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Cancer Policy Monitor: June 11, 2024

Congressional Update

-Benjamin Krinsky, PhD

With appropriations season underway, the House of Representatives has begun consideration of fiscal year (FY) 2025 spending bills and funding levels. On May 23, by a vote of 32-21, the House Appropriations Committee approved a slate of funding allocations to the 12 subcommittees that oversee funding for the various parts of the federal government. The allocations, also known as 302(b)s, adhere to the funding caps imposed by the Fiscal Responsibility Act of 2023 but do not include the extra money from the so-called “handshake” agreements previously reached between the White House and Congress. As a result, the allocations together constitute an overall level of funding for non-defense programs that is approximately $75 billion (or 6%) less than in FY 2024.

In his opening statement, the Chair of the full Appropriations Committee, Congressman Tom Cole (R-OK), said that the Fiscal Responsibility Act is “the law of the land,” and that it was his responsibility, in the absence of a new spending agreement, to adhere to its limits. In contrast, Appropriations Committee Ranking Member Rosa DeLauro (D-CT), objecting to the reductions in non-defense funding, stated, “Like last year, we are beginning this year’s process with topline funding levels that fall well short of what the American people need, and well short of what both parties already agreed to.”

Under the House 302(b) allocations, the House Labor, Health and Human Services, Education, and Related Agencies (LHHS) Appropriations Subcommittee, which funds the National Institutes of Health (NIH), the National Cancer Institute (NCI), and other health programs, would receive approximately $186.6 billion, about $7.8 billion (or 4%) less than the comparable FY 2024 level. However, Democrats on the committee warned that due to additional spending adjustments, there may be further reductions to health programs in the House LHHS bill. It is currently expected that the House LHHS subcommittee will markup its bill in late June.

In other news, on May 16, the Health Subcommittee of the House Energy and Commerce (E&C) Committee marked up a slate of health policy bills. The subcommittee voted to approve several measures for consideration by the full committee, including four related to pediatric and other cancer patients: the Accelerating Kids’ Access to Care Act (H.R. 4758), the Give Kids a Chance Act (H.R. 3433), the Creating Hope Reauthorization Act of 2024 (H.R. 7384), and the Retaining Access and Restoring Exclusivity (RARE) Act (H.R. 7383). These bills, respectively, seek to broaden Medicaid access for pediatric patients across state lines, expand pediatric cancer clinical trials involving combinations of drugs, extend a Food and Drug Administration (FDA) pediatric drug priority review voucher program, and clarify the market exclusivity period for drugs to treat rare diseases and conditions.

Meanwhile, on the other side of Capitol Hill, the Senate is continuing to hold hearings with Executive Branch officials to review President Biden’s proposed budget for myriad agencies and programs. On May 23, the Senate LHHS Appropriations Subcommittee heard testimony from the leaders of NIH, NCI, and other NIH Institutes and Centers (see “Bipartisan Appropriations Leaders Declare Medical Research a Top Priority in Senate Hearing”). Behind closed doors, Senators of both parties are continuing to negotiate the path forward on appropriations. Senate Appropriations Chair Patty Murray (D-WA) and Vice Chair Susan Collins (R-ME) have not yet released 302(b) allocations that would allow the various appropriations subcommittees to begin working in earnest on their spending bills.

White Paper from Sen. Cassidy Calls for NIH Reforms

-Matt Gontarchick

Improving the effectiveness of funding, ensuring the nation’s leadership in biomedical research, and restoring trust in public health are the three objectives of a recently released white paper from Sen. Bill Cassidy (R-LA) on ways to modernize the National Institutes of Health (NIH). The proposals detailed in the white paper are based on comments from academic institutions, researchers, patients, advocates, and other stakeholders in response to a request for information (RFI) issued in September 2023 on ways to improve biomedical research in the U.S.

To allow NIH dollars to be more efficiently allocated, the white paper recommends providing more tools for policymakers and researchers to better balance competing interests between applied research and investigator-driven research. According to the white paper, a growing focus on targeted research in recent years at the expense of basic research could lead to a decline in treatments and cures that are eventually developed by the private sector. Furthermore, to address redundancy, the white paper calls for the integration of existing clinical trial networks into a more cohesive, agency-wide clinical trials system.

Additionally, to counter China’s ambitious investment in biomedical research, the white paper offers several recommendations to secure the U.S.’ long-term competitive advantage in science. Among the recommendations offered in the white paper are for policymakers to incentivize innovation and reduce bias by reforming the peer review process. The white paper also calls for term limits for program officers to ensure that NIH is exposed to fresh ideas and up-to-date knowledge.

The white paper additionally makes the claim that insufficient transparency and “political biases” in the COVID-19 pandemic response have caused public trust in science to decline. To restore trust, the white paper recommends reconvening the Science Management Review Board, which was initially created to review NIH operations and suggest reforms. Other recommendations include the expansion of the Department of Health and Human Services Office of Research Integrity’s investigative authorities to better identify and prevent research misconduct.

While legislation based on these recommendations has yet to be reintroduced, the white paper serves as a preview of how Senate Republicans could approach NIH reform in the future. This is especially the case if the GOP regains a majority in the Senate following the general election this November and Sen. Cassidy subsequently becomes chair of the Health, Education, Labor, and Pensions Committee (HELP), where he currently serves as the committee’s top Republican. Given the HELP Committee’s jurisdiction over NIH, Sen. Cassidy would then have wide latitude in conducting oversight and introducing legislation related to biomedical research.

