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. Two recent announcements occurred regarding US international collaboration on global health research and development (R&D). Earlier this week, the US National Institute of Allergy and Infectious Diseases and the Office of AIDS Research at the National Institutes of Health announced a collaborative project with the Indian Ministry of Science and Technology and Department of Biotechnology to fight tuberculosis in India as part of the Indo-US Vaccine Action Program. On Tuesday, the US Department of Health and Human Services and the European Commission released the first report of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), which is a joint commitment by the US and EU to fight antimicrobial resistance. Dr. Lucas Otieno Tina—a physician and researcher at the Kenya Medical Research Institute/US Army Medical Research Unit-Kenya collaboration program—writes in AllAfrica.com about why he has spent his career working to develop a malaria vaccine. He also discusses the promise of the RTS,S malaria vaccine and his involvement in the clinical trials for the vaccine supported by PATH’s Malaria Vaccine Initiative. Last week, the NTD Roundtable—a group of global health partners committed to fighting neglected tropical diseases (NTDs) —hosted briefings in the US House of Representatives and Senate to discuss America’s leadership in the fight against NTDs and the need for greater NTD R&D. The briefings were attended by representatives from key House and Senate committees, the NGO community, and the African diplomatic corps. Among other topics, participants discussed the need for the development of new diagnostic tools and treatments for NTDs. TechCrunch reports about a grant from the Bill & Melinda Gates Foundation to Sure Chill Company in Wales, which has developed a way to store vaccines at a proper temperature without the need for an electrified or gas-powered refrigeration source. The technology reduces problems with vaccine distribution caused by vaccines that lose their efficacy without proper refrigeration.

As more detailed information about the President’s fiscal year (FY) 2015 budget requests to Congress is released, the results continue to be a mixed bag for global health research and development (R&D). The Congressional Budget Justifications—annual presentations to Congress to justify requests for funding—help shed a light into the administration’s priorities for FY 2015. National Institutes of Health (NIH) While the President made a modest request for overall NIH funding, the release of the NIH congressional budget justifications gives us a better sense of how the President hopes to fund specific institutes and programs at the agency. The National Institute of Infectious Diseases (NIAID) did include increases of $5.76 million for Biodefense and Emerging Infectious Diseases, $6.95 million for infectious and immunologic diseases, and $23.4 million for HIV and AIDS research compared with funding for FY 2014. The President’s request for the Office of AIDS Research—which covers all HIV and AIDS activities within all of the centers at NIH—was $3.004 billion. While this is nearly a $20 million increase from 2014 enacted levels, this number is still below enacted numbers for 2011 and 2012. Within this request was a decrease of 0.4 percent from 2014 funding for microbicides, an increase of 0.8 percent for vaccine research and a decrease of 1.4 percent for therapeutics research. Centers for Disease Control and Prevention (CDC) Historically, research at the CDC has led to major advances against devastating diseases, including the eradication of smallpox and advances in AIDS research. With a disappointing funding request for NIH, we were glad to see a much stronger request for the global health budget within the CDC. The President’s request included $445.29 million for Emerging and Zoonotic Infectious diseases, a $54.85 million increase from FY 2014 levels. Included in this was the $30 million requested for the Advanced Molecular Detection Initiative. The $30 million will go towards investments in advanced molecular detection technologies to help speed up outbreak detection and increase response efficacy. We’re glad to see the Administration acknowledging the need for the CDC to be cutting-edge in an increasingly global arena. US Food and Drug Administration (FDA) Amongst the government agencies involved in various stages of the development pipeline, the FDA has a vital role to play in accelerating the review of new global health products and strengthening the global regulatory system. Despite the tough budgetary times we currently face, Congress has been asking the FDA to do more with less. That said, we were pleased to see the President acknowledge that increased authority should also mean increased funding, with a robust request of $4.7 billion for the FDA, an 8.1 percent increase from Congress’ appropriation for 2014. The FDA’s Congressional Budget Justification acknowledged the unique role of the agency as an important international collaborator for global health through research and information sharing. The language specifically highlights the Biologics Program and its work to promote research and information sharing to facilitate access to vaccines and other products, harmonize regulatory standards, and establish and maintain standards for biologics. Another highlight is the news that FDA is in the process of drafting a proposed rule to add to their current list of neglected diseases for which they can allow accelerated reviews, and is specifically considering adding Chagas disease. US Agency for International Development (USAID) As we reported in our first blog post, while funding for global health at USAID and the Department of State was fairly disappointing, we were pleased to see an increase in the President’s request for malaria. Notable in this request was acknowledgement of the need for continued funding for R&D to support “the development of new malaria vaccine candidates, antimalarial drugs, new insecticides, and other malaria related research with multilateral donors.” Also in the USAID request was $153 million in central funding to accelerate science, technology innovation, and partnership. USAID describes this aim to “develop and scale breakthrough solutions and accelerate the transformation of the United States’ development enterprise by leveraging outside resources and improving the sustainability of development programs by attracting private-sector, market driven resources.” Department of Defense (DoD) DoD is the only US agency that funds global health research and product development from discovery to introduction. While we’re still sifting through all of the details in the Defense budget justifications, R&D at the agency—including health R&D—increased overall by 1.7 percent over FY 2014 enacted levels. Much of the global health research at DoD is funded through the Army’s Research, Development Testing and Evaluation (RDT&E) division as well as the Defense Health Program—including research on HIV and AIDS, malaria, and leishmaniasis. While we’re grateful the administration is continuing to recognize the need for sustained, robust support for global health R&D across several agencies, the decline of global health research funding in some key accounts remains concerning. We’ll look to Congress to equip these agencies with the necessary resources to carry out their essential role in developing new global health tools.

