Breakthroughs Blog: US budget

On Friday, President Joe Biden signed into law a US$1.7 trillion spending bill that will fund the US government through fiscal year 2023 (FY23), which ends September 30, 2023. The package includes significant funding increases across nearly every line relevant to global health research and development (R&D), as well as complementary directives that will support global health R&D across several agencies.How it passedUntil mid-December, the outcome of the spending package was still uncertain. Many Republicans in the House and some in the Senate were hoping to see a continuing resolution—a stopgap measure to postpone negotiations—into next year when they would hold more leverage with control of the House. Top House appropriator Rosa DeLauro (D-CT) responded by threatening to only pass a full-year resolution if no progress was made. As talks froze, Democratic lawmakers turned up the tension forcing a breakthrough weekend negotiation in early December. A few more bumps laid in the way, especially in the Senate, where energy permitting reform and Title 42 amendments were set on the table but ultimately shoved away, clearing a last-minute path for passage.New fundingPassage of the bill is mostly great news for global health R&D. Nearly every funding line across the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), the US Agency for International Development (USAID), and the State Department relevant to the sector has increased. Some notably large increases include:A 10 percent increase for universal influenza vaccine research at the National Institute of Allergy and Infectious Diseases (NIAID).A 50 percent increase for the Advanced Research Projects Agency for Health (ARPA-H).A 10 percent increase for NIH’s Fogarty International Center.A 9 percent increase for CDC.A 7 percent increase for the CDC Center for Global Health.A 9 percent increase for the CDC National Center for Emerging and Zoonotic Infectious Diseases.A 21 percent increase for global tuberculosis programs at CDC.A 16 percent increase for Global Public Health Protection at CDC.A 26 percent increase for BARDA.A 28 percent increase for the Global Fund to Fight AIDS, Tuberculosis and Malaria.A 7 percent increase to USAID global health programs, of which most goes to a 29 percent increase for global health security at USAID.New directivesIn addition to funding, spending bills are passed with corresponding plain-language texts called bill reports. which include directives from Congress. These reports do not hold the same legal power as the spending bills themselves, but they are a way for Congress to urge or direct agencies to change their policies or to spend their funding in specific ways. Nearly all GHTC’s requests for report language to Congress were reflected in the final FY23 package (either through the House bill reports or the joint explanatory statements, for those keeping count). Some notable wins include:Direction for USAID to increase health-related R&D funding and to consult with representatives of affected communities, as well as technical experts and nongovernmental organizations specializing in biomedical product development (House report).General continued support for USAID’s role in health-related R&D (House report).Requirement for USAID to submit a report on its health-related R&D investments (joint explanatory statement; also includes request for details on investment in antibiotic research).Request for an update from the Department of Health and Human Services on coordinating global health research activities using metrics (House report).Recognition of the need to increase resources for NIH’s Fogarty International Center and expand their role in pandemic preparedness and health research capacity-building (House report).Support for CDC’s role in global health security and developing and validating new global health tools (House report).Support for BARDA to provide robust funding for emerging infectious diseases and naturally occurring threats to global health security and to account for the constraints of low-resource settings in the development of new products (joint explanatory statement).Urges BARDA to publicly and regularly report on pathogen-, product-, and project-level data for all its funding (House report and joint explanatory statement).Relevant RidersThis year’s package also included quite a few riders—bills less relevant to funding that were amended onto the omnibus package. Nearly all elements of the PREVENT Pandemics Act were attached, including:Authorization of ARPA-H as a new entity within NIH. Despite its technical placement under NIH, the accompanying report language encourages ARPA-H to be physically and culturally separated. The authorization includes prioritizing awards to entities that conduct their work in the United States (a provision that GHTC has opposed).Establishment of a NIAID-BARDA “multidisciplinary research program with research centers to advance the discovery and preclinical development of antivirals and other medical products to combat priority virus families.”Expansion of the FDA fast-track designation for new antimicrobials that are biologics.The bill also includes several amendments to the US Food and Drug Administration (FDA) that had been dropped from the FDA user fees negotiations earlier this year. These include:Requesting a Government Accountability Office report on nonprofit pharmaceutical organizations, including the “impact of such organizations on the development, availability, and cost of prescription drugs, and any challenges to manufacturing or other operations.”Establishes a pathway for accelerating the review of advanced manufacturing technologies that either combine or incorporate novel technologies or techniques for manufacturing drugs, biologics, or active pharmaceutical ingredients.Requires sponsors of new drugs and devices to submit diversity action plans for clinical trials (exceptions permitting).Requires FDA to convene wide stakeholder meetings to solicit input on “increasing the enrollment of historically underrepresented populations in clinical studies.”Requires FDA to submit a report to Congress on progress for diversity action plans in aggregate.Requires FDA to issue guidance on decentralized clinical studies for drugs and devices and “how to advance the use of flexible and novel clinical trial designs” to increase diversity of participants.Requires FDA to issue guidance on the use of digital health technologies in clinical trials.In summaryDespite the delay, GHTC applauds lawmakers for passing increased funding, smart report language, and riders that will strengthen global health security and medical product regulation. The FY23 omnibus package is a significant win for most global health and global health research programs. Many pundits predict that in the next Congress we are less likely to see similar funding increases given the split control. Regardless, GHTC looks forward to working with offices on both sides of the aisle to advance bipartisan priorities for global health R&D.

