National Institutes of Health
– The National Institutes of Health (NIH) budget would rise 3.3 percent to $31.3 billion.
– NIH’s fiscal year (FY) 2016 budget highlights four long-running themes: basic research; translational medicine; big data and technology; and fostering talent and innovation in the biomedical workforce.
– NIH is central to several major White House initiatives, including the Precision Medicine Initiative, the BRAIN Initiative, and Antimicrobial Resistance.
OVERVIEW OF THE FY 2016 NIH BUDGET
NIH, part of the Department of Health and Human Services (HHS), is the second largest supporter of R&D in the federal government, after the Department of Defense. In its mission to promote biomedical research and other fundamental inquiries that may lead to medical advances, it is by far the largest federal supporter of basic research, applied research, and R&D at colleges and universities.
Originating from a one-room lab in 1887, NIH has grown to 27 institutes and centers and is a major player in the biomedical research arena. Its success stories are numerous; more than 100 researchers supported by NIH have won Nobel Prizes. However, the previous decade has brought challenges to the agency. Though NIH saw its budget double between 1998 and 2003, its budget from 2004 onward has declined significantly in real dollars, and NIH finds itself in a weaker position than it was a decade ago in terms of purchasing power. Success rates—indicating the percentage of reviewed grant applications that receive funding—have also declined, and the average age for a researcher to get his or her first Research Project Grant (called the R01) has hovered around 42. There are genuine fears that numbers like these will deter the next generation of potential researchers.
The across-the-board cuts known as sequestration chopped 5 percent from the NIH budget in FY 2013; subsequently, the Ryan-Murray budget agreement resulted in some much-needed relief for FY 2014 and FY 2015. For FY 2016, the President is pushing for an end to sequestration, calling it “mindless austerity” (see Chapter 3).
The FY 2016 NIH budget request is $31.3 billion, a boost of an even $1 billion, or 3.3 percent, over FY 2015. NIH classifies 95 percent of its budget as R&D, including R&D facilities; the remainder is for overhead costs and research training. NIH R&D would total $29.6 billion next year.
The Office of Management and Budget projects the rate of inflation in the economy as a whole to be 1.6 percent in FY 2016. In addition, NIH calculates a Biomedical Research and Development Price Index (BRDPI), an index that estimates the inflation rate for goods and services purchased by the NIH budget. NIH predicts the BRDPI rate for FY 2016 to be 2.4 percent. BRDPI has been slow to grow in recent years in part because of a freeze on federal civil employee salaries and a cap on salaries for extramural investigators.
NIH INSTITUTES IN THE FY 2016 BUDGET
The NIH budget is actually appropriated in 27 separate budget accounts, roughly corresponding to NIH’s institutes and centers (ICs). There are 20 institutes with separate budgets, along with four centers, an Office of the Director (OD) and a Buildings and Facilities account. There are three other centers that are not separately budgeted. An additional appropriated account, the NIEHS superfund account, is part of the Interior bill.
In the FY 2016 budget, most ICs would see budget boosts of approximately 2 to 4 percent. A notable exception is the National Library of Medicine, with a whopping 16.8 percent jump, due in part to expansions in big data and the volume of ClinicalTrials.gov. Other standouts this year include the National Institute on Aging (NIA) at 5.8 percent, National Institute of Allergy and Infectious Diseases (NIAID) at 4.5 percent, and the National Center for Advancing Translational Sciences (NCATS) at 4.3 percent.
Trans-NIH initiatives in the Common Fund would receive $566 million, an increase of 3.5 percent over FY 2016. This fund, designed for multidisciplinary collaborative research, would represent about 1.8 percent of the total NIH budget.
NIH FUNDING MECHANISMS
The majority of NIH’s budget is distributed to external performers through Research Project Grants (RPGs), which are investigator initiated, peer reviewed, and competitively awarded throughout the NIH budget. NIH projects an increase in the number of RPGs in FY 2016 to 35,447, up from 34,206. Within that number, Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) grants total 1,841. NIH expects to offer 10,303 new (competing) RPGs in FY 2016, a solid increase of 1,227.
For FY 2016, NIH is estimating a success rate of 19.3 percent, a bump up from the FY 2015 rate of 17.2 percent. From funding an average of 1 out of 3 grant applications early in the past decade, NIH’s success rate has hovered below 1 in 5 applications in recent years. Total funding for RPGs would be $17.2 billion (with $765 million going to SBIR/STTR).
NIH distributes about 9 percent of its budget through R&D contracts. Funding for these contracts would remain $2.9 billion in FY 2016. NIH funding of research centers would shrink a bit to $2.6 billion for support of 1,399 centers.
The institutes also operate an enormous federal research enterprise, mostly in Bethesda, MD. Intramural research would total $3.5 billion in FY 2016, a $95 million boost; this constitutes 11 percent of NIH’s budget.
NIH is heavily involved in training the next generation of biomedical researchers. Research training programs would receive $785 million in FY 2016, up from FY 2015. NIH would have 15,735 full-time training positions, up by 204.
