Breakthroughs Blog: US budget

2022 G-FINDER report highlights the inadequacy of global health R&D funding: GHTC offers key takeaways for the global health communityThe release of the 2022 G-FINDER report sheds light on current funding trends in global health research and development (R&D). Despite hard-won advocacy victories by GHTC and the global health advocacy community, neglected diseases are living up to their moniker from a funding standpoint, as global investment in HIV/AIDS, tuberculosis (TB), malaria, and neglected tropical diseases (NTDs) remains far below levels required to overcome these persistent and devastating health threats. The new report highlights several new and ongoing funding trends. GHTC has identified three findings of particular importance to the global health research community.Funding for NTDs dropped precipitously; funding shortfalls for HIV/AIDS, malaria, and TB persist.Funding for NTDs included within the G-FINDER scope decreased by 10 percent in 2021, falling to their lowest total since 2009. NTDs impact more than a billion people each year, disproportionately afflicting women and children. The reduction in funding is particularly alarming given that many of the targets set in the WHO roadmap on NTDs (2012-2020) have not been met. Outside of NTDs, funding for malaria saw a substantial 5.7 percent dip, HIV/AIDS investment experienced a modest uptick of 2.7 percent, and TB funding remained virtually flat, dipping less than a tenth of a percent. While these three diseases receive more resources than NTDs, their funding levels are significantly below that which is needed to overcome these health crises and reach global health and development targets, like the Sustainable Development Goals.Funding for Product Development Partnerships (PDPs) declined for the fourth consecutive year.PDPs are the leading engines of medical innovation for diseases that lack sufficient commercial market incentives. Thus, it is distressing to see that neglected disease R&D funding for PDPs fell by 18 percent in 2021, continuing a multiyear backslide. Current PDP funding sits 40 percent below its peak, which was 13 G-FINDER cycles ago. The most recent dip was driven by reduced investment from large donors like the Bill & Melinda Gates Foundation, the UK Foreign, Commonwealth & Development Office, and the US Agency for International Development (USAID). These findings also highlight the need to further diversify funding sources for PDPs, as well as global health R&D more broadly. Specifically on the US government funding front, PDP funding was not the only area in which USAID funding declined. Neglected disease R&D funding from the agency reached a record low, further highlighting the need for additional mechanisms within USAID to facilitate supporting medical innovations for unmet needs. During the virtual launch event for the report, keynote speaker Dr. Peter Hotez noted the vital role that US agencies like USAID and the US National Institutes for Health play in the global health R&D ecosystem.Funding for platform technologies and non-disease-specific investment is on the rise. For the seventh consecutive year, funding for non-disease specific (NDS) R&D increased, rising by 5.6 percent. Specifically, investment in platform technologies grew for the fourth consecutive year and now accounts for 22 percent of NDS funding. Much of the past year’s growth was buoyed by an increase in drug-related platform technologies, which historically received the smallest share of funding. This trend dovetails with a larger shift of investments toward drugs, as overall drug R&D funding eclipsed vaccine R&D funding for the first time in 2021.Overall, the global health advocacy community has made incredible strides in protecting and growing funding for global health innovation. This past year in the United States, GHTC helped support the passage of a global health research-friendly fiscal year 2023 omnibus package, which included significant funding increases across nearly every line relevant to global health R&D, as well as complimentary directives that will support global health R&D across several agencies. However, the challenges of competing global interests and tough funding environments are formidable, as shown by the G-FINDER report. This coming year presents a number of strong opportunities to elevate attention and support for resources for global health innovation, including United Nations High-Level Meetings on TB and universal health coverage. We urge leaders around the world to step up and invest in lifesaving global health R&D, and our advocacy community partners to continue to hold the world accountable for ensuring health and health equity for all. 

