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The Cancer Letter – Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent

The Cancer Letter – Trump proposal for FY2020 to slash NIH by 12 percent, NCI by 15 percent

President Donald Trump has proposed to cut $4.7 billion from the NIH budget, with almost $900 million coming out of NCI during the fiscal year 2020.


According to the White House’s proposal, “A Budget for a Better America: Promises Kept. Taxpayers First.” released March 11, NIH would lose 12 percent and NCI, 15 percent.


If Trump’s budget request is enacted, the NIH budget would shrink from $39.1 billion in FY19 to $34.4 billion in FY20. The NCI budget would be slashed to $5.2 billion, down from $6.1 billion.


Trump’s latest budget proposal marks the third consecutive year in which he has advocated for severe cuts to federal agencies that fund biomedical research (The Cancer Letter, May 26, 2017, Feb. 16, 2018). These cuts are proposed without explanation or justification.


FDA, by contrast, stands to get a $643 million boost above the FY19 continuing resolution level, which would bring the agency’s budget to $6.1 billion. The budget proposal would also increase user fees by $281 million, and the FDA budget authority by $362 million.


The Health Resources and Services Administration would get a $1 billion cut, and the Centers for Disease Control and Prevention would lose $1.3 billion. The budget also reduces funding for cancer screening and prevention programs  by $34.5 million at CDC.


Trump’s FY20 budget focuses on boosting funding for the Department of Defense by $33.4 billion—a 5 percent increase. Of that amount, $3.6 billion would be allocated to “new military construction resources for barriers,” bringing total funding proposal for Trump’s  border wall to $8.6 billion.


Overall, the White House requests $2.7 trillion in spending cuts. and HHS would be cut by $87.1 billion, which is $18.28 billion, or 12 percent, below the fiscal 2019 level.


Congressional Democrats declared Trump’s budget request “dead on arrival.”


“For the third year in a row, President Trump has sent a budget proposal that is dead on arrival and divorced from reality,” said Sen. Patrick Leahy (D-VT), vice chairman of the Senate Appropriations Committee. “It is not worth the paper it is printed on, and it will be rejected by Congress.”


“Yet again, the president has proposed shortsighted cuts that would slash investments in infrastructure, medical research, and American families, cuts that have been rejected by Congress two fiscal years in a row,” Leahy said in a statement March 11. “This is not a serious proposal. President Trump should work with Republicans and Democrats in Congress to reach a bipartisan budget agreement so we can begin the fiscal year 2020 appropriations process.


“Without an agreement, the law requires that we cut $71 billion (minus 11 percent) from defense programs and $54 billion from non-defense programs (minus 9 percent). The clock is already ticking, and we cannot and should not waste our time on partisan proposals and failed policies.”


Speaker of the House Nancy Pelosi (D-CA) called Trump’s budget “cruel and short-sighted.”


“House Democrats will reject this toxic, destructive budget request which would hollow out our national strength and fail to meet the needs of the American people,” Pelosi said in a statement March 11. “Instead of building a stronger, healthier nation, President Trump’s budget would take away Americans’ health care and devastate the pillars of economic security for seniors and families.


Trump’s budget request includes a $500 million commitment to pediatric cancer research, which is consistent with a pledge he made at his State of the Union address earlier this year (The Cancer Letter, Feb. 8).


“Many childhood cancers have not seen new therapies in decades,” Trump said in his March 11 “budget message” to Congress. “My budget initiates a new effort that invests $500 million over the next 10 years to support this critical life-saving research.”


NCI has developed a plan for building a comprehensive data federation—starting with pediatric cancer data—which would be set in motion if congressional appropriators concur with that feature of Trump’s request (The Cancer Letter, March 8).


A breakdown of Trump’s budget published by HHS states that NIH will invest $50 million in FY 2020 “to launch an initiative to accelerate and expand drug discovery and clinical trials, understand the biology of all pediatric cancers, and create a national data resource for pediatric cancer.


