Breakthroughs Blog: Congress

Although we’re several days into sequestration, details about the full impact of funding cuts are still hazy. On Friday, the Office of Management and Budget (OMB) released a report to Congress, which details funding cuts required to offset $85 billion in the fiscal year (FY) 2013 budget. In order to reach this goal, the OMB report indicates that global health research and development (R&D) programs will be subjected to cuts of either 5 percent or 7.8 percent. But because the cuts must take place over a seven month period (instead of a full year) to fit within the fiscal year, OMB calculates that these cuts could actually be at a rate of 9 percent and 13 percent with the remaining funding for this year. OMB’s report provides some specific details on how the cuts are calculated. It also provides illustrative examples of what the sequestration cuts might look like if applied equally within federal agency budgets. However, because agency heads will have discretion over how specific cuts affect their agencies, the exact implications of sequestration will be determined in the coming weeks. Estimates are emerging regarding the widespread impact of sequestration on the agencies that support global health R&D. Photo credit: PATH While waiting for these details to come out, we are starting to see some estimates emerge regarding the impact of sequestration on the agencies that support global health R&D. For example: The National Institutes of Health’s discretionary budget will be reduced from $30,899,000 to $29,321,000 for FY13, a cut of over $1.5 billion. The sequester would equate to a $2.6 billion reduction to the State Department and US Agency for International Development (USAID) FY13 budget, translating to a $1.7 billion cut to foreign assistance programs. In particular, sequestration will cut over $400 million from global health initiatives at the State Department and USAID, including R&D initiatives. Global health programs at the Centers for Disease Control and Prevention are likely to be reduced by taking 5 percent from HIV and AIDS initiatives and then taking 5 percent from the remainder of the account. Discretionary spending for the Department of Defense (DoD) is subject to a 7.8 percent reduction, which would include any global health R&D initiatives embedded in DoD programs. Some reports indicate that the US Food and Drug Administration will lose about 9 percent of its budget for FY13. The Obama Administration is urging Congress to allow the agency to spend $41 billion-worth of user fees. In the meantime, the government is currently running on a Continuing Resolution, which expires on March 27. Congressional leaders and President Obama have expressed hopes about successfully negotiating a new spending bill by March 27, in order to avoid a government shut-down. These negotiations may also provide an opportunity to reverse the sequester, before the full impact of the cuts are felt across the government. The President’s budget request for FY14 is also on the horizon, with reports indicating that it might be released on March 25. The House and Senate will begin to take up FY14 budget resolutions, which each Chamber must pass by April 15. It’s becoming increasingly clear that sequestration is the wrong way to reduce the nation’s debt, especially when the impact would set back innovation and devastate global public health. Policymakers should use the upcoming budget negotiations as an opportunity to reverse sequestration and develop a long-term budget solution that protects and—where possible—increases funding for global health product development. Slashing funding will interrupt scientific progress and leave us without the urgent tools we need to address health needs now and in the future.

