Breakthroughs Blog: Congress

Yesterday, the White House released President Obama’s much-anticipated budget request for fiscal year (FY) 2015. After hearing that the budget would be released in two phases, we weren’t sure what level of detail or clarity to expect from the top-line numbers. As it turns out, the message is murky—for now. Below are some initial takeaways on the budget proposal’s impact on global health research and development (R&D). State and USAID Global Health Programs While funding for the overall 150 international affairs account remained fairly stagnant compared with FY 2014, funding for the State Department’s global health programs—which fund most global health R&D at the US Agency for International Development (USAID) and the State Department—took a concerning downward shift, falling by 4.6 percent overall. The Maternal & Child Health, Tuberculosis, and Global HIV and AIDS programs that fund research for many new global health tools all saw decreases to varying degrees when compared with the levels that Congress just approved for them in its FY 2014 budget agreement. There were a few ‘winners’—a relative term only; USAID’s Malaria and Family Planning programs saw small increases, and GAVI—which works to scale up currently available vaccines—saw its request increased by $25 million over FY 2014. As many in the community have voiced, the flat-funding of the President’s Emergency Plan for AIDS Relief—coupled with a possible $300 million decrease in the US’s contribution to the Global Fund to Fight AIDS, Tuberculosis, and Malaria—is disappointing, if not unexpected. Funding for the State Department’s global health programs—which fund most global health R&D at the US Agency for International Development (USAID) and the State Department—took a concerning downward shift, falling by 4.6 percent overall. Although these cuts are concerning, the President’s budget request did indicate that the administration is aware of the need for sustained global health R&D programming and recognized the important role that USAID plays in fostering innovation. The President requested $146.3 million for the new Global Development Lab at USAID, which “will consolidate and expand USAID's efforts in science, technology, innovation and partnerships, creating a world-class capability to discover, incubate, test, and scale transformational solutions to the greatest development challenges that we face today.” However, according to the budget justification text, only about $5 million of this funding will go to global health programs.   Global Health R&D at NIH, CDC and FDA The President requested $30.2 billion for funding at the National Institutes of Health (NIH), a slight increase from 2014 appropriations levels of $29.9 billion, but still lower than the President’s request for FY 2014—continuing a troubling decline. It is estimated that NIH’s funding has decreased 15 percent since FY 2004. Within the NIH, the National Institute of Allergy and Infectious Diseases was funded at $4.423 billion, a 3.4 percent decrease from the President’s request for 2014, but a slight increase from the 2014 appropriated budget of $4.359 billion. The National Center for Advancing Translational Science saw a slight cut from FY 2014 appropriations and previous requests, while the National Institute of Child Health and Human Development and the Fogarty International Center were essentially flat-funded. There was potentially better news for global health R&D funding at the Centers for Disease Control and Prevention (CDC). The President requested a total of $464 million for CDC’s Center for Global Health—a significant increase over FY 2014. CDC’s Center for Emerging Zoonotic and Infectious Diseases also received a welcome increase. Both of these CDC centers are involved in the new Global Health Security Agenda programming. While the budget text says that the President requested $45 million for the new initiative, it’s not yet clear where this funding will come from. In more positive news, the President also requested just over $4.7 billion for the US Food and Drug Administration (FDA), allaying fears that the strong FY 2014 funding ($4.3 billion) would not be continued. The funding also assumes $2.612 billion in user fee income. Opportunity, Growth and Security Initiative Adding to the opaque nature of several parts of the global health and science accounts within the President’s budget request is the new $56 billion Opportunity, Growth and Security Initiative. Funds in this category include the $300 million that would go to the Global Fund if other nations are able to increase their own commitments, as well as other funding that would go to NIH and the Science, Technology, Innovation and Partnerships (STIP) in Development program via the new Global Development Lab at USAID. It’s still unclear whether this money will be allocated as stated, and many in the global health community are concerned that it would draw funds away from other health-related programs that have already been flat-funded or seen cuts. While we’re still waiting for more figures for NIH and the Department of Defense’s global health R&D programs, and details from additional budget justification documents—it’s clear that Congress has its work cut out for it in protecting global health R&D programming across the US government. When the appropriations committees from the House and Senate develop their own proposals later this spring, they should work to sustain and protect global health research and product development at USAID, CDC, NIH, FDA and the Defense Department in order to keep up the fight against global health diseases.  

