What does the FY13 NIH Congressional Justification Say?

Now that I have recovered (more or less) from some particularly hellish Cycle I submissions, I can turn my attention to other matters until the Cycle II crunch begins. February is the time that the Appropriation process begins at NIH. On February 13, the Administration released their Congressional Justification for FY13, which runs from October 1, 2012 – September 30, 2013. Click here for the full report.

President Obama is requesting $30.86 billion for FY13, essentially freezing the budget at FY12 levels. There is a great deal of language in the report concerning the economy—specifically, NIH’s efforts to reduce health care costs and disease burden on society, as well as the economic growth associated with the research enterprise supported by NIH. From the cover letter:

“With continued support, NIH investigators will help to revolutionize patient care, reduce the growth of health care costs, and generate significant national economic growth… NIH must continue to seek innovative solutions to ensure rapid advances in science even in these uncertain economic times. Strategic investments will support research with the highest potential for improving public health and to preserve the scientific workforce… Investment in the future of public health has never been more important. In addition to the health benefits to all Americans in the future, such investment can play a key role in reinvigorating the economy now. Numerous economic analyses have illustrated the role that NIH research plays in creating jobs and spurring economic growth. In the face of growing global competition investment in biomedical and behavioral research and the scientific workforce will propel scientific discovery for the benefit of human health and the U.S. economy, both now and in the future.”

A call-out box early in the report states:

Every dollar of NIH funding generates about $2.21 in economic output.” (In Your Own Backyard, Families USA, June 2008.) 

AND

In fiscal year 2010, NIH extramural research funding generated $68.035 billion in new economic activity nationwide and supported more than 487,900 jobs.” (An Economic Engine, United for Medical Research, Spring 2011.)

In a budget briefing on Feb 15, NIH Director Francis Collins stated that despite the budget freeze, the President’s budget proposal would allow a 7% increase in new and competing RPGs in FY13. He stated that this increase would be made possible because there was an increased turnover in grants (i.e., decrease in the duration of grants because “science is moving more quickly” than it has in the past), together with a 1% reduction to noncompeting grants.

Other items of interest in the report:

  • Funds are sought from the Public Health Prevention Fund (part of the Affordable Care Act) to make a significant increase in Alzheimer’s research.
  • The ratio of funding between basic and applied research (54% basic, 46% applied) remains constant -as has been the case for several years.
  • The National Center for Advancing Translational Sciences (NCATS) would receive an 11% increase to $639 million, which includes significant funding ($50 million) for the Cures Acceleration Network.
  • The overall Health and Human Services budget request is 8.5% lower than last year.
  • The request for the National Science Foundation is up 5% to $7.373 billion.
  • The request for the Agency for Healthcare Research and Quality (AHRQ) is up by roughly 1% to $408.8 million. However, the proposal cuts investigator-initiated research grants by more than 31%, and comparative effectiveness research grants by 41%.

The Administration’s Congressional Justification is drawing criticism from the research community, who are quick to point out that when adjust for inflation, NIH funding has been in decline since 2003. Yet up until now, NIH has been spared the devastating budget cuts seen in many agencies in the past few years. It is likely that their luck has run out, given that virtually all discretionary spending, and in particular all aspects of the Affordable Care Act, risk being slashed dramatically when the budget request reaches the Hill.

Click here for more coverage provided by the American Association for Dental Research.

What Does the NIH FY12 Appropriations Report Actually Say?

Why should we follow the Appropriations process? Aside from the obvious reason—to know how big the pot of extramural money will be next year and to understand the government’s commitment (or lack thereof) to science funding—there is another important reason: If you know the language worked into Appropriations testimony you can strategically design your research and incorporate key language and ideas into your NIH proposal in order to improve your odds of funding. (In these competitive funding times, every little advantage helps.) So without further ado, here are some key concepts from the NIH FY12 Appropriation report:

NIH has requested $31.987B for FY12. In the cover letter for the report from the Office of the Budget, Francis Collins states: “The requested funding will enhance NIH’s ability to support research that prolongs life, reduces disability, and strengthens the economy. NIH-funded research contributes to economic growth, produces well-paying jobs, and helps to keep the United States competitive on the global stage.” He continues: “For the FY 2012 budget request, NIH has identified one major area of extraordinary opportunity and three other themes that are exceptionally ripe for investment and integral to improving the health of the American people.” The one major area of opportunity of course is the proposed highly-controversial National Center For Advancing Translational Science (NCAT), which Collins refers to as “a new paradigm for turning lab discoveries into cures and treatments through targeted investments in translational science and medicine.” The three themes that NIH has deemed “instrumental in paving the way for more rapid scientific advances across all areas of human health and disease, including global applications”:

 1) Technologies to Accelerate DiscoveryThis area focuses on genes and the environment (I guess we will see more of those FOAs), and directly lists advanced technologies such as DNA sequencing, microarray technology, nanotechnology, new imaging modalities, and computational biology.

