Breakthroughs Blog: PEPFAR

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.

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. On Thursday, the US Senate confirmed Dr. John Nkengasong as US global AIDS coordinator to head the President's Emergency Plan for AIDS Relief, or PEPFAR. Dr. Nkengasong, a Cameroonian virologist who currently serves as director of the Africa Centres for Disease Control and Prevention (CDC), is the first person born on the African continent to take on the global AIDS coordinator role. President Joe Biden nominated him for the position last September, following a gap in permanent leadership since Dr. Deborah Birx departed in 2020. Prior to his position at Africa CDC, Dr. Nkengasong worked at PEPFAR on strengthening laboratory capacity across Africa. Africa CDC Deputy Director Dr. Ahmed Ogwell Ouma will head the agency in the interim while the African Union Commission selects a new director.The World Health Organization (WHO) last week released a rapid communication stating that patients 15 and older with multidrug-resistant tuberculosis (TB) or rifampicin-resistant TB can take a six-month, all-oral treatment regimen—comprising the drugs bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM)—instead of a regimen lasting nine months or longer. The guidance also indicates that patients with multidrug-resistant TB or rifampicin-resistant TB who have developed resistance to fluoroquinolones can subscribe to the same six-month treatment regimen, but without moxifloxacin—known as BPaL. WHO has previously recommended the BPaL and BPaLM treatment regimens, but only under operational research conditions; the new recommendation will allow programmatic implementation of treating almost all forms of drug-resistant TB with either of the shorter regimens.Two novel COVID-19 vaccine platforms—a plant-based coronavirus-like particle vaccine and a receptor-binding domain (RBD)–dimer-based vaccine—showed promising results, according to studies published last week based on phase 3 clinical trials. The two-dose, plant-based particle vaccine, developed by Medicago and GlaxoSmithKline, showed 69.5 percent efficacy against symptomatic COVID-19 caused by five variants identified in sequencing, and no severe cases or deaths were recorded. The RBD-dimer-based vaccine, developed by Anhui Zhifei Longcom, is a three-dose shot that showed 75.7 percent efficacy against infection and 87.6 percent efficacy against severe to critical disease. Neither vaccine requires extreme cold chain storage, which makes them appealing candidates for global COVID-19 vaccination efforts.

The Trump administration’s budget request for fiscal year 2020 (FY20) includes cuts that—if enacted—would hamstring the research and development (R&D) of new global health technologies funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), US Agency for International Development (USAID), and Department of Defense (DoD). Since the release of the budget request in early March, however, lawmakers from both parties have expressed their commitment to shielding these critical funding strings from the president’s scissors.Among the proposed cuts is a 12 percent reduction for NIH. On April 11, the Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee (LHHS) held a hearing to review the budget request for NIH. From the beginning, it was clear the administration’s proposal would face bipartisan pushback. Subcommittee Chairman Roy Blunt (R-MO), in his opening remarks, said, “I'm disappointed, of course, that the 2020 budget request would cut the agency by 13 percent. I'm confident that this committee will not do that, but we'll talk to you today about the reasons that we should continue in the direction we're in rather than head in another way.”Chairman Blunt was followed by Ranking Member Patty Murray (D-WA), who delivered an even stronger rebuke: “At a time of remarkable possibility in medical research, a time where we can and should continue leading the world in medical discovery, the Trump administration wants to cut funding for NIH… President Trump's damage -- damaging budget is wildly out of step with the sentiments of Congress, thankfully, and the American people. And I feel confident, working with our Chairman, that we will once again reject it.”Later in the hearing, Senator Richard Shelby (R-AL), who serves as Chairman of the full Senate Appropriations Committee, also voiced his support for an NIH funding increase:“What you do is more important than most [of] what we do in America. I'm not interested in cutting your budget. I'm interested in increasing it…I think this is a great investment for America, for the world, for humanity, what you do… it's not only a financial investment, which is good for the economy. It is the leading