95 million (5.3 percent) to State and USAID global health programs.Much of this reduction is due to a decrease in funding by $350 million for the US contribution to The Global Fund to Fight AIDS, Tuberculosis and Malaria, which fell from $2 billion in FY23 to $1.65 billion in FY24. While this is a large cut, it was both expected and supported by advocates, given that US law caps the maximum contribution that the United States can make to the fund relative to the contributions of other donors. Thus, the “cut” was implemented in line with the cap to avoid a harsh drop-off in US funding in the coming years. Accordingly, many advocates are not viewing it as an actual cut. The remaining decrease in funding comes from a significant $200 million (22 percent) cut to USAID Global Health Security (GHS). The FY24 funding for GHS of $700 million retains a $100 million carve-out for a US contribution to the Coalition for Epidemic Preparedness Innovations, or CEPI, but advocates are still piecing together what the $200 million slash could mean for other GHS programming. This picture is further complicated by the opaque nature of how the US government intends to fund a contribution to the World Bank Pandemic Fund, which is neither specified in the bill in terms of a funding number nor in the programmatic budget line. The Biden Administration announced last year its intent to contribute $250 million to the fund, but this contribution is not actually detailed in the spending package, so it remains unclear how this commitment will be realized. Slightly cushioning the overall cut to State and USAID global health programs are some modest increases to the budget lines for the maternal and child health (through an increase in funding to GAVI, the Vaccine Alliance), nutrition, and other public health threats programs.In a key win for global health research advocates, Congress also included accompanying report language for SFOPS directing USAID to increase its spending for health R&D over the prior fiscal year and to publish an annual report on its health R&D activities and investments. Notably, the reauthorization of the US President’s Emergency Plan for AIDS Relief, or PEPFAR, was also included in the SFOPS bill but only for one year, so authorization will expire next March. This one-year reauthorization tees up another battle, which will certainly be shaped by the political climate and controlling parties following the presidential and congressional elections this fall.DefenseWhile few may think of the US Department of Defense (DoD) as a key global health player, the agency’s spending supports R&D against epidemic-prone diseases and other health issues that pose a risk to US national security and service members stationed abroad—so its investments contribute to combating diseases endemic in many of the world’s poorest places. Encouragingly, language supporting DoD's research on infectious diseases and the development of medical countermeasures was included in the accompanying Defense bill report.Unfortunately, however, Congress did not include tuberculosis among the diseases eligible to be funded via the DoD-led Congressionally Directed Medical Research Program’s (CDMRP’s) Peer Reviewed Medical Research Program (PRMRP), as has been the case in years past. This is a point of future advocacy since the CDMRP PRMRP funds other neglected and emerging diseases in line with the list of eligible diseases defined in the Senate’s Defense bill each year.FY25 President’s Budget: A story of lowered ambitionOn March 11, President Joe Biden released his FY25 budget request, outlining his administration's recommendations to Congress for spending for the next fiscal year. The FY25 PBR is more moderate than Biden’s FY24 proposal, which can be largely attributed to the administration upholding their end of the debt ceiling bargain to keep overall spending levels capped at roughly FY23 levels. But even still, the lack of boldness for global health activities across the board was felt by advocates.With respect to global health programs at State and USAID, the budget proposes an overall decrease of approximately $733 million (7 percent) compared to FY23 enacted levels. This includes a $175 million (4.2 percent) cut to USAID and a $558 million (8.9 percent) cut to State global health programs. Concerning the latter, the cut comes from the PBR proposing a $1.19 billion contribution to the Global Fund, which would be an $810 million reduction from FY23 levels. As previously noted, this drastic cut is due in large part to the cap imposed on maximum US contributions; however, advocates are still pushing for $1.65 billion in FY25, citing projections that the US contribution can be set higher without violating the cap. The proposed USAID cut is more nuanced and comes from an accounting choice by the administration to transfer funding for the US contribution to the Pandemic Fund ($250 million) from under the Global Health Security line at USAID to the budget for State’s new Bureau of Global Health Security and Diplomacy, which will now manage US engagement with the fund. In conversations with the agency, the movement of this funding is not being perceived as a cut—leaving USAID’s global health programs largely untouched in the PBR. Most programs are flat funded, though the budget proposes a modest $30 million (3.3 percent) boost to USAID’s maternal and child health programs and a reduction of $26 million (4.5 percent) to USAID’s family planning account.On the LHHS side, the budget proposal is slightly rosier, though far from ambitious. The PBR proposes increases of $20 million (2.1 percent) for BARDA and $1.4 billion (2.3 percent) for NIH overall, with the latter including a modest boost of $18.72 million (0.3 percent) for NIH’s National Institute of Allergy and Infectious Diseases but flat funding for NIH’s Fogarty International Center, which supports global health research and training. CDC received a proposed increase of $465.4 million (5 percent) in the PBR, with NCEZID receiving a $30 million (4 percent) increase and the Center for Global Health flat funded.Notably, CDC’s congressional budget justification proposes that $20 million of this funding for NCEZID be put towards wastewater surveillance, which is programming that is currently being supported unsustainably via emergency funding for the COVID-19 response. Additionally, in the BARDA congressional budget justification, the administration suggests a $20 million boost “to increase BARDA’s Broad Spectrum Antimicrobials and Combatting Antibiotic-Resistant Bacteria portfolio" through engagement with the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, an international partnership focused on accelerating the development of new antibacterial innovations.While GHTC understands the administration’s fiscal situation and negotiating position with Congress, the discrepancy between the administration’s ambitions from the FY24 PBR to the FY25 PBR are stark, with some agencies seeing decreases of over $1 billion between the two presidential requests.FY25 outlook: Not great, but not badWhile it may feel cruel for advocates, there is no breathing room between the FY24 and FY25 appropriations processes. Additionally, the constraints the global health community felt in 2024 in the wake of the Fiscal Responsibility Act of 2023—also known as the Biden-McCarthy Debt Ceiling Deal that capped spending growth—are still with us. Even though the outcomes of the FY24 spending package were discouraging for global health advocates—it went better than many expected. For FY25, while a robust and bold global and public health budget is the goal—holding off any cuts and returning to FY23 topline budgets for global health programs will be critical. GHTC will be working to communicate that message clearly while keeping in mind the uphill battle caused by the parameters forced upon appropriators by last June’s debt ceiling deal.Other obstacles like election-year politicking and a remarkable loss in global health champions in Congress will make future negotiations harder and will require advocates to go more on the offense. Pushing for stronger toplines and no cuts will be vital in FY25 to get the gains the community needs to get the world back on track toward eradicating neglected diseases and better preparing for emerging threats.