Breakthroughs Blog: USAID

On February 15, President Trump signed into law a bipartisan spending bill—averting another partial government shutdown and ensuring full-year funding for the government for the remainder of fiscal year (FY) 2019. The move followed several days of speculation about whether discord between Congress and the President on funding for a border wall would imperil the spending measure passed by Congress to fund the remaining one-quarter of the federal government.The months-long saga ended with some great news for global health and research and development (R&D)—a roughly US$150 million funding increase for global health programs in the State and Foreign Operations (SFOPs) bill, as well as a significant boost to the Food and Drug Administration (FDA) under the Agriculture bill included in the package.The bill included some welcome increases to global health accounts which have been flat-funded for five years running, including a $50 million (1.16 percent) increase to the President’s Emergency Plan for AIDS Relief (PEPFAR) and a $2.5 million (2.5 percent) increase to the US Agency for International Development’s (USAID) Neglected Tropical Disease Program compared to FY 2018. Nutrition saw a $20 million (16 percent) increase and Maternal and Child Health got a $5.5 million (0.66 percent) boost. But perhaps the most notable win in the bill was a long-sought increase to USAID’s tuberculosis (TB) program. After TB was in the spotlight at the United Nations High-Level Meeting on TB in September, the United States backed up its pledge of additional support for the global fight against TB by including a $41 million (15.71 percent) increase to the program in the final spending package for FY 2019—the largest increase to the program in more than five years. All other global health accounts were level-funded compared to FY 2018, resulting in an overall increase of 3.23 percent for USAID Global Health—a stark difference from the 36 percent cut proposed in the President’s budget.While most accounts of relevance to global health R&D within the Department of Health and Human Services were funded for the entire fiscal year in a spending package passed in September, the FDA was one agency whose funding was still in limbo. The FDA’s unique funding structure—divided between budget authority, or discretionary funding (appropriated by Congress), and fees (paid by FDA users) —shielded the agency from some of the worst impacts of the partial government shutdown in December and January as it drew down on user fees to continue most operations. But the final FY 2019 funding package included a welcome $460 million (9 percent) increase for the agency, including a $269 million (9 percent) increase in budget authority.As the FY 2019 appropriations process lurched across the finish line, advocates were already gearing up for another budget battle for FY 2020. Check back for regular updates as appropriations hearings begin and GHTC continues monitoring the prospects for global health R&D accounts in the coming year.  For reference, the text of the Conference Report to accompany H.J. Res. 31, the Consolidated Appropriations Act, 2019, is available here, the text of the Joint Explanatory Statement is here (with the Global Health Program breakdown on page 454 of the PDF), and a division-by-division summary is available here.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. On Friday, February 15, President Trump signed into law a spending bill covering funding for State & Foreign Operations (SFOPs) for fiscal year (FY) 2019. The bill provides US$8.8 billion to the overall Global Health Programs account at the State Department and US Agency for International Development (USAID), which is a $150 million increase from the FY18 enacted level and $2.1 billion above the President’s FY19 request. Funding for all global health programs at the State Department and USAID either increased or remained flat compared to the FY18 enacted level and were also well above the President’s budget request. The World Health Organization (WHO) is working to contain an unprecedented outbreak of Lassa fever in West Africa, which has killed 59 people in recent weeks. This Ebola-like virus is transmitted to humans via exposure to contaminated rate urine and droppings, as well as from person-to-person. Although Lassa fever is endemic in parts of West Africa with outbreaks occurring yearly, health officials have confirmed at least 275 cases in Nigeria—the epicenter of the outbreak—since the beginning of the year. WHO has expressed concern regarding the high number of cases so early in the Lassa fever season, which is due to last another four months. Controlling Lassa fever is a challenge because its symptoms can be vague, such as headaches and chest pain, making the disease difficult to diagnose, and there is no licensed vaccine yet available. To contain the current outbreak, WHO is forming a regional coordination mechanism to share, process, and evaluate information regarding suspected cases and is also intensifying public awareness efforts about how to deter rats. In experimental studies conducted in mice, an antibiotic drug called AN12855 was shown to be more effective against tuberculosis (TB) than isoniazid, one of the standard treatments available. The new drug demonstrated both a much lower tendency to develop resistance, and it remained in the tissues where the bacteria that causes TB resides for longer, thus killing the bacteria more effectively. Further studies are required to determine if these outcomes will translate to improvements in treatments for humans. Current treatment for TB can range from six months to more than a year; thus, researchers are working to develop new drug regimens that shorten and simplify treatment.

