Breakthroughs Blog: USAID

  2018 is shaping up to be another important year for US policy related to global health and medical research. As Congress returns for a busy work session and the White House continues to roll out policy reforms, here are the top five issues GHTC will be following in 2018: 1. US funding for global health R&D President Trump’s fiscal year 2018 (FY18) budget proposal called for dramatic cuts to global health, medical research, and public health accounts across the National Institutes of Health, US Centers for Disease Control and Prevention, US Agency for International Development (USAID), and the Department of State. While legislators pushed back sharply on these proposed cuts, Congress has not yet passed final FY18 spending bills. This means that we still do not have a final picture of what US government funding for global health and medical research will look like for this year. As Congress tries to navigate budget caps and other pressures that may constrain overall government spending, GHTC will continue to advocate for strong, stable public funding for critical global health and medical research programs. We’re also looking ahead to the fiscal year 2019 (FY19) budget and appropriations process, and bracing for a proposal from President Trump that may include even more significant spending cuts than those proposed in FY18. Despite verbal acknowledgement from the Trump Administration that US global health and medical research programs remain critically important, as the Administration continues plans to streamline government activities and reign-in spending, we do not expect to see prioritization of these issues reflected in Administration-driven spending proposals. GHTC will closely monitor FY19 proposals in the coming months and continue to engage with Congress, who ultimately sets government spending levels. 2. USAID and State Department reorganization As part of the Trump Administration’s plans to streamline and reshape the federal government, it has announced plans to reorganize the State Department and USAID. USAID plays an important role in global health research and development (R&D), supporting late-stage clinical research and implementation research as well as operating Grand Challenges to identify and advance promising health innovations from around the world. USAID and the State Department submitted reorganization plans to the White House Office of Management and Budget on September 15, 2017, but details of those plans have not yet been made public and further information remains scarce. GHTC will continue to monitor evolving plans and policy and strongly advocate for continued leadership of USAID in global health innovation. 3. BARDA reauthorization The Pandemic and All-Hazards Preparedness Act (PAHPA), which authorizes the Biomedical Advanced Research and Development Authority (BARDA), is due for reauthorization this year by Congress. In recent years, BARDA has played an increasingly important role in the advanced development of medical countermeasures for emerging infectious diseases, like Ebola and Zika, and antimicrobial resistance. Reauthorization presents a potential opportunity to bolster BARDA’s role in the global health R&D space. GHTC will monitor the PAHPA reauthorization process and work with Congress to support a strengthened role for BARDA in the emerging infectious disease space. 4. Global health security GHTC is also watching US efforts to promote global health security, including continued support for the Global Health Security Agenda (GHSA)—an international partnership launched in 2014 to help countries strengthen their ability to respond to health threats. The United States is now funding GHSA through the one-time emergency Ebola supplemental funding, which expires in FY19, so future financing for the program remains uncertain. Without renewed commitment and financial support for global health security activities, the United States will have to pull back critical disease detection, prevention, and response operations around the world. GHTC will also work to include R&D in global health security policy decision-making. During the two most recent global disease epidemics, Ebola and Zika, a lack of proactive, sustainable funding for R&D meant that United States and the world did not have the drugs, diagnostics, and other tools needed to contain these diseases. Despite this, GHSA in its current form lacks any prioritization or commitment to R&D to detect, prevent, and respond to global epidemics. As domestic and global discussions on global health security continue, GHTC will advocate for R&D as a critical component of epidemic preparedness and response. 5. US engagement with key multilateral bodies Multilateral organizations and partnerships are vital mechanisms to help advance a healthier and more secure world. In our modern and increasingly globalized world, new, emerging, or long-standing health challenges, which do not respect borders, cannot be tackled by individual countries alone. Strong US leadership and funding for organizations like the United Nations (UN), the World Health Organization, and the Global Fund to Fight AIDS, Tuberculosis and Malaria are key to advancing global health and ensuring that these organizations function effectively in support of US priorities. Despite several senior Trump Administration officials expressing support for strong multilateral engagement, the United States’ role in pushing for a recent $285 million cut to the UN’s overall budget appears more indicative of how the United States can be expected to engage in the near future. While it is currently unclear exactly how these cuts will be implemented across the various UN health-related programs, GHTC anticipates significant impact on the various UN technical agencies’ ability to support global health, including R&D. GHTC is committed to leading strong, coordinated action to advance US leadership in global health R&D in 2018 and beyond. The United States has long been a leader in global health, development, and medical research, and we look forward to sustaining and bolstering this legacy in the years ahead.  