“This initiative will support research to develop new, more effective, and safer treatments for childhood cancers, and complement ongoing research within the NCI. Through this initiative, NCI will aggregate data from pediatric cancer cases and coordinate with others that maintain data sets to create a comprehensive, shared resource to support childhood cancer in all its forms.”


Also, the HHS document states that NIH will invest $15 million in the IDeA States Pediatric Clinical Trials Network to “support studies such as a multi-site clinical trial, which will evaluate the dosing, safety, and efficacy of drugs that are commonly prescribed to children.”


However, the HHS interpretation of the White House’s budget request doesn’t mention the provision for $500 million over 10 years for childhood cancer research.


“The budget supports a targeted investment in the National Cancer Institute to accelerate pediatric cancer research,” the HHS breakdown of the president’s budget states. “Through this initiative, NIH will enhance drug discovery, better understand the biology of all pediatric cancers, and create a national data resource for pediatric cancer research. This initiative will develop safer and more effective treatments and provides a path for changing the course of cancer in children.”


The cuts to NIH and NCI are unlikely to materialize, insiders say. Not only has Congress ignored the cuts to NIH requested by Trump over the past two years, appropriators—in a sustained bipartisan effort—voted to increase the NIH budget by $3 billion in FY18 and $2 billion in FY19 (The Cancer Letter, March 30, April 6, Sept. 28, 2018). Since FY16, Congress has increased funding for NIH by 30 percent.


“During the past four years, Congress has prioritized medical research because of the extraordinary number of scientific opportunities that now exist to save the lives of cancer patients and improve the quality of their lives,” Elizabeth Jaffee, president of the American Association for Cancer Research, and deputy director of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, said in a statement.


“Clearly, this is not the time to be cutting the lifesaving research that the NIH and the National Cancer Institute so effectively support.”


The president’s State of the Union pledge of $50 million per year for pediatric cancer research is a “long-awaited prioritization” of pediatric cancer, said Nancy Goodman, founder and executive director of Kids v Cancer.


“Mr. Trump’s pledge underscores the reasons government institutions like the NCI exist—to support societal goals when private industry cannot,” Goodman said to The Cancer Letter. “And above all else, Americans want Grace—the beautiful childhood cancer survivor introduced to us by Mr. Trump—to be healthy. But, pharmaceutical investment in pediatric cancer is de minimus. NCI must take the lead in pediatric cancer research.”


As it stands, it’s unclear whether the initial $50 million in FY20 will be appropriated as new funds, on top of NCI’s current budget level. Also, the president’s request to cut NCI’s budget by almost 15 percent comes across as counterintuitive, since the institute is a major funder of pediatric cancer research.


“That said, when President Trump slashes the NCI’s budget by $900 million, he not only undermines the NCI, he also hurts children like Grace,” Goodman said. “Pediatric cancer research and all cancer research relies on across-the-board programs at NCI. The loss of $900 million to NCI can’t be remediated by an extra $50 million to kids.


“NCI has a terrific project for the pediatric cancer funds—a data federation for pediatric cancer which I hope will also have clinical deep genomic sequencing and clinical records, and private industry partnerships to design, construct, and populate of this dataset. Fully funded, it can have major impact.


“The president’s budget is just a recommendation and the NCI cut is not set in stone. We will have to turn to Congress now.”


The White House budget proposal highlights a number of initiatives at NIH that align with presidential priorities:

  • $1 billion for opioid and pain research.
  • This includes the continuation of the 2018 Helping to End Addiction Long-term Initiative
  • $33 billion to improve public health “by advancing knowledge of living systems to tackle major health challenges and improve diagnosis, prevention, and treatment of diseases and disorders.”
  • “With this investment, NIH would continue to address the opioid epidemic, make progress on developing a universal flu vaccine, and support the next generation of researchers. NIH has provided upfront funding for certain projects in recent years and would continue this approach in 2019 and 2020 to facilitate efficient management of NIH resources across multiple years. The Budget also supports cutting-edge intramural research by addressing the backlog of repair and improvement across NIH facilities.”


