Federally Funded Research: The Politics and Process of Medical Research Funding

September 15, 2014

As part of an effort to highlight the critical role of our national investment in scientific research, and to educate and mobilize its membership to call for a renewed and increased support for federally funded cancer research, ASCO has developed this educational series that explores the decade-long decline in federal funding and presents the case for reversing it. This second article in our series focuses on the Congressional funding process and the political challenges facing Congress.

Introduction

Significant progress has been made in the treatment and management of cancer. Our nation’s investment in cancer research is paying off as people with cancer are living longer and with better quality of life. More than 13 million cancer survivors are alive in the United States today largely because of the nation’s commitment to cancer research. Sustained funding of the National Institutes of Health and the National Cancer Institute is critical to maintaining the pace of scientific discovery, continued progress against cancer, and the development and delivery of new cancer therapies for millions of current and future patients.

But even as research propels us toward a new understanding of cancer, the magnitude of the problem is growing as the U.S. population ages. Largely viewed as a disease associated with aging, cancer remains the second-biggest killer of Americans, and more than 7.6 million people worldwide will die from cancer this year alone. It’s predicted that by 2030, the annual number of deaths worldwide from cancer will be over 12 million, with the majority occurring in the lower-income regions of the world.

“Stagnant and declining value of federal funding is causing investigators to leave the field and eroding the cancer research infrastructure. These events have serious potential long-term consequences,” said ASCO President Clifford A. Hudis, MD, FACP. “Opportunities to advance patient care will be lost or delayed. And, once gone, it will take many years to rebuild our investigator workforce and the research infrastructure.”

Future progress that will bring promising new treatments from the researcher’s lab to the patient’s bedside depends on continued commitment to cancer research, both in the laboratory and in the clinic. And dissemination of research findings to every segment of our population requires continued support of population science research.

Yet the current economic and political realities threaten the pace of progress. A sharply divided Congress and the automatic, across-the-board sequestration cuts are converging to seriously undermine our nation’s continued investment in medical research.

Historical Perspective: Big Investment Equals Big Progress

The pace of progress in modern oncology care was largely spurred as a result of the National Cancer Act, signed into law by President Nixon in 1971. This unprecedented legislation aimed to develop a national cancer program that significantly expanded NCI’s authority and scope, while maintaining it as an institute within the NIH. The act specifically mandated that the NCI develop its programs with the advice of a new National Cancer Advisory Board, and submit an annual budget directly to the President. In addition, the measure established the President's Cancer Panel, a three-member panel specifically required to submit an annual report to the President. This sweeping legislation granted broad authority to NCI’s Director to plan and develop an expanded, intensified and coordinated National Cancer Program that includes the NCI and related programs, other research institutes, and federal and nonfederal programs.

The National Cancer Act also authorized the development and funding of cancer centers by NCI. The new law gave a mandate to the centers that includes research, excellence in patient care, training and education, demonstration of technologies, and cancer control. The initial model for a cancer center was drawn from several of the older, free-standing institutions: Roswell Park, Memorial Sloan-Kettering, MD Anderson, and Fox Chase. In 1974, Congress broadened NCI authority to include information collection, analysis and dissemination responsibilities, and award grants to build new research centers. This expanded authority resulted in establishment of the Cancer Information Service and awarding of the first cancer control grants to state health departments. While the Cancer Centers Program has changed since its formal establishment in 1971, its core mission—to promote, conduct and disseminate cancer research—still resonates today.

These early days in “the war on cancer” produced major advances in cancer care. Lumpectomy, for example, replaced more invasive and disfiguring mastectomy surgery in the treatment of breast cancer. Advanced understanding about childhood leukemia and chronic myeloid leukemia produced effective treatments for cancers that were once considered deadly diseases.

“The National Cancer Act jump started a surge of progress in the treatment and management of cancer that has saved the lives of millions of cancer patients,” said ASCO Government Relations Committee Chair Denis A. Hammond, MD. “We need to renew that level of national commitment and investment today so future generations are able to reap the benefits of cancer research.”

The late 1990s brought a groundswell of support for medical research. The effort to double the NIH budget began as a movement among Senate Republicans and had bipartisan support in both the House and Senate beginning the first session of the 105th Congress in 1997. NIH's FY 1999 appropriation was an unprecedented 15-percent increase, $2.03 billion over the FY 1998 level, which was claimed by the Chairs of the House and Senate Appropriations Subcommittees on Labor, Health and Human Services (HHS) and Education as the first installment in doubling NIH's budget by 2003 to a level of $27.22 billion.

In 2001, President George W. Bush presented a budget to Congress that would continue the effort to double NIH's 1998 funding level in 5 years by increasing the agency's funding by $2.8 billion over the 2001 level, for a total of $23.1 billion in 2002. This proposed budget increase represented an extraordinary commitment to accelerate NIH funding, which had doubled roughly every 10 years over a four-decade span.

However, such robust funding abruptly ended in ensuing years. A growing national deficit and national security priorities have left NIH funding largely stagnant since 2003, leading to a decrease in the amount of inflation-adjusted NIH and NCI funding. The NIH budget has declined by more than 22 percent ($6.1 billion) over the last decade after adjusting for biomedical inflation bringing the current NIH budget to its lowest point since 2001.