The 2022 midterm elections on November 8 were expected to deliver a decisive power flip from Democrats to Republicans. However, as the new landscape comes into focus, it appears that Democrats will hold the Senate, and Republicans are likely to win the House of Representatives by a handful of seats. These margins and the composition of new committees will determine the trajectory of global health research and development policy over the next two years.Both chambers on a knife edge splitRepublicans underperformed most analysts’ projections in both chambers. In the House, they are expected to eke into power by only a handful of seats. In the Senate—where several Republican candidates failed to overtake their competitors in close races—Democrats have retained control and may even net gain one seat, depending on the outcome of a special runoff election in Georgia on Tuesday, December 6, between incumbent Senator Raphael Warnock (D) and Herschel Walker (R).Implications on makeup of key committeesNext steps for both parties include electing new party leaders, which is expected to happen later this year. Following that, early next year, the parties will designate committee assignments, which will impact oversight and policymaking for the next two years of global health research. In the House, committee majorities will be determined by who holds the majority in the full House. In the Senate, if the final split is 50-50, then committees will also be evenly split. But if Senator Raphael Warnock wins his reelection in Georgia, then the Senate will be 51-49, and Democrats will take the majority on each committee with one extra seat.Though we do not yet know exactly how the committees will look next year, we do know which members from the 117th Congress will return to the 118th and which current members will be stepping down.Leadership of most committees relevant to global health research and development (R&D) are expected to remain relatively stable with top Democrats and Republicans trading positions as chairs and ranking members. Some exceptions include Representative Karen Bass, chairwoman of the Subcommittee on Africa, Global Health, Global Human Rights and International Organizations, who is stepping down in pursuit of becoming the next mayor of Los Angeles and Rep. Hal Rogers (R-KY), ranking member of the House Appropriations State, Foreign Operations, and Related Agencies Subcommittee, who may become chair of the subcommittee or may be replaced by Rep. Mario Diaz-Balart (R-FL).Among the members currently serving on the House Foreign Affairs Committee who have retained their Congressional seats are Reps. Susan Wild (D-PA), Maria Elvira Salazar (R-FL), Young Kim (R-CA), and Abigail Spanberger (D-VA). Members who were defeated include Reps. Tom Malinowski (D-NJ) and Steve Chabot (R-OH). Some other members of Congress on relevant appropriating and authorizing committees to global health research who are retiring or lost their primaries earlier this year include Reps. Albio Sires (D-NJ), David Price (D-NC), Lucille Roybal-Allard (D-CA), Cheri Bustos (D-IL), Jaime Herrera-Beutler (R-WA) and Fred Upton (R-MI). In the Senate:There were no major losses among incumbents on the Foreign Relations Committee; Health, Education, Labor, and Pensions (HELP) Committee; or the Appropriations Labor, Health, nor on the Human Services, Education, and Related Programs (LHHS) and State and Foreign Operations subcommittees. Some big names will be retiring, including Sens. Richard Shelby (R-AL), ranking member on the Appropriations Committee; Roy Blunt (R-MO), ranking member on the LHHS Subcommittee; Richard Burr (R-NC), ranking member on the HELP Committee; and Rob Portman (R-OH).Some leadership changes are expected. Sen. Patty Murray, previous chair of the Senate HELP Committee, is expected to become the head of the Senate Appropriations Committee. The Senate HELP Committee will likely be led by Sen. Bernie Sanders (I-VT) and Sen. Rand Paul (R-KY) or Sen. Bill Cassidy (R-LA). The Senate LHHS subcommittee may be led by Sen. Joe Manchin (D-WV) and Sen. Marco Rubio (R-FL). Both 2022 GHTC Innovating for Impact award winners, Sen. Sherrod Brown (D-OH) and Sen. Todd Young (R-IN) retained their seats.  A potentially challenging landscapeWith Democrats elected to retain control of the Senate in the 118th Congress, leadership in both parties of the current Congress may be more interested in passing an end-of-year funding package so that the 118th Congress can begin with a clean slate. The same may not be true next year, though. If Republicans have a slim majority in the House as projected, it could empower more conservative members to dangle threats to regular governance, such as annual passage of an appropriations package, as bargaining chips—a threat some members have already referenced. Such a dynamic may also lead to hardball negotiations over raising the debt ceiling, a final agreement on which is due in July of next year. Ultimately, these dynamics could limit the potential for global health R&D funding growth in the next two years, despite the need for greater resources. Beyond the funding picture, if Republicans win control the House, they plan to increase oversight over many US government agencies, including several public health and research agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention. Oversight over the executive branch is a critical function of Congress, but aggressive oversight can also threaten the basic functioning of these agencies as staff efforts are redirected. This could ultimately impact the pace of progress for global health research and science in general.Looking aheadGlobal health R&D has historically received bipartisan support, yet this will be the first Congress to be seated after the COVID-19 pandemic, a global health catastrophe that has provoked some policymakers to question the value of certain types of research and the global health status quo. The results of this election are still being finalized, but regardless of who is in charge, there will remain opportunities for crafting and passing good policy. Whether progress happens and at what pace will largely depend on the ability of advocates to make the bipartisan case for why global health R&D is a force multiplier for creating a healthier and safer future for Americans and all global citizens.  

