Breakthroughs Blog: USAID

As the partial government shutdown stretches into a fifth week – the longest in United States history – news of its impact on agencies essential to global health broadly, and research and development in particular, is taking clearer shape. While less visible than long lines at Transportation Security Administration (TSA) airport check-points, the consequences of shuttering the US Agency for International Development and furloughing broad swaths of the State Department and Food and Drug Administration workforce for more than a month will only become more obvious as the dispute between Congress and the administration over funding for a border wall continues.Here’s what we know now, based on news reports, anecdotal evidence, and intel from agency contacts:Food and Drug AdministrationThe Food and Drug Administration (FDA) has managed to continue many activities in the midst of the shutdown by drawing down on prescription drug user fees, with reviews of submissions filed and paid for ahead of the partial shutdown on December 22, but drug reviews will stop completely as that funding dwindles in the coming weeks. A sign-on letter sent this week on behalf of “millions of American patients, caregivers, healthcare providers, and researchers” raised alarm that the shutdown “has begun to put future scientific discovery and innovation in jeopardy” by forcing the FDA to “make difficult choices regarding to which essential functions its greatly reduced resources are directed,” and urging that “the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients.”State Department/PEPFAROn January 17, the State Department announced it would be “taking steps to make additional funds available to pay employee salaries” to resume most personnel operations and fund most salaries beginning this week and continuing through at least February 14. The announcement from Bill Todd, Deputy Under Secretary for Management, specified that “although most personnel operations can resume, bureaus and posts are expected to adhere to strict budget constraints with regard to new spending for contracts, travel, and other needs.” For the remainder of this interim fix, it appears most of the President’s Emergency Plan for AIDS Relief (PEPFAR), funded through the State Department, should be operating as usual.  US Agency for International DevelopmentIn advance of the shutdown, the US Agency for International Development (USAID) released guidance noting that about half of its 3,100 person staff would be furloughed, with the remainder exempt and expected to continue working, including “those who are funded through mechanisms other than annual appropriations; employees whose jobs are considered necessary for the protection of life and property or necessary to carry out the president’s constitutional duties; or those who are authorized because of their connection to operations that will continue.” While this allows many contract employees across the agency to continue working, only a handful of full-time agency staff within the Global Health Bureau are reported to be in the office.The development and global health community is slowly beginning to feel and communicate the impact of USAID’s staffing and funding shortages. Last week, Devex detailed one example of a USAID funding commitment delayed by the shutdown, though most development leaders they contacted for comment suggested that the shutdown has had limited effect thus far as USAID-funded programs continue operating on prior year funds, but could soon slow funding approvals and dry up grant funds if protracted. This week, we began to hear anecdotes from implementing nongovernmental organization partners to that end, detailing agency guidance to slow spending and even cease activities on some USAID-funded projects.The Washington Post reported this week that White House Acting Chief of Staff Mick Mulvaney has asked agency leaders to provide him with a list of high-impact programs at risk if the shutdown continues into March and April, which increased concern that a compromise is not imminent. On Thursday, two bills with the potential to end the shutdown failed in the Senate, and no immediate path to resolve this impasse and reopen the government has emerged. Of note, a spending package released by House Democrats last week – based on compromise bills drafted last year by House and Senate negotiators – which is expected to shape final funding outcomes, increased global health programs by US$147 million over fiscal year 2018 enacted levels, including boosts to HIV and AIDS, nutrition, tuberculosis, maternal, newborn and child health, and neglected tropical diseases, as well as positive language about USAID’s role in product development.GHTC continues to track reports of how the shutdown may be affecting global health research and development (R&D) activities. Please email Emily Conron (econron@ghtcoalition.org) to share details of any impacts your organization or partners are experiencing as a result of agency closures.