Yesterday, the White House released President Obama’s much-anticipated budget request for fiscal year (FY) 2015. After hearing that the budget would be released in two phases, we weren’t sure what level of detail or clarity to expect from the top-line numbers. As it turns out, the message is murky—for now. Below are some initial takeaways on the budget proposal’s impact on global health research and development (R&D). State and USAID Global Health Programs While funding for the overall 150 international affairs account remained fairly stagnant compared with FY 2014, funding for the State Department’s global health programs—which fund most global health R&D at the US Agency for International Development (USAID) and the State Department—took a concerning downward shift, falling by 4.6 percent overall. The Maternal & Child Health, Tuberculosis, and Global HIV and AIDS programs that fund research for many new global health tools all saw decreases to varying degrees when compared with the levels that Congress just approved for them in its FY 2014 budget agreement. There were a few ‘winners’—a relative term only; USAID’s Malaria and Family Planning programs saw small increases, and GAVI—which works to scale up currently available vaccines—saw its request increased by $25 million over FY 2014. As many in the community have voiced, the flat-funding of the President’s Emergency Plan for AIDS Relief—coupled with a possible $300 million decrease in the US’s contribution to the Global Fund to Fight AIDS, Tuberculosis, and Malaria—is disappointing, if not unexpected. Funding for the State Department’s global health programs—which fund most global health R&D at the US Agency for International Development (USAID) and the State Department—took a concerning downward shift, falling by 4.6 percent overall. Although these cuts are concerning, the President’s budget request did indicate that the administration is aware of the need for sustained global health R&D programming and recognized the important role that USAID plays in fostering innovation. The President requested $146.3 million for the new Global Development Lab at USAID, which “will consolidate and expand USAID's efforts in science, technology, innovation and partnerships, creating a world-class capability to discover, incubate, test, and scale transformational solutions to the greatest development challenges that we face today.” However, according to the budget justification text, only about $5 million of this funding will go to global health programs.   Global Health R&D at NIH, CDC and FDA The President requested $30.2 billion for funding at the National Institutes of Health (NIH), a slight increase from 2014 appropriations levels of $29.9 billion, but still lower than the President’s request for FY 2014—continuing a troubling decline. It is estimated that NIH’s funding has decreased 15 percent since FY 2004. Within the NIH, the National Institute of Allergy and Infectious Diseases was funded at $4.423 billion, a 3.4 percent decrease from the President’s request for 2014, but a slight increase from the 2014 appropriated budget of $4.359 billion. The National Center for Advancing Translational Science saw a slight cut from FY 2014 appropriations and previous requests, while the National Institute of Child Health and Human Development and the Fogarty International Center were essentially flat-funded. There was potentially better news for global health R&D funding at the Centers for Disease Control and Prevention (CDC). The President requested a total of $464 million for CDC’s Center for Global Health—a significant increase over FY 2014. CDC’s Center for Emerging Zoonotic and Infectious Diseases also received a welcome increase. Both of these CDC centers are involved in the new Global Health Security Agenda programming. While the budget text says that the President requested $45 million for the new initiative, it’s not yet clear where this funding will come from. In more positive news, the President also requested just over $4.7 billion for the US Food and Drug Administration (FDA), allaying fears that the strong FY 2014 funding ($4.3 billion) would not be continued. The funding also assumes $2.612 billion in user fee income. Opportunity, Growth and Security Initiative Adding to the opaque nature of several parts of the global health and science accounts within the President’s budget request is the new $56 billion Opportunity, Growth and Security Initiative. Funds in this category include the $300 million that would go to the Global Fund if other nations are able to increase their own commitments, as well as other funding that would go to NIH and the Science, Technology, Innovation and Partnerships (STIP) in Development program via the new Global Development Lab at USAID. It’s still unclear whether this money will be allocated as stated, and many in the global health community are concerned that it would draw funds away from other health-related programs that have already been flat-funded or seen cuts. While we’re still waiting for more figures for NIH and the Department of Defense’s global health R&D programs, and details from additional budget justification documents—it’s clear that Congress has its work cut out for it in protecting global health R&D programming across the US government. When the appropriations committees from the House and Senate develop their own proposals later this spring, they should work to sustain and protect global health research and product development at USAID, CDC, NIH, FDA and the Defense Department in order to keep up the fight against global health diseases.  