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.President Biden signed an executive order establishing a new national biomanufacturing initiative and pledging more than US$2 billion to fund building or expanding drug manufacturing facilities and ensuring an adequate supply of raw materials. The Biden administration’s goal is to strengthen the biotech supply chain and maintain US competitiveness with foreign manufacturers in the wake of major supply chain challenges and shortages during the COVID-19 pandemic. $40 million of the pledge will go toward expanding the production of antibiotics and the base materials needed to produce products for future pandemic responses.A new study looking at antimicrobial resistance (AMR) records from laboratories in 14 African countries found that the basic requirements for testing for drug-resistant pathogens are unmet in most areas despite plans to tackle antimicrobial resistance on the continent. The researchers found that only 1.3 percent of the 50,000 medical laboratories included in the study were conducting bacteriology testing. Of those laboratories that were, even fewer were equipped to test for AMR and among those who were testing for AMR, only a third of the high-priority antibiotic-resistant pathogens designated by the World Health Organizations were being tested consistently. The study highlights larger challenges in Africa including limited access to antibiotics, imperfect use of antibiotics, and a lack of information about the impact of AMR because of incomplete and fragmented data.The smallpox treatment tecovirimat, or TPOXX, is undergoing a phase 3 clinical trial to test efficacy in treating monkeypox after preliminary data from the Centers for Disease Control and Prevention showed some alleviation of symptoms in patients. The trial is being run by the AIDS Clinical Trial Group in locations nationwide and will enroll more than 500 people who test positive for monkeypox. The intent is to provide stronger data that federal officials and agencies can use to inform decisions about the use of TPOXX in the national response to monkeypox.

Last Friday, President Joe Biden signed into law a $1.5 trillion spending bill that will fund the US government through the remainder of fiscal year 2022 (FY22), which began October 1, 2021, and concludes in September. The outcome followed months of tense negotiations by Congress—which had passed a series of temporary funding measures, known as continuing resolutions, to keep the government funded at FY21 levels since the start of this fiscal year—and last-minute maneuvering to try to pair annual spending with emergency aid for Ukraine and the COVID-19 response domestically and globally.While the bill ultimately included welcome boosts across key agency programs that fund global health and medical research, summarized below, in very disappointing news, emergency funding for COVID-19—including $4.5 billion for the global response—was stripped from the final package at the 11th hour due to disagreements on how to cover costs. This leaves an uncertain path ahead for the Biden administration to execute its COVID-19 plan, as previously appropriated funds for the domestic and global response are nearly depleted—raising the prospect of having to halt ongoing government-sponsored COVID-19 research trials, among other impacts. House Democrats have promised to advance a stand-alone COVID-19 emergency funding package, which could provide an influx of urgently needed funds, but it’s unclear whether such legislation could gain the 60 votes needed in the Senate since Republicans are demanding any new bill be paid for via offsets of unspent funds, a requirement many Democrats are opposed to.Below GHTC takes a detailed look at the spending bill and its impact on accounts that finance global health research and development (R&D) programming.State and Foreign OperationsThe final spending bill included $9.8 billion in funding for Global Health Programs at the State Department and US Agency for International Development (USAID), which represents an increase of $630 million, or 6.9 percent, over FY21 enacted levels. The vast majority—$510 million—of that increase is designated for global health security programming at USAID, a 268 percent increase over FY21 funding. This funding includes a $100 million allocation for the Coalition for Epidemic Preparedness Innovations (CEPI) to support vaccine development for potentially epidemic threats, which is both welcome news and higher than the $50 million pledge for this fiscal year announced by USAID Administrator Samantha Power at the CEPI pledging summit just a few days prior.Beyond global health security, the remainder of the increase—$130 million—was spread across other global health accounts. The tuberculosis and maternal and child health program lines at USAID received the largest increases at $52 million (16.3 percent) and $34.5 billion (4 percent) respectively, while nutrition, malaria, and neglected tropical diseases were each increased by $5 million and vulnerable children was increased by $2.5 million. USAID’s HIV/AIDS and family planning lines received flat funding compared to last