Ashley Bennett

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

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.

Now that Labor Day has passed and Washington, DC, is starting to cool down, members of Congress are filtering back into town from their August recess travels. Some were conducting district work, others were on vacation, and still others traveled to some of the hotspots for global health programming and research. With just nine working days left in the congressional calendar before the beginning of fiscal year 2014, the only thing most in Washington can agree on is that there won’t be a long-term budget deal by October 1. This means that we’re looking at another continuing resolution to keep the government open for the rest of the calendar year. Even beyond October, there are not very many days that Congress—particularly the House of Representatives—will be in session between now and the end of the year. What should Congress do with the limited working time it does have? Here are a few priorities. With the limited time Congress has between now and the end of the year, lawmakers should focus on avoiding a government shutdown, passing a budget agreement, and supporting global health R&D programs. 1. Avoid a government shutdown. First and foremost, Congress needs to pass legislation to keep the government open past September 30. Preferably, this legislation would support programs at least at their current levels. It should also include an expiration date far enough away to avoid yet more political battles related to the debt ceiling. 2. Pass a smart budget agreement that dodges sequestration while protecting key programs. Francis Collins, director of the National Institutes of Health (NIH), must be exhausted from explaining over and over the dire consequences of budget sequestration at his agency. NIH’s purchasing power has been reduced by 25 percent compared with fiscal year 2003. At least 700 NIH grants that would have been funded in the absence of sequestration have been denied support. Collins has stated that key vaccine research programs that are near fruition are at risk because of sequestration funding cuts. The case is similar at other US agencies that fund global health research and development (R&D). Congress must get past its political arguments and pass a budget that supports programs focused on saving lives and producing efficiencies and cost savings—thereby helping to avoid another round of sequestration cuts. Which leads us to… 3. Move legislation forward that creates efficiencies in global health and international development. One priority that the Obama Administration and Congress agree on is using efficiencies gained by technology and innovation to create cost-savings and promote US interests. The 21st Century Global Health Technology Act and the Foreign Aid Transparency and Accountability Act both achieve those goals. Congress should move to see them through committee approval and toward full House and Senate consideration. 4. Sustain global health programs, including global health R&D. Global health programs are recognized as effective and necessary by political champions of all stripes—particularly R&D for new global health technologies. Not only do these programs save lives at home and abroad, they also have a positive impact on local and global economic prosperity and save money in the long run. However, none of these positive effects is felt if budgets are indiscriminately slashed or if research is relegated to the back burner in order to save a few dollars upfront. Government shutdowns and sequestration cuts that slow R&D here in the United States impact populations far beyond our national borders—effects that reverberate back to the US. In addition to economic and political consequences, there is a growing burden of neglected diseases in the United States. For instance, there are an estimated five million impoverished Americans who live with neglected tropical diseases, including a previously hidden burden of neglected diseases among the poor in the southern United States. Supporting research to develop new health tools will help fight these diseases both at home and abroad. No one expects large budget increases this year, but Congress can halve the negative effects that even small decreases have by sustaining funding for global health and health research programs. 5. Act on the good stuff. Let’s end on a positive note. Recently at the US Agency for International Development’s Saving Lives at Birth Development XChange, author Dan Heath gave a TED-talk-like presentation on a model of thinking that does not get nearly enough emphasis: Instead of focusing on the problems, find the successes. As Heath put it, "Find a bright spot, and clone it." Congress appears to be at a standstill due to disagreements over budget levels, immigration programs, national security, and a host of other issues. However, members of Congress have the opportunity and the means to shake their obstructionist reputation and make progress on items they agree on—including supporting innovative global health research. There are lots of areas that Congress by and large agrees on, but which rarely make headlines. Members need to start acting on such unifying issues such as global health R&D and advance legislation that can have a positive impact on people’s health around the world.

