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Cancer Policy Monitor: December 10, 2024

Appropriations Update

-Matt Gontarchick

Negotiations remain underway on Fiscal Year (FY) 2025 appropriations in the wake of the 2024 general election. However, a timeline for finalization of FY 2025 spending bills remains elusive as the president-elect, congressional leadership, and top appropriators are divided on next steps. The medical research community has been monitoring the FY 2025 appropriations process closely, as any delays or final decisions will impact funding for the National Institutes of Health (NIH).

The federal government is currently operating under a continuing resolution (CR) that keeps government funding at FY 2024 levels through December 20. Democratic and Republican leaders of the House and Senate appropriations committees have expressed a desire to wrap up all spending bills by the end of the current calendar year. Some Republicans would like all FY 2025 appropriations bills to be signed into law this year because it would allow them more time to focus on other priorities, namely proposals to renew or expand expiring tax cuts and measures that can be advanced through the budget reconciliation process to help enact President-elect Donald J. Trump’s agenda for the first 100 days of his term. However, there is a nearly $100 billion difference between House and Senate’s versions of FY 2025 spending bills, and time is quickly running out for appropriations leaders in both chambers to reach an agreement.

Additionally, some Republican leaders such as Speaker Mike Johnson (R-LA) have expressed a desire for a new CR that would last until as late as March 2025. The GOP will be in control of the White House, Senate, and House of Representatives starting next year, and many conservative Republicans believe that this environment will allow them to finalize an appropriations bill that is more favorable to their priorities. However, a new CR to March 2025 would raise the prospect of a full-year CR for FY 2025.

Whether Congress finalizes FY 2025 appropriations this year or delays into next year could depend on President-elect Trump. For instance, the president-elect could express to Speaker Johnson and conservative Republicans a desire to make a deal with congressional Democrats and pass all FY 2025 spending bills this year. However, the longer the president-elect opts to not weigh in on appropriations negotiations, the more likely that gridlock will persist and that Congress will be forced to approve another CR that extends into the new year.

Finalized in March 2024, the FY 2024 appropriations bill marks the first time in nearly a decade that NIH did not receive a funding increase. As a result, the medical research community is awaiting whether Congress will continue to disrupt research through another CR, pass spending bills that keep NIH funding stagnant or reduced, or empower medical researchers by providing a much-needed funding boost. The American Association for Cancer Research will continue to monitor the FY 2025 appropriations process and work with stakeholders to advocate for robust funding increases for NIH, NCI, and other health and research programs.

2024 Elections Recap

-Carly McCallie

Former President Donald Trump and Senator JD Vance (R-OH) defeated Vice President Kamala Harris and Minnesota Governor Tim Walz in the 2024 U.S. presidential election. The Republican ticket won the Electoral College 312-226.

Republicans flipped four seats in the general election and will have a 53-47 majority in the U.S. Senate entering the 119th Congress. 

Republicans were able to maintain control of the U.S. House of Representatives in what will be the most narrowly divided House since the Great Depression. The balance of power will be 220 to 215 when the new Congress takes the oath of office, but up to three Republican seats are likely to be open by the end of the month as members resign to join President Trump’s administration leaving the true balance of power 217-215.

The 119th Congress will be sworn in on January 3, 2025. For the first time since 2016, Republicans will have unified control of both Congress and the White House. 

President Trump Appointments 

Department of Health and Human Services (HHS) 

On Thursday, November 14, President-Elect Donald Trump announced his intention to nominate Robert F. Kennedy, Jr. to serve as Secretary of the Department of Health and Human Services (HHS). If confirmed, Kennedy will oversee public health and medical research agencies, including the National Institutes of Health (NIH). In a statement accepting the nomination, Kennedy emphasized the importance of ridding the HHS of “corruption” and vowed to “provide Americans with transparency” so they can make individual health decisions. 

Kennedy laid out his areas of focus in an interview with NPR News following the election. 

“President Trump has given me three instructions. He wants the corruption and the conflicts out of the regulatory agencies. He wants to return the agencies to the gold standard, empirically-based, evidence-based, science and medicine that they were once famous for. And he wants to end the chronic disease epidemic with measurable impacts on a diminishment of chronic disease within two years.” 

Kennedy has pledged to take major steps to reshape the nation’s public health guidelines. In interviews and appearances since the election, Kennedy has mentioned making significant personnel cuts at public health agencies, including replacing 600 officials at the NIH with hand-picked staff and cutting workers in “the nutrition departments” at the U.S. Food and Drug Administration.

