Breakthroughs Blog: US budget

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.

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.

  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.  

2017 was a year that brought changes, upheavals, and uncertainties for the global health and development community: From the inauguration of a US president that expressed skepticism about foreign assistance and beget uncertainty about the United States’ continued leadership in global health, to the election of a new leader at the World Health Organization (WHO) that faces a tough task of reforming the agency and proving it’s up to the job in the wake of missteps during the Ebola crisis. While the landscape seemed to shift continuously under our feet this year, the community was also buoyed by evidence of our shared progress and success. In developing countries, more women than ever have access to contraceptives. The end of polio is truly within sight. And we have the largest pipeline of promising global health technologies ever in history. As the year comes to an end, GHTC is reflecting on the global health innovation stories and news that shaped 2017. Here are some of those moments: 1. Coalition formed to develop vaccines to prevent pandemics The 2014 Ebola epidemic prompted some real reckoning by the global community and raised important questions on how we can be better equipped with the tools and systems to stop outbreaks before they become epidemics. While the world still remains woefully unprepared, 2017 saw an important step forward with the formation of the Coalition for Epidemic Preparedness Innovations (CEPI). Launched with nearly $600 million in funding from the governments of Norway, Japan, and Germany, and in partnership with the Wellcome Trust and the Bill & Melinda Gates Foundation, CEPI aims to develop vaccines against the diseases most likely to cause the next epidemic. 2. US global health and research funding saved from the chopping blockCDC researcher handles pathogen in biosafety lab. Photo: CDC/ Dr. Scott Smith  The year started on an ominous note with the release of the Trump Administration’s fiscal year (FY) 2018 budget proposal, which called for deep cuts to US global health and medical research programs for FY18 as well as proposed rescissions to the US Agency for International Development’s (USAID) global health funding for FY17. While advocates feared Congress would take a cue from the Administration as it finalized FY17 budget negotiations, champions in Congress stepped up and defended these investments. When the dust finally settled, the FY17 omnibus budget passed with sustained funding across these areas, including slight boosts to global health funding at USAID and the US Centers for Disease Control and Prevention, and a US$2 billion increase for the National Institutes of Health (NIH). While budget negotiations remain ongoing for FY18, advocates are optimistic Congress will continue to sustain strong funding for global health and medical research. 3. G20 makes first-ever pledge to support R&D to combat global health challenges The world’s wealthiest nations paid some serious lip service to advancing global health research and development (R&D) this year. In their 2017 summit declaration, G20 leaders committed to working together to advance R&D for antimicrobial resistance (AMR) and potentially pandemic diseases— marking the first time R&D for global health has featured on the G20 declaration. Leaders pledged support for coordinated R&D initiatives, like the WHO R&D Blueprint and CEPI as well as called for a new AMR R&D collaboration hub. Although the G20 focused on R&D through the lens of AMR and health security—which addresses only a portion of global health challenges—this was a good sign that the world’s leaders are embracing the importance of health R&D to global development. It is now imperative that words turn into concrete action and that leaders sustain this momentum as Argentina takes helm of the G20 in 2018. 4. Demise of an R&D pooled fund at WHONot all news can be good news. This year brought a disappointing resolution to an over decade-long effort to stand up a voluntary pooled fund at WHO to finance R&D for neglected diseases. At this year’s World Health Assembly, WHO announced that it would cease work on the pooled fund and its initial round of demonstration projects—citing a lack of contributions pledged to support the sustainability of the fund. While this is a disappointing end for global health advocates, on a positive note, WHO pledged to continue a companion effort—the WHO Global Observatory on Health R&D—which was created to facilitate coordination and guide prioritization for global health research. 