Breakthroughs Blog: Congress

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.  

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.

Many experts have speculated that 2022 could bring the end of this acute stage of the COVID-19 pandemic. But if this proves true, what our new normal will be, and whether we’ll be better prepared for future crises, will depend on the decisions that our policymakers make in the months ahead. As 2022 begins, here are some of the top policy issues GHTC will be tracking.1. Will we achieve targets to vaccinate the world and what curveballs will COVID-19 still throw our way?What trajectory the pandemic will take in 2022 will depend in significant part on how successful efforts are to vaccinate the world. Last year, world leaders coalesced around a goal of vaccinating at least 70 percent of the world’s population by mid-2022, with an interim goal of vaccinating at least 40 percent of people in each country by the end of 2021. But a number of cascading challenges—from unexpected manufacturing disruptions with key suppliers to surging demand for booster shots in wealthy nations—slowed global efforts. As the year drew to a close, more than 90 countries missed the interim target, with many of the poorest nations in sub-Saharan Africa stuck at single digit vaccination rates. In a glimmer of positive news, the COVAX global vaccine facility delivered a record number of vaccine doses in December, hopefully setting a positive trend for the months ahead. Yet it remains clear there is much lost ground to make up as the year kicks off. Reaching the 70 percent target will require a significant influx of resources to boost manufacturing and overcome on-the-ground delivery and administration challenges, as well as continue research to respond to variants and deliver second generation vaccines better suited for distribution in low-resource settings. While leaders of the world’s richest nations have pledged their support for this global goal, few additional commitments of resources have materialized and nearly three-quarters of promised dose donations have yet to be shipped as of December. GHTC will be watching closely in 2022—particularly as President Joe Biden is expected to host a follow-up COVID-19 summit in March—to see whether the world embraces new urgency and accountability to close these gaps. As we’ve seen with the delta and omicron variants, COVID-19 could also still throw some unexpected curveballs our way that could upend existing efforts. 2. Will reams of recommendations turn into meaningful multilateral reforms?One might call 2021 the year of recommendations as several eminent groups, including the Global Preparedness Monitoring Board, the Independent Panel for Pandemic Preparedness and Response, and the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response, issued reports recommending actions to reduce the world’s vulnerability to pandemic threats. This included several significant proposed reforms to the existing multilateral architecture, including establishing a new Global Health Threats Council to elevate preparedness to the highest level of political leadership, creating a new financial intermediary fund or financing facility at the World Bank to support countries in strengthening their preparedness capacity and to finance surge response during a crisis, making permanent a structure like the Access to COVID-19 Tools Accelerator (ACT-A) to support end-to-end product development for epidemic threats, and advancing a pandemic treaty or framework convention on health preparedness to reform or build upon existing International Health Regulations. Now it remains to be seen whether 2022 will turn into a year of action to make these reforms a reality. GHTC has long advocated that research and development (R&D) is an essential pillar of health preparedness. As these discussions advance, we will be monitoring closely to see how ACT-A evolves and pushing for any such international agreement or financial fund to support countries in strengthening their research and manufacturing capacity.3. Will the US COVID-19 spending spigot still flow in 2022?During the first year of the pandemic, policymakers in Congress seemed willing to throw unlimited money at the problem, passing a series of huge emergency spending bills to finance response efforts and cushion the pandemic’s reverberating economic impacts in the United States—though money for the international response was slower to arrive and lower than advocates and experts recommended. Now that we’re nearly two years into this crisis, many are asking whether Congress has hit pandemic spending fatigue or whether the spigot will still flow. The last major emergency supplemental funding package—the American Rescue Plan Act (ARPA)—was signed in March 2021, more than ten months ago. But the need for additional resources seems as acute as ever as 2022 begins. On the domestic front, omicron is overwhelming US hospital systems and fueling increased demand for tests and boosters, while on the global front, reports are the US Agency for International Development (USAID) is fast running out of resources, as it has already spent or earmarked most of the money it received through ARPA to support global vaccination and response efforts—just as a significant influx of vaccine doses are finally arriving in partner countries and the international response is entering its most operationally intensive phase yet.Political observers are now watching closely whether Congress will put together a new emergency funding package, possibly pairing it with the regular fiscal year (FY) 2022 spending bills that it must pass before the continuing resolution now funding the government expires on February 18. As these talks advance, global health advocates are pushing for any such package to include substantial resources to replenish the coffers of USAID, the State Department, and the Centers for Disease Control and Prevention (CDC) to lead the international response.4. How exactly will the United