Ashley Bennett

Last week, a bipartisan group of legislators in both the House and Senate introduced the Foreign Aid Transparency and Accountability Act of 2013. Sens. Marco Rubio (R-FL) and Ben Cardin (D-MD) and Reps. Ted Poe (R-TX) and Gerry Connolly (D-VA) introduced the companion bills. Rep. Poe is co-chair of the Congressional Caucus for Effective Foreign Assistance. According to the Modernizing Foreign Assistance Network, the legislation puts in place guidelines on foreign aid that would apply to all relevant US federal agencies, along with metrics to measure progress. It would also require the president to maintain and expand the Foreign Assistance Dashboard, an online resource that allows users to examine, research, and track US government foreign assistance investments. Under the bill, the Dashboard would be broadened to include all US agencies that administer foreign aid programs. Currently, only five are represented: the State Department, the US Agency for International Development, the Millennium Challenge Corporation, the US Department of the Treasury, and the Department of Defense. Sens. Marco Rubio (R-FL) and Ben Cardin (D-MD) and Reps. Ted Poe (R-TX) and Gerry Connolly (D-VA) introduced companion bills that would reform several aspects of US foreign aid programs. A previous version of the bill came very close to becoming law during the last congress—the bill passed the House unanimously, but was held up at the last moment in the Senate. Supporters are hopeful that this new legislation won’t face the hurdles of previous versions, and already there are signs the bill could pass this year. Leaders from the global health and international development community have expressed broad support for the bill and have called on Congress to move it through the legislative process quickly. The reforms in the bill are welcome improvements in how the US government reports on its progress, as well as its challenges, with its foreign aid programs. As is the case with most global health research and development programs, hard data on how programs are funded, successes, and educational failures can be difficult to synthesize. Publicly available data that shows the effectiveness of the broad array of US foreign aid activities could boost support from US taxpayers and communities in target countries—ideally leading to a more adaptive, stronger foreign assistance platform.

Congress is heading for its July 4 recess next week, having made a few incremental steps toward a fiscal year (FY) 2014 budget for the federal government—including releasing spending levels for several agencies and programs that support global health and research efforts. The Senate released its FY14 302(b) allocations last week (the House released its own allocations a few weeks back). 302(b) allocations set limits on congressional appropriations for key accounts. As expected, the Senate’s allocations are overall higher than their House counterparts. For example, the State and Foreign Operations budget, which includes global health research and development (R&D) programs under the State Department and US Agency for International Development, is funded at $50.6 billion—essentially flat compared with the FY 2013 enacted level. It is also somewhat lower than President Obama’s FY 2014 request for that account. In contrast, the House budget level for this account is $10 billion lower than the Senate version and would require significant cuts from current spending. The Senate’s budget for the Labor, Health and Human Services (HHS) account—another controversial account—is a whopping $42 billion higher than the House level of $121.8 billion. This account include key programs at the Centers for Disease Control and Prevention, as well as the National Institutes of Health. Congress recently released spending levels for several agencies and programs that support global health and research efforts. Credit: Richard Franco. This pattern should sound familiar, as recent appropriations cycles have seen similar cavernous differences between the House and Senate. And as we know very well, the threat of budget sequestration has not been enough to bridge the gap. These huge disparities will make it extremely difficult for policymakers to agree on a final budget level for the government, meaning that we are almost certainly headed for another continuing resolution to keep the government open past September. There are some positive signs on the policy side of the appropriations saga. Both the House and Senate included report language in recently passed appropriations bills that would improve the US Food and Drug Administration’s (FDA) engagement in global health by boosting its global partnerships and ensuring its ability to review and license new global health technologies for all neglected diseases. Language was also included in the House’s version of US Department of Defense legislation promoting the development of a malaria vaccine, although the full House has not passed this bill yet. Aside from the Defense and FDA bills, neither the House nor Senate has progressed on appropriations legislation that directly affects global health R&D. Neither chamber has taken up bills for State and Foreign Operations or Labor-HHS. If past years are any indication, it’s very unclear whether this will happen at all. On a more positive note, the House Foreign Affairs Committee Subcommittee on Africa and Global Health is holding a hearing today to examine the need for new treatments for neglected diseases. As Subcommittee Chair Rep. Chris Smith (R-NJ) stated, “A number of so-called ‘neglected diseases’ receive little attention from researchers in such critical areas as detection, strategies, vaccines, or drug therapies.” Although research into new tools to combat neglected diseases does rely on researcher interest, even more essential to this effort is a strong combination of US government and private-sector funding and support for programs and partnerships that conduct global health research. Still, this hearing is a welcome contrast to potential threats to global health research faced in ongoing budget sequestration and the stalled appropriations process. Whether through FY 2014 budget negotiations or other legislative mechanisms, Congress should help move this cause forward by protecting US research and product development funding and promoting a comprehensive, thoughtful, and coordinated strategy for global health R&D.

