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Cancer Policy Monitor: April 8, 2025

Congress Passes Full-Year Spending Bill with Flat NIH and NCI Funding 

-Matt Gontarchick 

On March 15, President Donald Trump signed into law the Full-Year Continuing Appropriations and Extensions Act, 2025, which funds the government through the end of fiscal year (FY) 2025 on September 30. The bill maintains flat funding for most federal agencies, including the National Institutes of Health (NIH) and the National Cancer Institute (NCI), with NIH remaining at approximately $47 billion and NCI at $7.22 billion. However, NIH’s topline funding includes a $280 million reduction due to the expiration of temporary funding provided by the 21st Century Cures Act. This reduction does not directly impact cancer research, as Cancer Moonshot funding from the Cures Act concluded in FY 2024. 

The bill’s passage followed a series of intense negotiations. On March 11, the House narrowly approved the measure by a 217-213 vote, with nearly all Republicans supporting it and most Democrats opposing it. House Republican leadership secured the support of the conservative House Freedom Caucus, while Democrats pushed for a shorter-term continuing resolution (CR) to allow for more time to negotiate. Despite these differences, the Senate approved the bill on March 14 by a 54-46 vote, with Senate Majority Leader Chuck Schumer (D-NY) ultimately backing the measure to avoid a government shutdown. 

While the CR avoids a government shutdown, the decision to freeze funding—amid rising inflation and growing scientific opportunity—poses serious challenges for the biomedical research community and creates uncertainty for long-term scientific progress. 

The AACR is urging Congress to provide at least $51.303 billion for the National Institutes of Health (NIH) in FY 2026. This investment would represent a $4.222 billion—or 9.0%—increase over the final FY 2025 funding level and is essential to accelerating lifesaving research, supporting the scientific workforce, and improving outcomes for patients with cancer and other serious diseases. 

Senate Democrats Host Forum on NIH Disruptions and the Impact on Cancer Research 

–Carly McCallie 

On March 26, U.S. Senators Tammy Baldwin (D-Wisconsin) and Peter Welch (D-Vermont) hosted a Senate forum titled “Cures in Crisis: What Gutting NIH Research Means for Americans with Cancer, Alzheimer’s, and Other Diseases.” The forum addressed the detrimental effects of recent disruptions at the National Institutes of Health (NIH), featuring testimony from former NIH Director Dr. Monica Bertagnolli, researchers specializing in Alzheimer’s disease, and patients whose lives have been directly impacted by NIH-funded clinical trials. 

The forum focused on how recent administrative decisions and funding cuts have placed the future of life-saving research at risk, particularly for those battling cancer, Alzheimer’s, and other serious diseases. 

Participating Senators included Chuck Schumer (D-New York), Catherine Cortez Masto (D-Nevada), Patty Murray (D-Washington), Chris Van Hollen (D-Maryland), Tina Smith (D-Minnesota), Ed Markey (D-Massachusetts), Maggie Hassan (D-New Hampshire), Dick Durbin (D-Illinois), Sheldon Whitehouse (D-Rhode Island), Jeff Merkley (D-Oregon), Jacky Rosen (D-Nevada), Amy Klobuchar (D-Minnesota), Angela Alsobrooks (D-Maryland), Jeanne Shaheen (D-New Hampshire), and Elizabeth Warren (D-Massachusetts). 

The AACR worked with the staff on the Senate Labor, Health and Human Services (HHS), Education and Related Agencies (LHHS) Appropriations Subcommittee as they prepared the forum, including securing the participation of Dr. Larry Saltzman, a cancer survivor who discussed the devastating cuts at NIH that are jeopardizing cures for many cancers.

Saltzman, who suffered from chronic lymphocytic leukemia, was featured in the 2022 AACR COVID-19 and Cancer Report. In addition, he recently published an op-ed in the Sacramento Bee titled, “Sacramento doctor: If not for NIH funding, I wouldn’t have survived my leukemia diagnosis.” His op-ed addresses the impact of the Administration’s actions on NIH and medical research.

The following witnesses shared their perspectives and personal experiences, highlighting the real-world consequences of the NIH funding cuts: 

Dr. Monica Bertagnolli, former NIH Director, spoke about the damaging effects of funding freezes and grant terminations. She highlighted that over 300 grants had been terminated, and $1.5 billion in funding delays had significantly impacted ongoing research. Bertagnolli warned that these actions threatened not only scientific progress but also the future of cancer cures. 