  As we discussed yesterday, lawmakers in the House and Senate have been busy with several pieces of legislation that would fund global health and research efforts across the federal government. Our first post yesterday detailed implications for global health research and development (R&D) activities at the US Department of State and US Agency for International Development. Today, we provide highlights for other key agencies involved in global health R&D. Labor-HHS The Senate Appropriations Committee has approved legislation to fund the Labor, Health, and Human Services (HHS) account, which includes support for the National Institutes of Health (NIH) and the US Centers for Disease Control and Prevention (CDC). Currently, there is no House version of this bill—a hearing scheduled for last week was canceled—so while we don’t have those figures to compare funding levels with, we do know that the House allocation for this account is drastically lower than the Senate version. Lawmakers in the House and Senate have been busy with several pieces of legislation that would fund global health and research efforts across the federal government. including the DoD, CDC, FDA, and NIH. The Senate bill would fund the NIH at $30.9 billion, which is a welcome but small increase of $307 million over FY 2013. Many key institutes and centers—including the National Institute of Allergy and Infectious Diseases, the National Institute of Child Health and Human Development, and the Fogarty International Center—were funded at levels higher than the final FY 2013 allocations but lower than the levels President Obama requested for FY 2014. One exception is the National Center for Advancing Translational Science, which received a total of $662.4 million under the bill—a boost in funding of $87 million over FY 2013. This includes a total of $50 million for the Cures Acceleration Network. The legislation would fund CDC at $6.9 billion, an increase of $681 million over FY 2013 and $300 million over the President’s request. This funding includes $391 million for the Center for Global Health, a significant increase of $46 million over FY 2013. The National Public Health Institutes received a $10 million allocation under the bill, which also included a large bump for polio eradication: $146 million versus the $131 million the President requested and the $116 million from FY 2013. The National Center for Emerging Zoonotic and Infectious Diseases was funded at $335 million, an increase of $44 million over FY 2013. FDA The House recently passed its appropriations legislation to fund the US Food and Drug Administration (FDA), providing the agency with $2.485 billion (not including income from user fees). This is roughly $20 million more than the agency received in FY 2013 and $40 million more than the President requested. Language was included in the bill that would ensure the FDA can review products for all neglected diseases, encourage the agency to “build stronger partnerships with global regulatory stakeholders, and strengthen its internal capacity to review products for neglected diseases.” Similar language was included in the Senate version of the legislation, which funds FDA at a higher level of $2.562 billion, or roughly $77 million more than the House version. Defense The full House passed a Department of Defense funding bill, in which the entire agency was provided with $513 billion. The bill would also provide $9.6 million for malaria vaccine development efforts, and welcome language is included in the bill report regarding the need for such a vaccine. The Senate Appropriations Defense subcommittee voted on its version of Defense funding yesterday, July 30th. We’re still waiting for the release of the accompanying bill report to determine any implications for global health R&D. As we pointed out yesterday, it’s clear that many global health R&D programs are being flat-funded year after year. If Congress is unable to reach a long-term budget deal, sequestration cuts will take effect again, further hampering efforts to develop urgently needed new technologies. Congressional policymakers could still reverse this trend by fully funding global health and health research programs through the FY 2014 budget conference later this year, as well as through negotiations around the impending debate on the US debt ceiling. However, with the difficult political climate, it’s unclear whether they will take advantage of this important opportunity. Links to other helpful analyses: American Association for the Advancement of Science Alliance for a Stronger FDA

Recent weeks have seen a flurry of activity for both the House and Senate appropriations committees. Congressional policymakers have approved several pieces of fiscal year (FY) 2014 budget legislation, including bills for accounts that fund global health research and development (R&D). However, with August recess looming and the end of FY 2013 only eight weeks away, it’s looking even more likely that we’re heading for another continuing resolution to keep the government running. Below, we provide highlights from recent Congressional budget activity that will determine funding levels for State and Foreign Operations, including global health and R&D programs at the State Department and the US Agency for International Development (USAID). Tomorrow, we’ll provide an update on budget activities that will impact R&D programs at other key federal agencies that support global health R&D. Congressional policymakers have approved several pieces of FY 2014 budget legislation, including bills for accounts that fund global health research and development. State and Foreign Operations As expected, the Senate version of this bill was much friendlier to several global health programs compared with the House version. The Senate bill would: Provide $8.455 billion for global health programs, which is $140 million above President Obama’s FY 2014 budget request level and $280 million above the House’s version. The difference between the House and Senate versions of the bill seems to be entirely contained in USAID’s Global Health Programs account and the State Department’s family planning programs, as funding for the Global Fund to Fight AIDS, Tuberculosis, and Malaria and the President’s Emergency Plan for AIDS Relief through the State Department were even between the House and Senate. One stark difference between the House and Senate bills is the family planning funding levels. The House version of the bill would prohibit funding to the United Nations Population Fund (UNFPA) and allocates a total of $461 million to all State and USAID family planning and reproductive health programs. The Senate bill, by contrast, includes $670 million for the same accounts, with $40 million of that money going to UNFPA. On a positive note, funding for tuberculosis programs was restored to $236 million, its FY 2012 level, in the House bill and to $225 million in the Senate version—much higher than the $191 million requested by the President. Funding levels aside, the policy language included in the Senate bill report contained several mentions of global health research, including key language on contraceptive R&D: “The Committee recognizes that there is a need to accelerate research and development of contraceptives that are more effective, affordable, and easier to deliver and may also prevent sexually transmitted diseases,” the bill reads, adding that USAID should increase funding to its Office of Population and Reproductive Health for such efforts. There is also some good news in the policy language in the House bill report. On neglected tropical diseases, the House bill “encourages USAID to support research into new drugs to address these diseases,” which is a step in the right direction. The bill also includes supportive language for malaria and HIV vaccines, microbicides, and pediatric HIV diagnostics and treatments. For the first time, it also includes a paragraph on USAID’s role in developing new health technologies: “The Committee continues to support USAID’s health technologies programs, including the development of technologies that maximize the limited resources available for global health and ensure that products and medicines developed for use in low-resource settings reach the people that need such products and medicines.” As with past years, global health programs fared better than other international development sectors in the State and Foreign Operations bills, particularly in the House version. However, as our next update will illustrate, we continue to see a clear pattern of flat-funding key programs across all federal agencies supporting global health and R&D. Combined with the threat of indiscriminate sequestration cuts, this is not an effective way to set long-term fiscal and programmatic goals. Furthermore, in both the short and long term, cuts to these programs undermine the immense progress made in global health research and threaten the future of the US global health mission. Tune in tomorrow for more details. Links to other helpful analyses: Kaiser Family Foundation Science Speaks blog InterAction