Bipartisan Appropriations Leaders Declare Medical Research a Top Priority in Senate Hearing      

-Matt Gontarchick

Both the top Democrat and the top Republican on the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies voiced that investment in biomedical research must be a top priority in a May 23 hearing to review the President’s Fiscal Year (FY) 2025 budget for the National Institutes of Health (NIH). The hearing comes as NIH faces another difficult appropriations cycle due to caps on discretionary defense and non-defense spending that expire at the end of FY 2025.

Early in the hearing, Subcommittee Chair Tammy Baldwin (D-WI) warned that spending caps could put NIH on a path of stagnant funding, similar to what the agency experienced over a decade ago. To avoid a repeat of this stagnation, Sen. Dick Durbin (D-IL) urged the formation of a new group of bipartisan senators on the Appropriations Committee to advocate for regular funding increases for NIH.

Baldwin’s Republican counterpart on the subcommittee, Ranking Member Shelley Moore Capito (R-WV), voiced the importance of investing in NIH even amid a “challenging funding year” due to the agency’s role in driving economic growth as well as finding cures and treatments for cancer. Echoing Capito’s comments on the current appropriations environment, full Committee Chair Patty Murray (D-WA) stressed the need for parity between discretionary defense and non-defense spending, which would increase the amount of money available for NIH in FY 2025.

Access to clinical trials in rural areas was another important topic discussed in the hearing, which featured witness testimony from NIH Director Dr. Monica Bertagnolli and National Cancer Institute (NCI) Director Dr. W. Kimryn Rathmell. In response to questions from Sen. Capito and Sen. Katie Britt (R-AL), Dr. Rathmell discussed how NIH is working with other government agencies and non-profit organizations to build out clinical trial capacity in order to form a new clinical trials network that can reach people in rural areas.

Near the conclusion of the hearing, Sen. Baldwin and Dr. Bertagnolli discussed issues facing early-career researchers. While Sen. Baldwin said she is pleased that NIH has raised pay levels for post-doctoral researchers by 8% to $61,008 per year and provided a childcare benefit, she noted that the raise falls short of a working group’s recommendation to raise postdoctoral stipends to $70,000 per year. In response, Dr. Bertagnolli said she is working to increase stipends as funding for NIH grows, and she noted that the number of new early-stage investigators has increased from the usual level of 1,100 annually to 1,600 in 2023.

The Senate Appropriations Committee is expected to begin consideration of FY 2025 spending bills in June. As the appropriations process continues to move forward, the AACR is committed to working with policymakers to advocate for robust funding for medical research.  

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

AACR Holds Congressional Briefing to Present 2024 Cancer Disparities Progress Report to Policymakers

-Blake William Rostine

Over 70 attendees, including congressional staff, patient advocates, and federal relations professionals, attended the AACR’s Congressional Briefing to highlight the release of the AACR Cancer Disparities Progress Report 2024. This briefing, the AACR’s first in-person briefing since 2019, was held in the Rayburn House Office Building. The widely attended event gathered an esteemed panel of Dr. Robert Winn (VCU Massey), Dr. Brian King (U.S. Food and Drug Administration), Dr. Marcia Cruz-Correa (University of Puerto Rico), and Dr. Sanya Springfield (National Cancer Institute), as well as patient-advocates highlighted in the report. The panel was also joined by Representative Castro (D-TX), who shared his journey with cancer, and how investments in cancer research are essential for breaking down healthcare disparities. Attendees were able to hear about the strides discussed in the landmark Cancer Disparities Progress Report and were given information on the AACR’s congressional Call to Action, a set of policy recommendations to make further progress towards health equity and ending cancer. A recording of the Congressional Briefing is available to view.

In addition to the briefing to Congress, the AACR will be hosting a virtual Roundtable Discussion of the 2024 Cancer Disparities Progress Report on Monday, June 24, from 12:30 p.m.–1:45 p.m. ET. This interactive discussion will feature several scientific leaders who served on the report steering committee, as well as patient advocates whose stories are featured in the report. The online discussion will provide an opportunity for the public to ask questions and engage with the panel. Registration information is available online.

AACR Joint Hill Day with AACI Conducted Over 100 Congressional Meetings

On May 16, 2024, the AACR partnered with the Association of American Cancer Institutes (AACI) to hold the annual AACR-AACI Joint Hill Day. Over 100 participants representing 25 states came to Washington, D.C., for strategic meetings with Congressional offices and to advocate for robust and sustained National Institutes of Health investments. This year, patient advocates from the AACR Cancer Disparities Progress 2024 (CDPR) joined the Hill Day to share their stories with Congress following a Congressional Briefing presenting the CDPR to Congress. In addition to the Hill Day, the AACR and AACI were honored to present Senator Dick Durbin (D-IL) and Representative Rob Wittman (R-VA) with the Cancer Research Ally Award, celebrating their career-long dedication to ending cancer as we know it.

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

-Tristen Tellman, PhD

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 with 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 travel requirements for in-person attendance at special events is 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 webpage.

Recording Available: FDA-AACR Workshop on How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases

Rukiya Umoja, PharmD

The U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) hosted a hybrid workshop on May 9, 2024, in Bethesda, Maryland, to explore trial design and potential for overtreatment in the perioperative space for early-stage breast, lung, and other cancers. Panelists from the FDA, the European Medicines Agency, the pharmaceutical industry, academia, and patient advocacy groups discussed various topics including the feasibility of sequential multiple assignment randomized trials (S.M.A.R.T.), incorporation of biomarkers, and best practices to integrate patient voice to inform clinical trial design for perioperative regimens. The workshop brought together over 2,000 people from around the world, highlighting the vast commitment to optimizing treatment regimens with multiple phases for early-stage cancers.

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