There is no doubt that the past decade has brought transformative breakthroughs in global health innovation, from new medicines, to combatting leading child killers like malaria and tuberculosis (TB), to interventions that are making an AIDS-free generation possible. These game changers have saved millions of lives and helped unlock better health and opportunity for people around the world. The Global Health Technologies Coalition (GHTC) spent this past decade standing side-by-side in partnership with scientists and innovators, working to ensure they have the resources and supportive policies needed to advance innovation that truly drives impact. As we close out our tenth anniversary year and mark our first decade of advocacy, we wanted to take a moment to reflect on our shared progress and celebrate the headlines and moments that shaped global health research and development (R&D) over the past decade. Here are ten highlights: Could pills taken daily prevent HIV infection? That was a key question on researchers and activists minds in the early 2000s.By the end of the decade, the evidence pointed to yes. In 2012, the US Food and Drug Administration (FDA) approved the use of the antiretroviral drug Truvada as pre-exposure prophylaxis (PrEP) to prevent HIV infection. While it took several more years for PrEP to begin to be approved and introduced in low- and middle-income countries (LMICs), it has proved a powerful new tool in the global fight against HIV and AIDS. Revolutionary. Simple. Empowering. These are words that have been used to describe Sayana Press, an all-in-one injectable contraceptive developed by GHTC member PATH. Sayana Press combines a long-acting contraceptive with the easy-to-use Uniject injection system that involves minimal training, making it an especially suitable tool for low-resource settings and for women to self-administer. Since its introduction in 2014, more than 1 million doses of Sayana Press have been delivered to women worldwide, giving them greater power and autonomy over their reproductive health. Despite the fact that over 70 percent of all malaria deaths are children, before 2009 there was not a single high-quality malaria drug designed for kids. Instead, parents would crush adult tablets in what amounted to a daily struggle to provide an accurate dose as well as convince their kids to swallow these bitter tasting pills. This changed with the introduction of Coartem Dispersible, the first malaria medicine designed for children. Developed by GHTC member Medicines for Malaria Ventures, the medicine is affordable, easy-to-administer, sweet-tasting, and dosed for children. As of 2016, over 300 million treatments have been distributed worldwide, saving an estimated 750,000 lives. For more than a century, meningitis has ravaged a swath of the African continent known as the “meningitis belt,” killing one in ten people it sickened. But thanks to the efforts of a coalition of partners, including GHTC member PATH, we’ve stopped deadly meningitis A epidemics in their tracks. In 2010, MenAfriVac—a low-cost vaccine against mengingitis A—was introduced in Africa. Since then, more than 270 million people in 26 countries have been vaccinated, and thankfully, meningitis A is becoming a disease of the past. HIV and AIDS remains one of the greatest threats to women’s health globally, yet women and girls still lack the range of tools they need to protect themselves. Thanks to over a decade of effort by a unique partnership led by GHTC member the International Partnership for Microbicides, the future looks different. The partnership has advanced a new woman-center HIV prevention tool: a monthly, vaginal microbicide ring that deliver antiretroviral drugs. The groundbreaking new tool was found to reduce HIV risk in women in late-stage clinical trials in 2016, and it is now under regulatory review and poised for potential introduction worldwide. For parents with kids suffering from TB, getting their child to take multiple pills a day for months was a serious struggle, from trying to split up pills, to achieving the right dosage, to convincing children to swallow bitter tasting medicine. In 2016, this process became easier with the introduction of the first kid-friendly TB drugs. Developed by GHTC member TB Alliance, the drugs are appropriately dosed for children, dissolvable in water, and fruit-flavored to appeal to children. Already close to 80 countries, have adopted this improved treatment, with 700,000 courses ordered. Malaria has plagued humanity for tens of thousands of years. Fortunately, this past decade has brought a number of new and improved tools and approaches to tackle this age-old scourge, including the world’s first approved malaria vaccine, Mosquirix. In 2017, the World Health Organization announced plans to pilot the vaccine—developed by GHTC member PATH—in sub-Saharan Africa. While developing a high-efficacy vaccine against malaria has proved challenging due to the parasite’s complexity, Mosquirix, which reduced the rate of infection in children by 39 percent in clinical trials, is an important scientific breakthrough, and health officials hope it will prove a valuable addition in fighting malaria used alongside existing interventions. In 2014, the world’s deadliest Ebola outbreak caught the global community unaware and unprepared, devastating nations in Western Africa. While health workers went to work in the field to contain the immediate crisis, scientists went to