This afternoon, President Trump signed into law a spending bill that pairs full-year fiscal year (FY) 2019 funding for Labor, Health and Human Services (LHHS) and Defense with a stopgap measure to keep other agencies funded through December—staving off a partial government shutdown on the eve of the end of the fiscal year. The “minibus”-plus-continuing resolution (CR) legislation boosts funding for medical research across the Department of Health and Human Services (HHS) for FY19, while maintaining funding for global health at the US Agency for International Development and the Department of State through December 7 via the CR measure. Given Trump already signed into law a spending package covering Energy, Veterans Affairs, and the Legislative Branch, now 75 percent of the government is funded for the full fiscal year; while the remaining agencies will remain funded through the CR as lawmakers work to finish full-year funding bills for them. While this year’s appropriations approach may be unusual, by recent historical standards, it was also remarkably efficient: Today marks the first time in 22 years that the government has succeeded in getting at least five of the twelve annual spending bills signed into law before the new fiscal year begins. Here’s a breakdown of how global health and medical research funding fared in the spending package: National Institutes of Health The National Institutes of Health received an impressive US $2 billion boost overall (a 5 percent increase over FY18), including increases of 3-9 percent to each center involved in global health research and development (R&D). In increasing order, the package provided a boost of 3.4 percent for the Fogarty International Center, 3.75 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 5 percent for the National Institute of Allergy and Infectious Diseases, and 8.62 percent for the National Center for Advancing Translational Sciences. Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) also saw an overall increase from FY18 – depending on how you do the math. In the FY18 omnibus appropriations bill passed in March, CDC received a one-time $480 million funding infusion to support the construction of a replacement Prevention Biosafety Level 4 high containment laboratory to enable continued research on dangerous pathogens like Ebola. Less the cost of that lab, CDC’s overall year-on-year budget rose 1.63 percent. The Center for Global Health was level-funded, while the National Center for Emerging and Zoonotic Infectious Diseases received a 1 percent bump. The bill also established a new CDC-wide Infectious Disease Rapid Response Reserve Fund with an initial infusion of $50 million, a key win for global health security advocates. Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) saw a $25 million budget increase in the bill (a 4.66 percent boost). This—coupled with the House passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018—earlier this week, which reauthorized BARDA and authorized $250 million annually for five years for a new emerging infectious diseases program—is welcome news for those looking to BARDA to play an increasingly robust role in global health R&D. However, given the Senate still needs to pass their own version of a bill and continues to pursue a general all-hazards approach in their bill, a call out for emerging infectious diseases may not come to fruition in the final reauthorization. US Agency for International Development & State Department Global health accounts at the US Agency for International Development and the Department of State will be level funded through December 7 since the funding package signed into law today includes a CR for the State and Foreign Operations appropriations bill.   The bottom line: Yet again, strong congressional support has protected global health R&D from deep cuts to key agencies proposed in the President’s budget request and even won significant increases to some accounts. As we get closer to the midterm elections, we will keep a close eye on political developments that could affect our funding prospects for FY20.

For many mothers and babies around the world, the first 48 hours after birth are the most dangerous of their lives. For eight years, Saving Lives at Birth—spearheaded by USAID—has challenged problem solvers worldwide to create innovative solutions to make birth safer and save lives. Here are ten incredible innovations from this initiative: Many newborns struggle to breathe. While in developed countries, doctors use CPAP machines, these devices are too costly for most health facilities in low-resource nations. Fortunately, innovators at Rice University have developed a low-cost solution—the Pumani bCPAP. Delivering comparable treatment at 1/15th the cost, the Pumani has tripled the survival rate of babies with respiratory distress.   Blood pressure (BP) disorders like pre-eclampsia are a leading cause of maternal death. BP cuffs have been used to monitor BP since the early 1900s, but they can be hard to maintain and read by less-skilled health workers. A startup named Biospectal is reinventing this approach. It has developed the OptiBP, a cuff-less smartphone app that allows instant, accurate BP monitoring through a fingertip.   