Breakthroughs Blog: US budget

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.

In the past, the United States has contributed to important breakthroughs in global health—from the eradication of smallpox to a 74 percent drop in measles deaths worldwide. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. In fact, the US government is the largest supporter of global health R&D in the world, supporting the development and delivery of vaccines, drugs, diagnostics, microbicides, and devices. However, as we sit at a very important moment in global health product development, the political and economic environment in the United States is causing some to worry. Budget constraints have put funding at risk at many of the federal agencies involvement in global health R&D. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. Photo: PATH/Evelyn Hockstein Today, the GHTC launches a new fact sheet outlining the important contributions the US government has made to global health R&D and why it’s critical the United States continues to robustly support the global health research pipeline. There are currently more global health products in the pipeline than ever before—with more than 365 new tools under development as of April 2012. Contributing to the success of many of these products is the US government’s partnerships with nonprofit product developers. These organizations partner with the public and private sectors to maximize resources and create tools for patients in low- and middle-income countries. Increased investments in global health research by the United States have the potential to increase the amount of tools combating global diseases. Just some of the products currently in the research pipeline include: The RTS,S malaria vaccine candidate, which is currently being tested and a policy recommendation for its use could be issued as early as 2015. Such a vaccine could reduce the burden of sickness and death from malaria. A new oral drug for sleeping sickness, fexinidazole, which recently entered late-stage clinical trials in patients in the Democratic Republic of the Congo. As a simple, short-course oral pill, fexinidazole could transform care for African sleeping sickness, which is fatal without treatment, and could potentially reduce its incidence among the most afflicted populations and accelerate elimination of the disease. Cost-effective diagnostics that are under development for malaria, tuberculosis, and neglected tropical diseases. These diagnostics could be administered in a variety of health care settings and could rapidly and accurately identify sick patients. An antiretroviral‐based microbicide which offers hope for women’s HIV prevention. Though more testing is needed following promising results from a 2010 advanced clinical trial, a microbicide could give women the power to protect themselves with or without their partners’ cooperation. In sub-Saharan Africa, where the epidemic has hit hardest, women 15 to 24 years old are at least twice as likely to be infected with HIV as young men.   In the research pipeline for global health products, 200 of the 365 products under development have some sort of US government support. With so much investment from the United States, there is even more at risk if funding is cut. Over the past several years, the US Congress has not been able to agree on a long-term budget for the federal government. Policymakers have allowed sequestration, or widespread automatic budget cuts, to affect all federal programs. These constraints have the potential to push back or halt promising research supported by several federal agencies involved in global health R&D—including the Centers for Disease Control and Prevention, the Department of Defense (DoD), the US Food and Drug Administration, the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Due to sequestration: DoD is expected to receive budget cuts between 8 and 10 percent in fiscal year (FY) 2013. The DoD has been instrumental in the development of several global health technologies, many of which are used to protect Americans soldiers serving abroad. These cuts could affect the Walter Reed Army Institute of Research, the Naval Medical Research Center, and the Military HIV Research Program. NIH, the largest funder of global health R&D in the world, was forced to cut $1.7 billion from its budget by the end of FY 2013. NIH conducts nearly half the early-stage global health research, and supports thousands of domestic jobs all around the United States. USAID—with a presence in more than 100 countries—is best suited to support the clinical trials in low- and middle-income countries that ensure basic research is translated into appropriate health products. USAID is the largest supporter of HIV vaccine and microbicide development—both of which will be essential to achieve an AIDS-free generation. For many of the products currently in the global health research pipeline, continuous US support is essential. Without it, much of the breakthrough research that pushed these products to later-stage development will be lost—sometimes forever. US leaders should seize upon the recent successes in global health R&D and pass a long-term budget that ensures America’s legacy as a leader in innovation and science is not forgotten.

In this guest post, Jenny Howell—senior policy & advocacy associate at PATH working with the GHTC—writes about the new budget compromise that re-opened the federal government, as well as the effect of the government shutdown on health research programs. After more than two weeks of a federal government shutdown, with concurrent concerns about the threat of the debt ceiling being reached this week, policymakers finally reached a deal last night to re-open the government. Details of the budget compromise are finally starting to emerge, including the impact on global health research and development (R&D) programs. Things looked grim on Tuesday night after House Speaker, Rep. John Boehner (R-Ohio), was unable to get enough support from his own party for a House bill to reopen the government and raise the debt ceiling. Thankfully, Senate Leaders were quick to ease fears and announced they had come up with a bi-partisan deal early Wednesday morning. After more than two weeks of a federal government shutdown, with concurrent concerns about the threat of the debt ceiling being reached this week, policymakers finally reached a deal last night to re-open the government. Congress approves Senate plan The Senate’s proposal extends current government spending levels through January 15th, 2014, immediately re-opening the government and allowing federal employees to return to work this morning. The debt limit would be extended through February 7th, 2014, giving Congress more time to work out a permanent deal and avoid default on US debt obligations. After all the drama around delaying the Affordable Care Act (ACA), the Senate plan changes very little, only requiring stricter income verification requirements for determining who is eligible for federal subsidies through the ACA. The proposal also calls for a budget conference, made up of appointed members from both chambers of Congress who will be tasked with reconciling House and Senate budgets and agreeing to a long-term spending plan by December 13th, 2013. Unable to come up with their own plan to end the government shutdown and short on time, House Republicans voted to approve the Senate’s deal late last night, avoiding a default that would have put the nation’s credit rating at risk and potentially sent the economy into relapse. Impacts of the shutdown Despite the agreement, after 16 days of only a partially operating government, impacts were felt deeply across the nation. With the shutdown coming on the back of the budget sequester, research activities have been particularly hard hit, with four of the five Nobel-prize winners currently employed by the government furloughed. NIH Three-fourths of the staff at the National Institutes of Health (NIH) were furloughed. While the NIH has continued to provide care for patients in ongoing clinical trials, admitting new patients and beginning new trials has halted for all but the most critical life-threatening cases. In a typical week the NIH admits 200 new patients, in the wake of the shutdown, only 12 new patients have been admitted for trials. CDC Almost as hard hit as the NIH, the shutdown has meant that two-thirds of the staff at the Centers for Disease Control and Prevention (CDC) were furloughed. The timing of the shutdown comes just at the peak of flu season, significantly altering the CDC’s ability to monitor the spread of influenza and engage in vaccination outreach. NSF The National Science Foundation (NSF) furloughed 98 percent of its staff and has completely stopped issuing any new research grants. As federal employees come back to work and normal government functions resume, it will be hard to deny the long-term impact that the 16-day shutdown had across our nation. We may never know what discoveries have been delayed and whose health has been put at risk from the shutdown, but we’re hopeful lawmakers will stop playing games and will move forward with long-term solutions.