On Friday, President Joe Biden signed into law a US$1.7 trillion spending bill that will fund the US government through fiscal year 2023 (FY23), which ends September 30, 2023. The package includes significant funding increases across nearly every line relevant to global health research and development (R&D), as well as complementary directives that will support global health R&D across several agencies.How it passedUntil mid-December, the outcome of the spending package was still uncertain. Many Republicans in the House and some in the Senate were hoping to see a continuing resolution—a stopgap measure to postpone negotiations—into next year when they would hold more leverage with control of the House. Top House appropriator Rosa DeLauro (D-CT) responded by threatening to only pass a full-year resolution if no progress was made. As talks froze, Democratic lawmakers turned up the tension forcing a breakthrough weekend negotiation in early December. A few more bumps laid in the way, especially in the Senate, where energy permitting reform and Title 42 amendments were set on the table but ultimately shoved away, clearing a last-minute path for passage.New fundingPassage of the bill is mostly great news for global health R&D. Nearly every funding line across the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), the US Agency for International Development (USAID), and the State Department relevant to the sector has increased. Some notably large increases include:A 10 percent increase for universal influenza vaccine research at the National Institute of Allergy and Infectious Diseases (NIAID).A 50 percent increase for the Advanced Research Projects Agency for Health (ARPA-H).A 10 percent increase for NIH’s Fogarty International Center.A 9 percent increase for CDC.A 7 percent increase for the CDC Center for Global Health.A 9 percent increase for the CDC National Center for Emerging and Zoonotic Infectious Diseases.A 21 percent increase for global tuberculosis programs at CDC.A 16 percent increase for Global Public Health Protection at CDC.A 26 percent increase for BARDA.A 28 percent increase for the Global Fund to Fight AIDS, Tuberculosis and Malaria.A 7 percent increase to USAID global health programs, of which most goes to a 29 percent increase for global health security at USAID.New directivesIn addition to funding, spending bills are passed with corresponding plain-language texts called bill reports. which include directives from Congress. These reports do not hold the same legal power as the spending bills themselves, but they are a way for Congress to urge or direct agencies to change their policies or to spend their funding in specific ways. Nearly all GHTC’s requests for report language to Congress were reflected in the final FY23 package (either through the House bill reports or the joint explanatory statements, for those keeping count). Some notable wins include:Direction for USAID to increase health-related R&D funding and to consult with representatives of affected communities, as well as technical experts and nongovernmental organizations specializing in biomedical product development (House report).General continued support for USAID’s role in health-related R&D (House report).Requirement for USAID to submit a report on its health-related R&D investments (joint explanatory statement; also includes request for details on investment in antibiotic research).Request for an update from the Department of Health and Human Services on coordinating global health research activities using metrics (House report).Recognition of the need to increase resources for NIH’s Fogarty International Center and expand their role in pandemic preparedness and health research capacity-building (House report).Support for CDC’s role in global health security and developing and validating new global health tools (House report).Support for BARDA to provide robust funding for emerging infectious diseases and naturally occurring threats to global health security and to account for the constraints of low-resource settings in the development of new products (joint explanatory statement).Urges BARDA to publicly and regularly report on pathogen-, product-, and project-level data for all its funding (House report and joint explanatory statement).Relevant RidersThis year’s package also included quite a few riders—bills less relevant to funding that were amended onto the omnibus package. Nearly all elements of the PREVENT Pandemics Act were attached, including:Authorization of ARPA-H as a new entity within NIH. Despite its technical placement under NIH, the accompanying report language encourages ARPA-H to be physically and culturally separated. The authorization includes prioritizing awards to entities that conduct their work in the United States (a provision that GHTC has opposed).Establishment of a NIAID-BARDA “multidisciplinary research program with research centers to advance the discovery and preclinical development of antivirals and other medical products to combat priority virus families.”Expansion of the FDA fast-track designation for new antimicrobials that are biologics.The bill also includes several amendments to the US Food and Drug Administration (FDA) that had been dropped from the FDA user fees negotiations earlier this year. These include:Requesting a Government Accountability Office report on nonprofit pharmaceutical organizations, including the “impact of such organizations on the development, availability, and cost of prescription drugs, and any challenges to manufacturing or other operations.”Establishes a pathway for accelerating the review of advanced manufacturing technologies that either combine or incorporate novel technologies or techniques for manufacturing drugs, biologics, or active pharmaceutical ingredients.Requires sponsors of new drugs and devices to submit diversity action plans for clinical trials (exceptions permitting).Requires FDA to convene wide stakeholder meetings to solicit input on “increasing the enrollment of historically underrepresented populations in clinical studies.”Requires FDA to submit a report to Congress on progress for diversity action plans in aggregate.Requires FDA to issue guidance on decentralized clinical studies for drugs and devices and “how to advance the use of flexible and novel clinical trial designs” to increase diversity of participants.Requires FDA to issue guidance on the use of digital health technologies in clinical trials.In summaryDespite the delay, GHTC applauds lawmakers for passing increased funding, smart report language, and riders that will strengthen global health security and medical product regulation. The FY23 omnibus package is a significant win for most global health and global health research programs. Many pundits predict that in the next Congress we are less likely to see similar funding increases given the split control. Regardless, GHTC looks forward to working with offices on both sides of the aisle to advance bipartisan priorities for global health R&D.