scientists, the cutting edge of scientific research that you add. And we all benefit from it immensely.”The week prior, the House Appropriations LHHS Subcommittee had held their hearing on the NIH budget. Subcommittee Chairwoman Rosa DeLauro (D-CT) said that Congress would reject proposed funding cuts to the NIH. In her opening statement she emphasized the value of scientists’ work: "Funding [biomedical] research has the power to do more good for more people than almost anything else within the purview of this subcommittee.”Referring to the administration’s newly launched effort to end the transission of HIV and AIDS in the United States, Chairwoman DeLauro continued: “Decades of research supported by NIH led to the development of the very treatment and prevention approaches that have put achieving this goal within reach, specifically antiretroviral therapy and PrEP. The NIH must be involved, if we are to continue to make progress in reducing HIV and AIDS, domestically and abroad.”In other budget hearings, lawmakers focused on important funding sources for global health R&D outside of NIH—including the DoD. In the House Appropriations Defense Subcommittee hearing on the US Army budget on April 9, Rep. Betty McCollum (D-MN), Vice Chair of the Subcommittee and Co-chair of the House Global Health Caucus, pressed the Secretary of the Army and Army Chief of Staff about proposals to divert funding from malaria vaccine research funded by the US Army: “Given that malaria remains the number one infectious disease threat for troops deployed in these regions, and we know that we have issues with [treatment] compliance, whether it’s State Department, military, even Peace Corps volunteers because of the side of effects from these diseases, it remains critically important that the Army’s research on malaria vaccines continue. I’m concerned in the FY20 budget that the justification appears that the funding for the project that conducts malaria vaccine research is being realigned into other projects. Given nearly all the most effective widely-used anti-malarials were developed in part by the US military research team, I find the possibility of losing momentum in research extremely alarming.” With the ongoing outbreak in the Democratic Republic of the Congo (DRC), Ebola is another infectious disease high on lawmakers’ radar. On March 14, the Senate Appropriations LHHS Subcommittee held a hearing on the Ebola outbreak in DRC and other emerging health threats. Subcommittee Chairman Blunt’s (R-MO) opening statement emphasized, “It is clear that our investments to improve global health have a direct impact on the wellbeing of every American.” He highlighted recent funding increases he has championed for the NIH National Institute for Allergy and Infectious Diseases, the CDC, and the Global Health Security Agenda. Senator Richard Durbin (D-IL) also expressed his support for global health research: “If you wanted to look at the most important room in Washington, DC, when it comes to medical research over the last few years, it would be this room, this subcommittee. Under the leadership of Chairman Blunt and Senator Murray, we have seen for four straight years a 5 percent increase and real growth at the NIH. I think an overall 30 percent over that period of time, the 5 percent real growth each year. Increases to the CDC I wish were equal, but they had been good. We hope they'll get better in the future. I reject the President's budget out of hand. This notion of 12 percent cut to the NIH is just unacceptable and I think most Democrats and Republicans would agree.”In addition to defending investments in biomedical R&D, lawmakers have expressed support for funding for international aid and development—which would be cut by 24 percent under the President’s budget proposal. On February 27, the House Appropriations State and Foreign Operations Subcommittee held an oversight hearing on USAID Programs and Policies. In her opening statement, Appropriations Committee Chairwoman Nita Lowey (D-NY) emphasized the value of USAID, stating, “Failing to maintain our position as the leader in global development and humanitarian assistance will cost lives, risk the spread of infectious diseases, and reduce American influence around the world.” Included in the budget proposal is a US$1.35 billion reduction to the President’s Emergency Plan for AIDS Relief (PEPFAR). In response, several lawmakers vigorously defended the United States’ role in addressing the international HIV and AIDS epidemic. On March 6, Rep. Eliot Engel (D-NY), Chairman of the House Foreign Affairs Committee, said, “I'm particularly opposed to cuts in funding for global AIDS programs. There's a 22 percent cut in PEPFAR used to treat millions internationally, mostly in Africa.” Later