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Cancer Policy Monitor: April 9, 2024

FINAL NIH Appropriations Information for FY2024

-Benjamin Krinsky, PhD

On March 23, the President signed the final set of fiscal year (FY) 2024 appropriations bills, thereby establishing the budget for the current fiscal year. The legislative package previously passed the House by a vote of 286-134 and the Senate by a vote of 74-24. Enactment of these bills culminates a long stretch of painstaking negotiations over the federal budget, and finally gives federal programs and agencies some certainty despite the fact that the fiscal year began more than five months ago. This last set of spending measures encompasses the following six bills: Defense; Financial Services and General Government; Homeland Security; Legislative Branch; State, Foreign Operations, and Related Agencies; and Labor, Health and Human Services, Education, and Related Agencies (which funds biomedical research and other health programs).

The budget agreement reached by Congress in January imposed strict limits on discretionary spending in the FY 2024 bills. As a result, appropriations for the National Institutes of Health (NIH) and the National Cancer Institute (NCI) are constrained in the final FY 2024 budget. Overall, available funding for NIH decreases by $378 million, including a $96 million decrease for NCI.

These budget challenges for NIH and NCI are exacerbated by a decrease in funding from the 21st Century Cures Act, enacted in 2016. That law created a special fund to support several areas of biomedical research, including cancer research. However, as specified in the 21st Century Cures Act, this extra fund decreased by $678 million between FY 2023 and FY 2024, including the expiration of $216 million to support the Cancer Moonshot.

Despite these constraints, Congress backfilled $300 million of the lost 21st Century Cures funding to support specific NIH and NCI programs in the final FY 2024 budget. These include an allocation of $120 million to NCI to help boost grant paylines, and incremental increases to eight other NIH Institutes and Centers. The Advanced Research Projects Agency for Health (ARPA-H) has level funding of $1.5 billion in the final FY 2024 budget. Cancer programs at the Centers for Disease Control and Prevention (CDC) also receive level funding compared to FY 2023, except for a small ($0.5 million) increase to $15 million for Ovarian Cancer within the CDC National Center for Chronic Disease Prevention and Health Promotion.

Looking ahead to FY 2025, under the current budget agreement, overall domestic discretionary spending would increase by only 1 percent. In this difficult funding environment, the AACR will continue to forcefully advocate for robust federal investments in biomedical research.

White House Releases FY 2025 Budget Request for NIH

-Matthew Gontarchick

President Joe Biden urges additional funding for the National Institutes of Health (NIH) in his proposed Fiscal Year (FY) 2025 Budget Request, which was released on March 11. President Biden’s recommendations come just days after the 2024 State of the Union, where he reiterated calls to “end cancer as we know it.”

The FY 2025 Budget Request proposes $48.3 billion for the base NIH budget, which amounts to a $1.2 billion or 2.7% increase over FY 2024 funding. Additionally, the budget calls for $7.8 billion in FY 2025 funding for the National Cancer Institute (NCI), a $615 million increase from FY 2024 appropriations.

Crucially, the White House also proposes $1.5 billion in FY 2025 funding for the Cancer Moonshot, which expired in 2023. Initially launched in 2016, the Cancer Moonshot provides additional funding for NCI to support more cancer research opportunities.

Furthermore, the president’s budget request calls for $1.5 billion in FY 2025 appropriations for the Advanced Research Projects Agency for Health (ARPA-H), which is unchanged from FY 2024. In his recent State of the Union address, President Biden urged Congress to continue to support this new agency.

The release of President Biden’s budget request marks the beginning of the FY 2025 appropriations process. It is important to note that the president’s budget request is largely a wish list of the administration’s priorities, and it is ultimately up to Congress to negotiate and determine spending allocations for FY 2025. The AACR applauds the Biden administration for taking steps to ensure that the biomedical research community can achieve the Cancer Moonshot’s goal of “ending cancer as we know it.” As the FY 2025 appropriations process gets underway, the AACR encourages advocates to contact their members of Congress and urge them to prioritize robust, sustained, and predictable annual funding increases for NIH.

AACR Annual Meeting Regulatory Science and Policy Track  

-Rukiya Umoja, PharmD, RPh 

April 9 marks the last day of the Regulatory Science and Policy Track at the American Association for Cancer Research (AACR) Annual Meeting 2024. Many stakeholders from international and U.S. regulatory agencies, the private sector, academia, and patient advocacy groups discussed how regulatory science and science policy are driving innovation in cancer therapy development. The sessions featured topics related to diversity in clinical trials, how to incorporate overall survival as an endpoint, and the future of risk assessment for multi-cancer detection tests. We also heard from the director of the National Cancer Institute (NCI), Dr. W. Kimryn Rathmell, and Dr. Danielle Carnival, deputy assistant to President Biden for the Cancer Moonshot, on ways the government is mobilizing to expedite cancer progress. In case you missed a session, the entire program will be available for on-demand streaming to registered attendees on the AACR Annual Meeting 2024 website.