The 2022 midterm elections on November 8 were expected to deliver a decisive power flip from Democrats to Republicans. However, as the new landscape comes into focus, it appears that Democrats will hold the Senate, and Republicans are likely to win the House of Representatives by a handful of seats. These margins and the composition of new committees will determine the trajectory of global health research and development policy over the next two years.Both chambers on a knife edge splitRepublicans underperformed most analysts’ projections in both chambers. In the House, they are expected to eke into power by only a handful of seats. In the Senate—where several Republican candidates failed to overtake their competitors in close races—Democrats have retained control and may even net gain one seat, depending on the outcome of a special runoff election in Georgia on Tuesday, December 6, between incumbent Senator Raphael Warnock (D) and Herschel Walker (R).Implications on makeup of key committeesNext steps for both parties include electing new party leaders, which is expected to happen later this year. Following that, early next year, the parties will designate committee assignments, which will impact oversight and policymaking for the next two years of global health research. In the House, committee majorities will be determined by who holds the majority in the full House. In the Senate, if the final split is 50-50, then committees will also be evenly split. But if Senator Raphael Warnock wins his reelection in Georgia, then the Senate will be 51-49, and Democrats will take the majority on each committee with one extra seat.Though we do not yet know exactly how the committees will look next year, we do know which members from the 117th Congress will return to the 118th and which current members will be stepping down.Leadership of most committees relevant to global health research and development (R&D) are expected to remain relatively stable with top Democrats and Republicans trading positions as chairs and ranking members. Some exceptions include Representative Karen Bass, chairwoman of the Subcommittee on Africa, Global Health, Global Human Rights and International Organizations, who is stepping down in pursuit of becoming the next mayor of Los Angeles and Rep. Hal Rogers (R-KY), ranking member of the House Appropriations State, Foreign Operations, and Related Agencies Subcommittee, who may become chair of the subcommittee or may be replaced by Rep. Mario Diaz-Balart (R-FL).Among the members currently serving on the House Foreign Affairs Committee who have retained their Congressional seats are Reps. Susan Wild (D-PA), Maria Elvira Salazar (R-FL), Young Kim (R-CA), and Abigail Spanberger (D-VA). Members who were defeated include Reps. Tom Malinowski (D-NJ) and Steve Chabot (R-OH). Some other members of Congress on relevant appropriating and authorizing committees to global health research who are retiring or lost their primaries earlier this year include Reps. Albio Sires (D-NJ), David Price (D-NC), Lucille Roybal-Allard (D-CA), Cheri Bustos (D-IL), Jaime Herrera-Beutler (R-WA) and Fred Upton (R-MI). In the Senate:There were no major losses among incumbents on the Foreign Relations Committee; Health, Education, Labor, and Pensions (HELP) Committee; or the Appropriations Labor, Health, nor on the Human Services, Education, and Related Programs (LHHS) and State and Foreign Operations subcommittees. Some big names will be retiring, including Sens. Richard Shelby (R-AL), ranking member on the Appropriations Committee; Roy Blunt (R-MO), ranking member on the LHHS Subcommittee; Richard Burr (R-NC), ranking member on the HELP Committee; and Rob Portman (R-OH).Some leadership changes are expected. Sen. Patty Murray, previous chair of the Senate HELP Committee, is expected to become the head of the Senate Appropriations Committee. The Senate HELP Committee will likely be led by Sen. Bernie Sanders (I-VT) and Sen. Rand Paul (R-KY) or Sen. Bill Cassidy (R-LA). The Senate LHHS subcommittee may be led by Sen. Joe Manchin (D-WV) and Sen. Marco Rubio (R-FL). Both 2022 GHTC Innovating for Impact award winners, Sen. Sherrod Brown (D-OH) and Sen. Todd Young (R-IN) retained their seats.  