work in their labs to develop a vaccine to prevent future epidemics. Thanks to research on Ebola vaccines that had been undertaken in the early 2000s, researchers were able to accelerate the leading Ebola vaccine candidate—RVSV-ZEBOV—from preclinical testing to phase III trials in less than two years. In 2016, it was announced that the vaccine was found nearly 100 percent effective in these trials. The vaccine could be approved by the FDA as early as 2019. More than two billion people worldwide suffer from hidden hunger—a condition characterized by deficiencies in micronutrients such as zinc, iron, and Vitamin A, which can cause stunted growth, blindness, and learning disabilities. In the 1990s, a young economist Howarth Bouis had a kernel of an idea: What if we could create better crops to provide better nutrition? His answer was biofortification, a process of naturally breeding sustenance crops so they are rich in micronutrients. After years of proof of concept research, in 2009, the nonprofit he founded—GHTC member HarvestPlus—introduced its first wave of crops in LMICs, providing nutrient-rich food for people in need. For decades, diagnosing multi-drug resistant TB (MDR-B) meant using older testing methods that took weeks to deliver results and required expensive laboratory equipment. In 2010, this began to change with the introduction of the Xpert MTB/RIF test, an automated diagnostic test developed by GHTC member FIND, which does not require microscopes or a laboratory, involves very little training to operate, and can deliver results in less than two hours, start to finish. FIND and partners will soon introduce a next-generation version—the Genexpert Omni—that is smaller, more portable, and battery-operated, which should further expand access to improved TB diagnosis. View a slideshow of more moments and milestones in global health R&D over the past decade. Here’s to ten more years of progress! At GHTC, we are proud to work with so many believers, innovators, and changemakers who are driving progress in global health. As we embark on 2018 and beyond, we recommit to continuing this momentum and look forward to another decade of advancing innovation to save lives.

On Tuesday, the Trump Administration released its full fiscal year 2018 (FY18) budget proposal, “A New Foundation for American Greatness.” As foretold by the “skinny budget” proposal released in March, this budget proposes dramatic increases in defense spending and border security, offset by cuts to discretionary spending—including significant cuts to programs that support global health and medical research at the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the US Agency for International Development (USAID). Dramatic cuts to global health programs at the State Department & USAID At a high-level, President Trump proposed roughly a 25 percent cut to global health programs at the State Department and USAID, when compared to final fiscal year 2017 (FY17) funding levels. Looking just at USAID global health programs, funding levels were reduced over 50 percent from FY17 levels, from US$3.05 billion to $1.5 billion. The Administration also used the budget proposal to advance goals of streamlining USAID and State Department operations to find cost savings and efficiencies. Despite strong bipartisan support for the United States’ flagship global HIV and AIDS program, the President’s Emergency Plan for AIDS Relief (PEPFAR), HIV and AIDS programs across State and USAID were targeted for cuts and consolidation. Direct funding for PEPFAR through the State Department received a $477 million cut, dropping to $3.85 billion from $4.32 billion, and USAID funding for complementary HIV and AIDS programs was zeroed—reflecting a funding cut of $330 million. The zeroing of HIV and AIDS programs at USAID also means associated research and development (R&D) funding for HIV vaccines and microbicides was eliminated. Man and woman standing in front of a sign that reads "USAID." (PATH/Felix Masi)Other funding cuts include a $62 million cut to global tuberculosis (TB) programs—including cuts to the TB drug facility and multidrug-resistant TB financing—a $65 million cut to maternal and child health programs, a $47 million cut to nutrition programs, and a $25 million cut to programs for neglected tropical diseases. USAID malaria programs (the President’s Malaria Initiative) received an $81 million cut, after factoring in a proposed $250 million transfer of remaining Ebola funds. USAID family planning programs were eliminated.Slashed funding for medical research at NIH and public health protection at CDC Biomedical research also saw significant cuts, with a proposed $7 billion or 21 percent cut to NIH. Of particular importance to global health R&D, the Administration proposed a $1.1 billion cut to the National Institute for Allergy and Infectious Diseases—which leads research in infectious diseases like HIV and AIDS, Ebola, and Zika—and elimination of the $70 million Fogarty International Center, which builds partnerships and trains researchers around the world. Instead, the Administration allocated $25 million to the Office of the NIH Director to coordinate global health research. At the CDC—our lead agency for preventing, detecting, and responding to public health threats at home and abroad—overall budgets were cut by $1.3 billion, over 15 percent. This included a $70 million cut to CDC’s National Center for Emerging and Zoonotic Infectious Diseases and an $85 million cut to the Center for Global Health.What happens next for global health R&D?These broad and wide-ranging cuts proposed for global health and medical research programs are deeply concerning, and threaten to reverse gains achieved through our landmark global health programs, stall progress in promising research, and ultimately jeopardize lives at home and abroad. They also are in stark contrast to stated goals of the Trump Administration to honor our commitments to global health, bolster global health security, and support high-priority biomedical science.Fortunately, Congress has ultimate control over government spending, and leadership on both sides of the aisle has asserted that dramatic cuts to foreign aid, global health, and medical research will not pass muster. As FY18 negotiations continue in Congress, GHTC will continue to stress the importance of global health R&D programs across the US government and highlight the critical role US-supported research plays in saving lives at home and around the world.

Office of Management and BudgetLast Thursday, the Trump Administration released an outline of its budget proposal for fiscal year (FY) 2018, proposing dramatic cuts to US agencies involved in global health research and development (R&D) including the State Department (State) and US Agency for International Development (USAID) and the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH). If enacted, these cuts would have significant impact on programs that advance global health innovation and protect the world and Americans from global disease threats. As an introduction to the Trump Administration’s budget priorities, this short and “skinny” budget outline lays out only high-level issues and proposes spending levels for top-line accounts. A more detailed funding proposal is expected in May that will include funding levels for individual agencies and programs. Still, while short on detail, the proposal is clear on targets for proposed reductions: the budget calls for nearly a one-third reduction in funding to State and USAID (cuts of $10.1 billion) and an 18 percent reduction in overall funding for HHS (cuts of $15.1 billion). Within HHS, a one-fifth reduction in funding (cuts of $5.8 billion) is proposed for NIH. The only US agency involved in global health R&D to receive a proposed increase in funding is the Department of Defense (DoD)—which is proposed to receive a 9 percent ($54 billion) boost. It remains unclear whether any of this increased funding would be directed to medical and infectious disease research. Reading between the lines, the President’s “skinny” budget foretells a challenging funding climate for global health R&D at State, USAID, and HHS: State Department and US Agency for International DevelopmentFunding for State and USAID was among the hardest hit in the President’s proposed budget. The blueprint calls for a 28 percent cut to State and USAID base funding, which grows to 30 percent when reductions to overseas contingency funds are included. USAID is a critical component of the US government’s support for global health R&D: In 2015, USAID provided nearly US$80 million in funding to support global health R&D. Cuts to USAID funding could stall promising innovations under development and halt efforts to roll out new technologies in USAID programs. While the President’s proposal does express support for US global health initiatives including the President’s Emergency Plan for AIDS Relief (PEFPAR); the Global Fund for AIDS, Tuberculosis and Malaria; Gavi, the Vaccine Alliance; and US malaria programs; the level of support proposed for these programs remains unclear. Language in the blueprint does not indicate if these programs would continue robust or expanded activities, or indicate whether these programs would be supported at current funding levels. It is also important to note that not all global health programs were called out in the budget, leaving uncertainties about how critical programs supporting maternal and child health, nutrition, tuberculosis, and neglected tropical diseases will be prioritized by the Administration. The budget also articulates a dramatic overall shift in America’s approach to diplomacy and development assistance with specific proposals calling for consolidation of State and USAID activities, linking aid and assistance to strategic interests, and reducing funding for the United Nations and affiliated agencies. It will be important to continue to monitor the impact of these proposals. Department of Health and Human Services The Administration’s budget proposes an 18 percent reduction to HHS funding across the board—cuts that if enacted would bring HHS to its lowest level of funding in nearly two decades. This would significantly reduce funding for HHS agencies engaged in global health R&D, including NIH, the US Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Biomedical Advanced Research and Development Authority. Not only would cuts of this level have real impact on ongoing and future research needs, they could also undermine America’s leadership in global health R&D and diminish our ability to prevent, detect, and respond to emerging health threats. A full picture of the President’s proposal for HHS is not yet available, but limited details follow below: National Institutes of Health The President’s budget proposes a 19 percent cut to the NIH budget. NIH leads the world in financial support and technical expertise for global health