Faces of Innovation: Dan Littlefield, researcher at Modality Solutions

This week, months of tense negotiation between leaders in the Democratically-controlled US House of Representatives, the Republican-held Senate, and the White House concluded with the congressional passage of two massive spending packages encompassing all federal government spending for fiscal year (FY) 2020 —nearly three months behind schedule. Two continuing resolutions, passed by Congress to allow additional time for the process to play out after the start of the new fiscal year on October 1, have kept the government operating at FY19 levels, while from week to week, it was anyone’s guess whether the stalemate over funding levels and contentious items like border wall funding could be broken to avoid another government shutdown.A long process to produce two very long billsIn November, the appropriations “cardinals”—chairs and ranking members of both chambers’ Appropriation Committees—announced they had reached a deal on overall spending for each of the 12 appropriations bills, figures known as 302(b)s. This marked a critical step in the negotiations, given that at the time the House and Senate passed a two-year budget deal over the summer, each chamber had been working off of different overall blueprint funding envelopes: The House had already passed its appropriations bills assuming much higher funding levels than were ultimately included in the deal, while the Senate was developing its bills under the more modest final caps.Once the gulf was bridged and the 302(b)s were set, the leaders and their staff worked quickly to develop final compromise appropriations bills, which they grouped into two “minibus” funding packages released on December 16: a “national security appropriations” minibus and a “domestic priorities and international assistance appropriations” minibus, which included the bills for Labor, Health and Human Services, and Education (LHHS) and State and Foreign Operations (SFOPS).Funding increases included for several key accounts The later minibus encompassing LHHS and SFOPS was a mixed bag for accounts that support global health research and development (R&D). In the LHHS division of the minibus, overall funding for the National Institutes of Health (NIH) was boosted 6.7 percent from FY19 enacted levels—including increases of 6.7 percent for the National Institute of Allergy and Infectious Diseases, 3.3 percent for the National Center for Advancing Translational Sciences, 3.4 percent for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and 3.4 percent for the Fogarty International Center. The joint explanatory statement accompanying the division also notes “an increase of no less than $25,000,000 over the fiscal year 2019 level for HIV and AIDS research” at NIH.The Centers for Disease Control (CDC) saw even greater overall growth than NIH, with an increase of 8.7 percent; however, GHTC-priority accounts that finance global health R&D were mostly flat-funded. While the Center for Global Health (CGH) received a 16.8 percent bump, the entirety of the increase went to Global Public Health Protection—which funds global health security activities—and a new Global Tuberculosis line—which represents level funding of an amount previously transferred annually from a domestic tuberculosis (TB) line to support global TB activities. All other CGH lines were flat-funded. The National Center for Emerging and Zoonotic Infectious Diseases got a modest 1.6 percent bump. The final GHTC priority account in the LHHS bill, the Biomedical Advanced Research and Development Authority (BARDA), was flat-funded.The SFOPS division of the minibus increased overall funding for Global Health Programs at the State Department and US Agency for International Development (USAID) by 2.9 percent. This is slightly lower than what had been proposed in the Senate SFOPS bill earlier this fall and significantly lower than the House proposal to increase by 5.2 percent, but overall still a positive trend reflecting strong support for global health among appropriators, who were working under the constraints of a modest overall SFOPS allocation in the final agreement. At USAID, most health area-specific allocations were flat-funded or increased by about two to four percent—the big exception being the Global Fund for AIDS, Tuberculosis, and Malaria, which was increased by 15.6 percent to reflect the higher pledge made by the US government at the Global Fund’s international pledging conference in October.Report language signals policy support for global health R&DGHTC successfully advocated for the inclusion of several sections of report language, included in the original House and Senate SFOPS bill reports, that will hold under the final agreement. Report language serves as guidance from Congress to US agencies on how it would like to see funding implemented. Language that will hold for FY20 includes GHTC-supported language on USAID’s important role in and reporting on health-related R&D and inter-agency collaboration and coordination on global health product development, as well as support for “CDC’s continued and enhanced work in research and development aimed at creating new tools to respond to health threats at home and abroad” and BARDA’s contributions to emerging infectious disease outbreaks and other naturally occurring threats.The “domestic priorities and international assistance minibus” not only included some positive funding increases and report language, but also advanced a bill supported by GHTC—the End Neglected Tropical Diseases (NTD) Act, which supports R&D activities by USAID to control and eliminate NTDs.The House passed both packages Tuesday afternoon, with the Senate following suit Thursday and now the bills are awaiting signature by the President. GHTC applauds Congress for their strong continued support for global health R&D evidenced by the final deal and looks forward to building on this foundation for our advocacy as we enter a new decade full of opportunities for global health innovation.

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.  British drug maker GlaxoSmithKline (GSK) applied for a license to market its HIV drug, dolutegravir, in a child-friendly formulation that, if approved by regulators, will become the first new generation HIV medicine available in a child-friendly form. Developed by GSK’s HIV drug division ViiV Healthcare, this new formulation of dolutegravir is designed to be easier for babies and children to swallow. Because there is no licensed version of dolutegravir for children, doctors often prescribe older HIV medicines that can be less potent, harder to take, and have more side effects. GSK plans an initial rollout of the child-friendly formulation at “cost of production” early next year, pending licensure by US and European regulators, and is also planning licensing agreements with two generic drug makers who aim to make cheaper versions of the medicine available within months of the initial rollout. According to UNAIDS, approximately 1.7 million children are living with HIV, most of them in sub-Saharan Africa. According to reports released by Treatment Action Group (TAG) and the Stop TB Partnership, global funding for tuberculosis (TB) research and development (R&D) has reached an all-time high, though funding targets for efforts to eliminate the disease remain far from being met. According to the TAG report, TB R&D funding reached its highest level in 2018 at US$916 million, representing three consecutive years of funding increases. However, the Stop TB Partnership’s updated Global Plan to End TB—which aligns with the commitments made at the United Nations High-Level Meeting on TB in September 2018—calls for $2.6 billion per year for R&D for new diagnostics, drugs, and vaccines, in addition to the $13 billion needed for TB prevention and care. The Stop TB Partnership notes that reaching these funding goals would help provide care for 40 million people living with TB, enable 30 million to get preventive treatment, and put new diagnostics and treatment tools within reach by 2030. A new program approved by the board of Gavi, the Vaccine Alliance (Gavi), will fund a global emergency stockpile of Ebola vaccines that will be open for use by those in need of outbreak and prevention efforts. The program will be funded for $178 million through 2025 and will focus on low- and middle-income countries who will have access to the stockpile free of charge and will also receive support for the operational costs of vaccination campaigns. The World Health Organization’s SAGE Working Group on Ebola Vaccines and Vaccinations state that the stockpile should maintain 500,000 licensed doses of vaccines. In addition to the Ebola vaccine stockpile, Gavi will allocate another $1.6 million in funding for the RTS,S malaria vaccine implementation program from 2021-2023, which is ongoing in three African nations, which will evaluate the vaccine’s effectiveness in reducing childhood deaths when used in real word settings.