The White House’s funding priorities for FDA include:

  • $55 million to strengthen FDA’s activities in response to the Nation’s opioid crisis.
  • $55 million to advance digital technology.
  • $13.5 million for ensure that compounded drugs are safe and effective.
  • $20 million for a pilot program to develop and test technology that could detect pathogens in the blood supply.
  • FDA’s annual user fee cap of $712 million would be increased by $100 million and future collections of all tobacco related products would be indexed to inflation.
  • “This proposal would ensure that FDA has the resources to address today’s alarming rise in youth e-cigarette use as well as new public health threats of tomorrow.”

The budget proposal also includes policy suggestions for FDA:

  • Reform exclusivity for first generics to spur greater competition and access.
  • Amend the 180-Day forfeiture provision addressing failure to obtain tentative approval.
  • Codify FDA’s approach to determining new chemical entity exclusivity.
  • Provide FDA enhanced authority to address abuse of the petition process.
  • Encourage biosimilar development.

The budget requests a total of $3.8 billion for medical product safety investments, which is $428 million above FY 2019. This total includes $1.8 billion in budget authority and $1.9 billion in user fees. It includes $220 million to “continue proposing several initiatives promoting public health and spur growth in the domestic economy.”


For CDC, the White House requests:

  • $476 million for CDC to continue current activities in support of all 50 states and territories, as well as local jurisdictions, to track and prevent overdose deaths related to the opioid crisis.
  • $58 million for CDC to address the infectious disease consequences of the opioid epidemic
  • $140 million for CDC to reduce new HIV infections by working closely with State and local health departments on intensive testing and referral to care efforts.
  • Increase of $10 million for CDC’s influenza activities.
  • $100 million to support CDC’s global health security activities, an increase of $50 million.

The budget proposal recommends that CDC focus on:

  • Confronting the opioid crisis.
  • Helping to end addiction long–term.
  • Improving outcomes for neonatal abstinence syndrome.
  • Creating safer options for pain control in acute to chronic conditions.
  • Creating a national research resource to help advance precision medicine.
  • Ending the HIV epidemic.
  • Researching a universal influenza vaccine.
  • Leveraging data and AI.

Comments from cancer groups on the president’s budget request follow:

Monica Bertagnolli

We strongly oppose the White House budget proposal for Fiscal Year 2020, which would stall our nation’s progress against cancer and impede access to needed care for the millions of Americans dealing with cancer. The proposal would make drastic, unprecedented cuts to the U.S. Department of Health and Human Services—which houses the NIH, the NCI, and the Centers for Medicare & Medicaid Services. These reductions would undo efforts of the past four years to revitalize the NIH and the NCI, including recent funding increases supported by the administration. It would also further aggravate access to care challenges faced by Medicare and Medicaid beneficiaries every day.


The nation’s fragile biomedical research infrastructure has only just started recovering from a decade of flat funding. The White House budget would unravel years of progress and significantly impede our nation’s ability to conquer cancer. While we’re pleased that the President’s budget does include $50 million specifically for pediatric cancer research, any possible gains will be undermined by the nearly 15 percent proposed funding cut to both the NIH and the NCI overall.”


The proposal would also harm beneficiary access to high-quality cancer care under both Medicaid and Medicare in several ways, such as transitioning federal funding for Medicaid to block grants, permitting Medicaid to impose work requirements across the board, imposing new utilization controls on some cancer therapies, and moving some drugs currently covered under Medicare Part B to Part D. Such changes do not meet ASCO’s principles for healthcare reform and could disrupt care for patients with cancer.


We urge Congress to reject the proposed cuts to NIH and to affirm its bipartisan commitment to the millions of Americans with cancer by providing $41.6 billion to the NIH and $6.5 billion to the NCI in FY 2020. We also urge policymakers to preserve and enhance access to high-quality cancer care for all Americans by rejecting the proposed changes to Medicaid and Medicare.

Patrick White

The administration request is not going to happen. The issue now is the president proposes and Congress disposes. The real issue is going to be whether or not the administration and Congress can agree on a budget cap deal and the appropriators will appropriate. My hope is we’ll see an increase for NIH.