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.

  “You’re in a position to make such a difference and to be innovative with your thinking,” Margaret McCluskey, senior technical advisor at the US Agency for International Development (USAID), said to an audience of Congressional staffers at a briefing yesterday on Capitol Hill. The briefing, co-hosted by GHTC and PATH, focused on the critical role USAID plays in supporting lifesaving global health research and development (R&D) for new health tools. Panelists also stressed the need for policymakers in Congress and across the US government to support the development of new and innovative health products. All of the panelists at yesterday’s briefing called on the US government to continue its strong investment in global health research. Rep. Albio Sires (D-NJ)—lead co-sponsor of the 21st Century Global Health Technology Act, a bill that would strengthen health R&D and product development at USAID—spoke at the briefing and reiterated this important message. “New vaccines, drugs, and tests are desperately needed, but progress cannot be sustained without R&D,” he said, adding that the United States has a legacy of supporting global health R&D and that health R&D is a smart economic investment. Rep. Sires: “New vaccines, drugs, and tests are desperately needed, but progress cannot be sustained without R&D." Photo credit: Aeras/Liz Roll Much progress in global health R&D has been made over the years, and USAID has unquestionably supported many of today’s success stories—including new tools for malaria, HIV and AIDS, child health, family planning, and reproductive health. Several panelists stressed that product development for global health tools doesn’t happen overnight, and that USAID’s sustained commitment to research has been a crucial element of these health R&D success stories. Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, stressed that R&D can take many years, and thanked USAID for its support for mircobicide research—as well as for providing dedicated resources and long-term investments in global health product development.   Panelists also emphasized that despite this progress, there is still a need for sustained investment in R&D today to ensure that there are appropriate tools for diseases of poverty tomorrow. Rosenberg warned that complacency with today’s current tools is the wrong mindset, saying, “As soon as you think you’ve got [a health issue] under control, you’ve lost.” Kari Stoever, vice president of external affairs at Aeras, noted that investing now in tuberculosis (TB) vaccine research will save billions of dollars in future spending for TB treatment programs in low- and middle-income countries, which currently costs $8-10 billion per year. She added, “Without an effective vaccine, many lives are at risk.” USAID does not currently fund TB vaccine R&D. Additionally, USAID’s partnerships with the private and nongovernmental sectors have been key to its success in developing effective public health tools. One particularly effective partnership is USAID’s support for nonprofit product developers (NPPDs). These organizations combine the resources of governments, the experience of the private sector, and the know-how of nonprofit groups. PATH is one such NPPD that, with USAID support, partnered with Becton, Dickenson and Company (BD) to develop the SoloShot™ syringe and Uniject™ system. Both devices are designed specifically for use in low- and middle-income countries. “Though BD is a for-profit company, we share a common goal of providing access to important devices where they are needed most,” said Renuka Gadde, vice president of Global Health at BD. She added at none of these successes would have happened without government agencies like USAID looking at complex global health problems and spurring various sectors to become involved through programs like the Saving Lives at Birth Grand Challenge. Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, stressed that R&D can take many years, and thanked USAID for its continuous support. Photo credit: Aeras/Liz Roll While USAID is a key player in global health R&D, coordination between the other US agencies involved in this work—such as the Centers for Disease Control and Prevention, the Department of Defense, the US Food and Drug Administration, and the National Institutes of Health (NIH)—is crucial. The 21st Century Global Health Technology Act requests that USAID work to align its health-related research strategy with similar strategies at other agencies, with the goal of creating a whole-of government approach to global health R&D. Greater coordination among US agencies can held lead to more efficient health R&D—for example, Rosenberg noted at the briefing that both USAID and NIH are supporting the organization’s microbicide clinical trials. We are at a critical juncture in much of the global health R&D currently underway, and USAID will be instrumental in ensuring these technologies come to fruition. As McCluskey said at the end of the briefing, “Don’t be business as usual with infectious diseases.” Dr. Joanne Carter—executive director of RESULTS/RESULTS Educational Fund and moderator of the briefing—summed it up nicely: “Investments in R&D are what’s needed to take us to the next level in global health.”

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.