The House State and Foreign Operations (SFOPS) Appropriations Subcommittee on Friday held a hearing on its fiscal year (FY) 2014 budget legislation. The bill funds programs at the State Department and US Agency for International Development (USAID), including key global health research activities. Overall, global health programs fared relatively well under the bill, compared with other SFOPS accounts. That said, the Global Health Programs account, which includes activities at the State Department and USAID, was funded at $8.175 billion—a $140 million cut from the FY2014 request from President Obama but an increase of $200 million compared with the final FY2013 funding level. Under the bill: USAID would receive $2.505 billion in FY2014 for global health programs, which is a reduction of $140 million from Obama’s request. The State Department’s global health programs would receive $5.67 billion, which is equal to the FY2014 requested level. Therefore, it seems that spending cut to global health programs was taken from USAID and not the State Department. The House SFOPS bill would reduce funding for global health and research programs at the State Department and USAID. Photo: Evelyn Hockstein/PATH There’s not much detail offered on funding levels for specific diseases and sectors. There is language in the bill that implies full funding for the Global Fund to Fight AIDS, Tuberculosis, and Malaria within the State Department budget. However, no dollar amount is mentioned. One exception to this pattern is family planning. The legislation caps this funding at $461 million (equivalent to the FY2008 level) and contains language that would reinstate the Mexico City Policy. Accounts for international development banks, United Nations programs, and development assistance were slashed heavily. Development assistance programs would be funded at $2.0 billion under the bill, or a cut of $838 million from Obama’s FY2014 request of $2.837 billion. As we’ve seen in recent House versions of this legislation, all funding for the United Nations Population Fund (UNFPA) and the United Nations Educational, Scientific, and Cultural Organization (UNESCO) would be prohibited. Key umbrella funding mechanisms like the International Organizations and Programs (IOP) account were cut by more than 50 percent from FY2013 levels. This is important to note as some widely popular programs, such as the United Nations Children Fund (UNICEF), are included in the IOP category. Therefore, if programs like UNICEF are cut due to IOP reductions, allies may try to restore their funding by reducing support for other accounts, such as global health. The subcommittee hearing itself was short. Co-Chair Rep. Nita Lowey (D-NY) criticized the wide range of cuts included in the bill. The full Appropriations Committee plans to vote on this legislation later this week. As a result of sequestration, Congress is operating under tight budget caps for nearly every account. Even with these broad requirements, however, the House and Senate approaches to funding SFOPS programs are vastly different. The House version of the SFOPs bill is roughly 22 percent lower than the post-sequestration FY2013 level. It’s also 25 percent lower than the Senate version. The Senate SFOPs subcommittee will vote on its version on Tuesday. These two bills need to be reconciled on a funding and policy basis before any progress can be made. Funding delays and severe, indiscriminate budget cuts have a devastating impact on global health research and development programs, halting the creation of products that will save millions of lives. Congress should move quickly to protect these programs in upcoming Committee discussions and final budget negotiations later this year. Ashley Bennett is the GHTC’s policy officer.