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Cancer Policy Monitor: July 9, 2024

Congressional Update

-Benjamin Krinsky, PhD

As summer continues in Washington, D.C., the fiscal year (FY) 2025 appropriations process is following two divergent paths in the House of Representatives and Senate, respectively. Republicans in the House have been rapidly moving bills through the Appropriations Committee. Back in May, House Republican leadership stated their goal of passing all twelve appropriations bills by the beginning of the August congressional recess. As of mid-June, the Committee has passed six of the twelve spending bills (Defense; Financial Services; Homeland Security; Legislative Branch; Military Construction-VA; and State and Foreign Operations) despite unified opposition from Democratic appropriators.

On June 26, the House Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Subcommittee unveiled their FY 2025 bill, which encompasses funding for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and other health programs. The bill would provide $48.581 billion for NIH (including ARPA-H), the same total funding as the final FY 2024 budget. However, there is an interesting wrinkle: The bill proposes a major reorganization of NIH, consistent with a recently released framework drafted jointly by Representative Cathy McMorris Rodgers (R-WA), Chair of the House Energy and Commerce Committee, and Representative Robert Aderholt (R-AL), Chair of the Labor-HHS Appropriations Subcommittee (see Top E&C Republican Proposes Structural Reforms for NIH). In short, instead of appropriating funds for the existing 27 institutes and centers (ICs), the House Labor-HHS bill appropriates funds for 15 new, consolidated ICs, as well as $127 million in additional funding as specified in the 21st Century Cures Act.

It is challenging to discern how many existing NIH programs would fare under the proposed NIH overhaul. The House bill would continue to fund NCI as its own Institute and provide it with approximately $7.875 billion, an increase of $651 million compared to FY 2024. This level is also $555 million above FY 2023, the final year of 21st Century Cures Act Cancer Moonshot Funding. Conversely, the House bill would provide only $500 million for ARPA-H (a cut of $1 billion), and significantly reduce funding for other health agencies, including a $1.7 billion cut to the Centers for Disease Control and Prevention (CDC).

Meanwhile, the Senate appropriations process is moving much more slowly. Given the rancorous debates over topline funding levels and the caps on overall spending, Senate appropriations leaders have not yet reached an agreement on spending allocations for all of the appropriations subcommittees. As Senate Appropriations Chair Patty Murray (D-WA) outlined in a speech on the Senate floor, the current caps imposed by the Fiscal Responsibility Act are not adequate to provide robust funding for a wide range of domestic programs. However, in a sign of some progress, Chair Murray has directed three of the Senate Appropriations Subcommittees (Agriculture, Legislative Branch, and Military Construction-VA) to markup their bills in July.

In other congressional news, on June 12, the Senate Judiciary Committee led by Chair Dick Durbin (D-IL) held a hearing on e-cigarettes and the youth vaping epidemic (see Senate Judiciary Committee Holds Hearing on Enforcement of Illicit E-Cigarette Sales).

Top E&C Republican Proposes Structural Reforms for NIH

-Matt Gontarchick

A reorganization of the National Institutes of Health (NIH) and a pause on gain of function research are among the top recommendations laid out in a strategic framework from Representatives Cathy McMorris Rodgers (R-WA) and Robert Aderholt (R-AL). The framework’s release comes as the world’s largest funder of biomedical research faces scrutiny from Capitol Hill. In May, Senator Bill Cassidy (R-LA) released a white paper outlining NIH reforms.

Both Rodgers and Aderholt have more influence over NIH than the typical lawmaker, with the former in charge of the committee that has jurisdiction over the agency and the latter leading the subcommittee that determines NIH funding. Chief among the report’s recommendations is a plan to shrink the number of institutes and centers at NIH from 27 to 15. According to the report, streamlining the number of institutes and centers is a necessary reform for an agency that has become “increasingly fragmented” and siloed. Among the proposed groupings are the creation of a National Institute on Body Systems Research that would encompass heart, lung, blood, kidney, and skin diseases; and a National Institute on Neuroscience and Brain Research that would entail neurological, eye, dental, and craniofacial research.

Another major recommendation would impact how NIH conducts gain of function research, which refers to research that manipulates pathogens. According to the framework, NIH would relinquish its ability to oversee research of certain pathogens to a publicly run independent oversight agency. The proposal addresses the concerns of some Republican lawmakers that gain of function research may have created SARs-CoV-2.

Other recommendations outlined in the framework would set five-year term limits for NIH institute directors, incorporate national security reviews into the grant approval process, and add conflict-of-interest policies.

Some of the report’s recommendations have already been included in a House appropriations bill that advanced the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies on June 27. Even if the reform proposals are not codified in a spending bill, they could be introduced as legislation next year—if Republicans grow their majority in Congress.

FDA Releases New Draft Guidance on Diversity Action Plans in Clinical Trials 

-Tristen Tellman, PhD

On June 26, the U.S. Food and Drug Administration (FDA) released their much-anticipated new draft guidance on diversity action plans for sponsors of clinical trials. The release of this draft guidance is a result of provisions included as part of the 2022 Food and Drug Omnibus Reform Act (FDORA), which allows the FDA to require clinical trial sponsors to submit diversity action plans for late-stage drug trials and most device studies. This draft guidance builds on previous draft guidance released in 2022 and includes details on how diversity action plans should be formatted, what they should include, which products require these plans, and the process for submitting the plans to the FDA. These plans must include the sponsor’s rationale for enrollment goals based on age, ethnicity, sex, and race, though other underrepresented groups should also be included. Diversity action plans are designed to enhance enrollment of historically underrepresented populations and encourage clinical trial participation that reflects the prevalence of the disease or condition among demographic subgroups. It is important that trial data submitted to the FDA for approvals should reflect the people that will ultimately receive these treatments. While the draft focuses on late-stage studies, the FDA encourages companies to consider implementation of these plans throughout the entire clinical development process.  

