Breakthroughs Blog: HHS

From the development of new drugs for malaria and tuberculosis to the mapping of debilitating but preventable diseases, research and development (R&D) can be a catalytic force for scaling up impact. Many of USAID’s [US Agency for International Development] global health successes in preventing child and maternal deaths, controlling the HIV and AIDS epidemic, and combating infectious diseases can be partially attributed to breakthrough research and development that altered the course of an illness or accelerated diagnostics and treatment through breakthrough innovation and ingenuity. This year’s report to Congress coincides with our new five-year strategy, which focuses on three interrelated goals. Our first goal is to accelerate the development, introduction, scale-up, and sustained use of new technologies, health tools, and approaches; secondly, we want to influence the adoption of priority life-saving health and development interventions; and finally, we want to strengthen the capacity of people, systems, and partnerships to conduct research and utilize results to improve health outcomes.Photo caption and credits: A lab technician in Rwanda. Riccardo Gangale for USAID/ Courtesy of Photoshare  Although R&D can take years to come to fruition, when it does, it can save lives and be a total game changer. Take malaria for instance. One of the most notable areas of R&D investments for USAID is the development of new vaccines, medicines, and insecticides for malaria prevention and control, as well as research to improve malaria programs. Many lives have been saved since the launch of the U.S. President’s Malaria Initiative (PMI) in 2005, but continued success depends on strategic R&D investments.Last year, the sustained efforts of many partners paid off and led to the development of three new classes of malaria drugs, including the drug Tafenoquine which, if approved, could be the first new medicine to treat relapsing malaria in more than 60 years. In Cambodia, research on the safety and tolerability of single, low-dose Primaquine, a drug used for reducing malaria transmission, has been recommended for adoption in areas moving toward malaria elimination.Another health challenge with the potential for high returns on investment in terms of R&D is multidrug-resistant tuberculosis (MDR-TB). USAID knows from experience that this is a very complex and expensive disease to treat because of its severity and long-term treatment plan, which is why the agency has been supporting several clinical studies evaluating the efficacy of shorter drug regimens.For treatment that can last for as long as two years, medicine adherence has been a huge challenge in combating MDR-TB. Shorter and simpler to administer regimens may help increase adherence and acceptability, while decreasing side-effects and transmission. Interim results from STREAM Stage-1, one of the USAID-supported studies of shorter MDR-TB regimens, have potential to inform global guidelines and improve the lives of millions of people.Along with high-quality research, USAID has continued to invest in ground-breaking tools and innovations that have been deployed in countries around the world. These cost-effective tools have not only saved lives, but millions of taxpayers’ dollars. They have also contributed to strengthening our national security by enabling countries to mitigate impact and contain the spread of infectious diseases.During the 2015-2016 Zika outbreak in Central and Latin America, for instance, USAID supported 26 innovations to combat Zika and future threats through the Combating Zika and Future Threats Grand Challenge. Innovations range from mosquitoes infected with Wolbachia, a naturally-occurring bacteria that prevents the transmission of diseases to humans, to a disease surveillance digital platform that could protect vulnerable communities from becoming hot spots not only for Zika but also for malaria, dengue, chikungunya, and other infectious diseases, including currently known and unknown threats.School students in Paris, Colombia participate in growing and releasing their own Wolbachia mosquitoes as part of a science project. Photo Credit: World Mosquito Program Colombia.The Grand Challenges enable us to adopt an open-source model that empowers more people from all walks of life to offer solutions to global health problems. Research and partnerships spur innovation, which in turn harnesses the ingenuity and expertise of an increasingly diverse global development community. USAID facilitates this process and opens the door for new ideas. Supporting innovative research approaches in disease mapping is another way for USAID to maximize global health impact. Knowing where diseases are most prevalent can shed light on their root causes, strengthen programs and more effectively target interventions.Lymphatic filariasis or LF, for instance, is a parasitic disease spread by mosquitoes and one of seven neglected tropical diseases that USAID prioritizes. Last year, USAID supported the expanded roll-out of a new survey protocol to assess the LF in low prevalence settings. In Ethiopia, the study mapped the disease in 45 districts, and results showed that only three of them warranted treatment. This finding saved millions of dollars that may have otherwise been spent to provide treatment in areas where the disease was not endemic. The World Health Organization has endorsed the new survey protocol to be used in other areas of uncertain disease prevalence, including Vietnam and Cameroon.These handful of tools and research projects are only a small fraction of the global health R&D portfolio that USAID has supported around the world. Despite the fact that USAID investments in health R&D are often working behind the scenes, their contribution to saving and improving lives is significant. These types of strategic investments continue to change the way communities think about what is possible in disease prevention and health promotion. You can download a copy of USAID’s latest global health-related R&D report here.This blog originally appeared on USAID’s website and has been cross-posted to Breakthoughs with USAID’s permission.  

