Breakthroughs Blog: USAID

Earlier this month, GHTC obtained a copy of a report that the US Agency for International Development (USAID) submitted to Congress in November 2024 on its global health research and development (R&D) activities. This report—which was mandated by Congress but never released publicly—provides detailed information on the R&D investments made across health areas and the specific innovations supported by the agency in fiscal year (FY) 2023.Given USAID’s decades-long track record of advancing affordable, high-impact global health innovations, GHTC closely monitors these annual R&D reports to track shifts in the agency’s investments and innovation pipeline and to help ensure that taxpayer resources are strategically directed toward the greatest global health impact. While each year’s report is noteworthy and essential for accountability, this latest report is of particular significance, as it gives the clearest picture we have to date of what health R&D USAID was funding prior to recent funding shifts. It also offers a stark illustration of the scale of promising research that is now at risk.  Our analysis of the report along with circulating lists of active and canceled USAID awards suggest that the vast majority of R&D programs and partnerships highlighted in the report have since been terminated as the United States rapidly scales back its foreign assistance footprint and reorients its approach to foreign policy. What’s changed from FY 2022 to FY 2023?Before analyzing the potential impact of recent political shifts, we first examined what had changed in USAID’s funding approach from the prior reported year. Our analysis shows a slight decrease from FY 2022 to FY 2023 in products and projects supported by the agency but an overall increase in funding allocated to health R&D.The report appendix details 56 individual products or projects supported by USAID R&D investments in 2023, which is down slightly from the 63 listed in 2022. Overall, the agency’s portfolio in 2023 looked similar to 2022 in terms of the health areas and product types financed, with the addition of new investments in diagnostics for emerging infectious diseases. The report also revealed that in 2023, USAID budgeted $252.2 million in funding for global health R&D projects—an increase of $37.4 million, or roughly 17 percent, from 2022. This is noteworthy as it represents the highest non-inflation-adjusted baseline funding for R&D ever reported by the agency since 2006. This a welcome increase, and it also indicates that USAID was following a report language directive from Congress for the agency to increase its annual health R&D spending (for which GHTC had advocated).The largest increases were seen in funding for global health security R&D, which grew by $41.96 million or 68 percent, and funding for “other public health threats,” which grew by $5.86 million or 114 percent from the prior year. The latter is a catchall that appears to include funding for neglected tropical diseases; water, sanitation, and hygiene; health system strengthening research; and anything else that falls outside the groupings of HIV/AIDS, tuberculosis (TB), global health security, maternal and child health, family planning and reproductive health, and nutrition.USAID funding for R&D for TB and nutrition also grew by 14 percent and 44 percent respectively. Meanwhile, funding for HIV/AIDS remained the same, while funding fell for family planning and reproductive health by 54 percent, for malaria by 26 percent, and for maternal and child health by 20 percent. It’s not entirely clear to what degree these changes reflect a shift in political prioritization versus the normal cyclical shifts that can occur in R&D costs as products advance through the R&D process. Other contributing factors may include increased private-sector investment, particularly in areas like HIV; strategic pivots toward later-stage implementation or procurement; and adjustments based on the anticipated regulatory or market readiness of specific technologies.While the $252.2 million budgeted funding for R&D in 2023 represents the highest ever reported by the agency, when R&D spending is calculated as a proportion of overall USAID global health spending, there is far more tempered cause for celebration.While proportional spending on R&D in FY 2023 rose slightly by 0.51 percent from FY 2022, bringing it to just over 6 percent, this is still below the 8 percent peak that the agency spent on R&D in 2006, representing a slight upward slope in an otherwise years-long trajectory of decline in the agency’s proportional R&D spending.A higher proportion investment helped ensure that the United States remained a leader in driving innovation for diseases disproportionately affecting low- and middle-income countries.What’s now at risk?While GHTC is pleased to see the increase in USAID’s FY 2023 global health R&D funding and the increased proportion of overall global health spending it represents, this report highlights the many promising research advancements now at risk and the valuable agency expertise that could be lost amid recent political shifts.It is challenging to determine with certainty which USAID-supported R&D efforts listed in the report have been ended under the US government’s foreign assistance overhaul, given 1) that there have been different and contradictory lists reported of which USAID awards remain active/terminated, and 2) the appendix of USAID-supported health products/projects