Breakthroughs Blog: Congress

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Senate Appropriations Labor and Health and Human Services (LHHS) Subcommittee released its fiscal year 2015 appropriations legislation, after a lengthy internal debate on domestic health concerns. The legislation is—for the most part—good news for funding levels and policy issues for several key global health research programs at the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), and the Office of Global Affairs at the Department of Health and Human Services. Since its discovery nearly 40 years ago, we have learned a lot about Ebola. Yet there are still no effective treatments or vaccines to protect people against this deadly disease. According to an article in Vox, this is not because of “a lack of human ingenuity or scientific capacity,” but rather due to a global innovation system that does not prioritize the health research needs of world’s poorest populations. Drs. S. Patrick Kachur, MD, MPH, FACPM—chief of the Malaria Branch in the Division of Parasitic Diseases and Malaria at CDC’s Center for Global Health—and Larry Slutsker, MD, MPH—director of the Division of Parasitic Diseases and Malaria at CDC’s Center for Global Health— write in Breakthroughs about the emerging global security threat of anti-malaria drug resistance and CDC’s efforts to prevent, detect, and respond to this growing threat. They write: “…to sustain momentum and move toward elimination of malaria, new tools and technologies will be required.” Despite progress made to prevent maternal and child deaths by the United Nations’ Millennium Development Goals (MDGs), still too many mothers and children are compromised or killed by preventable diseases. PATH President and CEO Steve Davis writes for Devex about the need to take advantage of the progress made thus far by the MDGs and accelerate innovation to meet the health needs of millions of people in low- and middle-income countries. It’s World Breastfeeding Week (August 1-7) and as breastfeeding has served as the primary method for a mother to feed her infant since the dawn of humanity, we wonder if this could be a way for a mother to administer life-saving medicines to her baby? According to a group of researchers in the United States and United Kingdom, the answer is yes. Two recent promising developments in the fight against malaria were announced last week. Malaria is one of the leading killers of women and children in the world, and in sub-Saharan Africa particularly—where 90 percent of the more than 620,000 annual malaria deaths occur—new tools to fight the disease are desperately needed.

Last week, we reported on exciting policy language included in the Senate Department of Defense appropriations legislation, and earlier this summer, the House and Senate State and Foreign Operations bills also included recognition of the role that new technologies could play in advancing global health. Today we have even more good news to report: The Senate Appropriations Labor and Health and Human Services (LHHS) Subcommittee released its own fiscal year (FY) 2015 appropriations legislation, after a lengthy internal debate on domestic health concerns. Senate supports global health R&D in LHHS appropriations bill. Photo: NIAID Senate calls for increase in NIH funding; still lags behind need The legislation covers funding and policy issues for several key global health research programs at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Office of Global Affairs at the Department of Health and Human Services (HHS). At GHTC we’ve voiced concern that funding for NIH has lagged behind both inflation and the research program needs of the agency. Last week, we learned that the Senate LHHS appropriations subcommittee has appropriated $30.6 billion for NIH—which represents an increase of $606 million over FY 2014. This is a welcome increase; however, as the subcommittee noted in its report introduction, NIH’s funding is still unacceptably low, even with this improvement. Report language supports global health programming at NIH Within NIH, several key research centers were funded at reasonable levels, including the National Center for Advancing Translational Sciences (NCATS) and the National Institute for Allergy and Infectious Disease. The committee expressed its support for continued funding for neglected tropical diseases (NTDs), microbicides, and antibiotic research, as well as government-wide research collaboration, among other priorities. In an exciting move, the committee also included NCATS report language requesting that NCATS include a report in its FY 2016 budget justification “on initiatives targeted at neglected diseases and global health conditions, with specific focus on global health technologies and devices.” Global health is an essential part of NCATS’s mandate, and this language will ensure that it is prioritized within the program. CDC global health programming receives increased funding in bill The legislation also provides strong support for research at the CDC’s global health programs. Under the bill, the National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) would receive an increase over FY 2014 funding levels. In addition, the subcommittee’s report mentions the Chikungunya outbreak in the Caribbean and the United States and encourages coordination between NCEZID and the CDC’s Center for Global Health on global health security efforts. Speaking of the Center for Global Health, this program received a rare increase in the Senate bill over even the President’s FY 2015 budget request. This is likely a result of support for the new Global Health Security Agenda. Most notable was the inclusion of a new line item in the Center’s budget for “Global Health Protection.” The bill also included positive language on CDC’s work on malaria and NTDs and provided continued funding for the National Public Health Institutes—an epidemiology and research capacity-building program in select countries. House LHHS bill has not been released; continuing resolution likely The House Appropriations LHHS Subcommittee has not released a bill for FY 2015 and may not do so at all. As it looks more likely that a continuing resolution will be necessary to continue uninterrupted government funding for NIH, HHS, and CDC global health R&D programs, Congress should work to come to an agreement that robustly supports funding and smart policy improvements for these programs. Ashley Bennett is GHTC’s policy officer.