Appropriations: The Key for Federal Funding

The Constitution mandates that all expenditures for federal agencies and programs be approved by Congress and signed by the President. Congress and the President establish programs through the authorization process. Congressional committees with jurisdiction over specific program areas write the legislation. Legislation can authorize the expenditure of funds from the federal budget, but it does not actually provide the funds. That is where the appropriations process comes into play. It is through appropriations bills that Congress and the President propose the amount of money that will be spent on federal programs during the fiscal year.

Once Congress appropriates these funds, it is expected that the money will be used by specific federal agencies during the fiscal year for which it is appropriated. Congress must enact annual appropriations bills by the beginning of each fiscal year (October 1) or provide interim funding through a continuing resolution. Sometimes, Congress will combine several appropriations bills at the end of the year and pass them all together as an “omnibus” bill.

The first step of the appropriations process typically involves the House and Senate Budget Committees developing a resolution that sets the overall budget goals for the federal government. These resolutions do not have the force of law and are not signed by the President, but they give the appropriators the outline for the overall budget. The House and Senate Appropriations Committees take these budget resolutions and then assign each subcommittee a specific amount of funding to apportion to the departments, agencies, and programs within their jurisdiction.

The House generally begins the process by having the Appropriations Committee's subcommittees hold extensive hearings on each of the spending bills. Hearings usually begin in early March, soon after the President's budget is submitted to Congress. (The President’s State of the Union address, usually given before Congress in late January, typically signals the Administration’s budget priorities.)

Normally, the House starts voting on appropriations bills in May and seeks to complete this by the time Congress recesses in August and Members return to their respective jurisdictions. In recent years, however, many of these votes have not occurred until the fall and others have not happened at all. The Senate may begin committee work on its 12 spending bills and may even vote on the bills before the House completes its work.

If the House and the Senate pass different versions of an appropriations bill, a conference committee, consisting of equal numbers of House and Senate members, meets to reconcile any differences.

The legislative language and conference report that provides additional commentary about the intent of the bill is then sent to both the House and Senate for final approval. If approved, it is then sent to the President. After the President signs a bill, each funded department or agency reviews the bill, makes the regulatory changes mandated by Congress, and begins allocating the funding to appropriate departments and projects referenced in the bill.

Both the U.S. House of Representatives and the Senate have appropriations subcommittees that are responsible for appropriating funds to NIH and NCI. The leadership and members of these subcommittees play key roles in determining funding levels. Congressional appropriations subcommittees that have jurisdiction over the NIH budget (and current subcommittee leadership) include the following:

With a federal budget that totals $3.8 trillion, lawmakers face an enormous task and endless demands from competing priorities in developing a workable budget for the federal government each year. Complicating the appropriations process is the fact that Congress has not passed a budget resolution in more than three years, and is currently operating under a continuing resolution (CR) as described above. While some adjustments can be made, the CR primarily keeps the government operating until a specific date and provides funds at levels consistent with a previously approved Congressional budget. The current CR will expire on October 1, 2013. At that point, Congress has to pass another continuing resolution, a formal FY14 budget, or face the possibility of a government shutdown.

Sequestration and the Federal Budget

Under the current continuing resolution, Congress has allocated $30.6 billion for NIH appropriations representing flat funding from FY 2012. Compounding the stagnant funding level is the effect of sequestration. Mandated by law due to Congress’s inability to agree on a plan to decrease the federal deficit by $1.2 trillion over ten years, sequestration required NIH to cut 5 percent or $1.5 billion of its FY 2013 budget. This brought the actual total funding of NIH for FY 2013 to $29.1 billion. NIH applied the cut evenly across all institutes and centers and allowed the institute and center directors to determine how to absorb the budget reductions. This means every area of medical research is potentially affected but some may be hit harder than others. In his 2013 State of the Union address, President Obama called these cuts devastating to national priorities such as medical research.

“We’ve seen troubling reports of researchers having to stop ongoing trials or delay new trials as a result of sequestration,” Dr. Hudis said. “It’s a travesty to impede research that has the potential to reveal life-saving treatments and inform future practice guidelines, undermining a key component of American scientific leadership.”

The President’s FY 2014 Budget would replace sequestration and proposes budget cuts in specific programs. The president’s budget proposes an FY 2014 budget for NIH of $31.3 billion, an increase (of $500 million) over the FY 2012 program level of $30.6 billion. While the increase is a step in the right direction, at least $32 billion in FY 2014 budget appropriations is needed simply to keep up with biomedical inflation. And, the same political realities that have caused some of the recent cuts are still at play. Congress is nearing the October 1 deadline to pass a budget, and with other national priorities heating up, it appears likely that Congress will only pass another CR.

ASCO’s Advocacy Work

Building on the Society’s long-standing history as an advocate for research funding, this fall ASCO is increasing its efforts to draw attention to the urgent need to sustain NIH and NCI funding. ASCO members will be on Capitol Hill talking to Congressional leaders and staff, joining the broader medical community in a rally for research funding, and calling upon its members to mobilize and take action.

“Now more than ever before, we need to sound the alarm on the critical need for cancer research,” Dr. Hammond said. “Draconian cuts to biomedical research will slow our progress at the moment of greatest scientific potential and increasing worldwide need.”

ASCO members can take action right now. Join ASCO’s ACT Network and tell your elected officials that progress is threatened, and the future of cancer research is at stake. Our country’s research infrastructure is at stake and standing on the sidelines is not acceptable.

The third and final article in this series will delve deeper into the NCI grants system. To learn more about how federal funds actually support cancer research, stay tuned to www.asco.org/advocacy/nih-funding.