In the grand scheme of things, administration in and administration out, presidential budget requests have not been taken very seriously except for the people in the executive branch who work so hard to put it together. I doubt very seriously that the president or the leadership of this administration singled out NIH, they are instead trying to essentially do the impossible. NIH was just caught in that process, and just about everything else was caught in that process.


Congress is the decider here, and the administration merely requests.

Lisa Lacasse

If passed, the proposed cut to NIH and NCI funding would squander years of renewed momentum and progress in advancing discovery in cancer and other chronic diseases.


These investments have long enjoyed strong bipartisan support and have led to incredible understanding in how to detect, diagnose and treat cancer that still claims the lives of more than 600,000 Americans each year.


The additional $50 million dedicated to childhood cancer research, while welcome, will not be as effective as possible if overall research funding is significantly reduced. Childhood cancer research is intertwined with all of cancer research and cuts to NIH and NCI funding will consequently have deleterious effects on such research regardless of age.


We are deeply troubled by the proposed cuts and elimination of proven cancer prevention, screening and early detection programs at the CDC. The proposed block granting of all chronic disease funding could essentially eliminate federal tobacco prevention and control programs. Tobacco use remains the number one cause of preventable premature death in the U.S.


The inclusion of a new e-cigarette manufacturer user fee to help fund FDA regulation of the electronic cigarette industry is a welcome acknowledgement of the epidemic in youth e-cigarette use. However, FDA’s urgent regulatory work to address this crisis should not be dependent on the assessment of this fee.


Capping out-of-pocket prescription costs for seniors on Medicare Part D and allowing some low-income enrollees to be spared cost-sharing on generic drugs would be welcome changes and could help enrollees better afford their care.


However, transforming Medicaid funding into a block grant would likely leave millions of Americans unable to access critical health services. Medicaid serves as an essential safety-net for more than 2.3 million Americans with a history of cancer, including one-third of all pediatric cancer patients at the point of diagnosis.


Budget realities require setting priorities. Federal funding for medical research and access to preventive and curative medical care is essential to ensuring our country can lead, innovate and save the most lives from cancer as possible. On behalf of the more than 1.7 million Americans expected to be diagnosed with cancer this year, we urge Congress to reject these cuts, raise the impending budget caps and ensure cancer research and access to health care remains among our nation’s the top priorities.

Ryan Hohman

The increase in the FDA budget is a very positive thing, however, you can’t look at the budget of the FDA in a vacuum. You have to look at it with the significant proposed cuts to NIH and NCI, you’re really looking at stunting the growth of the exceptional science that is going on at the agency. Boosting the FDA is great, but if you’re cutting the basic science that the FDA is reviewing then you’re not having a full picture, or the piece to complete the puzzle to help patients.


I would say that we’re confident in the continued champions in both the House and the Senate that they will protect the NIH and NCI from this proposal for what the budget might look like. We do hope the House and Senate consider the significant increase to the FDA, but we also need to protect the NIH and NCI. We’re fully confident in the historic support that those bodies have given.

Mary Woolley

The President’s 2020 budget proposal attempts to build on decades of hard-fought victories in the U.S. against childhood cancer and the transmission of HIV. It also includes an increase for FDA, an agency with critical responsibilities for our nation’s health and safety.


But it is not possible to meet these priorities, nor any other goal or aspiration of the American people, if the fuel it takes to drive success is drained from the tank. Unfortunately, that’s what this budget blueprint proposes.


The proposal embraces steep cuts on top of dysfunctional budget caps. It would eviscerate non-defense discretionary spending, including, for example, 12 percent decreases in both NIH and NSF funding, forcing the U.S. to retreat from medical progress, public health readiness, and science and technology investment crucial to both job growth and the overall economy.


The U.S. must not rest on its laurels as other countries usurp our science and technology leadership and health threats like opioid addiction and cancer undermine health and hope. We urge members of Congress and President Trump to raise the budget caps and craft spending bills that drive science, technology, and better health for all.