Alex Long, MS

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.

Earlier this year, the US Agency for International Development (USAID) released its latest legislatively mandated report to Congress on its global health research and development (R&D) programs for fiscal year 2023. The report, which was recently shared with global health stakeholders following an October townhall with USAID Assistant Administrator for Global Health Dr. Atul Gawande, provides detailed information on individual products supported by the agency and key research advances in 2022, as well as budgeted funding for R&D across health areas.Because of USAID’s unique role as a key sponsor of global health product development, the Global Health Technologies Coalition (GHTC) closely tracks these annual reports to catalog the agency’s investments in its research pipeline and technological advances for low-resource settings.What has changed from last year?The most recent report, which comes on the heels of the agency’s new Global Health Research and Development Strategy 2023–2028, shows an increase from fiscal year 2021 (FY21) to fiscal year 2022 (FY22) in both products supported by the agency and budget allocated to advancing new lines of research and partnerships.The repeat details that the agency supported at least 63 individual products via its R&D investments in 2022, up 4 from 2021. Not surprisingly, the agency’s R&D portfolio in 2022 looked similar to 2021 in terms of the core health areas and product types financed.The report also revealed that in 2022, USAID budgeted $214 million in total baseline (non-supplemental) funding for global health R&D projects. This represents an increase of roughly $49 million from 2021, with the lion’s share coming from a plus up via the Global Health Security line for the Coalition for Epidemic Preparedness Innovations (CEPI), from $4 million in FY21 to $55 million in FY22. It is worth noting that in FY21, USAID allocated $50 million in COVID-19 supplemental funding from the American Rescue Plan Act for Global Health Security R&D. Thus, with supplemental funds included, FY21 funding numbers were more on par with FY22. This leads us to speculate that the supplemental increase in FY21 funds laid the groundwork for successfully justifying an increase in FY22 base funding for global health security-related R&D.While the $214 million budgeted for R&D in 2022 represents the highest non-inflation-adjusted baseline funding for R&D ever reported by the agency since 2006 (when R&D spending is viewed as a proportion of total USAID global health spending), the picture that emerges is far less rosy. While proportional spending on R&D rose slightly by 0.4 percent from FY21, bringing it to 5.5 percent—this was still far below the 8 percent peak that the agency spent on R&D in 2006 and unfortunately does not fundamentally shift the trajectory of the years-long decline in proportional R&D spending by the agency.The path aheadWhile GHTC is pleased to see the increase in base funding for global health R&D and R&D spending as a proportion of overall global health funding, as GHTC’s analysis indicates, there are still core gaps in the agency’s R&D investment areas and a need to better resource the global health R&D portfolio after years of decreased proportional investment since 2006. GHTC has been advocating for the creation of a new disease-agnostic fund for global health R&D at USAID, deemed the Supporting Innovative Global Health Technologies (SIGHT) Fund, to direct more dedicated resources to R&D. Earlier this month, we welcomed the first step towards that vision, with the House introduction of the bipartisan SIGHT Act (H.R. 6424), which would establish the programmatic structure at USAID for such a fund to be realized. We look forward to advancing the SIGHT Act, as well as what similar calls for greater investment in global health R&D spending can do for advancing health and well-being in all settings.