2) Enhancing the Evidence Base For Health Care Decisions. Language here includes “comparative effectiveness” and “personalized medicine.” He also cites the new HMO Research Network, which “will bring together HMOs caring for more than13 million patients for the purpose of accelerating research in the high priority areas of epidemiological studies, clinical trials, and electronic-health-record-enabled health care delivery.”

3) New Investigators, New Ideas. Here Collins mentions two programs: “the NIH Director’s New Innovator Award, which supports new investigators with potentially high-impact projects, and the Early Independence Award, which enables our most talented young scientists to move directly from a doctoral degree to an independent research career.”

If you write NIH grants, I strongly encourage you to spend some time with the full Appropriations report put out by the NIH Office of the Budget. (click here)

The Administration requested $31.829B for NIH FY12. Here are highlights that the Administration pulled from the NIH report (and therefore deem important):

*The FY12 budget proposes to support a total of 9,158 competing Research Project Grants (RPGs), a reduction of 228 from FY10. In total, NIH projects it will support 36,582 RPGs (competing and non-competing) in FY12, an increase of 43 grants from 2010.

*The budget also proposes a 4 percent increase in stipends under the Ruth L. Kirschstein National Research Service Award (NRSA) program. The goal is to “improve NIH’s ability to attract high-quality research investigators to the field of biomedical research.” This will result in an increase in NRSA funding of $19 million over FY10, for a total of $794 million.

*The Cures Acceleration Network would receive $100 million in FY12; it is included in the budget of the Office of the Director.

*As in previous years, $300 million is transferred out of the budget of the National Institute of Allergy and Infectious Diseases (NIAID) for the Global Fund to Fight HIV/AIDS, Malaria, and TB.

*Although the budget narrative specifically mentions implementation of the National Center for Advancing Translational Sciences (NCATS), the National Center for Research Resources (NCRR) remains a line item in the FY12 budget.

*At a briefing of NIH advocates, NIH Director Francis Collins said that within the next month, the agency expects to file a budget amendment detailing the movement of NCRR programs into NCATS or other NIH institutes and centers.

*The National Children’s Study would receive $194 million, the same level as FY10; the Common Fund would receive $557 million, an increase of $13 million.

*NIH intramural research would increase by $50 million, to a total of $3.382 billion, which is approximately a 1.4 percent increase.

*NIH estimates it will be able to save more than $15 million in administrative costs in FY12. The agency plans to do so through such means as using technology to save study section travel costs by holding virtual peer review sessions.

To illustrate the achievements of NIH, Dr. Collins used two particularly compelling examples at the budget briefing:

*A 21-year-old diagnosed today with HIV/AIDS has a life expectancy of 70 years, thanks to the anti-retroviral         therapy made possible by NIH funding.

*Gains in life expectancy supported by NIH-funded research result in $3.2 trillion in annual savings.

NIH identified in its FY12 budget justification priority areas and initiatives related to the following diseases: autism; cancer; Alzheimer’s disease; type 1 diabetes; and HIV/AIDS.

Some scientific program areas of accomplishment or special emphasis provided by NIH include: bioinformatics and computational biology; National Technology Center for Networks and Pathways programs; epigenomics; genotype-tissue expression; global health; Gulf oil spill long-term follow-up; health economics; high-risk, high-reward investigator initiated research; the HMO research collaboratory; the human microbe project; and nanomedicine.

The New National Center For Advancing Translational Sciences

NIH Director Francis Collins is looking to leave his mark on the NIH: He has proposed a highly-controversial National Center For Advancing Translational Sciences (NCATS). On January 22, the New York Times reported on it.

The NIH Office of the Director responded with a document entitled “Separating Fact From Fiction”:

The five main points of the OD piece are: 1) NCATS will be assembled primarily from existing programs; 2) NCATS is not intended to be a drug company; 3) The final budget is unknown; 4) There is no plan to “cannibalize” (the word used in The Times piece) the budgets of other ICs to form NCATS; and 5) NIH remains committed to basic, translational, and clinical research.

It is a fact that it costs a tidy sum to bring a drug to market, and as a result research in the pharmaceutical industry has been declining for 15 years. Whether the government can step into that gap successfully and without damaging other research enterprises is hotly debated. Collins is quoted in The Times piece as saying, “I am a little frustrated to see how many of the discoveries that do look as though they have therapeutic implications are waiting for the pharmaceutical industry to follow through with them.”

He goes on, “There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight. But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

Such language has many researchers deeply concerned, especially given that the NIH may be facing budget cuts in FY12. Because Congress recently expanded the powers of an NIH Director, NCATS would be realized as early as October.

Scientists aren’t the only ones who are concerned. A January 27th piece in Science magazine states that Congress has demanded answers.

And a January 28 piece in Science indicates some lack of internal support at NIH. This piece quotes Yale Chemistry Professor Scott Miller as stating, “If the reason [to create NCATS] is to derisk opportunities for industry, I think that’s quite bizarre and contrary to the entrepreneurial spirit.” James Stevens, a senior research fellow at Lilly Labs, adds, “If there is any organization that is slower and less agile than industry, it is the federal government.”

I hope that people who are involved in the biomedical research community in this country will stay informed, discuss, debate, and publicly comment on these developments.