that month, Rep. Karen Bass (D-CA) also defended PEPFAR: “The administration has maintained most Africa focused aid initiatives launched by previous Congresses, and in some cases have sought to fund them, however at far lower levels. These include the global President's Emergency Plan for AIDS or PEPFAR…and I'm glad that those initiatives have continued but concerned about the cuts in funding. I will conclude by stressing…that US relations with Africa has always enjoyed bipartisan support here in Congress, and we expect to continue to work together. Each time the administration has sought to reduce funding, the State Department or USAID, especially those that would impact African countries, we have worked together in a bipartisan manner to restore that funding.”In early April, Rep. Eliot Engel (D-NY) again affirmed his belief “in development as a way to advance American interest and security that’s rooted firmly in our values.” In reaction to the President’s budget proposal, he noted that, “Tuberculosis and malaria and AIDS patients all around the world” would be pushed aside by the “heartless and harmful approach to foreign policy.” The Trump administration’s budget request, if enacted, would slash funding for lifesaving research, development, and implementation of new global health technologies. Fortunately, lawmakers, with support from advocates, have diligently opposed these cuts. It’s our job to ensure this continues.

On February 15, President Trump signed into law a bipartisan spending bill—averting another partial government shutdown and ensuring full-year funding for the government for the remainder of fiscal year (FY) 2019. The move followed several days of speculation about whether discord between Congress and the President on funding for a border wall would imperil the spending measure passed by Congress to fund the remaining one-quarter of the federal government.The months-long saga ended with some great news for global health and research and development (R&D)—a roughly US$150 million funding increase for global health programs in the State and Foreign Operations (SFOPs) bill, as well as a significant boost to the Food and Drug Administration (FDA) under the Agriculture bill included in the package.The bill included some welcome increases to global health accounts which have been flat-funded for five years running, including a $50 million (1.16 percent) increase to the President’s Emergency Plan for AIDS Relief (PEPFAR) and a $2.5 million (2.5 percent) increase to the US Agency for International Development’s (USAID) Neglected Tropical Disease Program compared to FY 2018. Nutrition saw a $20 million (16 percent) increase and Maternal and Child Health got a $5.5 million (0.66 percent) boost. But perhaps the most notable win in the bill was a long-sought increase to USAID’s tuberculosis (TB) program. After TB was in the spotlight at the United Nations High-Level Meeting on TB in September, the United States backed up its pledge of additional support for the global fight against TB by including a $41 million (15.71 percent) increase to the program in the final spending package for FY 2019—the largest increase to the program in more than five years. All other global health accounts were level-funded compared to FY 2018, resulting in an overall increase of 3.23 percent for USAID Global Health—a stark difference from the 36 percent cut proposed in the President’s budget.While most accounts of relevance to global health R&D within the Department of Health and Human Services were funded for the entire fiscal year in a spending package passed in September, the FDA was one agency whose funding was still in limbo. The FDA’s unique funding structure—divided between budget authority, or discretionary funding (appropriated by Congress), and fees (paid by FDA users) —shielded the agency from some of the worst impacts of the partial government shutdown in December and January as it drew down on user fees to continue most operations. But the final FY 2019 funding package included a welcome $460 million (9 percent) increase for the agency, including a $269 million (9 percent) increase in budget authority.As the FY 2019 appropriations process lurched across the finish line, advocates were already gearing up for another budget battle for FY 2020. Check back for regular updates as appropriations hearings begin and GHTC continues monitoring the prospects for global health R&D accounts in the coming year.  For reference, the text of the Conference Report to accompany H.J. Res. 31, the Consolidated Appropriations Act, 2019, is available here, the text of the Joint Explanatory Statement is here (with the Global Health Program breakdown on page 454 of the PDF), and a division-by-division summary is available here.