R&D—so cuts of this magnitude would have a detrimental and lasting global impact on ongoing and future research projects. The budget also proposes a reorganization of NIH Institutes and Centers and calls for the elimination of the Fogarty International Center. Fogarty plays an important role in global health R&D. Its programs build partnerships between US and international researchers and strengthen the capacity of scientists in low-income countries to address critical global threats like HIV and AIDS, Ebola, and other emerging infectious diseases. Calls to eliminate this center are concerning. Cutting the Fogarty Center—a small center with a $70 million budget—would save little in the overall federal budget, while increasing our vulnerability to global disease threats. The President’s blueprint also calls for a “rebalance” of federal contributions to NIH research funding, which warrants careful consideration and further monitoring. If NIH research priorities are shifted to align only with disease burden in the United States—as is sometimes proposed—important research on neglected diseases and conditions will be jeopardized, ceding US leadership in this arena and potentially leaving Americans more vulnerable to infectious and emerging disease threats. Centers for Disease Control and Prevention and health preparedness The President’s budget proposal does not include overall funding levels for CDC, nor does it call out specific CDC programs for support or reductions. However, given the magnitude of cuts in the overall HHS budget, it is clear CDC funding is also at risk. The only CDC mention in the blueprint is a proposal to shift $500 million in CDC funding to block grants to be administered by the states. While details on this proposal are scarce, it’s likely these funds would be repurposed from within CDC’s budget, rather than represent new funding. CDC leads the United States’ public health defense system against infectious diseases, so robust funding for the agency is a global health and national security imperative. The agency plays a unique and important role in global health R&D by developing new tools and techniques for disease surveillance, training researchers and health workers overseas, and developing new health tools to advance disease detection, prevention, and response efforts. The budget also proposes the creation of a new Federal Emergency Respond Fund to enable rapid response to public health threats like Zika or Ebola. Such a dedicated fund has been championed by many public health leaders, including former CDC Director Tom Frieden. However, in the President’s request, there are few details regarding the fund’s approach or operations. It remains unclear how large the fund would be, whether it would support preventative R&D, or whether funding for the program would come at the expense of current US government emergency response and preparedness initiatives. As the budget proposal also call for reforms to “key public health, emergency preparedness, and prevention programs” under HHS—which could include CDC and other global health security programs—there remains more questions than answers. Food and Drug Administration The FDA also plays an important role in global health R&D by facilitating the review of new global health products to ensure they are safe and effective before entering the market. While the President acknowledged the need to direct more funding to the FDA, the budget blueprint does not propose increased government support for the agency, but rather calls for doubling user fees paid by healthcare companies for the regulatory review of their products—from $1 billion to $2 billion. Noting the constrained budget environment, the proposal says that companies benefiting from FDA approval “can and should pay for their share.” In addition to user fee increases, the Administration also proposes to take new, unspecified actions to speed the development and approval process for drugs and other medical products. Patient advocate groups and the private sector alike have stressed their belief that current review procedures appropriately balance thorough review of safety and efficacy with efforts to expedite products through the review process. Department of Defense The Presidential budget proposes a 9 percent ($54 billion) increase to discretionary funding for DoD. DoD plays a critical role in R&D for infectious diseases; however, the budget blueprint does not address DoD’s medical research activities and provides little information about what increased defense funding may be targeted. Congressional response and next steps The President’s budget proposal is the first official declaration of policy and spending priorities for the Administration and marks the beginning of months of discussions within Congress and the Administration on how best to allocate funds. Congress ultimately controls government spending, and many members on both sides of the aisle have expressed skepticism or criticism about the Administration’s budget blueprint, including its proposed cuts to foreign assistance and medical research. While there are calls in Congress to reduce government spending, and we may see cuts to US agencies engaged in global health R&D, the spending bills passed by Congress will likely look much different than the President’s proposal. GHTC will continue to monitor the FY18 budget and appropriations process and advocate for robust funding for all programs that support global health R&D.