As the DC summer kicks into full swing, Congress has had a busy month moving forward fiscal year (FY) 2015 funding legislation for a variety of government programs including global health research and development (R&D). Global health R&D at USAID: Yesterday, both the House and Senate State and Foreign Operations (SFOPs) appropriations subcommittees held mark-ups of their draft bills. The House draft provides only topline spending numbers, with the addition of family planning/reproductive health, polio, the President’s Emergency Plan for AIDS Relief (PEPFAR), and the Global Fund funding levels. The House funded the overall account above the White House request, but below what was appropriated in FY 2014. Including the State Department and the US Agency for International Development (USAID) numbers, funding was $132 million below the numbers Congress appropriated in FY 2014, but a welcome $257 million more than what the White House had requested. For a quick comparison of numbers, check out the Kaiser Family Foundation’s SFOPs policy analysis. The other accounts called out in the House bill were $59 million for polio (the same as FY 2014, but 18 percent higher than the President’s request) and family planning at $461 million. Funding for family planning was a significant but not unexpected cut from both the FY 2014 number (24 percent cut) and the White House request (28 percent cut). As the full House appropriations committee has not yet marked up the bill (and it’s not clear that they will), details on the contents of the bill report’s priorities and other policy riders are not yet known. We do know the House bill reinstates the Mexico City Policy—which prevents nongovernmental organizations who receive federal dollars from promoting abortion services as part of family planning­—or prohibits any funding to the United Nations Population Fund (UNFPA). The full committee may take the bill up for consideration sometime next week. The Senate summary provides considerably more specific account figures for global health than the House bill. The Senate bill flat-funds the Global Fund and PEPFAR compared with FY 2014 and is even with the White House request—it’s interesting to note that for this overall account, the House bill appears to provide a higher funding level, even though we don’t yet know the exact funding distribution. Most other accounts were funded at levels either matching or slightly above FY 2014 funding. One exception is the tuberculosis (TB) account, which faces an $11 million cut from FY 2014 levels, although it is not as dire as the proposed White House funding level, which would have cut an additional $23 million. There is better news to be found for family planning and reproductive health, neglected tropical diseases, polio, and vaccine access. There’s no explicit word in either the House or Senate bills regarding the overall Maternal and Child Health account. NIH, CDC, and FDA Last week the Senate held its Labor, Health, and Human Services (LHHS) subcommittee mark-up and released a summary of their draft bill. A full Senate committee mark-up has yet to be scheduled, and the House has yet to move forward with its own draft bill. This account remains one of the most contentious, both because of ongoing efforts to alter the health care reform programs and because of a Senate plan to use the Overseas Contingency Operations account as a complicated and likely unsustainable mechanism to boost up funding for domestic priorities. The committee requested $30.459 billion for the National Institutes of Health (NIH), an increase to both the White House and FY 2014 levels by $324.0 million and $605.7 million, respectively, but still far less than the $32 billion needed. Global health programs within both NIH and the Centers for Disease Control and Prevention (CDC) also did quite well in the Senate bill—the CDC’s Centers for Global Health and Emerging Zoonotic and Infectious Diseases, the NIH’s National Institute of Allergies and Infectious Diseases (NIAID), and the Fogarty International Centers were nearly all funded at levels above both FY 2014 and the White House request. Both the House and Senate have also marked-up their legislation to fund the Food and Drug Administration (FDA). The House bill funds the FDA at $2.583 billion (this number represents budget authority and does not include user fees), which is a $23 million increase over FY 2014 and is about level with the White House request. The Senate bill funds the FDA at $2.588 billion, an increase of $36 million over FY 2014. The Senate is taking up this bill as part of a “minibus” along with the bills from the Commerce, Justice, and Science subcommittee, the Transportation subcommittee, and the Housing and Urban Development subcommittees. The Senate version of the bill also included some interesting report language around FDA’s international leadership to combat threats to global health and the global drug supply chain.  Defense The House Appropriations Committee approved their FY 2015 bill which essentially flat funds Department of Defense (DoD) R&D—which includes all research at DoD, not just neglected disease R&D—from FY 2014 levels. The American Association for the Advancement of Science provides a helpful summary of R&D funding within the draft bill which can be found here. The Senate Appropriations Committee has yet to mark-up a bill. In both the House and Senate, we see policymakers diverging from the priorities emphasized by the White House in its original budget request: there is little mention of any implementation of the infamous Opportunity, Growth, and Security account suggestions for global health or health research, although the Senate Appropriations Committee has developed its own plan for handling the declining budget caps while still supporting accounts they view as important to US health research programs. While the progress we’ve seen so far is commendable, Congress must speed its efforts to enact smart, evidence-based appropriations for global health R&D programs and their overarching accounts. As the end of the current fiscal year looms closer, policymakers must work together to avoid the stalemate that caused the government shutdown of the fall of 2013 and should support strong funding levels for global health R&D.

