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Cancer Policy Monitor: July 11, 2023

Appropriations Update from Capitol Hill

After months of negotiation, congressional leaders and senior White House officials reached a bipartisan, two-year deal to lift the $31.4 trillion debt ceiling. The resulting legislation, the Fiscal Responsibility Act of 2023, was passed by the House of Representatives May 31, and by the Senate June 1. President Biden subsequently signed the bill into law June 3.

The budget agreement suspends the debt ceiling through January 1, 2025, which allows the Biden administration and Congress to table politically difficult budgetary decisions until after the November 2024 presidential election.  The agreement also caps non-defense discretionary spending near Fiscal Year (FY) 2023 levels for FY 2024 and allows for a 1% increase in FY 2025. Additionally, the Fiscal Responsibility Act of 2023 rescinds unspent COVID-19 funds and requires borrowers to begin paying back their student loans. 

The budget deal also provides an incentive for members of Congress to complete the FY 2024 appropriations process in a timely fashion and avoid a year-long continuing resolution. If Congress fails to enact all 12 annual appropriations bills by April 30, 2024, the Office of Management and Budget will issue a 1% cut for defense and non-defense discretionary spending until the appropriations bills are passed. 

Enactment of the budget agreement allows Congress to move forward with the FY 2024 appropriations process. While the Senate is expected to draft bipartisan FY 2024 appropriations bills that fall within the parameters of the Fiscal Responsibility Act of 2023, key House appropriators are likely to push for additional cuts by capping non-discretionary spending at FY 2022 levels. 

Given continued calls to cut spending, this summer marks a critical time for medical research advocates to make their voices heard and urge their members of Congress to continue to make the NIH a top funding priority. The AACR joins the broader medical research advocacy community in urging Congress to adopt an increase of $3.47 billion for the NIH in FY 2024, for a total funding level of $50.924.

We encourage medical research advocates from across the country to join us at the 2023 Rally for Medical Research in Washington, D.C. Learn more information and register.

AACR Endorses Bill to Increase Access to Lung Cancer Screening

-Calais Prince, PhD

On June 22, 2023, the Increasing Access to Lung Cancer Screening Act (H.R. 4286) was reintroduced by Representatives Brian Higgins (D-NY), Brian Fitzpatrick (R-PA), and Kathy Castor (D-FL). This legislation would expand access to lung cancer screenings, smoking cessation treatment, and reduce barriers to annual preventative care for all Medicaid enrollees. Additionally, the bill would prohibit prior authorization for lung cancer screenings across payers and fund a national outreach campaign detailing the importance of lung cancer screening. The Government Accountability Office would also be authorized to conduct a study describing the demographics of populations undergoing lung cancer screening, diagnosed with lung cancer, and ways to improve lung cancer screening in high-risk populations.

In 2023, approximately two million people in the United States will be diagnosed with cancer. Lung and bronchus cancers are the third most common, but responsible for the greatest number of cancer-related deaths. As such, addressing lung health early can potentially save hundreds of thousands of lives.

The AACR enthusiastically supports the Increasing Access to Lung Cancer Screening Act as it will greatly contribute to ending cancer as we know it.  

There is Still Time to Register for the 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) are partnering to host a hybrid workshop July 18, 2023, at the Bethesda Marriot Pooks Hill hotel in Bethesda, Maryland, to improve how clinical trials collect and assess overall survival (OS) data and other endpoints. There is still time to register for free, but in-person spots are no longer available.

For more information, please visit the workshop website and read the background blog.

New Clinical Cancer Research Publication on Implementing Diversity Action Plans for Oncology Clinical Trial

– Nicholas Warren, PhD

Clinical trials in oncology have not typically sought to prospectively ensure participants represent the diversity of the U.S. patient population. The common retrospective strategy often yields trials that leave open questions about whether new therapies will work for patients from racial or ethnic minority groups, or if they may experience different side effects than found in clinical trials. Changing how clinical trials approach diversity, equity, and inclusion (DEI) is critical to maximize the benefits of novel cancer therapies and expand access to cutting-edge trials in historically underserved communities. This June, Clinical Cancer Research published a perspective article that discussed how clinical trial sponsors and the U.S. Food and Drug Administration (FDA) are becoming more intentional about incorporating aspects of DEI into clinical research.

In April 2022, the FDA issued draft guidance that recommended companies develop Diversity Action Plans to support increased trial participation from underrepresented racial and ethnic populations in late-stage trials. These voluntary recommendations became requirements in December 2022 when President Biden signed a new law granting FDA additional authority related to diversity in clinical trials. The new article in Clinical Cancer Research was inspired by a series of roundtable discussions convened by the American Association for Cancer Research (AACR) that brought together pharmaceutical company experts on clinical trials to share their experiences, challenges, and solutions for implementing Diversity Action Plans in cancer drug development. The companies identified several essential actions to improve DEI in trials, including: incorporating staff trained on diversity issues across research and regulatory teams; viewing diversity strategies with the same importance as other clinical development strategies, like selecting a primary endpoint; establishing enrollment goals and measuring real-time progress towards those goals; establishing long-term relationships with community and patient organizations work through hurdles to participation and inform trial designs; and investing in resources to expand clinical trials to local health clinics. In addition to improving DEI in clinical trials, this culture change for research has the potential to increase the speed of developing new therapies while improving access to high-quality cancer care in historically underserved rural and urban communities.

These efforts are just one part of a movement that will require the whole cancer community’s energy and input. The AACR will continue addressing disparities in cancer research and care through policy workshops and Annual Meeting sessions, an annual Conference on the Science of Cancer Health Disparities, a biennial Cancer Disparities Progress Report, the Minorities in Cancer Research Council, and other discussions and advocacy efforts.

Register Now 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 robust, sustained, and predictable 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 and please contact [email protected] with any questions.

Apply Now. 2023-2024 FDA-AACR Oncology Educational Fellowship

The AACR is accepting applications for the next class of FDA-AACR Oncology Educational Fellowships through August 14, 2023. Apply to this unique opportunity to learn directly from FDA and AACR experts about the drug development and regulatory process. Learn more and apply.

Now Streaming on Demand: AACR Patient Advocate Forum on The Evolution of Regulatory Science

This AACR Patient Advocate Forum convened hundreds of patient advocates to explore how regulatory science is evolving to meet the growing complexity of cancer research and optimize regulation to support the prevention, diagnosis, and treatment of cancers. Presentations featured SSP patient advocate Allison Rosen, FDA OCE Director Rick Pazdur, AACR Regulatory Science Committee Chair, Kenneth Anderson, CEO of ESSA Pharma David Parkinson, and CSO of Ellison Institute Anna Barker. Thank you to everyone who joined us!

Click here for on-demand viewing.