States build back better for global health innovation?While congressional policymakers spent 2021 largely in emergency response mode, as the new year begins, many are looking to the future of how we can strengthen US agency programs for health preparedness, as well as build upon the research successes and gaps illuminated by COVID-19. Several pieces of legislation are expected to advance this year, which could significantly transform our health innovation infrastructure.For example, the Senate Health, Education, Labor and Pensions Committee is formulating a new pandemic preparedness bill that will look at retooling and refining the capabilities of several Health and Human Services agencies, potentially including the Biomedical Advanced Research and Development Authority (BARDA). This federal agency, which is responsible for developing medical countermeasures against health threats, went from obscurity to a household name during the pandemic as it was entrusted with an influx of emergency funding more than 40 times its annual appropriated levels to advance COVID-19 vaccines, treatments, and tests. GHTC has long advocated for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza. Much of the agency’s work on EIDs has been funded via unsustainable “boom and bust” cycles of emergency funding appropriated only after a crisis has begun. This pandemic preparedness legislation opens fresh opportunity for Congress to authorize such a permanent funding line to fuel sustainable, proactive preparedness research.Additionally, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) are advancing bipartisan legislation dubbed Cures 2.0, a follow-up to their 2016 21st Century Cures Act, which among other things would authorize a new Advanced Research Projects Agency for Health (ARPA-H). Modeled after the Defense Advanced Research Projects Agency, this new federal agency would seek to speed the development of medical innovations by funding high-risk, high-reward projects not likely to be advanced by traditional commercial research activities. Given this goal, the agency’s work could encompass research on poverty-related and neglected diseases, a recognized area of market failure. But at the moment, ARPA-H is more of rough concept than a fleshed-out proposal. As Cures 2.0 advances, much will need to be worked out as to what the agency’s research scope will actually include; whether it will be housed within the National Institutes of Health as President Biden has proposed or as a separate entity as some stakeholders have advocated for; and how much money congressional appropriators will be willing to pony up for this new unproven agency.Alongside these legislative efforts, GHTC has also recently unveiled a proposal for the creation of a new catalytic fund at USAID to drive global health innovation, called the Supporting Innovative Global Health Technologies (SIGHT) Fund. Such a fund would allow USAID to supercharge its existing work to advance inclusive innovations for low-resource settings, as well as reverse a declining trend in the agency’s spending on R&D as a proportion of its global health budget. As the year continues, GHTC will seek to advance this proposal with policymakers in Congress and the agency.5. Will calls to decolonize global health be codified into policy and practice?Calls to decolonize global health gained steam last year as the world bore witness to the gross inequities in access to COVID-19 vaccines and other tools between rich and poor nations, and here in the United States, the Black Lives Matter movement forced Americans to reckon with our nation’s history of racism past and present. While many leaders in the global health and development field now recognize the need to correct long-standing power imbalances rooted in the colonial era, individual organizations—from nongovernmental organizations to international institutions to development agencies—are grappling with how to translate this goal into policy and practice. Here in the United States, new USAID Administrator Samantha Power, in one of her first public addresses in November, laid out her vision for a new era of “inclusive development” at USAID. This included targets to direct at least a quarter of USAID funding to local partners within the next four years and by the end of the decade to have 50 percent of USAID programming have in place “local communities in the lead” who are responsible for codesigning, implementing, and evaluating programs. As 2022 continues, the global health community will be watching closely how Administrator Power’s vision leads to concrete changes in programs and practices at the agency.6. Will funding for other global health areas grow to match evolving needs?Much has been documented about how the COVID-19 pandemic has set back progress in other areas of global health, from disrupting routine immunization programs and reliable access to HIV and tuberculosis drugs to increasing the cost and complications of conducting research and clinical trials. The common refrain from health practitioners is that more resources are needed not just to respond directly to COVID-19, but to shore up other vital global health programs to protect fragile progress. Here in the United States, we’ll be watching whether congressional appropriators take this need to heart in 2022 as they finalize FY 2022 spending bills and begin work on FY 2023. Outside of programs focused on health security, most global health-related funding lines at the CDC, State Department, and USAID have been flat-funded in recent years, in practice decreasing their purchasing power as COVID-19 has only increased the cost of doing business. As every country worldwide is feeling the weight of the latest omicron-fueled surge, the first few days of 2022 have unfortunately felt much like “2020, two.” But as the year continues, it is our hope the pandemic will turn a corner and that policymakers will embrace lessons learned from this crisis to ultimately usher in a healthier, safer, and more equitable world for all.