The AACR convened an industry roundtable in the fall of 2022 to discuss the first draft guidance on diversity action plans, resulting in a publication. Following the workshop series, sessions were held at the 2023 and 2024 AACR Annual Meetings. The AACR looks forward to continuing engagement on this topic with the FDA and convening future workshops to discuss the implementation of diversity action plans with engagement across all stakeholders, including sponsors, patient advocates, and the community of cancer researchers.

Senate Judiciary Committee Holds Hearing on Enforcement of Illicit E-Cigarette Sales

-Blake William Rostine

On June 12, the Senate Judiciary Committee, chaired by Senator Dick Durbin (D-IL), held a special hearing to examine the illicit e-cigarette market and the FDA’s plans to address this growing concern, with a focus on the impact on young people. With a backlog of nearly 27 million premarket tobacco product applications, the FDA says they are facing a major time and resource challenge and are unable to keep up with the rapidly growing backlog. However, panelists representing the tobacco and vapor technology industry noted that the FDA has set seemingly arbitrary timelines for the application process and that the “burden of proof” requirements necessary to determine if their products are “safe” is unclear. In response to the Committee, the FDA said that they are increasing efforts to send monetary fines and injunctions to businesses participating in the selling of illegal products marketed to children. However, the agency will need additional resources and e-cigarette user fees to address the issue. Additionally, the Committee expressed concern that illegal imports of Chinese e-cigarettes held the risk for additional harm to consumers, with the FDA clarifying that no e-cigarettes are safe, regardless of country of origin.

AACR Hosts Virtual Roundtable on 2024 Cancer Disparities Progress Report

On June 24, more than 600 people joined an AACR virtual roundtable discussion of the 2024 Cancer Disparities Progress Report. A recording of the event is available for viewing. The session, introduced by AACR President Dr. Patricia LoRusso, featured a distinguished panel of researchers and patient advocates led by the Chair of the AACR Cancer Disparities Progress Report 2024 Steering Committee, Dr. Robert Winn. Dr. Winn began the event with an overview of the report, mentioning both the progress that has been made to reduce cancer disparities and the work that needs to be done to achieve health equity. He also noted the report’s Call to Action, which urges Congress to help address cancer disparities through additional investments in research, prevention, and treatment programs. The presentation was followed by a lively discussion in which the panelists fielded questions from the audience on a range of topics, including both the science of cancer disparities and the needs of patients from diverse backgrounds.

Register Now: 12th Annual Rally for Medical Research

The 12th Annual Rally for Medical Research will be held September 18-19, 2024, 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 National Institutes of Health a national priority and bring attention to the importance of stable and robust investments in medical research. Both a participant training and a reception for advocates will be held on September 18, followed by the Rally Hill Day on September 19, in which participants will meet with congressional offices.

Register for the lobby day and book your room in the hotel block today. Please contact Rally organizers with any questions.

FDA-AACR Oncology Educational Fellowship Application Period Open for 2024-2025 Class 

The FDA-AACR Oncology Educational Fellowship is now accepting applications for the 2024-2025 class. This part-time fellowship is designed to provide early-career cancer investigators and clinicians unique learning opportunities related to oncology drug development and the regulatory review process. Fellows will participate in learning sessions that cover various topics such as investigational new drugs (INDs), new drug applications (NDAs)/biologics license applications (BLAs), expedited pathways animal studies, clinical pharmacology, statistics, clinical trial design, companion diagnostics, biomarkers, and precision oncology.  

Fellows will engage directly with experts from the AACR and the U.S. Food and Drug Administration (FDA) through monthly virtual webinars and will have an opportunity to attend the AACR Annual Meeting in Chicago, Illinois, April 25-30, 2025. Additionally, the fellowship capstone, Project ODAC Odyssey, will involve fellows developing and leading an in-person mock meeting of the Oncology Drug Advisory Committee (ODAC) in May 2025 at the FDA White Oak Campus. This experience simulates how industry sponsors make the case for a novel drug to ODAC and the FDA for their approval. 

To be eligible, candidates must have earned an advanced degree (DO, MD, PhD, MD/PhD, etc.) within the past 10 years. Current or pending AACR membership is a requirement for applying. Strong candidates will have excellent English writing skills and a demonstrated interest in oncology drug development and the regulatory review process. We welcome applications globally, but meeting visa and travel requirements for in-person attendance at special events are the responsibility of the fellow. 

Applications will be accepted until 11:59 p.m. ET, August 1, 2024. 

For more information, please visit the fellowship website.  

AACR Virtual Patient Advocate Forum: Activating Artificial Intelligence (AI) In Cancer Science and Medicine

Artificial Intelligence (AI) is promising to revolutionize cancer diagnosis, treatment, and patient care. But will it live up to the hype? Join us on Tuesday, August 20, for the next Patient Advocate Forum that will explore how AI is reshaping oncology and share insights into strategies to navigate the opportunity and uncertainty. Learn more about the AACR Virtual Patient Advocate Forum: Activating Artificial Intelligence in Cancer Science and Medicine.