Dr. Sterling Johnson, an Alzheimer’s disease researcher at the University of Wisconsin-Madison, shared the urgency of continued NIH funding for Alzheimer’s research. He explained that deaths from Alzheimer’s disease had increased in recent years and warned that continued delays in funding for Alzheimer’s research would leave millions of Americans without the hope of a cure. “The clock is ticking for them and their families,” Johnson said. 

Dr. Whitney Wharton, an Alzheimer’s disease researcher at Emory University, shared his personal experience with NIH grant terminations, noting that the loss of funding had a devastating impact on his research and patients. “The termination of grants awarded based on merit has devastating implications,” Wharton said, stressing the long-term harm this could cause to the research community. 

Dr. Larry Saltzman, a retired physician living with leukemia, spoke about the life-saving impact of NIH-funded clinical trials. He emphasized that NIH research had saved his life, and “without NIH funding, I don’t think I would be here today.” 

Jessy Ybarra, a veteran living with ALS, discussed the importance of continued NIH funding for experimental treatments, urging Congress to reject cuts and preserve funding for innovative medical breakthroughs. He said, “Investing in a cure for ALS is not only fiscally responsible; it’s good public policy. My life, and the lives of many others, depend on this funding.” 

A full recording of the forum is available online. 

The AACR strongly opposes the Administration’s cuts to NIH and cancer research. These actions jeopardize not only the progress made in advancing cancer treatments but also the future of countless patients who depend on continued innovation. The AACR remains dedicated to advocating for sustained, robust, and predictable funding for NIH, ensuring that essential research and treatments are not delayed or disrupted. We are committed to supporting the next generation of cancer research and ensuring that progress in developing new therapies and improving patient outcomes continues without interruption. 

HHS Reorganization Cuts Workforce, Consolidates Agencies, and Reshapes Public Health Infrastructure 

-Carly McCallie 

On March 27, the Department of Health and Human Services (HHS) announced a sweeping reorganization that will eliminate 10,000 federal jobs and consolidate nearly half of the department’s operating divisions. The plan will significantly reshape how the federal government delivers public health services and supports biomedical research. 

The reorganization is part of the Administration’s broader effort to reduce the federal workforce and centralize control across health agencies. HHS Secretary Robert F. Kennedy, Jr., described the changes as a response to inefficiency, duplication, and rising rates of chronic illness. In a video posted online, he pledged to redirect resources toward frontline providers and scientific staff, while eliminating what he called a bloated bureaucracy. The administration estimates the changes will save $1.8 billion annually—about 0.1% of HHS’ $1.8 trillion budget. 

Under the plan, HHS’ full-time workforce will shrink from approximately 82,000 to 62,000 employees. The number of operating divisions will drop from 28 to 15, and regional offices will be reduced from 10 to 5. Several existing agencies and offices—including the Office of the Assistant Secretary for Health, the Health Resources and Services Administration, and programs focused on addiction, occupational health, and environmental health—will be merged into a new entity called the Administration for a Healthy America. 

The cuts will also significantly impact the nation’s leading public health and biomedical agencies. According to HHS, the Food and Drug Administration will lose approximately 3,500 employees, or 19% of its workforce. The Centers for Disease Control and Prevention (CDC) will lose 2,400 employees, or 18%, and the National Institutes of Health will lose 1,200 employees, or about 6%. An additional 300 employees will be cut from the Centers for Medicare and Medicaid Services. Some layoffs are expected to take effect at the end of May. 

Implementation has been rapid and opaque. Many senior officials and staff reportedly learned of the reorganization from news coverage, and several agency leaders have since scrambled to determine which positions and programs are affected. The Department’s preparedness agency was given just two days to prepare a plan to fold into the CDC, and even lawmakers overseeing the department said they were not briefed prior to the announcement. 

HHS says the NIH staffing reductions will focus on administrative functions such as procurement, human resources, and communications, which will be centralized across the agency’s 27 institutes and centers. However, employees and public health experts have warned that cuts to support staff, along with attempted centralization of services like IT and procurement, could result in greater inefficiencies and reduced responsiveness across agencies. Some efforts to consolidate operations are already facing resistance, with concerns that critical contracts and services cannot be easily absorbed elsewhere. 

While the administration maintains that essential services will be preserved, current and former officials have warned that public health and regulatory functions could be significantly weakened. Internal confusion, deep staff morale issues, and fear of retaliation have compounded concerns that the changes are driven less by evidence than by ideology and political control. 