included in the R&D report does not include associated award IDs, names, or prime recipients, making it difficult to definitively compare and match projects against the aforementioned lists.However, using the descriptions and partners listed and leveraging additional online research, our own sectoral knowledge, and self-reported information from our members and partners, GHTC has attempted to match this information. Based on our analysis, we believe at least 49 of the 56 products/projects listed are associated with USAID awards that have been terminated (six were identified as active and one was affiliated with an award that ended in 2024).Given the recent actions taken to minimize USAID’s footprint and fold its remaining programming into the Department of State, we are unlikely to see a report on R&D investments undertaken in FY 2024—possibly leaving us without a full accounting of what’s been lost and the R&D community without essential data needed to understand the progression of these promising investments.Among the USAID projects we know are canceled from our analysis include efforts to develop the world’s first HIV vaccine, new tools to combat drug-resistant TB, next-generation malaria vaccines, novel insecticides and other vector control products, point-of-care diagnostics for neglected tropical diseases, and new HIV prevention products, including those designed for women and girls who are at high risk of infection.These findings are worrisome on many fronts. First, these changes risk squandering past progress and investments, and jeopardizing the next generation of promising global health breakthroughs. Today, we are still without essential technologies needed to achieve a future where pandemics are prevented and health is within reach for everyone—underscoring the need for donors to sustainably increase, not reduce, their investments.Second, USAID has for decades brought unique value, vision, and capabilities to the global health innovation space by focusing on the late-state development of technologies that are affordable, appropriate for last-mile settings, and prime for widespread global adoption. Career staff at USAID also had very strong subject matter expertise. There is concern that these skills and capabilities could be lost as the US government’s foreign assistance structure is reimagined and rebuilt, meaning that terminations and the broader foreign aid overhaul will have an outsized impact on the R&D ecosystem.Finally, these investments also deliver substantial returns to the United States by strengthening our economy, creating American jobs, and keeping Americans safe from deadly diseases—benefits that could now be lost as the United States draws back its support. Between 2007 and 2002, $46 billion in US government investment in global health R&D led to $104 billion in direct economic activity and the creation of more than 600,000 jobs nationwide. The follow-on effects from US-backed global health research are projected to generate $255 billion for the US economy.As the US government overhauls and reimagines what the future of US foreign assistance will look like, we believe it is critical that science, technology and innovation remain a cornerstone of its global health mission. These are strategic, win-win investments that bring benefits to the world and to Americans.See the below links to past USAID health R&D reports and strategies, which are no longer available on government websites.20082009201020122013201420152016Strategy (2017-2022)20172018201920202022Strategy (2023-2028)20232024

In 2001, I traveled to Ghana as a graduate student working on a US Agency for International Development-funded decentralization program. I arrived armed with materials on local governance best practices. But the mayors I met were focused on urgent public health issues: clean water, HIV/AIDS, tuberculosis, and malaria. That trip, meant to be an early lesson in governance, became my first and most personal education in global health. It also nearly killed me. I was taking mefloquine weekly to prevent malaria. Toward the end of our stay, my partner and I set off to explore the country. Somewhere along the way, I developed what I believed to be giardia. That infection likely compromised the absorption of the mefloquine and left me dangerously vulnerable. One night in the village of Kokrobite, I woke with a high fever and chills so intense I could barely stand. A local man saw me and immediately recognized it as malaria. He arranged for a taxi to take me back to Accra. Before I left, he handed me a small, crumpled packet labeled in Chinese characters. Inside was a blister pack of pills. The only word written in English on the package was artesunate. He told me it would help, and, in that moment, sick, scared, and weak, I took it. At the hospital, a blood smear confirmed that I had cerebral malaria caused by Plasmodium falciparum, the deadliest strain. Cerebral malaria can cause brain swelling, coma, and death. I drifted in and out of consciousness for days. At one point, hospital staff told my partner that there was nothing more they could do. I should “go home” and be “as comfortable as possible.”My partner worked relentlessly to get me on one of the next flights back to the United States. I was so sick that the airline nearly refused to let me board. Once we arrived home, I was seen right away by an infectious disease doctor at Johns Hopkins Hospital. After reviewing my labs and the herbal remedy package, he