Affecting 60% of newborns, jaundice can cause brain damage or death if left untreated. In low-resource nations, doctors often don’t have access to costly lab equipment needed to diagnose the disorder. That’s where the BiliSpec comes in. Developed by Rice University, this handheld, battery-powered device can diagnose jaundice within two minutes using just a $0.05 paper strip and a drop of blood.   Even a small dip in a newborn’s temperature can put her life at risk. Continuous temperature monitoring is key to detecting issues early, but in overcrowded health facilitates, it can be hours between readings. To address this gap, Rice University developed the Neonatal Temperature Monitor—a simple, affordable tool to continuously monitor and display infant temperature, alerting staff of problems.   Malaria during pregnancy is dangerous for both mothers and their unborn babies. Researchers are studying whether a promising new malaria vaccine candidate—Sanaria’s PfSPZ vaccine—could offer a solution. The research team will test the vaccine in pregnant women and monitor the mothers and newborns post-birth. If successful, the project could radically change malaria management in pregnant women.   Poor water and sanitation in low-resource health facilities can expose moms and babies to infection at birth. Chlorine is a commonly used disinfectant, but supply chain issues make it hard for facilities to ensure a steady supply. PATH and MSR Global Health created an innovative, low-cost tool—the SafiStation Chlorine Generator—to produce chlorine on site using just water, salt, and electricity.     While stillbirths are common in poor regions, increasing evidence suggests that non-breathing newborns are often misidentified as stillborn when they have heart rates (HR) and could survive with resuscitation. To address this gap in care, researchers developed the NeoBeat, a low-cost, belt-like device that takes seconds to put on a baby and provides a continuous digital display of newborn HR.   Jaundice is common among newborns. Fortunately, if found and treated early it is also curable. To facilitate diagnosis and treatment in low-resource areas, innovators developed the Bilikit, a comprehensive package of low-cost tools to manage jaundice. The kit includes the Bilistick, a rapid, hand-held, portable diagnostic device, and the Bili-Hut, a portable, high-intensity phototherapy device.   Blood donation shortages in Africa can leave health workers with few options if a woman is hemorrhaging blood during childbirth. Attendants often resort to using a soup ladle and gauze to try to salvage and recycle a patient’s own blood. The Hemafuse pump by Sisu Global Health is a cost-effective, hygienic alternative. This tool sucks up blood, filters it, and transfers it to a bag for reuse.   Over 100,000 women die annually from postpartum hemorrhage (PPH) or excessive bleeding. PPH is treatable, but the tools widely used to control dosage are too costly or infrastructure intensive for low-income nations. That’s a problem Shift Labs hopes to solve with DripAssist—a low-cost, battery-powered tool that constantly monitors medicine flow via an IV drip, sounding an alarm if it fluctuates.   View as a video below: Photo credits: PATH/Doune Porter; Pumani bCPAP: 3rd Stone Design, GHTC; OptiBP: GHTC: Bilispec: Rice University, 3rd Stone Design; Neonatal Temperature Monitor: GHTC; PfSPZ vaccine: Leiden University Medical Center, GHTC; Safistation: PATH/Adam Drolet; Neobeat: Laerdal; Bilikit: GHTC, Bilimetrix srl Trieste, USAID, Little Sparrow Technologies; Hemafuse: Sisu Global Health; DripAssit: Medgadget, GHTC

Last Friday, President Donald Trump signed into law a US$1.3 trillion spending bill to fund the US government through the rest of fiscal year (FY) 2018. Reluctantly signed by the President among a flurry of “will he, won’t he” tweets, the legislation represents a forceful rebuke by Congress of the Administration’s proposal to drastically slash funding for global health and medical research programs. Key US agencies and programs that advance global health research and development (R&D) not only saw their funding protected in the spending bill, but many also saw increases. This outcome demonstrates that our community’s appeals and messages have not fallen on deaf ears and that Congressional policymakers on both sides of the aisle want to see the United States continue its leadership in advancing innovation to improve the health of those in need around the world. Here are some of the key takeaways from the 2,000+-page bill: US Agency for International Development & State Department While the Trump Administration proposed slashing funding for global health programs at the US Agency for International Development (USAID) and the State Department by 25 percent, Congress stood firm in protecting these programs. The bill ultimately sustained overall funding for these programs at FY17 enacted levels. A few programs received increases including a boost of $15 million for GAVI, the Vaccine Alliance; $20 million for tuberculosis (TB); and $15 million for maternal and child health. Funding for USAID HIV and AIDS programming and family planning at State and USAID, which the President proposed eliminating fully, was protected at FY17 levels. Congress also directed $135 million from repurposed Ebola emergency supplemental funding to support USAID’s global health security programs.   