Many in the medical research community are especially concerned Kennedy may take steps to undermine the importance and effectiveness of vaccines. In response to these concerns, Kennedy has said he intends to study vaccine safety and efficacy but has promised not to “take vaccines away from anybody.”

National Institutes of Health (NIH)

On Tuesday, November 26, President-elect Donald Trump nominated Dr. Jay Bhattacharya to serve as Director of the National Institutes of Health. In his nominating statement, Trump wrote, “Together, Jay and RFK Jr. will restore the NIH to a Gold Standard of Medical Research as they examine the underlying causes of, and solutions to, America’s biggest Health challenges, including our Crisis of Chronic Illness and Disease. Together, they will work hard to make America healthy again.” 

If confirmed, Dr. Bhattacharya would lead an agency that employs more than 18,000 workers and funds nearly $48 billion in scientific research through nearly 50,000 grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other institutions. 

A Stanford-trained physician and economist, Dr. Bhattacharya is Professor of Health Policy at Stanford University School of Medicine He also directs the Stanford Center on the Demography and Economics of Health and Aging. According to his CV, Bhattacharya finished his medical degree in 1997 and then went straight into a career in academia. He did not complete a residency and is not a practicing physician. 

Dr. Bhattacharya’s research focuses on the economics of health care around the world with a particular emphasis on the health and well-being of vulnerable populations. 

Dr. Bhattacharya has advocated for a major shakeup of NIH and previously expressed concern that its former leaders, Dr. Francis Collins and Dr. Anthony Fauci, suppressed scientific debate and research during the pandemic. He was a co-author of the Great Barrington Declaration, a document that called for ending lockdowns and isolating the vulnerable so that young, healthy people could get infected and build up immunity in the population. His proposals for overhauling NIH include requiring more studies that repeat other studies to increase confidence in science, encouraging academic freedom among NIH scientists, and implementing term limits for NIH leaders.After his nomination was announced, Dr. Bhattacharya said on X, “We will reform American scientific institutions so that they are worthy of trust again and will deploy the fruits of excellent science to make America healthy again!” Former NCI Director Ned Sharpless, MD, commented, “ “Dr. Bhattacharya is a strong choice to lead the NIH. The support of moderate Senate Republicans will be critical to NIH funding, and Dr. Bhattacharya’s COVID work will give him credibility with this constituency.” 

To this end, Republican lawmakers are unveiling a framework of potential reforms for NIH, including moderate Senator Bill Cassidy (R-La.), who released a white paper on May 9, 2024, with a list of proposals intended to maximize the effectiveness of current funding for the NIH, sustain the United States’ international competitiveness in biomedical research, and restore public trust in science. Cassidy, who is an MD, and is in line to chair the Senate Health, Education, Labor, and Pensions (HELP) Committee next year, said in a post on X in response to President-elect Trump’s NIH nominee, “I am interested in how Dr. Bhattacharya sees using his background as a health economist to guide the NIH. I look forward to our meeting (when the Senate begins to consider his nomination).” 

Centers for Medicare & Medicaid Services (CMS)

On Tuesday, November 19, President-elect Donald Trump nominated Dr. Mehmet Oz to serve as the administrator for the Centers for Medicare and Medicaid Services, a key federal agency that oversees health insurance coverage for more than 150 million Americans. In his nominating statement, Trump wrote, “I have known Dr. Oz for many years, and I am confident he will fight to ensure everyone in America receives the best possible Healthcare, so our Country can be Great and Healthy Again! Dr. Oz will be a leader in incentivizing Disease Prevention, so we get the best results in the World for every dollar we spend on Healthcare in our Great Country.” 

Dr. Oz unsuccessfully ran for Senate in Pennsylvania in 2022 with Trump’s endorsement and has been a Trump ally ever since. He has been a strong proponent of expanding the private sector’s role in Medicare.

While the heart surgeon turned TV host has championed healthy lifestyle habits over the past many years, many in the medical research community are concerned about Dr. Oz’s history of promoting sham diet pills and ineffective COVID-19 treatments.

Centers for Disease Control and Prevention (CDC) 

On Friday, November 22, President-elect Trump nominated Dr. Dave Weldon to serve as the director of the Centers for Disease Control. In his nominating statement, Trump wrote, “Americans have lost trust in the CDC and in our Federal Health Authorities, who have engaged in censorship, data manipulation, and misinformation. Given the current Chronic Health Crisis in our Country, the CDC must step up and correct past errors to focus on the Prevention of Disease.” 