Last week, Reps. Gerry Connolly (D-VA), Karen Bass (D-CA), and Earl Blumenauer (D-OR) introduced the Global Partnerships Act of 2013. The bill is a welcome step to reform the US government’s foreign assistance programs, including strengthening important aspects of US global health research and development (R&D) efforts. Throughout the bill, research and innovation to improve health worldwide are highlighted as central components of US foreign assistance programs. For instance: Harnessing research, innovation and technology is included as one of the key elements of a new global health sector strategy required by the legislation. In addition to a new overarching Global Development Strategy, the bill would require strategies for all of the major foreign assistance sectors, such as global health, every four years. R&D for new health technologies and solutions is prioritized in the legislation as one of four programmatic health areas the bill would support. The others are: maternal health and child survival; family planning and reproductive health; and combating disease. Research for new technologies is also highlighted as essential to the overall success of US foreign assistance programs. The bill includes strong support for public-private partnerships, such as nonprofit groups that develop global health vaccines, drugs, diagnostics, and other products. Finally, the bill would establish a $50 million per year Innovation Fund at the US Agency for International Development. The fund would support “innovative projects and evidence-based solutions that may be tested, replicated, and scaled up in partner countries to significantly improve development outcomes,” including global public health. The bill provides a promising future for US foreign assistance programs—an effort that reflects former Rep. Howard Berman’s (D-CA) legacy in foreign aid policy (Rep. Berman introduced the same bill before he departed Congress at the end of 2012). The bill rightly places research and innovation at the crux of the global health sector, and provides guidance for needed reforms to the US foreign assistance system. As Rep. Connolly said when releasing the bill, “It is time for a complete overhaul of the way we administer foreign aid. The 21st century requires a foreign aid program that recognizes today’s priorities and streamlines the process in the post-Cold War era.” Congress should unquestionably move this legislation forward and introduce a Senate companion bill. However, given that Congress hasn’t made much traction on most pieces of legislation in the past few years, the Partnership Act’s fate isn’t clear. It’s also possible that sections of this legislation may spin off into their own separate bills and see success. The important thing is to keep the congressional dialogue around foreign aid reform going, and not to lose momentum for urgently needed reforms and improvements. You can read a press release from Rep. Connolly here, and a statement from the Modernizing Foreign Assistance Network here.

