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Cancer Policy Monitor: August 8, 2023

Appropriations Update from Capitol Hill 

-Blake Rostine 

With the release of President Biden’s Fiscal Year (FY) 2024 budget request and the enactment of bipartisan legislation, the FY 2024 appropriations process is now fully underway in Congress. On July 14, 2023, the House Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education, and Related Agencies approved its Fiscal Year (FY) FY 2024 spending bill along party lines. Overall, the bill would provide $43 billion in FY 2024 funding to the National Institutes of Health (NIH) and $7.1 billion to the NCI. Compared to FY 2023 spending levels, the bill would cut NIH funding by $2.8 billion, or 6 percent, and cut NCI funding by $216 million, or 3 percent.   

Paired with the estimated 3.1 percent increase to the Biomedical Research Development Price Index (BRDPI) this is a threat to robust, sustained, and predictable cancer research. Additionally, as the FY 2025 budget will be built upon this FY 2024 budget, this sets a dangerous precedent for reductions in biomedical research funding.

This bill, which is heralded by House Republicans as a step towards returning to fiscal responsibility, is a threat to the historic bipartisan support towards the fight to eradicate cancer. The bill will now be moved on to consideration by the full House Appropriations Committee this fall. 

In contrast, the Senate is taking a more bipartisan approach to the FY 2024 appropriations process. On July 27, the Senate Appropriations Committee approved legislation to provide $49.22 billion in FY 2024 funding for NIH, a $1.77 billion increase from FY 2023 appropriations. The AACR is grateful for the leadership of Appropriations Committee Chair Patty Murray (D-WA), Ranking Member Susan Collins (R-ME), Labor-HHS-Education Subcommittee Chair Tammy Baldwin (D-WI), and Subcommittee Ranking Member Shelley Moore Capito (R-WV) in continuing support for greater investment in cancer research. The FY 2024 appropriations process will resume once lawmakers return from August recess. As the appropriations process continues, the AACR will continue to advocate for robust, sustained, and predictable funding levels for the NIH and NCI. We encourage medical research advocates to join us at the 2023 Rally for Medical Research in Washington, D.C. Learn more information and register.

AACR Submitted Public Comments on U.S. Department of Health and Human Services Draft Tobacco Cessation Framework

-Calais Prince, PhD

Evidence-based smoking cessation has been instrumental in reducing cancer incidence and deaths during the past three decades, but there is more work to be done as smoking remains the top preventable cause of cancer. Many agencies within the U.S. Department of Health and Human Services (HHS), such as the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) are key to delivering evidence-based cessation services and increasing the use of tobacco cessation treatments. On July 30, the American Association for Cancer Research (AACR) submitted public comments on the HHS request for information to develop the Draft HHS Framework to Support and Accelerate Smoking Cessation. The AACR comment found that the proposed goals to eliminate smoking and cessation-related disparities, detailed in the HHS Draft Tobacco Cessation Framework, to be relevant for addressing the needs of populations affected by smoking. Thus, the AACR encouraged further coordinated support across agencies within HHS to provide all populations with the best available tobacco cessation services. The AACR recommended that FDA formally proposes a nicotine product standard, as well as, finalizing and implementing the proposed rules on menthol cigarettes and flavored cigars to support the elimination of tobacco cessation disparities. Additionally, improving coverage for tobacco cessation treatment across Medicare, Medicaid, and private insurance would greatly support community efforts to benefit those in greatest need. While the framework provides broad strategies to ensure access to comprehensive, data-driven cessation treatments that will benefit all populations, the AACR further encouraged that the most effective cessation therapies and behavioral support be made available without a prescription, at no cost, to people who want to stop using tobacco products. In alignment with increasing access to high-quality, comprehensive cessation treatment, the AACR also advocated for research across HHS to develop additional cessation approaches for youth and adults.

Quitting smoking is the single most beneficial thing someone who smokes can do to improve their health. Coordinated efforts at the local, state, and federal levels are needed to ensure equitable access to evidence-based smoking cessation resources and programs. The AACR will continue to support and advocate for patients with cancer and survivors of cancer seeking to quit smoking and tobacco use.

Register for the Rally for Medical Research!

The 11th Annual Rally for Medical Research will be held September 13-14, 2023, in Washington, D.C. The rally brings together advocates from around the country to call upon the nation’s policymakers to make funding for the NIH a national priority and bring attention to the importance of stable and robust investments in medical research. A participant training and reception will be held September 13, followed by the Rally Hill Day, September 14 ,in which participants will meet with congressional offices.