The global health research community has a reason to celebrate this weekend. Yesterday, Senator Patty Murray (D-WA) introduced in the US Senate a significant piece of global health legislation that would strengthen global health research programming within the US Agency for International Development (USAID) and improve coordination of global health research and development (R&D) across the US government. The legislation—known as the 21st Century Global Health Technology Act—is companion legislation to the House version of the bill, HR 1515, which was introduced by Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) in April 2013 and is now awaiting consideration in the House Foreign Affairs Committee. The House and now Senate introduction of the bill shows a growing recognition among US policymakers of the critical role investments in research and innovation play in improving public health worldwide.The 21st Century Global Health Technology Act would strengthen global health research programming within the USAID and improve coordination of global health R&D across the US government.Senator Murray and the House authors set out to create legislation that would (1) encourage the development of health products that are affordable, culturally appropriate, and easy to use in low-resource health systems, and (2) would—importantly in these fiscally-constrained times—cost taxpayers nothing. Thus, this legislation doesn’t mandate new funding. Instead it focuses on improving efficiency, coordination and cooperation across agencies and existing programs.The bill focuses on three main areas. The legislation: Establishes USAID’s mandate to conduct global health R&D and calls on the agency to create an overarching strategy which would help fill current gaps. Asks USAID to coordinate and collaborate with other agencies to create a cross-government strategy for global health research. Codifies into law USAID’s Health Tech program—which focuses on developing medicines and health products for use in low-resource settings. Let’s break down the significance of each of the bill’s three main impact areas:Strengthening USAID global health R&D mandate While recognizing the historic work of USAID in developing new products for use in the developing world, the bill gives an official mandate for USAID to conduct R&D across its portfolio by telling the agency that it should include research as part of each type of global health work it undertakes. This ensures health R&D remains a central focus of USAID’s work and makes sure current gaps across the agency’s portfolio are filled.Coordinating/collaborating with other agencies The US government is currently involved in 200 of the 365 global health products in the R&D pipeline, with work spread across many agencies including USAID, the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense and the Food and Drug Administration. That means there are a lot of cooks in the global health R&D kitchen. This bill calls on USAID to coordinate and collaborate with the other US agencies involved in global health to develop a “whole-of-government” approach to global health research and improve outcomes, leveraging US funding and ensuring US tax dollars are well spent. While the bill doesn’t mandate how that coordination should occur, it does require USAID to report to Congress progress made on this objective.Codifying US Health Tech program The Health Tech program has existed at USAID for over 25 years. It forges collaborations between the public and private sector—known as public-private partnerships—to develop health technology solutions for people in the developing world. It has produced many innovative products, such as the vaccine vial monitor—which changes color to indicate whether a vaccine has been stored at a proper temperature and remains effective. So if the program already exists and works, than why does “codifying” it matter? This legislation would make the Health Tech program an official part of US law. That’s important because in a difficult fiscal climate in which cuts are occurring, the program’s inclusion in US law helps protect it from elimination and assure it can continue to carry out its work.So what’s next for the bill? As we all know from the singing Bill on Capitol Hill, Senator Murray’s introduction of this legislation in the Senate represents one of the first steps in the long process it must go through to become US law. The bill will now be referred to the Senate Committee on Foreign Relations for further consideration.While the path ahead for the legislation is still uncertain, it’s worth pausing to celebrate this initial victory. The fact that this legislation has been championed by Senator Murray and such significant advocates in the House indicates recognition by US policymakers that global health R&D is both critical to US health and foreign policy goals and a smart economic investment. After all, sixty-four cents of every US dollar invested in global health research goes directly to US-based researchers.So this weekend when you are out with friends and family, raise a glass to Senator Murray for being a steadfast advocate and tirelessly working to advance US leadership in global health R&D.