This reorganization follows earlier efforts to purge probationary employees across HHS and NIH, including individuals recently promoted to senior positions. Though a judge has temporarily blocked those firings, the administration is appealing the decision. Within NIH, several top leaders have recently departed or been removed, and advisory boards responsible for scientific oversight of NIH’s intramural research programs have been quietly dismantled and restructured with little transparency. 

The reorganized structure will also transfer the Administration for Strategic Preparedness and Response—established as an independent division following COVID-19—under the CDC. Public health experts have raised concerns that this change could hamper the federal government’s ability to coordinate emergency response efforts and anticipate emerging threats. 

As this unprecedented restructuring moves forward, the AACR remains committed to safeguarding the future of cancer research, protecting the scientific workforce, and ensuring that federal agencies remain equipped to deliver on their lifesaving missions 

NIH Under New Leadership: Senate Confirms Bhattacharya Amid Unprecedented Turmoil 

-Carly McCallie 

On March 26, the U.S. Senate voted 53-47 to confirm Dr. Jay Bhattacharya as Director of the National Institutes of Health (NIH). A Stanford physician and health economist, Dr. Bhattacharya assumes leadership of the agency at a time of major transition, marked by workforce reductions, research funding disruptions, and increasing concerns about political interference in NIH operations. 

During his confirmation hearing earlier in March, Dr. Bhattacharya pledged to review, but did not commit to reversing, recent Administration actions, including a proposed 15% cap on indirect cost reimbursements and the layoff of approximately 1,200 NIH employees. While he acknowledged the importance of funding stability and transparency, he suggested broader audits may be needed before policy changes are made. A federal judge issued a preliminary injunction blocking the indirect cost cap on March 5. 

Just hours after his confirmation, NIH staff received an internal directive instructing them to identify grants and contracts related to “fighting misinformation or disinformation.” The urgent March 27 email instructed contracting officers to flag awards referencing terms such as media literacy, vaccine uptake, social distancing, and public health messaging about COVID-19, framing such efforts as potentially linked to censorship. While there is no indication that Dr. Bhattacharya, who had not yet been sworn in, was directly involved in issuing the directive, it aligns with his longstanding criticism of federal efforts to counter misinformation and his stated goal of fostering a “culture of dissent and free speech” at NIH. 

The NIH has already begun terminating grants related to COVID-19, vaccine hesitancy, LGBTQ+ health, and diversity, equity, and inclusion, fueling concerns that the administration is reshaping the agency’s research agenda based on political considerations. Public health experts have warned that eliminating these lines of research could undermine vaccine access, limit health education, and damage the NIH’s ability to fulfill its core mission. 

Dr. Bhattacharya’s confirmation also coincides with a growing wave of leadership departures across the NIH. On March 26, Tara Schwetz, the NIH’s deputy director for coordination, planning, and strategic initiatives, was placed on administrative leave. Schwetz played a key role in the creation of the Advanced Research Projects Agency for Health (ARPA-H) while on detail to the White House Office of Science and Technology Policy. Her removal follows the resignations of Larry Tabak, the agency’s longtime second-in-command, and Michael Lauer, deputy director for extramural research. Eric Green, director of the National Human Genome Research Institute, also stepped down in March after learning he would not be renewed for a new term. 

ARPA-H itself has seen its leadership reshuffled. Renee Wegrzyn, the agency’s inaugural director, was dismissed in February, and her deputy, Susan Monarez, was tapped as acting director of the Centers for Disease Control and Prevention (CDC). She was formally nominated to lead the CDC at the end of March. 

The AACR will continue to monitor how these leadership and policy shifts impact the NIH’s ability to support high-quality cancer research, protect scientific integrity, and promote evidence-based decision-making. 

SEnate Confirms Dr. Marty Makary as FDA Commissioner Amid Agency Upheaval and Deep Cuts 

-Carly McCallie 

On March 26, the U.S. Senate confirmed Dr. Marty Makary as Commissioner of the Food and Drug Administration (FDA) in a 56-44 vote, with all Senate Republicans and three Democrats in support. A pancreatic surgeon and health policy professor at Johns Hopkins University, Makary assumes leadership of the agency at a moment of significant internal upheaval. 

Makary’s relatively smooth confirmation positions him to help lead the administration’s broader “Make America Healthy Again” agenda. During his confirmation hearing earlier this month, he pledged to increase transparency, strengthen the FDA’s focus on chronic disease prevention, and reform food safety and regulatory advisory processes. He also voiced support for heightened scrutiny of food additives and improvements to the FDA’s approach to nutrition and drug labeling. 