Earlier this month, Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced the 21st Century Global Health Technology Act, which would make several important and welcome changes to global health research and development (R&D) programs at the US Agency for International Development (USAID). Previous versions of this legislation were introduced in 2009 and again in 2011, but did not advance past the committee level. Compared with the previous versions, the bill introduced this month includes several key changes that take a more comprehensive approach to global health R&D at USAID. Key provisions in the bill include: Codifying into law the Health Technologies (Health Tech) program at USAID, which would help ensure that this important program is sustainable. In its first 25 years of operation, the Health Tech program has produced 85 new global health technologies with more than 100 different partners, all aimed at addressing the needs of low-resource settings around the world. Requiring that the USAID administration develop an action plan on global health R&D. The bill would require that these action plans incorporate global health R&D into each of USAID’s global health programs, and would require the agency to develop metrics to measure success. Recognizing the importance of USAID’s Center for Accelerating Innovation and Impact (CAII). CAII conducts market analysis and product introduction studies across USAID’s global health product development portfolio, in an effort to improve and speed scale-up of important new tools. Requesting that USAID continue its annual reports on health-related R&D. These reports would include information on: health R&D progress within each of the agency’s global health programs; how USAID coordinates translational and applied research with other US agencies; and USAID’s investments in science, technology, and innovation—an area that USAID Administrator Rajiv Shah has stated is a priority for the agency. Requesting that USAID work to align its health-related research strategy with similar strategies at other agencies, with the intent of creating a whole-of government strategy for global health R&D. Earlier this month, Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced the 21st Global Health Technology Act, which would make several important and welcome changes to global health R&D programs at USAID. This new legislation—which was developed in close partnership with GHTC member PATH—supports global health R&D efforts across USAID. While it includes the Health Tech program, it also promotes research programming for every disease or health condition category that falls under USAID’s global health mission. This is an important sign of progress, as there are many health areas where new drugs, vaccines, diagnostic tools, and other technologies are sorely needed. This includes R&D for neglected tropical diseases and tuberculosis vaccines, which currently do not receive support from USAID. The legislation also looks across USAID’s spectrum of R&D work and takes into account introduction and scale-up needs, as well as harnessing the promise of science and technology—which Shah and President Obama have previously highlighted. Finally, the addition of strategy alignment with other US agencies is another welcome change. Because the United States is involved in the development of 200 of the 365 current technology candidates in the global pipeline, a strategy that aligns all US global health R&D would increase transparency and coordination among the major agencies that support this important work. It is unclear at this point how the bill will move forward, although there are several mechanisms available. For example, the bill could progress in Congress as a stand-alone bill, or as an amendment to a larger foreign affairs or global health package. At this point, there is no Senate version of the bill, although that may be a positive next step. If implemented, this legislation could provide promising improvements in US global health R&D transparency, coordination, and financing that would help new global health technologies reach those who need them most. You can find a press release from Rep. Sires here.

Wednesday, the White House released President Obama’s fiscal year (FY) 2014 budget request, which overall has mixed results for global health and research programs. Below, we provide specific details on funding levels at key agencies that support global health and research efforts, including the Centers for Disease Control and Prevention (CDC),the US Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Details are still forthcoming about how global health research fared at the Department of Defense. It’s important to note that figures are compared to final FY2012 levels, since Congress is still working on finalizing FY2013 levels. The president's budget for FY2014 requests funding for key US agencies engaged in global health product development. Credit: PATH. CDC CDC’s overall budget took a hit in the president’s request—the president’s FY2014 budget requested $5.2 billion for the agency overall, compared with $5.65 billion in FY2012. However, CDC’s global health programs were slightly increased and were spared major cuts. CDC’s Center for Global Health would receive $393 million in FY2014 under the president’s budget, compared with $376.7 million in FY2012. FDA The FDA got a much-needed increase in the president’s budget request, although much of it is due to an expected uptick in user-fee income. The agency would receive $4.65 billion in FY2014 under the president’s budget, compared with $3.83 billion in FY2012. As noted above, user-fee income plays a large part in this increase in FDA’s budget. User fees would comprise $2.09 billion of the agency’s budget under the president’s request, compared with $1.32 billion in user fees in FY2012. In recent years, Congress has not adequately appropriated stable funding to FDA, instead relying on user fees to make up the difference. Critics have said that relying on user fees is unsustainable and creates a conflict of interest between FDA and the industries it regulates. NIH NIH funding was mostly flat-lined at FY2012 