A potentially challenging landscapeWith Democrats elected to retain control of the Senate in the 118th Congress, leadership in both parties of the current Congress may be more interested in passing an end-of-year funding package so that the 118th Congress can begin with a clean slate. The same may not be true next year, though. If Republicans have a slim majority in the House as projected, it could empower more conservative members to dangle threats to regular governance, such as annual passage of an appropriations package, as bargaining chips—a threat some members have already referenced. Such a dynamic may also lead to hardball negotiations over raising the debt ceiling, a final agreement on which is due in July of next year. Ultimately, these dynamics could limit the potential for global health R&D funding growth in the next two years, despite the need for greater resources. Beyond the funding picture, if Republicans win control the House, they plan to increase oversight over many US government agencies, including several public health and research agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention. Oversight over the executive branch is a critical function of Congress, but aggressive oversight can also threaten the basic functioning of these agencies as staff efforts are redirected. This could ultimately impact the pace of progress for global health research and science in general.Looking aheadGlobal health R&D has historically received bipartisan support, yet this will be the first Congress to be seated after the COVID-19 pandemic, a global health catastrophe that has provoked some policymakers to question the value of certain types of research and the global health status quo. The results of this election are still being finalized, but regardless of who is in charge, there will remain opportunities for crafting and passing good policy. Whether progress happens and at what pace will largely depend on the ability of advocates to make the bipartisan case for why global health R&D is a force multiplier for creating a healthier and safer future for Americans and all global citizens.  

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.President Biden signed an executive order establishing a new national biomanufacturing initiative and pledging more than US$2 billion to fund building or expanding drug manufacturing facilities and ensuring an adequate supply of raw materials. The Biden administration’s goal is to strengthen the biotech supply chain and maintain US competitiveness with foreign manufacturers in the wake of major supply chain challenges and shortages during the COVID-19 pandemic. $40 million of the pledge will go toward expanding the production of antibiotics and the base materials needed to produce products for future pandemic responses.A new study looking at antimicrobial resistance (AMR) records from laboratories in 14 African countries found that the basic requirements for testing for drug-resistant pathogens are unmet in most areas despite plans to tackle antimicrobial resistance on the continent. The researchers found that only 1.3 percent of the 50,000 medical laboratories included in the study were conducting bacteriology testing. Of those laboratories that were, even fewer were equipped to test for AMR and among those who were testing for AMR, only a third of the high-priority antibiotic-resistant pathogens designated by the World Health Organizations were being tested consistently. The study highlights larger challenges in Africa including limited access to antibiotics, imperfect use of antibiotics, and a lack of information about the impact of AMR because of incomplete and fragmented data.The smallpox treatment tecovirimat, or TPOXX, is undergoing a phase 3 clinical trial to test efficacy in treating monkeypox after preliminary data from the Centers for Disease Control and Prevention showed some alleviation of symptoms in patients. The trial is being run by the AIDS Clinical Trial Group in locations nationwide and will enroll more than 500 people who test positive for monkeypox. The intent is to provide stronger data that federal officials and agencies can use to inform decisions about the use of TPOXX in the national response to monkeypox.