2021 is shaping up to be an extraordinarily consequential year for US policy for global health and medical research, as a new presidential administration and Congress take charge against the backdrop of a global pandemic that has killed 1.6 million people worldwide and set back decades of progress in global health. As 2021 begins, here are some of the top policy issues GHTC will be tracking: 1. Will the United States remain missing in action on the global COVID-19 response or finally step up? Global health advocates spent much of last year repeating the aphorisms “no one is safe until everyone is safe” and “a global crisis requires a global response”—which seemingly fell on the deaf ears of a Congress and administration consumed by the magnitude of the COVID-19 crisis within our own borders. Though Congress last year appropriated roughly US$2 trillion in emergency funding to respond to the pandemic, plus that much more in loans and tax relief, less than one-half of 1 percent of that funding was earmarked to support the international response—marking a major departure from the US government’s approach in past global health emergencies like Zika and Ebola, when it stepped up with both resources and global leadership.  While the $4 billion in funding for Gavi, the Vaccine Alliance, was a bright spot in the fifth emergency supplemental funding package passed at the end of December, it only meets a fraction of the interconnected needs for a strong global response to this global health emergency. As a new administration and Congress take the helm later this month, advocates are continuing to push for $20 billion in emergency funding for the global COVID-19 response. Within this are specific asks for the United States to join and contribute to the Access to COVID-19 Tools Accelerator (ACT-A) and its lead partners, including the Coalition for Epidemic Preparedness Innovations (CEPI), and for Congress to resource the US Agency for International Development (USAID) to advance COVID-19 innovations designed for low-resource settings. With greater political support for these proposals coming from the Democrat-controlled House than the now Republican-controlled Senate, future prospects may depend as much on the outcome of today’s Senate runoffs in Georgia as the hard work of advocates. Yet, beyond these budget battles, the incoming Biden-Harris administration can pursue other direct means to support the international response, including leveraging existing efforts like Operation Warp Speed to continue to advance next-generation tools suited for the needs of low-resource settings and donating any excess vaccines globally once immediate US needs are met. [Editor's update: On January 20, the Biden-Harris Administration announced that the United States would join ACT-A. The administration also outlined a proposal for a sixth emergency supplemental package that includes $11 billion in funding to support the international response to COVID-19 and mitigate the pandemic's impact on global health, though it will ultimately depend on Congress as to whether the plan will move forward. The two Democratic Party candidates, Jon Ossoff and Rev. Raphael Warnock, won the Georgia runoffs giving Democrats functional control of the Senate with Vice President Kamala Harris as a tie-breaking vote.] 2. Will we recommit to multilateralism—and fund it? The last four years have been a dark era in US multilateral engagement, punctuated most conspicuously by the Trump administration’s move last July to initiate US withdrawal from the World Health Organization (WHO). While the Biden-Harris administration has thankfully pledged on day one to end this withdrawal, this is only the first step in rebuilding US credibility on the global stage and advancing meaningful multilateral reforms. As COVID-19 has shown, much work needs to be done to build a smarter, more responsive international system for public health and emergency preparedness, including for research and development (R&D). We hope that the Biden-Harris administration will work alongside allies now leading these processes and signal strong support for reform efforts. In addition to pushing for the US government to re-engage with WHO—and fulfill outstanding financial obligations—and join ACT-A efforts, GHTC is also calling for the United States to formally join CEPI via a $200 million annual commitment and work alongside our partner countries in the Global Health Security Agenda (GHSA) to revamp GHSA’s Workforce Development & Medical Countermeasures Action Package to address gaps in R&D capacity. [Editor's update: On January 20, the Biden-Harris Administration sent a letter to United Nations Secretary-General António Guterres ending US withdrawal from WHO.] 3. Will we pursue and finance a “build back better” agenda for global health?  The COVID-19 pandemic has exposed how our nation has woefully underinvested in our domestic and global health infrastructure. And while the burden and death toll of COVID-19 is staggering on its own, the full impact of the pandemic is coming into clearer view. Due to pandemic-related disruptions, health programs worldwide have faced challenges sustaining routine immunization programs and treatment services for HIV and tuberculosis, which could cause millions more deaths, and many health researchers have had to pause promising projects. The latter is a key finding from a report GHTC released last month which found the global health R&D sector is being weakened by pandemic pressures that are diverting funding and expertise away from other long-standing threats, multiplying costs for supplies and operations, and putting clinical trials and other scientific endeavors worldwide on indefinite hold. Reflecting on this devastation, it’s clear that an “appropriations as usual” approach will no longer suffice. After years of largely flat-funding health agencies and programs like the Centers for Disease Control and Prevention, USAID Global Health Programs, and the Biomedical Advanced Research and Development Authority (BARDA), Congress must take bold action to boost their budgets—and sustain strong growth at the National Institutes of Health—to ensure these programs have the resources needed to fulfill their important mandates and help their implementing partners restart activities and mitigate added costs and challenges from the pandemic. 