NIH PRIORITY AREAS
NIH is playing a significant part in several major White House initiatives. These include:
Precision Medicine Initiative: NIH is the lead player in the White House’s new Precision Medicine Initiative (PMI), which would allocate $130 million to NIH for the creation of a national cohort of a million or more research volunteers. NIH’s vision is that volunteers would share genomic data, lifestyle information, and biological samples, all linked to their electronic health records. Early discussion has involved the use of mobile technologies and other advances to help pave the way. The National Cancer Institute would also receive $70 million to scale up efforts to identify genomic drivers of cancer.
Antimicrobial Resistance: The President is seeking $1.2 billion – double last year’s commitment – for a multiagency Antimicrobial Resistance program addressing the burgeoning challenges associated with infections that are resistant to treatment with antibiotics, which cause millions of illnesses and thousands of deaths each year and cost the nation billions of dollars in healthcare costs and lost productivity. NIH and the Biomedical Advanced Research and Development Authority (BARDA) would get $650 million to research new diagnostics and treatments and learn more about resistance. Research recommendations include a national database of genomic sequences for the antibiotic-resistant microbes that cause human infections and a $20 million prize for the development of better diagnostics.
BRAIN Initiative: Five agencies are now involved in the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. NIH would get $135 million in FY 2016, a boost of $70 million. Priority areas include the development of innovative technologies to advance basic neuroscience; the generation of methods to classify the brain’s diverse cells and circuits; and the development of new, non-invasive tools for human brain imaging. Last September, NIH gave out its first 58 BRAIN-related awards.
In addition, the White House continues to show a strong interest in Alzheimer’s disease, requesting a $638 million investment in FY 2016, an increase of $50 million. Alzheimer’s is one of four diseases targeted by NIH’s highly touted Accelerating Medicines Partnership (AMP), which would get $23 million in FY 2016. The AMP is a collaboration among NIH, FDA, industry and nonprofit groups to identify the right biological targets for drugs to affect, ideally leading to new therapies or other advances for patients.
Highlights of NIH’s vast basic research portfolio include several recent advances in cellular imaging techniques; efforts to study single cells, including through CRISPR, a novel tool recently developed by NIH-funded scientists that allows them to precisely target genes for deletion, addition, activation or suppression; and the 4D Nucleome Initiative, which studies the nucleus, the physical structure within each cell that houses most DNA.
On the translational medicine front, arguably nothing drew more headlines to NIH than the Ebola epidemic of West Africa, the largest and most complex outbreak of Ebola in history. Backed up by more than a decade of work on Ebola, NIH was able to launch several trials of human Ebola vaccines in the fall of 2014. Eyes are also on innovative clinical trials such as Lung-MAP, a unique public-private partnership in which lung cancer patients are assigned one of four drugs based on the results of a genetic screen. And stem cells – particularly induced pluripotent stem (iPS) cells derived from mature cells such as skin cells – are continuing to generate excitement. Meanwhile, scientists are working hard to achieve the goal of a universal flu vaccine, which would confer decades-long protection from any type of influenza, be it seasonal or possible pandemic (e.g., H5N1). HIV/AIDS research is another major priority, and the budget request includes an increase of $100 million to expand NIH’s efforts to find a vaccine or cure. Also of note is NIH Director Francis Collins’ announcement in December 2014 of the cancellation of the ambitious but costly National Children’s Study.
NIH is focusing on harnessing data and technology in areas such as cancer research and the human microbiome, centered on the trillions of microbes existing in and on the human body. NIH’s Big Data to Knowledge (BD2K) program, which seeks to help scientists analyze large swaths of digital datasets, would expand by nearly $20 million in FY 2016. NIH is also advancing the field of bioelectronic medicine, in which electronic impulses are used to stimulate nerves throughout the body, through a new program called SPARC.
Enhancing the biomedical workforce – as well as the diversity within it – continues to be a major concern of the agency, and several programs are underway to address this. These include the Broadening Experiences in Scientific Training (BEST) program, which supports innovative approaches to training graduate students and postdoctoral scholars for a range of career options; the Building Infrastructure Leading to Diversity (BUILD) Program, which is designed to provide under-resourced institutions with the opportunity to develop novel approaches to training and mentoring their students, many of whom come from backgrounds that are disadvantaged and/or underrepresented in biomedical research; and the National Research Mentoring Network, aimed at developing a nationwide network of mentors and mentees and providing strategies, standards, and training opportunities for mentors.
NIH will continue to support early-career investigators through programs such as the NIH Director’s Early Independence Award, which provides support for exceptional early investigators to skip the postdoc and jump into independent research. NIH also has awards that incentivize creativity: the NIH Director’s Pioneer Award, the New Innovator Award, and the Transformative Research Award.
R&D IN OTHER HHS AGENCIES
Total R&D in HHS would be $31 billion in FY 2016. NIH dominates the HHS R&D portfolio, but other agencies within HHS would fund a still-substantial $1.4 billion of R&D in FY 2016.
OUTLOOK FOR THE NIH BUDGET
In a difficult budget climate, NIH continues to grapple with its declining purchasing power, and there are real fears that the next generation of research stars will be dissuaded from entering the field. The agency’s champions in Congress are on a mission to seek legislative solutions that will help put NIH back on the path of sustained growth. The possibilities for an array of groundbreaking medical advances are tantalizingly real, if this country commits to reaching for them.