Biden Administration’s Landmark Executive Order Spearheads New Investments In Women’s Health Research

-Blake William Rostine

On March 18, President Joe Biden signed an Executive Order (EO), spearheading new initiatives to prioritize women’s health research and calling on Congress to invest $12 billion in this research. Joined by First Lady Jill Biden, the EO put forth major initiatives to invest $12 billion in new funding for women’s health research to combat underfunding and understudying of women’s health issues. Included in the EO are more than 20 new directives to the Departments of Health and Human Services, the Departments of Defense (DoD) and Veterans Affairs, and the National Science Foundation (NSF). Additionally, it includes a direct investment of $200 million in the National Institutes of Health for Fiscal Year 2025 to fund new research dedicated to women’s health.

Among the new initiatives proposed, the EO directs NSF to fund new proposals on emerging women’s health issues and  the Environmental Protection Agency to increase research on how environmental factors can impact women’s health. Additionally, the DoD will invest $10 million in the Military Women’s Health Research Partnership, which includes research on a diverse set of health issues affecting women in the military, including cancers, mental, and behavioral health.

As the EO notes, investments in women’s health research have led to the discovery of genetic factors that increase the risk of breast cancer as well as innovations in mammography. In turn, these discoveries have increased overall survival outcomes for women facing a breast cancer diagnosis through better prevention, early detection, and treatment options. The AACR applauds all investments in biomedical health research, including those that get us closer to ending cancer as we know it.

More details on the Biden Administration’s EO can be read here.

REGISTER NOW! FDA-AACR Workshop: How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases 

-Nicholas Warren, PhD 

The U.S. Food and Drug Administration (FDA) and American Association for Cancer Research (AACR) are hosting a hybrid workshop titled “How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases” on Thursday, May 9, at the Bethesda Marriott Pooks Hill Hotel in Bethesda, MD. Registration is now open. This workshop will discuss trial designs for treatment regimens with multiple stages of treatment, particularly in perioperative settings with early-stage solid tumors. This builds on recent workshops on overall survival and dosage optimization.   

Recently reported trial results and several approved treatment regimens in the perioperative space for breast, lung, and other cancers raise questions regarding optimal therapy and the potential for overtreatment. Many of these trials are not appropriately designed to evaluate the attribution of treatment efficacy between surgery, neoadjuvant therapy, and adjuvant therapy. Therefore, it is challenging to determine if neoadjuvant or adjuvant therapy are superior to one another or whether administering a systemic therapy both before and after surgery improves patient outcomes. It is important that future trial designs aim to elucidate the impact of each phase of treatment, and thus may require multiple trial arms. 

This workshop will bring together experts from academia, industry, FDA, and patient advocacy organizations to discuss the best practices of trial design, analyses, and interpretation of trials with multiple phases of treatment. Speakers will also explore considerations for the assessment and interpretation of overall survival and other endpoints to facilitate timely drug development.  

For additional information, please visit the workshop website

Register Now for the 2024 Cancer Disparities Progress Report Congressional Briefing!

-Blake William Rostine

A Congressional Briefing for the release of the 2024 Cancer Disparities Progress Report (CDPR) will be held on May 15, 2024, in Washington, D.C. This event will bring together patient advocates, medical experts, and Capitol Hill staffers to highlight the progress made in addressing cancer health disparities, while also bringing attention to the factors that continue to perpetuate these health disparities, and the importance of robust, sustained, and predictable investments in medical research.

Patient advocates featured in the CDPR will also be participating in the AACI/AACR Joint Hill Day, where they will meet with legislators to share their stories and share the importance of advancing cancer research and care at our nation’s cancer centers. AACR members can register for this Hill Day online.

Registration for the Congressional Briefing is also available. Please contact [email protected] with any questions.

Reminder: Register Today for the 2024 AACR-AACI Hill Day

-Matthew Gontarchick

Registration is now open for the American Association for Cancer Research (AACR) and the Association of American Cancer Institutes’ (AACI) Hill Day on May 16, 2024. This Hill Day provides an important opportunity for cancer center directors, researchers, physician-scientists, cancer survivors, and other advocates to come to Washington, D.C., to urge legislators to support enhanced federal investment in biomedical research through the National Institutes of Health and the National Cancer Institute. 

Learn more information about and register for the Hill Day.