However, Makary assumes leadership of an agency already in flux. Just one day after his confirmation, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr,. announced a sweeping reorganization that will eliminate 10,000 positions across the department—including approximately 3,500 at the FDA, or nearly 20% of the agency’s workforce. The cuts are focused on administrative and support roles in policy, IT, procurement, human resources, and communications. 

While FDA reviewers and inspectors may be spared, experts warn that eliminating the support personnel who enable their work could still disrupt operations and slow scientific progress. Many employees and senior leaders reportedly learned of the cuts from press coverage, and internal communication has remained limited. Morale has declined sharply across the agency, with termination notices expected to begin going out by the end of March and the layoffs scheduled to take effect on May 27. 

HHS has also implemented a strict in-office work policy, paused probationary firings under legal challenge, and centralized agency communications under department leadership—further tightening political control over FDA operations. 

Makary acknowledged concerns about the impact of the reductions at his hearing and committed to reviewing personnel needs if confirmed. Whether he will be able to conduct that assessment or slow the pace of reorganization remains unclear. Former FDA officials have expressed alarm about the scale and speed of the changes, warning that such disruption could undermine the agency’s ability to carry out its regulatory mission. 

The FDA currently draws approximately 46% of its total budget from user fees paid by industry to support product reviews, post-market safety evaluation, and regulatory research. While many of these programs may remain intact, the loss of supporting infrastructure and technology services could limit efficiency, delay progress, and contribute to further staff attrition. 

The AACR will continue to closely monitor developments at the FDA and advocate for a strong regulatory framework that protects patient safety, supports clinical trial innovation, and ensures continued progress in the fight against cancer. 

NIH Terminates Scientific Advisory Board Members Without Explanation 

-Carly McCallie 

In late March, the National Institutes of Health (NIH) abruptly removed members from its Boards of Scientific Counselors (BSCs), the external panels that provide essential oversight of the NIH’s intramural research programs. These terminations occurred across multiple NIH institutes and were not accompanied by public explanation or notice to the affected individuals. 

The BSCs are composed of independent scientists from outside the NIH who evaluate the quality and direction of the agency’s internal research. These boards review tenure-track investigators, make recommendations on tenure, and assess the broader impact of NIH’s scientific work. Members typically serve staggered five-year terms and convene two to three times per year to ensure ongoing evaluation of intramural programs. 

Termination notices were issued on March 21 and stated only that board members serve at the discretion of the NIH Director. Several individuals reported receiving no advance warning or rationale for their removal. In some cases, members learned of their dismissal only after their names were removed from institute websites or calendar invitations were withdrawn.

The individuals affected include scientists from underrepresented groups and researchers whose work aligns with areas that have recently come under political scrutiny, including diversity, equity, and environmental health. While the total number of terminations is not yet publicly known, multiple institutes appear to have been affected. 

The removals come amid broader restructuring efforts at the NIH and HHS, including leadership transitions, workforce reductions, centralized administrative functions, and terminated research funding in selected policy-sensitive areas. These developments have raised concerns about the politicization of research governance and the erosion of established systems for scientific oversight. 

The AACR remains committed to defending the integrity of scientific peer review and supporting independent, expert-driven evaluation processes that ensure research quality, protect public trust, and advance progress in cancer science. 

An FDA Educational Campaign, “The Real Cost,” Dramatically Reduced Youth E-Cigarette Use   

-Blake William Rostine  

A March 14, 2025 study co-authored by the U.S. Food and Drug Administration (FDA) reported that an estimated 444,252 American youth (aged 11 to 17 during the study) did not initiate e-cigarette use between 2023 and 2024 as a result of the FDA’s “The Real Cost” e-cigarette prevention campaign. This, alongside other efforts, contributed to youth e-cigarette use dropping to its lowest level in a decade.   

Originally launched in 2018 under President Trump, “The Real Cost” e-cigarette prevention campaign uses marketing tactics including social media communications to discuss the harms of tobacco use. The campaign was developed using evidence-based science and behavioral science principles. A similarly successful campaign also began in 2014 to address youth cigarette smoking. The success of these FDA efforts to prevent initiation of tobacco usage reinforces the demonstrated efficacy and utility of public health education initiatives. A previous report indicated that the anti-smoking arm of this campaign saved $180 per dollar spent, resulting in over $53 billion in returns. More importantly, these campaigns have resulted in communicating to American youth that there is no safe tobacco product and have protected them from a lifetime of nicotine addiction. Tobacco use remains the leading cause of preventable death and disease in the U.S., and efforts like “The Real Cost” and the FDA’s additional efforts to educate on and regulate tobacco are essential in combating this. These campaigns, and all of the FDA’s tobacco regulation efforts, are 100% funded by tobacco user fees. The AACR remains aligned with the FDA against the dangers of youth e-cigarette use and will continue to push for increased preventative efforts so that we can end cancer as we know it.  

