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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.

On February 20, Jamie Bay Nishi joined GHTC as its new coalition director. Marissa Chmiola, GHTC’s communications officer, sat down with Jamie during her third week on the job to find out more about her background, what inspires her, what challenges and opportunities she sees in advocacy for global health research and development (R&D), and what lies ahead for the coalition. What first got you interested in the field of global health and development, and what inspires you about this line of work? Jamie Bay Nishi. Photo: DevexI grew up as overseas as a “diplobrat,” so I consider an interest in international affairs and global development to be in my DNA. As the child of diplomats, I lived in Saudi Arabia, Egypt, France, and Germany, and had the chance to see firsthand the impact of US engagement in diplomacy and global development.I really fell into health as an area of interest after graduating college. I wanted to work overseas, but most of the opportunities available at the time were contractor positions in Iraq as part of the war effort. Because that wasn’t an interest area of mine, I took a job working at the Advisory Board Company where I helped launch their Technology Insights product, advising hospitals in the United States on their clinical technology purchasing needs. While I found the work interesting, I ultimately recognized that domestic health wasn’t my passion, so I pivoted my career trajectory toward the global development field. I earned a Master’s degree in Conflict Resolution and ultimately took a job at then startup-mode Devex, a membership organization and media platform for the development community (basically a Bloomberg for international development). Over a decade later, I am delighted to have landed at an organization that focuses on both health and development, marrying these two interests! What attracted you to the director role at GHTC, and what excites you most about leading this coalition? I joined GHTC after spending nearly nine years growing Devex’s membership, as well as building unique partnerships. When considering the GHTC director position, I was excited about the possibility of diving deeper into a technical area within the global development field, and exploring how my membership-building and media partnership development skills could be applied in the advocacy space. It’s also exciting to take helm of a coalition that has a decade-long track record of effectively mobilizing support for global health R&D. This gives me a strong foundation to build upon, while at the same time offering me the opportunity to consider new approaches to amplify our advocacy for even greater impact.You’ve been on the job for three weeks now. What are your first impressions?In my first few weeks on the job it has been my priority to meet with each of our coalition members. I have been continually impressed by the incredible and impactful work each organization is doing to advance innovation to save and improve lives around the world. It’s truly inspiring.It’s also clear I’ve come into this role at a pivotal time in American political history. The United States has long lead the world in global health and medical innovation, and now more than ever, there is a need for coalitions like GHTC to engage with policymakers to maintain this support and champion continued US leadership in improving health and well-being worldwide. This is especially the case for protecting investments in global heath R&D—forward-looking investments that can sometimes fly under the radar.Your professional background is in stakeholder engagement, strategic partnerships building, and marketing. How does this experience shape your thinking about advocacy and translate into this new role at GHTC? While I am relatively new to the policy and advocacy field, I feel my previous experience in member engagement and communications will be a useful skill set to bring into the advocacy space. I hope to bring a fresh set of eyes to the advocacy challenges we face today and drive forward innovative approaches to build momentum within the coalition and to achieve impact with policymakers.What do you see as some of the biggest opportunities and challenges right now in advocacy for global health R&D? This year has brought dramatic shifts in the US political landscape, which could alter the US government’s historic leadership role in global health R&D. As a coalition and community, we have a lot of work ahead to support continued US, as well as multilateral leadership, and prioritization of global health R&D, which includes efforts to maintain or increase funding. Maintaining bipartisan political support and buy-in will be our biggest priority—and to do this we will have to make sure that as a coalition we articulate both the need for and promise of new global health innovations, in the United States and around the world. Due to the highly nuanced and technical nature of R&D, this can sometimes be challenging to communicate.On the other hand, I am really looking forward to digging-in to expand and deepen GHTC’s relationships with key policymakers and thought leaders in the United States and multilateral space. To really drive the global health R&D agenda forward, it will be critical to broaden GHTC’s constituency to enlist new supporters, and elevate visibility both for the coalition’s advocacy work and the pivotal role R&D plays in the future of global health.Tell us about your vision for GHTC and what you will be focusing on in your first year as director. I look forward to bringing our members together this spring for GHTC’s first ever member summit, where together we will strategize the future of GHTC. I also look forward to adding to GHTC’s core competencies to complement the incredible efforts and activities of my team. I personally want to look at new ways to augment the visibility of the coalition and its members, engage new stakeholders without diluting the core mission and purpose of GHTC, and strategize new communications efforts that will resonate with policymakers.My team as a whole will also be doubling down on engagement with policymakers in Congress, federal agencies, and multilateral entities to promote continued and expanded engagement in global health R&D.What do you enjoy doing in your spare time? I have a lot of hobbies outside of work including being a Zumba instructor, salsa dancer, stand-up paddle boarder and beer/kombucha homebrewer.