fiscal year while the President’s Emergency Plan for AIDS Relief, or PEPFAR, under the State Department, was boosted by $20 million (0.5 percent). No global health-related accounts at USAID or State saw their funding cut. In other important news, in the joint explanatory statement accompanying the bill, Congress included language, for which GHTC advocated, directing USAID to develop and publicly release a new multi-year strategy on health R&D detailing its goals and how it plans to invest across health areas. USAID’s current health R&D strategy runs through 2022, so the fulfillment of this congressional directive will help ensure continuity and that research remains a priority for USAID’s global health programming.While it was positive to see Congress provide a major funding boost for health security programming and some modest increases to other global health accounts, overall, these funding increases fell short of what many advocates had hoped for, and in many cases what the House and Senate bill drafts released in 2021 had proposed. The COVID-19 pandemic has increased both the challenges and costs of operating health and research programs worldwide, so this funding package, even with increases, fails to match the scale of today’s expanding needs.Health and Human ServicesThe spending bill provided much larger, but uneven, increases across Department of Health and Human Services (HHS) subagencies and programs that support global health R&D. The National Institutes of Health (NIH) received $44.96 billion in funding, representing a $2 billion, or 4.7 percent, increase over FY21 levels. This included an increase of $253.1 million, or 4.2 percent, for the National Institute of Allergy and Infectious Diseases and a $2.8 million, or 3.4 percent, increase for the Fogarty International Center, which works to strengthen research capacity in low- and middle-income countries.Meanwhile, the Biomedical Advanced Research and Development Authority (BARDA)—an agency that supports development of medical countermeasures against health threats and a central player in COVID-19 R&D through then Operation Warp Speed—received a significant funding boost from Congress. It was appropriated $745 million in funding, a $148 million, or 24.9 percent, increase over the prior fiscal year. This funding envelope supports the agency’s entire research portfolio, which covers chemical, nuclear, radiological, and biological threats—both man-made and naturally occurring—so it is at the agency’s discretion to determine what of this funding it ultimately spends on R&D for naturally occurring health threats, including emerging infectious diseases, pandemic influenza, and antimicrobial resistance. Congress included in the bill’s accompanying joint explanatory statement language requested by GHTC expressing support for BARDA to expand its work on naturally occurring threats and provide more detailed reporting on such spending.The Centers for Disease Control and Prevention (CDC), which is a smaller but still important player in supporting global health R&D, received overall funding of $8.5 billion, a $582.4 million, or 7.4 percent, increase from the prior year. Within that, the Center for Global Health received a $54 million, or 9.1 percent, increase, with 93 percent of that increase designated for the global public health protection line focused on health security and the remainder spread across accounts funding global immunization, HIV/AIDS, tuberculosis, and parasitic diseases and malaria. The National Center for Emerging and Zoonotic Infectious Diseases, which funds select R&D for diagnostics and vaccines against infectious diseases, received a $45 million, or 6.9 percent, increase over FY21 enacted levels. These CDC increases were seen by many advocates as disappointing compared to evident needs. Challenges faced by the agency during the COVID-19 pandemic have underscored the need for a more significant influx of funding for this historically under-resourced agency to modernize its systems and improve staff retention.In addition to providing increases for the three HHS agencies above, Congress appropriated $1 billion for HHS to set up a new Advanced Research Projects Agency for Health, modeled after the Defense Advanced Research Projects Agency, to speed development of medical breakthroughs by funding high-risk, innovative projects. This funding was far lower than the $6.5 billion requested by the Biden administration and interestingly was designated to HHS to establish the agency under the Office of the HHS Secretary, rather than within NIH as the Biden administration and some congressional leaders had proposed. GHTC has pushed for this proposed agency to focus on poverty-related and neglected diseases, as a key area of market failure by industry; however, it remains unclear what health areas this new agency will initially prioritize as it is stood up.While FY22 was a bit of a mixed bag for global health R&D, with important increases across some programs but other areas falling short, advocates are already gearing up for the budget battle ahead for FY23, with the Biden administration expected to release its FY23 budget proposal soon.