After two-and-a-half weeks in limbo, government employees were able to return to work on October 17th—when Congress finally reached a temporary agreement to re-open the government. As we’ve highlighted previously, many federal employees involved in the day-to-day work of global health research programs were furloughed during the government shutdown, leading to lost research and delayed studies. While government employees have been catching up on email and trying to recover work that was slowed or halted by the shutdown, policymakers have been taking tentative steps toward negotiating a longer-term budget deal. While we have more answers now than we did a week ago, things are still murky—and long-term answers about the budget are still unknown. Policymakers have been taking tentative steps toward negotiating a long-term budget deal that will impact global health and research programs. October budget deal The congressional deal reached on October 17th contained short-term fixes to three major issues: It extended current spending levels through January 15, 2014. It extended the debt ceiling through February 7, 2014. It created a new committee tasked with developing and approving a long-term plan to fund the government by December 13, 2013. Spending levels for federal research programs The deal extended current fiscal year (FY) 2013 post-sequester spending levels through January 15, 2014. While FY 2013 levels for global health initiatives, including research programs, at the State Department and US Agency for International Development have fared relatively well when compared with other foreign aid accounts, we saw drastic cuts at agencies such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Department of Defense—all of which support vital global health research and product development efforts. These funding cuts will remain in the budget deal reached last month. It’s detrimental to scientific progress when increasingly reduced research budgets become the norm. Coupled with the lack of a compromise on the debt ceiling level, such actions hurt US financial credibility and the nation’s leadership in research for new technologies to aid in the fight against disease. Budget Conference Committee As part of the shutdown deal, Congress established a Budget Conference Committee, tasked with coming to agreement that both chambers can agree upon to fund the government past January 15, 2014. Leading the Budget Committee is House Budget Chair Paul Ryan (R-WI) and Senate Budget Chair Patty Murray (D-WA). The conference is a bi-partisan, bi-cameral group made up of 29 Members. While the committee has several options, a major focus will be replacing the sequester. A second round of sequestration cuts will automatically kick in on January 15, 2014, if Congress doesn’t pass a budget solution that includes targeted, smart cuts. Both Republicans and Democrats have expressed an eagerness to reach a deal, but ideas for how to do so continue to appear miles apart, with no sign of moving toward a compromise. It is more likely that if the Budget Conference Committee comes to an agreement, it will address the final FY 2014 budget—including the upcoming January 15, 2014, sequester cuts—but go no further. This approach is really nothing new, since it essentially replaces the normal order of appropriations for FY 2014. The Budget Conference Committee held its first meeting on October 30th, and its next public meeting is scheduled for November 13th. Opposition to the continued budget purgatory seems universal. Several advocacy groups, including InterAction and the Business Roundtable, have sent letters to members of the committee urging them to come to an agreement quickly. We agree with these pleas for a long-term budget solution. As we saw earlier this year, debating budgets for two different fiscal years simultaneously is not productive and is a poor way to set programmatic priorities. While it may seem usual business these days to have concurrent debates on the traditional budget, the sequester cuts, and the debt ceiling, we’re hopeful that this budget conference committee will act boldly to reset the process by rapidly agreeing on final FY 2014 funding levels and a long-term debt ceiling compromise. Congress and the Administration should then be able to move on to the myriad of other priorities they have on their plates.