5. WHO begins process to establish essential diagnostics listA PATH research examines onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKern One of the biggest innovations of 2017 could be something decidedly low-tech: a list. While WHO has operated the Model List of Essential Medicines for decades to guide countries in procuring drugs and treatments, this year a group of scientists asked an interesting question: If we have a list for medicines, why don’t we have one for diagnostics? After a sustained advocacy campaign, supported by GHTC, calling for WHO to establish an essential diagnostics list (EDL), the agency formally announced in June it would create an EDL and took the first step in doing so, creating an expert advisory group tasked with developed the list. While the list is not expected to be operational until early 2019, this welcomed move by WHO will improve diagnostic access and innovation and ultimately save lives. 6. Nonprofit-backed Chagas drug beats ex-“Pharma Bro” company’s bid for rival launch Readers always like a David vs. Goliath story, and this one captured a lot of media attention this year. This August, in a surprising move, a creative multisector partnership involving GHTC member Drugs for Neglected Diseases initiative (DNDi) successfully secured approval from the US Food and Drug Administration (FDA) for the Chagas drug benznidazole, achieving this milestone before a rival attempt by a company formally run by Martin Shkreli (aka “Pharma Bro”) to register their version of the drug. Under Shkrell’s leadership, this company announced plans to take benznidazole—a drug that has been around since the 1970s, but lacked FDA approval—and register it with the FDA to secure a tropical disease priority review voucher (PRV) to sell. It also expressed plans to its investors to then hike the price of the drug to nearly $1,000 a course (vs. the $60-$100 it’s now being sold at in Latin America). This alarmed advocates who worried the drug would become prohibitively expensive to the nearly 300,000 Americans impacted by Chagas’ disease. This partnership appears to be a win-win for both Americans and people around the world. The company involved in the partnership has committed to making the drug accessible to Americans at an affordable price, and under a provision in the partnership agreement, 50 percent of revenue from a PRV sale will be used to fund programs to expand access to the drug in the United States and other nations. 7. Innovators get creative in combatting the world’s deadliest animal Bill Gates famously reminded us that the world’s deadliest animal is not a shark or a lion, but the pesky, yet lethal mosquito. This year innovators got particularly creative in exploring ways to wipe out these deadly pests and the diseases they carry. Work continued on gene-drives, genetic modification of mosquitoes, and the introduction of the transmission-blocking Wolbachia bacteria. But scientists also tried to see if they could use mosquitoes rather than syringes to deliver malaria vaccines; created a crowd-sourced, mobile-based monitoring platform to track disease-carrying mosquitoes by the sound of their buzz; and innovated a way to introduce sterile mosquitoes into a population via temperature-controlled drone. 8. New global health technologies advance through pipelineOver the past year, several other promising new health innovations have moved through the development pipeline and one step closer to reaching people in need. Here are just a few highlights: A new low-cost, heat-stable rotavirus vaccine, ROTASIL—developed by GHTC member PATH—was found effective against severe rotavirus in Phase II clinical trials. A promising new HIV vaccine candidate that targets multiple strains of HIV—developed by Janssen Pharmaceutical Companies of Johnson & Johnson as well as the NIH National Institute of Allergy and Infectious Diseases (NIAID)—entered human clinical trials. This marks only the fifth time in history an HIV vaccine candidate has reached this milestone. The first vaccine specifically developed for leprosy entered a Phase I clinical trial, with results expected in 2018. A US Army-developed Zika vaccine candidate ZPIV performed well in three Phase I clinical trials, producing an immune response in more than 90 percent of participants. Building on the success of its monthly dapivirine microbicide ring, which is now under regulatory review, GHTC member the International Partnership for Microbicides announced the launch of clinical trials for a three-month vaginal ring that releases both dapivirine and a contraceptive. NIAID also sponsored Phase I and II trials of a promising Chikungunya vaccine candidate. Currently there is no available vaccine for the disease. A new, anti-malaria compound—developed by Novartis and GHTC member Medicines for Malaria Ventures—entered clinical trials in nine countries in Africa and Asia. Partners hope this new drug will help stave off the development of further malaria drug resistance and expects to complete Phase 2b studies by late 2019. A promising new oral therapy for sleeping sickness—fexinidazole—was found effective in curing the illness in Phase III clinical trials. The treatment—developed by DNDi and Sanofi—could receive regulatory approval as early as the end of next year. As we look forward to 2018, it is time for the global health community to redouble our efforts to make sure this vital progress in global health innovation continues to ensure that people around the world will have access to lifesaving and life-improving health technologies.