4. Will the incoming administration reinvigorate and tap USAID capabilities after four years of neglect? USAID has faced a tumultuous last four years, as the Trump administration has repeatedly sought to slash the agency’s budget and instill controversial appointees. And when President Trump mobilized his administration’s pandemic response infrastructure for COVID-19, he exposed his ignorance of the agency’s value once again. The White House did not include the USAID administrator—the head of the US agency foremost charged with advancing global health—on the Coronavirus Task Force, and it floated proposals to shift US leadership of global pandemic preparedness and response activities away from the agency. Meanwhile, Congress provided USAID with minimal emergency funding to support partner countries in responding to the pandemic, stretching already thin global health programs. Despite taking these bruises, USAID, with its expansive on-the-ground presence worldwide, continues to possess unique capabilities and expertise in global health that will be vital for the incoming Biden-Harris administration to tap and reinvigorate as it seeks to end this pandemic—while also combating long-standing and future health threats. One area the agency has rich expertise in is developing and adapting health technologies for use in low-resource settings where barriers like lack of reliable cold chains or laboratory capacity can necessitate different types of tools. To leverage this expertise and bolster the agency’s leadership in this arena, GHTC is calling for the creation of a Chief Science and Product Development Officer role to coordinate and elevate best practices across the agency’s health area–specific innovation programming and the establishment of a new USAID Global Health Security Grand Challenge program to rapidly elevate and advance innovation solutions for these settings. [Editor's update: The Biden-Harris Administration has nominated Amb. Samantha Powers for the position of USAID Administrator and announced that the USAID Administrator position will be elevated as a member of the National Security Council.] 5. Will we proactively bolster BARDA’s role in pandemic preparedness in COVID-19’s wake? BARDA entered 2020 as a relatively obscure federal agency responsible for developing medical countermeasures against health threats and ended it as a household name entrusted with an influx of COVID-19 emergency funding 42 times the size of its annual appropriated budget—as the agency became a key player in the US government’s ambitious Operation Warp Speed. Prior to the emergence of COVID-19, GHTC had pushed unsuccessfully for Congress to provide dedicated funding for BARDA to grow its R&D activities for naturally occurring health threats, including emerging infectious diseases (EIDs), antimicrobial resistance, and pandemic influenza, recognizing the real and present danger they pose alongside that of bioterror and man-made threats which precipitated the agency’s founding in the wake of the anthrax attacks of 2001 and have remained its historic focus since then. While the agency has been previously engaged in advancing products for EIDs, including Ebola and Zika, much of its funding to do so has come through emergency funding packages, rather than through annualized, sustained funding. This “boom and bust” cycle of Congress providing funding to the agency only after a crisis hits is not a good recipe for improving epidemic preparedness and must change. In the wake of COVID-19, GHTC is continuing to push for a permanent funding line, with an annual appropriation of $300 million, to enable BARDA’s sustained work on a range of EIDs and other naturally occurring health threats. GHTC is also advocating for the agency to place greater priority on ensuring, where possible, that the products it funds are designed to be readily deployable in low-resource and austere settings—recognizing we can’t prevent and end epidemics and pandemics unless we can ensure lifesaving tools can reach everyone, in every corner of America and the world. 6. How do we harness lessons learned to supercharge a new era of innovation? As the first COVID-19 vaccines are being delivered to health workers across our country, much is being written about this historic achievement and the power of science: just 11 months after scientists got their hands on the genetic sequence of the virus, we now have two effective vaccines approved by the US Food and Drug Administration for emergency use—a truly staggering achievement. Backed by considerable resources and building on the backbone of decades of investment in HIV/AIDS, tuberculosis, malaria, and other infectious disease research, scientists and product developers have poured their energy into fighting COVID-19, and in doing so, they have leapfrogged science to incorporate emerging approaches like mRNA vaccines, monoclonal antibodies, novel clinical trial designs, and more that could revolutionize the fight against other global health challenges. While there are many R&D lessons yet to be gleaned from this crisis, two already stand out: 1) With adequate resources and political will, science can solve health challenges that once appeared insurmountable, and 2) When governments pursue and finance product development with a clear end-to-end plan in mind—working in partnership with product developers to advance products each step of the way from early research through product procurement—we can achieve progress at speeds previously unimaginable.  It is our hope US policymakers will embrace these lessons learned in structuring and financing global health research efforts so we can supercharge a new golden era of global health innovation.