Dr. Weldon is the first nominee for CDC director who will need to be confirmed by the Senate. This new confirmation requirement was a provision from the “Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act,” which was included in the FY 2024 appropriations omnibus passed in December 2023.  

Dr. Weldon is an Army veteran and a medical doctor who served for seven terms in the U.S. House of Representatives (1995-2009). He held posts on several committees, including the Committee on Appropriations and the Committee on Science (now the Committee on Science, Space, and Technology).  

Dr. Weldon has been a persistent skeptic about the safety of some vaccinations for many years. While in Congress, Weldon introduced a bill that would give responsibility for the nation’s vaccine safety to an independent agency within HHS, removing most vaccine safety research from the Centers for Disease Control.  Dr. Weldon returned to private practice after leaving office. 

Dr. Weldon graduated from Stony Brook University in 1978, and he earned his M.D. degree at the University at Buffalo School of Medicine in 1981. 

Federal Drug Administration (FDA) 

On Friday, November 22, President-elect Trump nominated Dr. Marty Makary to lead the Food and Drug Administration. In his nomination statement, Trump said, “The Agency needs Dr. Marty Makary, a Highly Respected Johns Hopkins Surgical Oncologist and Health Policy Expert, to course-correct and refocus the Agency.” 

As Commissioner, Dr. Makary would lead more than 18,000 employees spanning the agency’s medical product, food and nutrition, and tobacco centers, and implementing regulatory frameworks that rely upon billions in taxpayer dollars and industry-collected user fees to sustain regulatory certainty for the premarket review of products overseen by FDA. Dr. Makary would replace Dr. Robert Califf, the FDA Commissioner under President Biden and former President Barack Obama. 

Dr. Marty Makary, M.D., M.P.H., a surgical oncologist, is Chief of Islet Transplant Surgery at Johns Hopkins University. A New York Times bestselling author, Dr. Makary has authored over 250 peer-reviewed articles published in medical journals on topics ranging from pancreatic surgery protocols to patient safety and healthcare costs. A visiting professor at over 25 medical schools, Dr. Makary received the Nobility in Science Award from the National Pancreas Foundation.  

A frequent guest on Fox News, Makary has also authored several books on health care and is a member of the National Academy of Medicine. During the COVID-19 pandemic, he emerged as a vocal critic of various aspects of the public health response, particularly vaccine mandates and what he called the “complete dismissal of natural immunity.”

A graduate of Bucknell University (BS), Thomas Jefferson University (MD), and Harvard University (MPH), Dr. Makary completed his surgical residency at Georgetown University and his specialty training at Johns Hopkins Hospital. 

Surgeon General 

On Friday, November 22, President-elect Trump nominated Dr. Janette Nesheiwat for surgeon general. In his nomination statement, Trump said, “Dr. Nesheiwat is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality health care, and believes in empowering individuals to take charge of their health to live longer, healthier lives.” 

If confirmed, Dr. Nesheiwat will oversee 6,000 U.S. Public Health Service Corps members. She will also have the power to issue advisories warning of public health threats and influencing how the government, public, and medical community respond to health crises in the country.  

Dr. Nesheiwat is a Fox News medical contributor and serves as a medical director at CityMD, a network of urgent care centers in New York and New Jersey.

 Some are expressing concern that Dr. Nesheiwat has very little public health credentials/ experience.

Dr. Nesheiwat graduated from the University of South Florida in 2000. She graduated from the American University of the Caribbean School of Medicine in St. Maarten in 2006 and then completed the family medicine residency program at the University of Arkansas for Medical Sciences in 2009. She also completed an ER rotation at Johns Hopkins Hospital in Baltimore. 

House Appropriations Subcommittee Reviews on NIH Budget Request for FY 2025

-Blake William Rostine

On November 19, 2024, the House Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies held a hearing to discuss FY 2025 funding for the National Institutes of Health (NIH). NIH Director Dr. Monica Bertagnolli was the sole witness. 

Subcommittee Chair Robert Aderholt (R-AL) opened the hearing by stating that the House-proposed NIH funding level is a starting point in funding discussions, and he acknowledged that robust funding for the NIH is instrumental to maintaining the United States’ global leadership in biomedical research.  

Rep. Aderholt also expressed a desire to continue discussions on proposals to restructure the NIH, which he first proposed with Rep. Cathy McMorris Rodgers (R-WA) in a June 2024 op-ed. He cited a 2003 report from the National Academies of Sciences, Engineering, and Medicine that found the NIH’s decentralized structure to be what he characterized as detrimental to the agency’s efforts to create strategic programs and interdisciplinary efforts.