A laboratory technician. Photo: PATH/Satvir MalhotraThe United States leads the world in research and development (R&D) for rare and neglected diseases, but we still need to take action to unlock scientific potential and accelerate the development of urgently needed drugs, vaccines, diagnostics, and other health tools. This message of leadership and potential long championed by GHTC was shared by President Trump in his first address to Congress on February 28th when he told the story of Megan Crowley, a twenty-year-old college student who, despite being diagnosed as an infant with Pompe Disease, a rare and incurable genetic disorder, is alive today thanks to innovative R&D that yielded an effective treatment.US leadership in medical and global health research has a tremendous track record of delivering new and innovative technologies for rare and neglected diseases that save lives in the United States and around the world. Scientists at the National Institutes of Health (NIH) first identified the HIV virus as the cause of AIDS and led the development of the first antiretroviral drugs. An estimated 14.4 million life-years collectively have been gained through the use of NIH supported HIV and AIDS therapies since 1995. US research supported the development of the GeneXpert diagnostic test for tuberculosis (TB)—the first test to rapidly diagnose drug-resistant and extensively drug-resistant TB, poised to be one of the world’s greatest infectious disease threats. USAID supported the development of Coartem Dispersible—the first artemisinin-based combination therapy specifically dosed for children, making malaria treatment safe and effective for all ages. President Trump is right: with a commitment to harnessing American innovation and ingenuity, “cures to illnesses that have always plagued us are not too much to hope.”"Cures to illnesses that have always plagued us are not too much to hope.”—President Donald Trump To achieve this goal, however, we must look at all the components that drive global health R&D. In his speech, President Trump identified regulatory processes as a primary barrier to innovation and access to new medicines, but there are other factors that must be considered. While there may be ways to streamline regulatory review to accelerate access to life-saving innovations, we ultimately want to advance American leadership in R&D that delivers safe, effective, and rigorously reviewed treatments for neglected diseases and conditions. This cannot be achieved by reducing regulations alone.First and foremost, sustainable, predictable funding is critical. It takes years of research and a reliable flow of resources to develop new drugs, vaccines, and other health tools. We cannot address rare and neglected diseases effectively with cuts to medical research funding, dramatic ebbs and flows in discretionary spending, or by relying on emergency allocations of R&D resources during a crisis. Indeed, one of the crucial successes in the search for treatment for Pompe Disease was the mobilization of US$100 million for research. The US government has the power to unlock scientific potential and catalyze R&D through dedicated funding, and support for partnerships that leverage government, private sector, nonprofit, and other donor funding.We also must recognize that that diseases do not respect borders, and investments that help diagnose, treat, and eliminate diseases overseas are investments that benefit the United States along with the rest of the world. We also must recognize that that diseases do not respect borders, and investments that help diagnose, treat, and eliminate diseases overseas are investments that benefit the United States along with the rest of the world. In fact, investing to address disease threats before they reach the United States is more efficient and cost-effective—and saves more lives—than waiting until diseases reach our shores to invest. This means that the entire world must be equipped with the necessary tools to address emerging and longstanding threats, no matter where they are. The United States can lead the world toward President Trump’s vision of accelerating cures for diseases that have plagued humanity, but not if we retreat from international engagement and development efforts—including strong engagement in global health R&D.The United States can lead the world toward President Trump’s vision of accelerating cures for diseases that have plagued humanity, but not if we retreat from international engagement and development efforts—including strong engagement in global health R&D. We share the same goal: to harness American innovation to strengthen US leadership in health R&D, keep American people safe from rare, neglected, and longstanding disease threats, and make sure that people around the world gain access to new medical innovations as quickly as possible. There is no one silver bullet to achieve this goal. To truly commit to innovation and unlock cures for long neglected diseases, we must adopt a holistic view and ensure that US support for innovation and R&D—including funding—remains strong and robust.