  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.  

On Monday, Congress struck a deal finalizing government spending legislation for the remainder of fiscal year (FY) 2017. Since October 1, 2016, the government has been operating on a series of continuing resolutions (CR)—maintaining government spending at FY16 levels until a full deal for FY17 could be negotiated. With the omnibus legislation in place, we expect both houses of Congress to pass the final FY17 bill this week.  There was strong bipartisan, bicameral support for advancing FY17 omnibus legislation that reflected priorities, compromises, and negotiations reached during the regular FY17 appropriations process. This means that strong congressional support for protecting medical research and global health in individual FY17 appropriations bills was carried through in the final legislation. While we know there will be more challenges in the FY18 budget and appropriations process, the FY17 omnibus was an encouraging sign that Congress understands the vital role of US global health and medical research programs. US Agency for International Development and State Department While the Trump Administration proposed rescissions for the US Agency for International Development’s (USAID) global health funding for FY17—including cuts to the President’s Emergency Plans for AIDS Relief (PEPFAR), polio, tuberculosis (TB), neglected tropical diseases (NTDs), and eliminating global health security funding—in the final FY17 omnibus, global health programs at USAID saw an 8 percent boost in funding, totaling just over US$3 billion versus $2.83 billion in FY16. Notable increases included $5 million for TB, $81 million for malaria, $40 million for Gavi, the Vaccine Alliance, and $70 million for global health security to create a new Emergency Reserve Fund to respond rapidly to emerging health threats. Other global health accounts within USAID and the State Department received level funding.USAID continues to play a leading role in the US government’s action on global health research and development (R&D), and it is critical that global health programs receive appropriate funding so that investments in R&D will continue to be prioritized among other activities. The combination of increased funding for some key programs and level funding for others in FY17 is a positive sign that Congress shares our priorities and will work to protect these accounts in more challenging budget and appropriations conversations for FY18.National Institutes of Health Strong bipartisan support for the National Institutes of Health (NIH) continued in the FY17 bill. Overall, NIH received a $2 billion increase, raising total funding for FY17 to $34 billion. However, it’s important to note that little of this increase will likely support global health programming. Much of this increase was to fund enactment of the 21st Century Cures Act, but notable increases that could benefit global health R&D included a 6 percent or $277 million increase for the National Institute of Allergy and Infectious Diseases, a $1.76 million increase for the Fogarty International Center, and additional funding for the National Center for Advancing Translational Sciences.While NIH has long enjoyed bipartisan support—and thus it is not surprising to see a funding boost in FY17—it was notable that the Trump Administration proposed over $1.2 billion in rescissions for NIH for FY17 and a 19 percent cut to NIH funding for FY18, including eliminating the Fogarty International Center. NIH leads the world in global health R&D, and its work in basic research is vital to advancing new drugs, vaccines, therapeutics, and other tools for neglected diseases and conditions. It is encouraging to see Congress maintain and increase NIH funding overall and prioritize US leadership in medical research for FY17; however, greater support is needed for NIH programs that advance research for neglected diseases and conditionsCenters for Disease Control and Prevention A laboratory worker wearing a surgical mask works with samples. (Photo: PATH/Mike Wang) The Centers for Disease Control and Prevention’s (CDC) funding for global health was also protected in the final FY17 omnibus. Overall, the CDC Center for Global Health saw an $8 million increase from FY16 funding levels, including targeted increases for global public health protection and global disease protection activities.Funding for polio and measles was increased, while parasitic diseases, malaria, and global HIV and AIDS funding remained level. In addition, the National Center for Emerging and Zoonotic Infectious Diseases received a $5 million increase. CDC plays an important role in detecting, preventing, and responding to infectious disease threats at home and around the world. This work is critical to developing new prevention and diagnosis technologies, particularly those to address endemic and emerging global health threats. Robust funding for CDC’s global health programs is vital to advancing global health R&D and promoting global health security. Department of Defense The Department of Defense’s (DoD) work in infectious disease R&D was also strengthened in the final FY17 omnibus. DoD’s Peer Reviewed Medical Research Program—which conducts research on antimicrobial resistance, diarrheal diseases, emerging infectious diseases, malaria, TB, and vaccine development for infectious diseases—received $300 million in funding. In addition, the bill included strong report language supporting DoD’s critical work in global health R&D and supporting continued and robust investments. The final FY17 spending bill is encouraging news for global health R&D as it protected funding for critical global health and medical research accounts across USAID, NIH, CDC, and DoD. However, this victory may be only temporary, as we know that many of these same accounts will face intense pressures in FY18 budget negotiations, given aggressive action by the Trump Administration to downsize activities and reduce government spending. GHTC will continue to champion strong US leadership in global health R&D and stress the impacts of these important programs in protecting health 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.