said plainly: this saved your life. The artesunate had bought me enough time to survive the journey and begin treatment. At the time, the World Health Organization had not yet formally endorsed artemisinin-based combination therapies (ACTs) as the global standard for P. falciparum malaria. That came in 2006. But the effectiveness of artesunate alone was already well known in many parts of the world. That medicine saved my life.I missed several weeks of school but made a full recovery. Without that drug and the help of my partner (now my husband) and friends in Accra, I wouldn’t be here today. More than two decades have passed, and we've made tremendous progress. Insecticide-treated bed nets, rapid diagnostic tests, and ACTs have saved millions of lives. Two malaria vaccines, RTS,S and R21/Matrix-M, have been approved. Long-acting monoclonal antibodies are showing promise as seasonal protection for children. Newer insecticide-treated nets help counter resistance. And researchers are exploring RNA-based therapeutics and single-dose cures.Many of these breakthroughs are being developed by members of the Global Health Technologies Coalition, where I now serve as Executive Director. These tools represent our best chance not just to control malaria but to end it.But progress is not guaranteed. Cuts to foreign assistance and global health research and development are already slowing the progress of innovations in the pipeline. Some promising tools may be delayed or abandoned. That means more children at risk, more untreated infections, and more drug-resistant strains emerging. The parasite has evolved before. It will do so again if we let it. And malaria is no longer a disease that happens mostly outside of the United States. In the past two years, locally acquired cases have been reported in Florida, Texas, and Maryland. Climate change, global travel, and changing mosquito habitats are making malaria a threat we can no longer treat as distant. I know how thin the line is between surviving this disease and not. For me, it’s not abstract. It’s the memory of a fevered body, the generosity of strangers, and a medicine in the right place at the right time. This World Malaria Day, I urge leaders and policymakers to stay the course. The science is moving forward. But science alone isn’t enough. If we don’t finish what we’ve started, we risk letting malaria surge back and take more lives with it. Science has given us the tools. The question now is whether we will act in time or let the disease outpace us once again. 

An estimated 257 million women globally who want to avoid pregnancy are not using safe, modern contraceptive methods, leading to around 121 million unintended pregnancies globally every year—nearly half of all pregnancies. Ensuring all who wish to use contraception have access to safe, effective, and acceptable options can enable all people of reproductive potential to enjoy greater autonomy over their lives and health. To meet the diverse needs of people of reproductive age, we need a variety of new contraceptive choices, including options that are longer-lasting, more discreet, have fewer side effects, and require fewer visits to a health care provider, as well as additional options for men to take more of the burden of pregnancy prevention off the shoulders of women. In recognition of this year’s World Contraception Day, GHTC is highlighting six technological solutions in the pipeline that could enable greater access to contraception by breaking down barriers, especially for underserved populations and those in low-resource settings. 1. Next-generation contraceptive vaginal rings   Intravaginal rings—flexible silicone rings that are self-inserted into the body and release contraceptives—offer an easy-to-use, convenient, and discreet contraceptive option for many women worldwide. Today, women can choose from either a monthly or a yearly ring—the latter of which was developed by Population Council and first approved by the US Food and Drug Administration (FDA) in 2018. However, both ring options use a combination of the same estrogen hormone, ethinyl estradiol, and different types of progestin hormones. While these hormone options work well for many individuals, for others, they can cause side effects or risks, creating a need for rings with alternative hormones and rings that are nonhormonal. Thankfully, several next-generation rings are on the horizon.These next-generation options include two rings under development by Population Council, which use alternative hormones. The first, the three-month Nestorone®/estradiol intravaginal ring uses a form of estrogen that, unlike ethinyl estradiol, is not associated with an increased risk of blood clots in the veins among women with a higher body mass index—who account for 15 percent of adult women. It is currently being evaluated for use in women with a higher body mass index in a Phase 2b study.  