Breakthroughs Blog: NIH

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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. A new report sponsored by the Bill & Melinda Gates Foundation examines the need for post-market surveillance for new drugs and vaccines in low- and middle-income countries. The report is based off the findings from the Safety Surveillance Working Group, and provides recommendations stakeholders should take to strengthen post-market surveillance of global health products. The University of South Florida’s Center for Drug Development and Innovation, and the College of Public Health’s Department of Global Health have been awarded a grant of $2.1 million from the National Institutes of Health. The focus of the research will be to see how parasites, like malaria, grow. At a recent event in Washington, DC, US Agency for International Development (USAID) Administrator Rajiv Shah underscored the agency’s commitment to public-private partnerships. According to Devex, 40 percent of USAID’s resources are programmed through public-private partnerships. New studies show that patients with multidrug-resistant tuberculosis (TB) and HIV and AIDS have a higher chance of living if they take simultaneous treatment for both diseases, as oppose to waiting to take HIV and AIDS treatment. The initial study was small in size, but concurs with three previous major studies of people with regular TB and HIV and AIDS.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Japan’s National Institute of Biomedical Innovation (NIBIO), GHTC member Aeras, and Create Vaccine Company have entered an agreement to collaborate on preclinical and clinical development of new tuberculosis vaccines. The partnership will advance vaccine candidates with the NIBIO technology through preclinical studies, with the goal of eventually testing candidates at clinical trial stages. According to SciDev, the UK Department for International Development (DFID)’s budget for research and development has fallen under the current government. DFID’s research budget in 2011-2012 was £11 million—or about US$18 million—below the £237 million that was available in 2009-2010, prior to the coalition government coming to power. In response to a US congressman, Roger Glass—director of the Fogarty International Center at the National Institutes of Health (NIH)—made the case for global health research supported by NIH. Glass writes: “In almost every branch of medicine, research overseas has allowed us to advance our discoveries faster, cheaper, and more efficiently than we ever could have at home. We are leaders in global health because we have been able to reach out and engage others to do studies that are locally relevant but can have clear implications for us at home. Global health research truly is the new frontier of science.” amfAR, The Foundation for AIDS Research has launched a new initiative—called Countdown to a Cure—aimed at funding a “broadly applicable cure for HIV by 2020.” The initiative plans to invest $100 million in cure research over the next six years.

UPDATE: since this post, the Senate also approved the spending package and President Obama has signed the final 2014 omnibus bill into law. In an increasingly rare show of bipartisanship, Congress has moved forward an appropriations agreement that should finally settle the issue of fiscal year (FY) 2014 funding levels. Yesterday, the House of Representatives approved the $1.1 trillion Omnibus spending bill, and the Senate is likely to pass the legislation later this week. In line with budget numbers previously agreed to, the bill includes an increase in discretionary spending of $45 billion, split equally between defense and non-defense spending. For global health research, the news is mixed. Funding for many accounts that fund research for new global health tools—such as those at the US Agency for International Development (USAID)—was higher than FY 2013 sequestered levels, and a few accounts even saw further increases. However, the National Institutes of Health (NIH) remains woefully underfunded, even as Congress increased its budget by $1 billion over last year’s post-sequestration levels. Below are a few key highlights from the omnibus agreement: State and Foreign Operations (SFOPS)—Although overall International Affairs funding saw a cut of $6.5 billion (39.7 percent) from last year’s levels, funding for global health actually increased by 4.7 percent over FY 2013 levels to $8.44 billion. Certain subaccounts that contain global health research programs within the SFOPs budget fared particularly well, including funding for the Maternal and Child Health account ($705 million) which saw a 12.4 percent increase from 2013 levels. Additionally, appropriators went above and beyond the President’s request for tuberculosis (TB) funding, allocating $236 million for bilateral TB programs, $45 million over the President’s request and an increase of 5.1 percent from 2013 enacted levels. In another positive move, the USAID Neglected Tropical Diseases program is funded at $100 million—potentially opening the door for the inclusion of research and development (R&D) programming. The bill also provides for $4.067 in funding for the President’s Emergency Plan for AIDS Relief program—which includes key product development programs for malaria, HIV and AIDS, and TB—an overall increase of 3.9 percent. Funding for both family planning and malaria remained similar to last year’s levels. Policy language that accompanied the omnibus also contained support for the continuation of important global health research programming. NIH—The omnibus sets overall 2014 funding for the NIH at $29.934 billion—a $1 billion increase from 2013 post-sequester levels. While this is certainly an improvement from the current situation, this number falls short of White House and Senate requests and represents a $950 million cut from 2012 levels. In more reassuring news, the NIH National Center for Advancing Translational Science (NCATS) was funded at a fairly robust $633 million, however report language included in the omnibus text requested that all funding for the Clinical and Translational Science Awards come out of NCATS funding in FY 2014, whereas in the past funding has been drawn from several centers. Other important centers such as the National Institute of Allergy and Infectious Diseases and the National Institute of Child Health were funded at $4.359 billion and $1.283 billion, respectively—both decreases from FY 2012 levels and the FY 2014 budget request. Centers for Disease Control and Prevention (CDC)—Overall funding for the CDCis set at $6.9 billion, a $567 million increase from 2013 post-sequestration levels. Within the CDC, the National Center for Emerging and Zoonotic Infectious Diseases was funded at $287.3 million, $93 million below the President’s request. CDC’s Global Health account, which includes funding for HIV and AIDS was funding at $383 million, slightly below the President’s request, but a $24 million increase from 2013 post-sequestration levels. In an intriguing move, language included in the CDC section calls for increase coordination of research programming between CDC, the US Food and Drug Administration (FDA), and NIH. You can read the full report here. FDA—Out of the major US agencies involved in global health research, FDA fared the best in the omnibus. FDA is funded at a total of $2.552 billion in discretionary spending, an increase of $91 million from 2013 post-sequestration levels. Notably the omnibus allows FDA to get back $85 million in user fee money that was withheld as a result of the sequester. Department of Defense (DoD)—While we’re still poring through the DoD’s appropriation package, early analysis reports that medical R&D funding saw increases, even as DoD’s overall budget was decreased. This may be a positive sign; as AAAS reports, research programs here may help lessen the impact of dire cuts at NIH. While Congress should be applauded for protecting many of the programs that fund global health research in the omnibus package, the recent downward trend in NIH funding is troubling. NIH is the world’s leading research institution, and has funded the groundbreaking work behind the majority of global health tools available today. The role of NIH in the global health product development cannot be replaced or replicated elsewhere; if support continues to decline, urgently needed innovations will not reach those who need them. Congress and the Administration must continue to push global health progress forward by supporting robust funding for all US agencies that fund global health R&D during the FY 2015 budget and appropriations process. Additional analyses: Kaiser Family Foundation AAAS InterAction budget table