In this guest post, Jenny Howell—senior policy & advocacy associate at PATH working with the GHTC—writes about how the government shutdown and budget negotiations in Congress will impact global health research and development (R&D) programs across the federal government. She also provides an update on new legislation that would impact the President’s Emergency Plan for AIDS Relief (PEPFAR). It’s been a hectic few weeks in Washington. When House Majority Leader Eric Cantor (R-VA) canceled last week’s scheduled recess—and lawmakers from both chambers stayed to work over the weekend—we hoped that policymakers could successfully prevent a government shutdown. Because members of Congress have been unable to agree on long-term budget deals, funding for the government has been based on short-term continuing resolutions (CR)—stopgap budgets that fund the government for a few months at a time. The last short-term deal, passed in March, funded the government through the end of September, requiring Congress to pass a new CR by midnight on September 30 or face a federal shutdown. What the shutdown means in practical terms varies across the government--from Congress to agencies such as USAID, NIH, CDC, and FDA. The past week has been a Ping-Pong between competing House and Senate budget bills, with Republicans in the House insisting on a CR that is coupled with the defunding or delay of the Affordable Care Act. Senate leaders, on the other hand, pledged that they will only consider a “clean CR,” or a bill that doesn’t contain major policy changes but only deals with funding. What the shutdown means in practical terms varies across the government. Congress On the Hill, it’s up to lawmakers to determine which staffers serve essential functions and which staffers are non-essential. Therefore, staffing will vary greatly from office-to-office. USAID The US Agency for International Development (USAID) issued a guidance outlining a few possible scenarios, but indicated that the majority of its contracts and grants are not dependent on new appropriations and will continue operations. The agency has promised to contact partners who have grants or contracts that will be directly impacted by the government shutdown. While most ongoing programs should remain safe with existing funding, this also means USAID won’t be investing in any new R&D funding, contracts, or grants until a budget deal is reached. HHS The Department of Health and Human Services (HHS) has also released its contingency plan in the case of a shutdown. The National Institutes of Health (NIH) will continue caring for patients in current clinical centers. However, health research will be severely impacted as NIH will not accept new patients for clinical research. This is on top of an already exhausted post-sequestration budget that NIH Director Dr. Francis Collins has described as delaying innovation. The Centers for Disease Control and Prevention (CDC) will continue to operate its 24/7 operations center, as well as activities funded through mandatory spending like PEPFAR, the Global AIDS program, and the Vaccines for Children program. The shutdown does impact CDC’s ability to support the annual flu program and much of its ongoing disease surveillance and R&D activities. The Food and Drug Administration (FDA) will continue activities related to critical public health issues, but will cease the majority of lab research, routine inspections, monitoring, and notification programs. The FDA will continue the majority of its programs linked to user fees, including product approvals, but approval times may be delayed as a result of understaffing. Moving on PEPFAR Amidst the tension of the budget battle, members of Congress have seemingly found something they agree on. On September 24, Sens. Robert Menendez (D-NJ) and Bob Corker (R-TN) introduced The PEPFAR Stewardship and Oversight Act of 2013 (S 1545). A day later, Reps. Eliot Engel (D-NY), Ed Royce (R-CA), Barbara Lee (D-CA), and Ileana Ros-Lehtinen (R-FL) introduced a companion bill in the House (HR 3177) Most of the PEPFAR program can continue to operate as long as Congress appropriates funds. However, some components—mostly reporting requirements—could end without renewal. The bill introduced last week is by no means a full reauthorization and is extremely limited in scope, only extending the PEPFAR program as it relates to HIV and AIDS with no specific extension of tuberculosis (TB) or malaria programming or funding. PEPFAR currently supports a variety of global health R&D projects, including research on microbicides and vaccines for HIV and AIDS, TB, and malaria. Bill status The bill is already moving quickly and with the addition of a short manager’s amendment, it was approved by the Senate Committee on Foreign Relations by voice vote earlier this week. The manager’s amendment added reporting requirements to include reporting on co-infections and co-morbidities of HIV and AIDS, including TB, as well as country efforts to improve health work force issues. The government shutdown makes next steps for the bill uncertain, but the strong bipartisan support makes it likely that leadership in both chambers will fast track the bill and bring it up for consideration without additional amendments. Looking ahead We hope support for PEPFAR isn’t the only thing Congress can come to an agreement on this week. While uncertainty about the impact of the shutdown remains high, the quicker that lawmakers can reach an agreement the less severe the negative effects will be across our nation and around the world. Whatever the outcome, we’ll continue to track the progress and its potential impact on global health R&D.