The second, the Nestorone®-only vaginal ring, has no estrogen, offering an alternative for those who have estrogen sensitivities, those who are at higher risk of blood clots, and postpartum breastfeeding mothers, who are often advised against using hormonal contraception that contains ethinyl estradiol due to its effect on milk production and composition. The ring will soon undergo a Phase 2 dose-finding study.On the nonhormonal front, Daré Bioscience is developing Ovaprene®, a monthly vaginal ring which uses a “semi-permeable polymer mesh barrier” to physically stop sperm from entering the cervical canal. Early clinical studies found that the ring is well-tolerated and acceptable to sexually active women and their partners. Additional clinical trial results announced in 2024 also demonstrated safety and efficacy, paving the way for a Phase 3 trial now underway.2. Biodegradable contraceptive implant  Today’s contraceptive implants are small, flexible rods inserted under the skin that continuously release hormones for pregnancy prevention. While they are safe and long-lasting, after three years, they must be removed by a medical provider. That can be an issue, particularly in low-resource settings worldwide where fewer trained health care workers, distance, and cost can serve as barriers to care. Biodegradable contraceptive implants, which dissolve into the body, offer promise as a more convenient option that could improve access by cutting out the need for a trip to a medical facility for device removal.FHI 360 and development partners pH Sciences and Gesea Biosciences, with funding from the Bill & Melinda Gates Foundation, developed a biodegradable implant called Casea S, which can provide protection against unintended pregnancy for 18 to 24 months. The implant is now being tested in a Phase 1 clinical trial, the first trial for a biodegradable contraceptive implant in more than 20 years.3. Microneedle contraceptive patches   Many women choose to use injectable forms of contraception for long-acting protection, but, for others, the need for regular shots and visits to a health care provider can make this a less desirable choice. But imagine if these injections were pain-free and did not require leaving home. That is the promise of microneedle or microarray patches, which are small Band-Aid-like patches that contain hundreds of microneedles that slowly release drugs into the body when pressed against the skin. The new technology, which is also being developed to deliver vaccines and therapeutics, could offer a discrete, user-controlled, and less painful option that could either be self-administered or administered by a health care provider with minimal training.  With support from the US Agency for International Development through the US President’s Emergency Plan for AIDS Relief, PATH is developing an easy-to-use, discreet, and self-administered contraceptive patch that could provide protection against unintended pregnancy and HIV, which is currently in preclinical development.FHI 360, in partnership with Population Council and the Georgia Institute of Technology, is also developing a three- to six-month, biodegradable, and progestin-only patch currently in the preclinical phase, with support from the US Agency for International Development and the Gates Foundation.4. Longer-acting contraceptive injectablesThe most commonly used contraceptive injection, depot-medroxyprogesterone acetate (DMPA), approved by FDA back in 1992, offers a longer-lasting option than the daily pill, with a three-month period between injections. However, DMPA requires users to return often to their health care providers, and it has the highest discontinuation rate among contraceptives in the United States due to unpleasant side effects like menstrual irregularities, weight gain, and bone density loss.FHI 360 is in the midst of a Phase 3 trial testing a six-month version of DMPA that is injected under the skin rather than into the muscle, which could offer a longer-lasting, lower-dose option that is more convenient and presents a lower risk of side effects for users. The product, which is the furthest-along six-month injectable in the pipeline, could be approved as early as 2025 or 2026 if trials prove successful.  FHI 360 is also developing a six-month self-injectable contraceptive that uses levonorgestrel rather than DMPA and is being advanced through Phase 1 clinical trials in collaboration with the Shanghai Institute for Biomedical and Pharmaceutical Technologies, with funding from the Gates Foundation. This product could offer another longer-lasting option with potentially fewer side effects and the convenience of using it at home.  5. Male contraceptivesThe need for male contraceptive options beyond condoms and vasectomy to allow men to more equally share the responsibility of contraception has been widely and increasingly recognized. There are a number of technologies in development, including technologies that use hormones to disrupt the sperm creation process. Population Council has developed a novel, easy-to-use, and reversible gel hormonal contraceptive method that is applied daily to the shoulders and, if approved, would be the first-of-its-kind option for men. Early studies showed that it is well tolerated and causes no serious adverse events. A Phase 2b study yielded promising results, with a second part of the trial now underway. The gel, which could enter the final phase of testing in 2025 with the go-ahead from FDA, has made it excitingly far in a pipeline lacking in male contraceptive technologies beyond the preclinical stage.While hormonal strategies require a long time to start and stop working because of the considerable months-long sperm development process and could have side effects due to hormone disruption, there are also nonhormonal technologies in early-stage development. These nonhormonal strategies target specific processes later in sperm development and could start and stop working more quickly, perhaps even to the point of an on-demand product taken right before intercourse. One recent study in mice identified a new nonhormonal, reversible method that targets a protein complex important during sperm production, with the drug successfully stopping the process without producing side effects or causing irreversible effects. Another recent study in mice identified a different protein target necessary for fertility, finding similarly positive results.  