levels—the president’s budget requested $31.3 billion for the NIH in FY2014, compared with $30.8 billion that the agency received in FY2012. The National Institute of Allergy and Infectious Diseases (NIAID), as well as the National Center for Advancing Translational Science (NCATS), received increases that could hint at new programming in those areas. The president requested $4.6 billion for NIAID in FY2014, compared with $4.5 billion the center received in FY2012. NCATS would receive $666 million under the president’s FY2014 budget, compared with $574 million in FY2012. State Department and USAID At USAID, several key programs that fund global health research were cut dramatically—most notably the agency’s tuberculosis (TB) program. Most other programs at USAID were flat-funded or saw small increases. Under the president’s budget, USAID’s global health programs would receive $2.645 billion in FY2014, which is pretty much the same figure ($2.649 billion) for FY2012. Under USAID’s global health programs, several key initiatives saw disappointing funding cuts. The TB program would be reduced to $191 million in FY2014, compared with $236 million in FY2012. The HIV and AIDS program would be cut to $330 million, compared with $350 million in FY2012. The neglected tropical diseases program would be cut to $85 million in FY2014, compared with $89 million in FY2012. Fortunately, the malaria program would see an increase to $670 million in FY2014, compared with $650 million in FY2012. The State Department budget element getting the most buzz is the 5.3 percent cut to the President’s Emergency Plan for AIDS Relief, while the Global Fund to Fight AIDS, TB, and Malaria saw a robust request of $1.65 billion for FY2014. Federal agencies have also released their budget justifications, which detail policy and programmatic priorities for FY2014. We’ll provide a comprehensive update on these budget justifications and key policies that could impact global health research and product development. Usually, the President’s budget request sets a precedent that the advocacy community and Congress respond to—whether they agree or disagree with its content. However, with the request being released so late in the year, Congress has already acted, passing drastically different FY2014 budget resolutions in the House and Senate. House and Senate budget committee activity is moving quickly, with key leaders from US agencies that fund global health research and product development scheduled to testify at appropriations hearings as early as next week. Congress must act to avoid further cuts and fund global health research programs at the robust levels that ensure availability of new technologies to the millions who need them worldwide.

Earlier this week, both the House and Senate passed a budget package to fund the government through the remainder of fiscal year (FY) 2013, thereby averting a government shutdown when current funding expires on March 27. The new compromise funds most accounts roughly at FY2012 levels, with an across the board cut of 0.092 percent. As a reference, the Centers for Disease Control and Prevention's Center for Global Health budget was $349 million in FY2012, while the National Institutes of Health was funded at $30.69 billion. In addition, global health programs at the State Department and US Agency for International Development (USAID) were funded at $8.167 billion. The budget package also makes some key changes to certain programs. For instance, global health programs at the State Department and at USAID, including those that fund global health research and development (R&D) initiatives, are increased over FY2012 levels by roughly 5 percent—potentially to counteract the effects of sequestration. The bill also gives greater flexibility to the Department of Defense to manage sequester cuts to its budget. It also leaves the sequester largely in place, instead of replacing it with balanced budget cuts, as many advocates in the global health community were hoping lawmakers would do. The bill now goes to President Obama’s desk, and he is expected to sign it. Budget negotiations in Congress will have far-reaching effects on global health R&D efforts at agencies such as CDC, DoD, NIH, and USAID. Photo credit: PATH/Evelyn Hockstein. If and when Obama signs the final FY2013 budget package into law, the funding levels will still be subject to sequestration—meaning that the final levels are really anywhere from 5 percent to 9 percent lower. For instance, USAID’s global health programs would see an overall cut of $193 million. While this is better than the $428 million cut it was facing before the Senate stepped in, it could still have a large impact on global health and R&D programs that fall under USAID. The House also passed its version of an FY 2014 budget resolution, which would replace sequestration with budget caps for the next decade. The House resolution would move most of the budget cuts away from the Department of Defense and onto non-defense accounts, including most global health R&D programs, and would balance the budget over the long term. The Senate has introduced its own budget resolution, which could pass today or tomorrow. The Senate version is very different from the House version, as it would make balanced cuts to both defense and non-defense programs and protect non-defense programs from the drastic cuts seen in the House budget. The Senate version does not include a plan to balance the budget in the short- or long-term, but contains a significant reduction in spending over the next decade. Although replacing sequestration with an actual budget plan is widely approved of, advocates for both domestic and global health programs believe that the House budget resolution would be devastating for key health and humanitarian programs. Therefore, as Congress makes decisions on FY2014 spending bills, lawmakers should use a balanced approach when allocating budget cuts (as seen in the Senate version), and increase support for global health and R&D when possible. Additionally, as agencies receive their final FY2013 budgets, they should ensure that global health and R&D programs are protected.