Register for the rally. Please contact [email protected] with any questions.

Recording Available: FDA-AACR-ASA Workshop on Overall Survival in Oncology Clinical Trials

The American Association for Cancer Research (AACR), American Statistical Association (ASA), and U.S. Food and Drug Administration (FDA) hosted a hybrid workshop on July 18, 2023, at the Bethesda Marriott Pooks Hill Hotel in Bethesda, Maryland, to improve how clinical trials collect and assess overall survival (OS) data and other endpoints. Approximately 3,000 people tuned in live online or in person.

A recording of the workshop along with the slide deck are now available on the workshop website.

New Project Livin’ Label Episode 10 – Ivosidenib Available for Streaming

Project Livin’ Label is a collaboration between the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) to help educate the cancer community about recently approved cancer therapies, and in particular, to help familiarize both providers and patients with complex product labels. Episode 10 – Ivosidenib is now available for on-demand streaming and offers 1.5 CME credits. The episode details the science and the story behind developing the IDH1 inhibitor, ivosidenib, including FDA, industry, academic, and patient perspectives.

Register for the latest activity – Ivosidenib.

New Administration Program Aims to Improve Cancer Outcomes in Low-Income Areas

-Matthew Gontarchick

On July 26, the Biden administration launched a new program intended to boost cancer outcomes in low-income communities by addressing structural issues. Known as the Persistent Poverty Initiative, the program hopes to achieve its goals by supporting community-based programs and cultivating more cancer prevention research.

The program will focus on persistent poverty areas, which are areas where 20 percent or more of the population has lived below the poverty line for the past 30 years.  The administration plans to reach these areas through five new Centers for Cancer Control Research in Persistent Poverty Areas that will work with a select number of persistent poverty areas to carry out and evaluate structural interventions aimed at preventing cancer, improving follow-up care, and promoting survivorship. Some of the structural issues the new centers will explore include smoking cessation, improving access to nutrition, boosting physical activity, and increasing access to better housing with supplemental income.

Additionally, the Persistent Poverty Program will create new opportunities for the next generation of cancer researchers by helping to train a new pipeline of early-career investigators to work with underserved communities by conducting multilevel intervention research.

Coordinated by the National Institutes of Health (NIH) and the National Cancer Institute (NCI), the program will distribute $50 million in initial funding to all centers involved over the next five years. The centers will then use the funds to test and evaluate specific interventions in the communities in which they operate. The Persistent Poverty Initiative will help advance key components of the Biden administration’s Cancer Moonshot by expanding access to cancer screenings and preventing more cancers before they start.

Registration Open! AACR Patient Advocate Forum: What’s Next for Drug Development and Discovery

The next decade promises to be a time of dramatic change for the cancer research community in terms of how new therapies will be discovered and developed. In keeping with advances in data science, drug discovery will be one of the areas of cancer research most significantly transformed through the application of artificial intelligence (specifically machine and deep learning). Enormous amounts of data, and data integration, will be required to power this information-driven transition, but the search for new cancer drug (and biologic) targets is well underway. These new approaches will present unique challenges for all aspects of drug development, including clinical trials and the regulatory review of these new agents. This AACR Patient Advocate Forum will explore what to expect in the months and years ahead in terms of the rate of progress for these new approaches.

Should we expect AI (Artificial Intelligence) to transform the field of drug discovery and enable an entirely new generation of safe, and more effective therapies for cancer – or is this too much to hope for at this point? Join us, as we meet some of the pioneers in the field who will share their opinions and thoughts on the possible.

Learn more on this forum and register.

AACR Hosts NCI Postdoctoral Fellows Interested in Science Policy and Advocacy Careers

On July 26, Intramural postdoctoral fellows from the National Cancer Institute (NCI) Explore On Site (EXPOSE) program visited the American Association for Cancer Research (AACR) Office of Science Policy and Government Affairs. The EXPOSE program provides tools and resources to enable NCI intramural postdoctoral fellows to pursue careers that align with their interests, capabilities, and values while providing opportunities to visit employers throughout the Washington, D.C., metropolitan area. AACR staff members across several departments gathered to describe how their scientific training prepared them for careers in science policy, publishing, and scientific reporting. Program attendees learned how their scientific skillset has prepared them for fulfilling professional careers that continue to support biomedical research and innovation.