Contraline and Next Life Sciences are also developing nonhormonal products that work by blocking the vas deferens, the tube in the male reproductive system that transports sperm, with an injectable gel. Contraline announced positive interim results from a first-in-human trial earlier this year. 6. Dual-use technologies for HIV, STI, and pregnancy preventionMultipurpose technologies that protect against unintended pregnancy, HIV, and other sexually transmitted infections (STIs) could be a game-changer in opening up access to prevention tools, particularly in low-resource settings, by reducing the burden on users and the health care system.In addition to the aforementioned microneedle patch for HIV and unintended pregnancy prevention, Population Council is developing several dual-use products. The two products likely to reach market fastest are a dual-use pill, which reformulates already approved medicines for oral pre-exposure prophylaxis and oral contraceptives into one tablet to be taken daily, and the dapivirine-levonorgestrel vaginal ring, which builds on the successful development of the one-month dapivirine ring for HIV prevention with a three-month ring that slowly releases the antiviral drug dapivirine and the contraceptive hormone levenorgestrel, drugs already approved in other forms. Other products in early development include a nonhormonal vaginal ring and a nonhormonal fast-dissolving vaginal insert, both designed to provide crosscutting protection against unintended pregnancy and STIs.Currently, contraceptive research and development is greatly underfunded, and there is an urgent need for new and improved products to better serve particular populations and those living in low-resource settings. The contraceptive technologies detailed above and others in the pipeline offer hope that we will in the future have a robust array of contraceptive options to ensure everyone globally who wants to use contraception has access to a product that works for them.  

Executive Director of the Global Health Technologies Coalition (GHTC) Dr. Kristie Mikus issued the following statement following the Senate Committee on Appropriations’ passage of the fiscal year 2025 (FY25) State, Foreign Operations, and Related Programs (SFOPS) bill:GHTC applauds the work of Senators Chris Coons (D-DE) and Lindsey Graham (R-SC), Chair and Ranking Member of the Senate Appropriations SFOPS Subcommittee, and Senators Patty Murray (D-WA) and Susan Collins (R-ME), Chair and Ranking Member of the full Senate Committee on Appropriations, for ensuring critical funding for US global health programs under increased fiscal pressure.  We especially thank Senate appropriators for including language in the Senate’s FY25 SFOPS appropriations report recognizing the importance of funding for global health research and development (R&D) and directing the US Agency for International Development (USAID) to examine the feasibility of creating a new dedicated global health R&D budget line.  This language is an important step toward realizing a GHTC-led proposal to create a Supporting Innovative Global Health Technologies (SIGHT) Fund—a flexible, disease-agnostic fund to be housed at USAID that would infuse new funding into R&D efforts to close the biggest gaps in our global health toolkit.R&D partnerships led by USAID have been instrumental in saving and improving millions of lives around the world while at the same time protecting the health of Americans and stimulating jobs here in the United States. US investments in global health R&D have infused $104 billion into the US economy and created more than 600,000 US jobs since 2007.  Appropriating dedicated global health R&D funds at USAID, to be implemented via a program like the SIGHT Fund, would intensify this tremendous impact and offer significant advantages over funding R&D solely through health-area-specific funding streams. It would ensure a strategic focus on innovation by reducing the trade-off between funding the implementation of existing tools and developing new and improved ones, as well as preserve the effectiveness of ongoing programs, enhance accountability, encourage risk-taking and partnerships, and strengthen the global health infrastructure for future challenges.    As the SIGHT Act (H.R. 6424)—legislation that would authorize the creation of a new global health R&D budget line—works its way through Congress in parallel, we are encouraged to see the Senate FY25 SFOPS report lay the groundwork for the incoming president to request—and Congress to appropriate—disease-agnostic funds specifically for global health R&D that are distinct from and do not compete directly with funding for program implementation or any other purpose.  GHTC calls on appropriators and authorizers in the House and Senate to build on this momentum and support USAID's global health R&D mandate by advancing the SIGHT Fund's mission in this and the next Congress. By committing to dedicated R&D funding, Congress can empower USAID to make groundbreaking advances in global health that could save millions of lives and improve health outcomes worldwide.