In response, Dr. Bertagnolli pointed to intra-agency projects such as the BRAIN Initiative as examples of the NIH carrying out the National Academies’ recommendations and fostering interdisciplinary collaboration. She also voiced concern that reducing the number of institutes and centers (ICs) would harm the public’s trust in the NIH because the ICs serve as “visual representations” of and points of contact for the various disease groups and constituencies.

Ranking Member Rosa DeLauro (D-CT) stated that she does not believe the appropriations process is the proper vehicle to advance NIH reform. She suggested a deliberative process with additional hearings to consider reform would be more appropriate. Rep. Steny Hoyer (D-MD) echoed this sentiment, expressing that it is the duty of the subcommittee to hold additional hearings to allow IC directors the opportunity to testify.  

Throughout the hearing, Dr. Bertagnolli fielded questions on clinical trial participation, including access and diversity in clinical trials, e-cigarettes targeting children, women’s health research, efforts made to avoid the duplication of funding between NIH and other agencies, incentives for early career scientists, and public mistrust of the NIH. Dr. Bertagnolli addressed public mistrust by stating the NIH can work to better communicate its successes, including an increased focus on working with underserved populations to directly address these concerns.

Rep. Aderholt specifically inquired about the future of the CURES Act and President Biden’s Cancer Moonshot, for which funding ended in FY 2024. Bertagnolli responded by stating that terminating any programs would be frustrating for the American people. She highlighted programs like the Cancer Moonshot created research ventures like the Childhood Cancer Data Initiative, a breakthrough in data sharing centered around childhood cancer care. Bertagnolli highlighted that any decrease in funding, including flat funding, would mean ending essential research programs like these, which save countless American lives every year.

The hearing can be viewed online. Rep. Aderholt’s remarks can be read here, and Dr. Bertagnolli’s remarks are also available. The American Association for Cancer Research will continue to advocate for robust and predictable funding for the NIH so that lifesaving research can continue.

REGISTER NOW: FDA-AACR Workshop: To Test or Not to Test—That Is the Question: DPD Deficiency and Weighing Potential Harms 

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the AACR are hosting a hybrid workshop titled “To Test or Not to Test—That Is the Question: DPD Deficiency and Weighing Potential Harms” on January 16, 2025, at the Bethesda Marriott Pooks Hill Hotel in Bethesda, Maryland. This workshop will explore the clinical, pharmacologic, device, and genomic considerations in dihydropyrimidine dehydrogenase (DPD) deficiency testing, and whether patients should undergo DPD deficiency testing before initiating chemotherapy with fluoropyrimidines. Registration is open for in-person and virtual attendance. 

Fluoropyrimidine drugs, such as 5-Fluorouracil (5-FU) and capecitabine (Xeloda), are commonly used to treat various solid tumors. The DPD enzyme is crucial for metabolizing these drugs into non-toxic compounds, and individuals with DPD deficiency are at a higher risk of experiencing severe adverse effects. This workshop builds on updated FDA product labeling for Xeloda and 5-FU which includes new information on DPD deficiency, as well as the FDA’s response to a Citizen’s Petition on DPD deficiency testing.

This workshop will bring together experts from academia, industry, the FDA, and patient advocacy organizations to examine the existing information and evidence surrounding DPD deficiency testing, consider the clinical implications of requiring testing, and discuss the regulatory considerations for modifying FDA product labeling to require testing. 

For additional information, please visit the workshop website.  

Registration Open for the AACR Patient Advocate Forum on Clinical Trials

Join advocates and researchers from around the world on Tuesday, January 21, 2025 (1-2:30 p.m. ET), for the virtual American Association for Cancer Research (AACR) Patient Advocate Forum: Exploring a New Generation of Patient-Centric Cancer Clinical Trials. The forum features moderator AACR SSP Founder Dr. Anna Barker from the Ellison Institute of Technology and presentations by AACR President Dr. Patricia LoRusso from Yale University, AACR Past President Dr. David Tuveson from Cold Spring Harbor Laboratory, and winner of the SABCS William L. McGuire Memorial Lecture Award Dr. Laura van ’t Veer from UCSF.

More people are living through and beyond cancer thanks in large part to clinical trials which have given countless cancer patients access to lifesaving treatments. As scientific research has driven progress in cancer diagnosis and treatment, it has also led to significant changes in the way clinical trials are conducted. These renowned speakers will explore cutting-edge developments revolutionizing the process and paving the way for more efficient, inclusive, and patient-centric clinical trials.