  “I’d be careful not to break something that would be hard to put back together,” Alan Magill—director of Malaria at the Bill & Melinda Gates Foundation—said this week at the GHTC’s annual congressional briefing. Sequestration, just days away, was a primary concern for Magill and others at the event, which focused on how US policymakers can protect the nation’s investments in global health research in upcoming budget discussions. As Magill and others stressed, sequestration and federal budget cuts would severely hamper research taking place across the US government to develop new vaccines, drugs, and other tools for global public health. According to moderator Lisa Cohen, executive director of the Washington Global Health Alliance, more than 350 health innovations are in the research pipeline. She added that 200 of these are supported by the US government through agencies such as the Centers for Disease Control and Prevention (CDC), the Department of Defense (DoD), the US Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the US Agency for International Development (USAID). (from right to left) Lee Hall from the National Institute of Allergy and Infectious Diseases, Caroline Ryan from the President's Emergency Plan for AIDS Relief, and Alan Magill from the Bill & Melinda Gates Foundation. Photo credit: PATH. Widespread budget cuts would stop scientific progress in its tracks—progress that cannot be seamlessly picked up again if funding were to resume in the future. “Many biomedical studies cannot survive cuts in funding in the middle of their work. It would be an irreversible mistake to halt these ongoing global health research efforts,” Cohen said, adding, “Halting funding would mean that the world may never benefit from these tools that are so close to development and delivery.” As the panelists stressed, there are several compelling humanitarian reasons to protect US investments in global health research. “Scientific advancements have brought us to a tipping point in the fight against HIV and AIDS,” Caroline Ryan, deputy coordinator for Technical Leadership at the President’s Emergency Plan for AIDS Relief (PEPFAR) said. She added that “science has set us on a new path—a path to achieving an HIV-free generation.” Lee Hall, chief of the Parasitology and International Programs Branch at the National Institute of Allergy and Infectious Diseases, said that the NIH is supporting research for an array of new, lifesaving health tools—including drugs, diagnostics, and vaccines for malaria, Chagas disease, and tuberculosis. “We’re standing at a very promising moment,” Hall said. “Looking at what’s on the horizon, it’s clear that a lot will come out of our support for global health research. We need new tools if we are to realize the benefits of US support for global health.” Speakers also emphasized that there are countless domestic benefits that come with US investments in global health research. “We live in a globalized world, whether we like it or not,” Magill said. “This presents us with the choice to exert America’s leadership role and shape the world how we’d like to see it—or let someone else do it for us.” Magill added that with the ease and speed of airline travel, “what’s happening in the middle of Africa today could be happening at Dulles tomorrow.” Hall also highlighted that many areas in the United States are vulnerable to tropical infections, and that diseases like Chagas are appearing throughout some Southwestern states. Lee Hall (left) and Alan Magill (right) at the GHTC's annual congressional briefing. Throughout the event, all three panelists underscored the importance of partnerships to advancing research and science for new health tools. According to Ryan, PEPFAR “gets more bang for our buck” by working in partnerships with other US agencies, such as the NIH and FDA, as well as philanthropic groups like the Gates Foundation. As an example, Ryan cited that PEPFAR and USAID are supporting the development of microbicides with a research infrastructure established by the NIH. Hall also cited NIH’s numerous partnerships with US academic institutions, nonprofit groups, and other federal agencies like the CDC and DoD. Magill stressed that from the Gates Foundation’s perspective, the US government is a critical partner in global health. “The Bill & Melinda Gates Foundation can only provide a small fraction of what the US can bring to the table,” he said, adding that investments in global health research should not only be seen as humanitarian aid—they are investments in science that provide “a lot bang for a little buck. We should save programs that are investments in the future.”

Since our last update on the latest budget action on the Hill, two significant events happened late last week in Congress and at the White House. First, the White House’s Office of Management and Budget (OMB) released a report on the potential impact of sequestration on federal agencies. Sequestration would require a reduction in government spending of $109 billion per year for nine years, beginning in January 2013. According to the report, most defense programs relevant to global health—including global health research and development (R&D) programs at the Department of Defense—would receive a 9.4 percent cut under sequestration. Non-defense programs—including most programs at the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the US Food and Drug Administration (FDA), the State Department, and the US Agency for International Development (USAID)—that are not exempt from cuts would receive an 8.2 percent cut. It’s important to note that some parts of these programs’ funds are exempt from cuts. For instance, out of a total budget of $34.249 billion for the NIH in fiscal year (FY) 2013, the sequestration applies to $30.861 billion. The rest is exempt. As for the primary agencies that fund global health and R&D programming, the report finds that: The total cut to NIH would equal $2.529 billion. This would put NIH’s total funding for FY 2013 at $31.720 billion. At USAID, the Global Health Programs account—the account responsible for all of USAID’s global health R&D work—would be cut by $670 million, leaving the final global health program’s funding level at $7.498 billion. The FDA, which plays a key role in regulating global health products, would see a cut of $318 million, with a final funding level of $3.624 billion (not including funding from user fees). The CDC would see a cut of $470 million from its overall funding, with $464 million coming from non-defense activities funding. This leaves CDC with a final funding level of $6.861 billion. These predictions are based on current FY 2012 funding levels. Many of these agency programs are already dealing with looming cuts to their funding levels for next year under various congressional budget proposals. If FY 2013 appropriations bills in Congress reduce agencies’ funding even further, the sequestration cuts would be even steeper than what’s outlined in the OMB report. Second, the House of Representatives late last week approved a Continuing Resolution (CR) for FY 2013, in order to keep the government running through the end of March 2013. The House approved the measure by a vote of 329-91, with 70 Republicans and 21 Democrats in opposition. The bill now moves to the Senate and is expected to pass this week. The CR funds the government at $1.047 trillion, consistent with the Budget Control Act. It also includes a slight 0.6 percent increase across the board for all federal programs, essentially maintaining spending at current levels. The CR provides a total of $55.2 billion for International Affairs, slightly higher than the $54.9 billion current level and higher than either the House or Senate FY 2013 appropriations recommendations. House Appropriations Committee Chair Hal Rogers (R-KY) said that lawmakers will aim to finalize appropriations bills when they return to work after the November elections. “We intend to use the lame-duck session to the fullest extent,” he said, adding, “Just because this CR will last until March 27 of next year, we will not rest on our laurels until that time.”

