Breakthroughs Blog: NIH

Today, the Senate appropriations committee approved a fiscal year (FY) 2014 appropriations bill that outlines funding levels for the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). The Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill would take the positive step of restoring sequestration cuts to CDC and NIH, although there is mixed news for global health programs at the agencies. NIH The bill would fund the NIH at a total of $30.9 billion in FY 2014, restoring this year’s five percent sequestration cut and providing a small increase over last year’s budget. Science Insider reports that the NIH had “strong support” from Senate Appropriations Committee Chair Barbara Mikulski (D-MD), who recently said that she is determined to reverse "reckless cuts to American biomedical research." In her opening remarks earlier today, Sen. Mikulski said, “Because of the investments we have made in NIH over the past decades, … HIV and AIDS is no longer a death sentence, and polio and small pox are essentially eradicated in this country. These medical breakthroughs didn’t just happen, they occurred because this Committee supported NIH, and the NIH supported dedicated scientists who sought knowledge and medical breakthroughs. We must keep up this support.” The bill includes $50 million, five times the FY 2013 level, for NIH’s Cures Acceleration Network, which aims to speed the translation of medical research discoveries in the laboratory that have not advanced far enough to attract significant investments from the private sector. According to Nature, in order to approve a new NIH budget—as opposed to passing yet another continuing resolution for FY 2014—the House and Senate must agree on a common figure for the agency. As a comparison, the House FY 2014 Labor-HHS bill would provide $8 million less for NIH compared with the Senate version. The Senate Labor-HHS appropriations bill for FY2014 would fund the NIH at $30.9 billion and the CDC at $7.022 billion. Credit: PATH/Evelyn Hockstein CDC The Senate bill would provide CDC with $7.022 billion in funding for FY 2014. The bill would restore the $800 million cut from CDC’s budget by sequestration and add a $22 million funding increase. The bill would provide $391.9 million for CDC’s Center for Global Health. This would include $116.9 million for CDC’s Global AIDS Program, which is equivalent to the FY 2013 level, but $15 million below President Obama’s FY 2014 request. The bill would provide $19.3 million for CDC’s Parasitic Diseases and Malaria program, which is comparable to FY 2013 levels, but less than the $22.2 million requested by Obama. CDC’s Division of Tuberculosis Elimination would receive flat funding at the FY 2013 funding level of $140 million. No additional funding for the division’s research programs was allocated. Finally, the bill also contains a total of $19.2 million for Global Public Health Capacity Development. These funds are for a new initiative to support public health capacity building in at least five developing countries over a two-year period to be overseen by CDC. The fate of the Labor-HHS appropriations bill is unclear from this point on. There is a $91 billion funding gap between the House and Senate overall budgets for FY 2014. And while the House Labor-HHS subcommittee has its overall budget, the subcommittee has not announced a date for consideration of a bill. Whatever happens, both the House and Senate must work to protect funding levels at the NIH, CDC, and all federal agencies that support global health and research programs.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The National Institutes of Health has released a fact sheet on the impact of sequestration. The fact sheet states that, due to budget cuts, approximately 700 fewer research project grants will be awarded this year compared to fiscal year 2012. New statistics show that the vaccine MenAfriVac™—developed through a partnership between the World Health Organization and PATH—has significantly reduced the number of cases of meningitis A in Africa. The most recent meningitis season marks the lowest number of cases in ten years. Scientists at Virginia Tech and the University of Florida are making progress in developing a new species-specific insecticide that would be lethal only to insects that carry malaria. Though they have seen positive results, the scientists still think it will be four to five years before they are ready to submit the compound for federal approval. Drugmakers in Japan have agreed to release data on experimental compounds for possible use to create drugs to combat malaria, tuberculosis, and neglected tropical diseases. The pharmaceutical companies are part of a five-year partnership called the Global Health Innovative Technology Fund.

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.

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.