On February 5, President Trump delivered his second State of the Union address. Among the long list of policy proposals and pledges in the speech was one of great interest to the global health research community—an announcement of a new whole-of-government plan to eliminate HIV transmission in the United States by 2030. Though just a few sentences long, this announcement hinted at a much-anticipated budget increase for HIV and AIDS efforts and linked the feasibility of this goal to “scientific breakthroughs”—many driven directly by US government investments in research for new tools to diagnose, treat, and prevent HIV and AIDS. As the President put it, “In recent years we have made remarkable progress in the fight against HIV and AIDS. Scientific breakthroughs have brought a once-distant dream within reach. My budget will ask Democrats and Republicans to make the needed commitment to eliminate the HIV epidemic in the United States within 10 years. We have made incredible strides. Incredible. Together, we will defeat AIDS in America. And beyond.”Though the announcement and the associated plan released shortly thereafter by the Department of Health and Human Services (HHS) is squarely focused on eliminating HIV transmission within the US, the wording of the statement and a subsequent editorial published in the Journal of the American Medical Association penned by key agency officials both connect to international efforts and reference advances in HIV research and product development supported by the US government.At this moment of excitement—a “once-in-a-generation opportunity,” as Alex Azar, HHS Secretary, put it in the release of the plan—it is worth noting how our “chance to end the HIV epidemic for the next generation” is based on decades of patient, bipartisan commitment by the US government to advancing our understanding of HIV and AIDS and our ability to diagnose, treat, and prevent it through the development of cutting-edge tools.As the AIDS crisis was growing in the 1980s, NIH research led to the development of the first screening tests to detect the virus in the blood supply and the first antiretroviral treatment, AZT. Later, NIH research led to strategies to prevent maternal-to-child transmission, improved combination therapies, and the discovery that antiretroviral therapies could be used to prevent and treat the disease—research that was foundational to the development of pre-exposure prophylaxis (PrEP). CDC research has expanded our understanding of the epidemiology of the disease, improved prevention and treatment programs, and supported the development of a novel diagnostic that can, for the first time, identify whether an infection is recent or longstanding to improve contact tracing.While many don’t associate the Defense Department with health research, the US Military HIV Research Program has been on the forefront of the battle against HIV to both protect US troops and reduce the global impact of the disease. The program supported a large-scale HIV and AIDS vaccine trial in Thailand that was the first to show that a safe and effective HIV vaccine is possible and continues to advance HIV vaccine research. The US Agency for International Development (USAID), in addition to funding the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR) programs in nearly 100 countries, has also supported HIV vaccine research, as well as the development of microbicides to reduce transmission among women—including a microbicide-based vaginal ring. The US Food and Drug Administration has also played a crucial role in ensuring the availability of HIV treatment and prevention tools for those in need globally. The agency operates a program to facilitate the “tentative approval” of antiretroviral drugs for purchase by PEFPAR programs and recently launched a pilot program with the World Health Organization (WHO) to expedite the review of HIV drug applications through WHO’s prequalification program.The progress we have achieved through sustained whole-of-government investment in HIV research is astounding, but a need for new and improved HIV and AIDS prevention and treatment tools, including a vaccine, remains. As President Trump said, we can end the HIV epidemic—through both the scale-up of existing interventions and continued investment in the development of new tools. Even a cursory glance at the history of HIV and AIDS shows that every new product developed for treatment or prevention has both increased our ambition to end the epidemic and fundamentally altered our approach. We cannot know for certain that the tools we have in hand today are the most effective we will ever have, so our continued commitment to discover the next game-changer must ramp up in tandem with our efforts to expand access to existing interventions.While the President’s pledge to end HIV and AIDS in the US and his acknowledgement of the importance of scientific breakthroughs is encouraging, his past actions have failed to match this rhetoric. In 2017 and 2018, the administration proposed the elimination of HIV and AIDS vaccine and microbicides funding at USAID and deep cuts to NIH and CDC programs that fund HIV research. As the President prepares to release his fiscal year 2020 budget request, we hope it will include the resources necessary to realize the goals of this welcome pledge, including strong funding for the programs which develop and deliver the tools needed to end AIDS domestically and globally. This is an area of historically bipartisan consensus that offers a rare but important chance at this moment of divided government for Congress and the administration to work together to achieve a bold vision: defeating AIDS in America—and beyond.

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