USAID plays a leading role in developing health technologies for low-resource settings through its various global health programs, so it is critical that these programs receive adequate funding, so they can continue to prioritize R&D among their other activities. In light of the President’s proposal for deep cuts to these programs, a combination of level funding for some programs and increases for others is a positive sign in the midst of a challenging budget environment. National Institutes of Health   Strong bipartisan support for the National Institutes of Health (NIH) continued for FY18. While the President proposed a 21 percent cut to NIH funding, the final spending bill instead provided the agency with an increase of $3 billion—8.8 percent—over FY17 levels. This represents a historic funding high for NIH in actual dollars with increases spread across various NIH institutes and programs. Notably, the National Institute of Allergy and Infectious Diseases received a 7.2 percent increase—39 percent above the President’s FY17 request—while the Fogarty International Center, which was targeted by the Administration for elimination, received a boost of 5.2 percent compared to FY17.   NIH is the world’s leading funder of R&D for neglected diseases, providing approximately 40 percent of total global funding, so any changes to its funding produce a ripple effect felt by global health research institutes and people around the world. It is encouraging to see Congress continue its record of bipartisan support for NIH and take action to strengthen our nation’s leadership in medical research. Centers for Disease Control and Prevention   The US Centers for Disease Control and Prevention (CDC) also received a plus up in the FY18 omnibus. The agency saw its funding increased by $1.1 billion—nearly 15 percent—over FY17 levels. This was in sharp contrast to the 16 percent cuts proposed by the Administration. The CDC Center for Global Health (CGH) received a 12 percent increase, compared to a 21 percent proposed cut. This included a $1.5 million boost for parasitic disease and malaria and a substantial increase of $50 million for global health security programming, which supports implementation of the Global Health Security Agenda (GHSA). Funding for global immunization and AIDS programming within CGH remained level. The National Center for Emerging and Zoonotic Infectious Diseases also received a more modest 5 percent increase over FY17 funding.   CDC plays a critical role in advancing technologies and improving health systems to better detect, prevent, and respond to infectious disease threats worldwide. There was much concern surrounding the FY18 budget for CDC as the agency is facing a funding cliff. CDC and USAID received $1 billion from the Ebola emergency supplement to fund GHSA, but this money is set to run out in 2019. As a result, the agency has already announced plans to scale back its GHSA work in 39 of 49 countries. While more funding is still needed to sustain these programs, and the agency has yet to clarify how it will adjust programming in light of its FY18 appropriations; it is promising to see Congressional appropriators recognize the value of CDC’s engagement in improving global health security. Biomedical Advanced Research and Development Authority   The Biomedical Advanced Research and Development Authority (BARDA), which develops medical countermeasures against health threats including emerging infectious diseases and antimicrobial resistance (AMR), also received a boost in the FY18 spending bill. The agency saw its funding increased by $25 million—about 5 percent—over FY17 levels.   BARDA has played an increasing role in R&D for naturally occurring threats and emerging infectious diseases in response to the Ebola and Zika epidemics. With its focus on bridging the “valley of death” in product development and its ability to use unique contracting mechanisms to forge innovative and long-term private-sector partnerships, BARDA is well positioned to make an impact in this space. However, the agency has been constrained by a lack of dedicated funding for its emerging infectious disease portfolio. While it is promising to see appropriators increase the agency’s overall funding for FY18, GHTC will be pushing for more dedicated funding for emerging infectious diseases in FY19. Department of Defense   The Department of Defense’s (DoD) activities in infectious disease research also saw increases in the omnibus. DoD’s Peer Reviewed Medical Research Program—a program that conducts research on AMR, diarrheal diseases, emerging infectious diseases, malaria, TB, and vaccine development for infectious diseases—received $330 million in funding, which is an increase of $30 million over FY17 levels.   The FY18 spending bill is a big win for global health R&D stakeholders and advocates, but this victory may only be temporary. The legislation funds the government through the end of September, and the Trump Administration has once against proposed drastic cuts to global health and medical-research programs for FY19. So while the ink dries on this year’s spending bill and we take a moment to celebrate, GHTC is already gearing up for another difficult battle ahead on next year’s budget.