The AACR offers this educational program to all members of the patient advocate and research community at no cost. If you can’t join the forum on January 21, register to access the recording.

Register online.

Time is Running Out: AACR Scientist↔Survivor Program® 2025 Applications

Time is running out to submit an application for the AACR Scientist↔Survivor Program® (SSP) at the AACR Annual Meeting 2025 in Chicago, Illinois (April 25-30. 2025). Now celebrating its 27th year, the AACR Scientist↔Survivor Program® is designed to build enduring partnerships among the leaders of the scientific, cancer survivor, and patient advocacy communities worldwide.

This special educational program provides patient advocates with plain language lectures, small group discussions, and other opportunities for the exchange of information on key aspects of cancer research, survivorship, advocacy, and public policy. Patient advocates will have an opportunity to learn about genomics, immunotherapy, biomarker development, clinical trials, advanced technologies; and to interact with scientists, regulators, health professionals, and other advocates.

Thanks to the generosity of supporters, this program is offered at no cost to SSP patient advocates. Please note that the request for application deadline is December 13.

Submit an application.

Applications Open for the 2025 AACR Early-Career Hill Day

The American Association for Cancer Research (AACR) is now accepting applications for its 2025 Early-career Hill Day, which will be held in Washington, D.C., February 25-26. This annual event provides a valuable opportunity for AACR associate members to learn about the advocacy process by taking their message directly to members of Congress in support of federal funding for cancer research at the National Institutes of Health and the National Cancer Institute.

Participants will receive training on advocacy and the federal appropriations process prior to the Hill Day. Please visit this page for more information and to apply for one of the limited spots to attend and network with your fellow early-career associate members. The deadline to apply is Friday, December 20, 2024.

Potential applicants who are not already AACR associate members can find more information about membership. There are no annual dues for associate members. Any questions may be directed to [email protected].

U.S. Surgeon General’s New Report Highlights Health Disparities Amongst Tobacco Use

-Blake William Rostine

A new report from U.S. Surgeon General Dr. Vivek Murthy highlights the persisting disparities among tobacco usage, as well as presenting potential solutions in addressing these concerns. Published on November 19, 2024, the report explains that despite an overall trend of cigarette use, progress in reducing tobacco use has not been equitable and that tobacco use rates are persistent amongst several U.S. populations, including underrepresented racial and ethnic groups, LGBTQ+ populations, and people living in rural areas.

As tobacco remains the leading cause of preventable death in the U.S., these findings present opportunities for working with populations impacted by these disparities. Dr. Murthy’s report presents solutions like tobacco product price increases, smoke-free air policies, media campaigns, and maximum nicotine yields as ways to combat tobacco use. Equitable access to cancer prevention and cancer treatment remains a commitment from the AACR, as no community should be left behind in the fight against cancer.  

The report can be accessed online.

ONCOLOGY APPROVAL RECAP  

Between October 25 and November 22, the Food and Drug Administration (FDA) granted accelerated approval to two new drugs, one of which includes approval for a companion diagnostic, a first-ever approval for two drugs, and updated product labeling.  

  • Asciminib was granted accelerated approval for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This brings asciminib into the first line, having been previously approved in pre-treated and/or BCR-ABL T315I mutated populations. This application received priority review, breakthrough, and orphan drug designations. The review was conducted under the Real-Time Oncology Review pilot program and FDA’s Project Orbis.  
  • Obecabtagene autoleucel was granted approval for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This is the first approval for this drug, an anti-CD19 autologous chimeric antigen receptor (CAR) T cell product, in any setting. It is the seventh FDA-approved CAR T cell product overall, but the first with no Risk Evaluation and Mitigation Strategies (REMS) program requirement. This application received regenerative medicine advanced therapy and orphan drug designations.   
  • Revumenib was granted approval for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older. This is the first drug indicated to treat patients with KMT2A-rearranged acute leukemia. This application received priority review, breakthrough, and orphan drug designations. The review was conducted under the Real-Time Oncology Review pilot program.  
  • Fludarabine phosphate was granted approval for updated drug labeling under Project Renewal and is now indicated as a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL); and for the treatment of adults with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least one alkylating-agent containing regimen. Additional labeling updates include revised dosage regimens to include the recommended dosage for use in combination with cyclophosphamide and rituximab; and the boxed warning was removed to be incorporated in the Warnings and Precautions section.  
  • Zanidatamab-hrii was granted accelerated approval for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. Along with this approval, FDA approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with zanidatamab. The application was granted priority review, breakthrough therapy designation, and orphan drug designation.