As the XIX International AIDS Conference continues in Washington this week, research for new tools to prevent and treat HIV and AIDS is standing out as a major theme. Below, we provide a summary of various sessions that have touched on research and product development topics. The US Congress and the Global AIDS Epidemic: Amid a group of protestors on Wednesday, former Sen. Bill Frist (R-TN) moderated a session with Sen. Chris Coons (D-DE), Sen. Mike Enzi (R-WY), Rep. Barbara Lee (D-CA), and Senator Marco Rubio (R-FL). When discussing her newly released bill—the Ending the HIV and AIDS Epidemic Act of 2012—Lee said that even in these “difficult” financial times, “we must move forward toward an AIDS-free generation.” Several other panelists stressed that a large part of achieving an AIDS-free generation will involve research for new products to prevent, test, and treat the disease. Speaking about recent scientific advances to create an HIV and AIDS cure, Rubio said that increased investment in innovation is critical to advancing these efforts. Coons echoed these comments, saying, “We need to double-down, we need to invest in basic science, invest in translational science, a vaccine, and new drugs. We need to innovate.” Rep. Barbara Lee (D-CA) at the International AIDS Conference. Photo credit: PATH. Effective Solutions to Combat HIV: Increasing Evidence of the Impact of Neglected Tropical Diseases on HIV Transmission and Disease Progression: In a session that examined the link between HIV and AIDS and neglected tropical diseases (NTDs), Giuseppe Pantaleo, chief of the Division of Immunology and Allergy at the University of Lausanne, said that 25 percent of people living with HIV worldwide are also co-infected with an NTD. He added that because of the high co-infection rate, there is a great need to focus on research, such as the clinical links between HIV and NTDs. Maria Aparecida Shikanai Yasuda from the University of Sao Paulo reiterated this point, saying that research is needed to develop new NTD drugs that are less toxic and more efficient. Astrid-Christina Koch, with the Delegation of the European Union to the United States, said that the second phase of the European and Developing Countries Clinical Trials Partnership will fund more stages of research. Currently the partnership covers research Phases II and III but will expand to cover Phases I through IV. This expansion could go a long way in addressing product development for NTDs and other global health diseases. Microbicides, pre-exposure prophylaxis (PrEP), and vaccines continue to take center stage at AIDS 2012. At a session to discuss The Role of Vaccines in Ending the Pandemic, panelists stressed that vaccines have proven to be one of the best, cost-effective global health solutions, and that research needs to continue to develop a vaccine for HIV and AIDS. Margaret McCluskey from the US Agency for International Development quoted Sen. John Kerry (D-MA), who has called an HIV and AIDS vaccine the “holy grail.” During a session on Wednesday on Microbicides and PrEP: Back to Basics, Ian McGowan from the University of Pittsburgh emphasized that a range of microbicide and PrEP formulations—from intra-muscular injections to vaginal and rectal products, rings, and oral pills—are needed to provide men and women worldwide with a range of HIV prevention choices that best fit their specific needs. Kim Lufkin is the GHTC’s communications officer.