Congressional negotiations are moving fast and furious as policymakers seek to reach an agreement to reauthorize must-pass legislation, known as the Pandemic and All-Hazards Preparedness Act (PAHPA), governing how the United States prepares for health threats. The latest 2019 reauthorization of the original 2006 law will expire on September 30, leaving legislators with a rapidly closing window to determine how national preparedness infrastructure should be reformed in the wake of the COVID-19 pandemic.Though this legislation has far-reaching implications for America’s entire preparedness architecture, most notably for global health research advocates, it authorizes the work of the Biomedical Advanced Research and Development Authority (BARDA), an agency charged with advancing the research and development (R&D) of medical countermeasures (MCMs) against health threats. BARDA was created via PAHPA in response to the 2001 anthrax attacks in the United States and in recognition of the need for the government to play a role in spurring R&D of tools for chemical, biological, radiological, and nuclear threats for which there is no commercial market. While historically, the agency has focused foremost on man-made bioterror threats, in the past decade, it has increasingly played a role in advancing vaccines, drugs, diagnostics, and other tools against naturally occurring global threats like Ebola, Zika, antimicrobial resistance (AMR), and COVID-19—for the latter, as one of the leaders of the US government’s Operation Warp Speed.While the COVID-19 pandemic underscored the unique value of BARDA’s R&D capabilities, it also brought the United States to a point of intense partisanship on issues of pandemic preparation and public health. These splits have plunged PAHPA—which has historically enjoyed an uncontroversial and bipartisan policymaking process—into a tense 2023 reauthorization cycle.Below we look at where negotiations stand in each chamber and where things could go from here.A bipartisan SenateOn the Senate side, the deliberations for a mostly clean reauthorization have gone relatively smoothly in the Health, Education, Labor, and Pensions (HELP) Committee. While an initial discussion draft released on July 3 reflected areas of disagreement between Chairman Bernie Sanders (I-VT)—who wanted to see the bill tackle drug pricing and supply chain challenges—and Ranking Member Bill Cassidy (R-LA) —who proposed changes to the priority review voucher (PRV) for MCMs—by the July 20 markup, the senators had worked out a bipartisan deal in the form of a managers amendment.The bill, which last week was approved to be reported out of committee, includes a comprise that would require drugmakers to alert the government of disruptions in the supply of drugs and pharmaceutical ingredients and a new government-directed study on policy solutions to delink drug prices from R&D costs in exchange for a straight five-year extension of the MCM PRV program. Importantly for global health research advocates, the bill also includes more expansive and explicit language directing BARDA to conduct R&D for known and as-yet-unknown pathogens with pandemic potential, as well as an amendment introduced by Sen. Hickenlooper (D-CO) to authorize the creation of a new US Food and Drug Administration (FDA) team tasked with reviewing MCMs for emerging pathogens—as was requested by FDA in their fiscal year 2024 priority letter. It is worth noting that the compromise forged between Sens. Sanders and Cassidy included new authorities for FDA that have been the cause of derision across the chamber on the House side.A partisan HouseIn the House, leading up to the Energy and Commerce (E&C) Committee’s July 19 markups, tensions remained heightened as Democrats and Republicans were still unable to reach bipartisan consensus on the two PAHPA bills introduced by Representative Richard Hudson (R-NC): H.R. 4421, the Preparing for All Hazards and Pathogens Reauthorization Act, which covers BARDA and its parent agency the Administration for Strategic Preparedness and Response (ASPR), and H.R. 4420, the Preparedness and Response Reauthorization Act, which proposes changes to the US Centers for Disease Control and Prevention (CDC). Rep. Hudson reportedly decided to split the House version of PAHPA into two bills to disentangle the more politicized portions of the bill, housed in H.R. 4420, from the ones with more consensus, housed in H.R. 4421.Both bills were approved last week to go to the floor of the House.Since the House’s preliminary June hearing on PAHPA at which Rep. Anna Eshoo (D-CA) announced that she had pulled her name from the legislation, Rep. Hudson’s PAHPA bills have advanced through the chamber on a purely partisan basis. Other vocal representatives, like E&C Committee Ranking Member Frank Pallone, Jr. (D-NJ), hammered Republicans for not including FDA authorities to address drug shortages in the scope of PAHPA. Unsatisfied with the Republicans’ response to their demands, House Democrats on the committee released their own version of PAHPA immediately before the July 19 markups. The Democrats’ draft bill includes provisions to strengthen CDC, increase funding for programs like the Strategic National Stockpile (SNS), and give FDA new authorities to mitigate drug shortages.This tension culminated in almost exclusively party-line votes approving 15 health policy-related bills that, among other provisions, would hamper CDC’s powers and, according to experts, underfund CDC, BARDA, SNS, and ASPR. In one small glimmer of good news, the Republican-led H.R. 4421 PAHPA bill, like its Senate counterpart, also included more expansive language directing BARDA’s research on emerging infectious diseases (EIDs).What now?For the first time, the House E&C Committee has sent PAHPA to the House floor on a partisan basis in striking contrast to the Senate HELP Committee’s mostly bipartisan process. Notably, House E&C Committee Chair Cathy McMorris Rodgers (R-WA) alluded to considering the Senate’s “more tailored approach to more FDA authorities” as a workable compromise, but only time will tell as the bills advance to the next stage in the process. If the current House and Senate versions of the bill receive the requisite votes to pass in each chamber, they will then be sent to the Conference Committee, where the differences must be reconciled, and the resulting bill will be sent back to the House and Senate floors for final votes.But with the partisan nature of the PAHPA bills in the House, the slim majority Republicans hold, and the difficult procedural hurdles in the Senate that have been used to hold up anything COVID-related, it could prove challenging for policymakers to reconcile around a bill capable of being passed in both chambers. The only sure thing is that this reauthorization process is unpredictable and at the whim of the current political climate.What is GHTC’s take?Earlier this year, GHTC put out a set of policy recommendations for the House and Senate to consider as they reauthorized PAHPA. Even though the process is not over, there are indications that some of our coalition’s priorities are represented in the draft bills from both the House and the Senate. As discussed, both bills contain explicit language highlighting the need for “advanced development and manufacturing of MCMs for viral families which have significant potential to cause a pandemic” and call out “emerging infectious diseases.” It is welcome news to see the bills specifically highlight the need for R&D for both known and as-yet-known, or Disease X, infectious disease threats.Additionally, the Hickenlooper amendment is also supported by GHTC since it would bolster FDA “activities to advance scientific research related to the development of tools, standards, and approaches to assess the safety, efficacy, quality, and performance of countermeasures.” The inclusion of both EID callouts and FDA’s fiscal year 2024 priorities are notable wins in a year marked by proposed funding cuts to global health programs.Of course, there are still areas of much-needed attention not fully addressed by the bills. The lack of boldness of either chambers’ bills can be attributed to the difficult fiscal environment Congress finds itself in—exemplified by the far more contentious appropriations bills that many believe are sending the United States on the path to a potential government shutdown. GHTC’s recommendations for Congress to create a dedicated EID funding line and authorize more money for AMR research at BARDA are not included in the bills—nor is there discussion on advancing the low-resource settings utility of BARDA products, inclusion of the Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act to incentivize AMR research, or provisions to give BARDA loan authorities.However, through our staff-level conversations on the Hill, the dial seems to be turning in a positive direction for these priorities. Especially in discussions on EID funding and AMR priorities (including PASTEUR), there is growing bipartisan agreement that these issues are important enough for standalone funding—just not in this specific PAHPA during this particularly difficult fiscal year. Whether or not PAHPA is the vehicle, we see tremendous strides in the Hill’s recognition of the issues central to GHTC and our future advocacy.