Join us at the AACR Annual Meeting 2025—Unifying Cancer Science and Medicine: A Continuum of Innovation For Impact 

There is still time to register for the AACR Annual Meeting 2025. The meeting will take place at the McCormick Place Convention Center in Chicago, Illinois on April 25-30. A major highlight of the Annual Meeting is the Regulatory Science and Policy Track, featuring discussions that will provide insight into the current state of play in federal science agencies and examine the future of cancer drug and device development. Learn more about each session by following the links below.   

**All times are listed in Central Daylight Time (CDT):

Saturday, April 26

12:30-2 p.m.: Bridging the Gap: Ensuring a Broad Representation of Patients in Cancer Clinical Trials  
2:30-4 p.m.: Rising Rates of Early-Onset Cancers: Understanding the Shift and Exploring Solutions 

Sunday, April 27

Monday, April 28  

Tuesday, April 29

Register Today for the 2025 AACR-AACI Hill Day 

Registration is now open for the AACR and the Association of American Cancer Institutes’ (AACI) Hill Day on May 22. This Hill Day provides an important opportunity for cancer center directors, researchers, physician-scientists, cancer survivors, and other advocates to come to Washington, D.C., to urge legislators to support enhanced federal investment in biomedical research through the National Institutes of Health and the National Cancer Institute. 

Learn more information about and register for the Hill Day. 

AACR Hill Day Scholarships Now Available for Patient Advocates 

AACR-AACI Hill Day provides a vital platform for patient advocates to speak directly with lawmakers about the impact of federal research funding. Their firsthand experiences provide undeniable evidence of how research funding drives progress and why continued investment is not just necessary but a matter of life and death.  

To ensure these perspectives are represented, the AACR is providing funding for five patient advocates to participate in the 2025 AACR-AACI Hill Day. Each selected advocate will receive up to $1,000 to support their travel expenses, allowing them to take part in important discussions on Capitol Hill and reinforcing the vital role of the patient perspective in shaping cancer policy.  

We encourage you to submit nominations and help bring these critical voices to Congress. Eligible nominees may include: 

  • Current or former patients 
  • Friends or family members of a patient 
  • Individuals enrolled in a clinical trial or receiving standard treatment 

Submit your nomination by Friday, April 11. Recipients will be selected and notified by Friday, April 25.  

Oncology Approval Recap

-Brad Davidson, PhD

Between March 1 and March 28, the U.S. Food and Drug Administration (FDA) granted four new oncology drug approvals, including one approval for a novel agent, one conversion from accelerated approval to traditional approval, and two new indications for previously approved agents.

  • Durvalumab was approved for adults with muscle invasive bladder cancer as part of a treatment regimen involving its combination in the neoadjuvant setting with gemcitabine and cisplatin, radical cystectomy, and single agent durvalumab in the adjuvant setting. This is durvalumab’s second perioperative indication, and ninth overall. This application was supported by priority review status.
  • Lutetium Lu 177 vipivotide tetraxetan received an expansion of its previous indication. Initially approved in 2022 for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who were treated with androgen receptor pathway inhibitor therapy and taxane-based chemotherapy, this treatment is now approved for patients who are considered appropriate for a delay of taxane-based chemotherapy.
  • Cabozantinib was approved for patients 12 years of age or older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumors (pNET) or well-differentiated extra-pancreatic neuroendocrine tumors (epNET). Review of this application was conducted under Project Orbis, involving collaboration with the Australian Therapeutic Goods Administration and Switzerland’s Swissmedic.  
  • Pembrolizumab was upgraded from accelerated approval to traditional approval in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This conversion includes a new provision not contained in the initial accelerated approval, now being indicated only for patients whose tumors express PD-L1 (CPS ≥1). While not a discussion of this specific indication, a September 2024 meeting of FDA’s Oncology Drug Advisory Committee discussed the utility of anti-PD-L1 therapy in the first line in gastric or GEJ patients. The majority of committee members voted that patients without PD-L1 expression displayed non-favorable risk-benefit profile. The development program for this indication was consistent with Project FrontRunner, an FDA Oncology Center of Excellence (OCE) initiative that encourages the development of treatments for advanced or metastatic disease in settings earlier than the traditional approach, wherein development programs typically target heavily pretreated populations. This application was also granted orphan drug designation.