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Cancer Policy Monitor: September 9, 2025

Congress Confronts NIH Budget Decisions as Shutdown Looms 

-Matt Gontarchick 

With government funding set to expire on September 30, Congress returned from its summer recess under mounting pressure to finalize fiscal year (FY) 2026 spending bills or pass a continuing resolution (CR) to avert a shutdown. Lawmakers face an unusually turbulent landscape, shaped not only by partisan divisions but also by new executive actions that have deepened uncertainty over federal funding. 

Before recess, the Senate Appropriations Committee approved its bipartisan FY2026 Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) bill. The measure provides $48.7 billion for the National Institutes of Health (NIH), a $400 million increase over FY2025, and $7.347 billion for the National Cancer Institute (NCI), a $150 million increase. By advancing these funding levels, Senate leaders including Appropriations Chair Susan Collins (R-Maine), Vice Chair Patty Murray (D-Washington), and Subcommittee leaders Shelley Moore Capito (R-West Virginia) and Tammy Baldwin (D-Wisconsin) firmly rejected the White House proposal to cut NIH funding by 40%, earning broad praise from the medical research community. 

The Senate bill also included language designed to protect the NIH from harmful administrative proposals. The committee report prohibits capping reimbursement for indirect costs at 15%, requires 180 days of notice before any restructuring of the NIH’s 27 institutes and centers, and limits the administration’s authority to issue multiyear forward-funded grants. 

The House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies marked up its FY2026 bill on September 2. A full committee markup has not yet been scheduled but is expected to follow in the coming days. In July, the committee released topline allocations that reduced overall spending from FY2025, though early indications suggest the House may join the Senate in rejecting the steep NIH cuts proposed by the White House. 

On September 2, the House Appropriations Subcommittee on Labor-HHS marked up its FY2026 bill after releasing text and a summary the day before. The bill provides $46.9 billion for the NIH’s base budget, a $99 million (0.2%) increase relative to the FY2025 comparable total, including funding from the 21st Century Cures Act. It also allocates $945 million for the Advanced Research Projects Agency for Health (ARPA-H), a $555 million (37%) cut from FY2025. Funding is maintained for all 27 NIH institutes and centers. 

The House bill also contains several controversial policy provisions, including: 

  • prohibiting NIH from reimbursing facilities and administrative costs above 30% for institutions subject to the endowment tax;
  • prohibiting the use of funds for research involving human fetal tissue obtained through induced abortion; and
  • prohibiting the use of funds to directly or indirectly support gain-of-function research. 

A full committee markup is expected the week of September 8, which should provide additional detail through the committee report. 

Meanwhile, the appropriations process has been further complicated by the administration’s controversial use of a so-called “pocket rescission.” On August 29, the White House declared $4.9 billion in FY2025 foreign aid unilaterally canceled, a move lawmakers in both parties view as an illegal end run around Congress’s constitutional power of the purse. Senate leaders from both parties, including Chair Collins and Vice Chair Murray, quickly rebuked the maneuver, warning it could derail bipartisan negotiations needed to keep the government open. 

As Democrats press GOP leaders for a “Big Four” meeting to resolve the standoff, options remain in flux. Some Senate Republicans favor a short-term CR to allow more time for negotiations, while hardline conservatives in the House are calling for a full-year extension at current spending levels paired with targeted cuts and policy riders. With both chambers scheduled for limited floor time in September and partisan mistrust running high, the risk of a shutdown remains significant. 

Despite these challenges, the AACR applauds congressional leaders for their bipartisan commitment to rejecting proposed cuts to NIH and NCI. At this critical juncture, lawmakers must continue that tradition by providing robust, stable funding that sustains medical research, supports scientists, and delivers lifesaving progress for patients and families. 

Rally for Medical Research Returns to Capitol Hill 

The Rally for Medical Research brings together more than 400 organizations and advocates from every corner of the country to call on Congress to make funding for the National Institutes of Health (NIH) a national priority. What began in 2013 as a single day of advocacy has grown into an annual movement that unites patients, survivors, researchers, clinicians, and families behind one message: Robust, sustained, and predictable funding for the NIH saves lives. 

This year’s Rally arrives at a defining moment. With the White House proposing a 40% cut to the NIH budget and Congress debating fiscal year 2026 appropriations, advocates will meet face-to-face with lawmakers to underscore what is at stake for patients, progress, and the nation’s global leadership in science and innovation. 

Events begin on September 17 with participant training and an evening reception. On September 18, advocates will head to Capitol Hill for a full day of meetings with congressional offices. Their message is clear: Bipartisan support for the NIH has fueled decades of lifesaving medical progress, and that legacy must be protected. Please contact Rally organizers with any questions.

AACR to Release 15th Cancer Progress Report at National Press Club on September 17 

The AACR will release its 15th edition of the landmark AACR Cancer Progress Report on September 17 at 12 p.m. ET at the National Press Club in Washington, D.C. This year’s report will provide a detailed overview of the tremendous progress that is being made in the prevention, detection, and treatment of cancer, and how these advances crucially depend on robust federal investments in medical research. The report will also highlight recent advances across the cancer care continuum, including immunotherapy and molecularly targeted therapies, while highlighting patient-advocates and their journeys. 

The event may be attended in person or virtually. Please see the AACR website for additional details. Event registration is available now. 

Executive Order Expands Political Control Over Federal Research Grants 

-Matt Gontarchick 

On August 7, the White House issued an executive order (EO) titled Improving Oversight of Federal Grantmaking that shifts control of federal research funding away from scientists and career staff and into the hands of political appointees. The order requires appointees to review and approve all funding opportunity announcements and discretionary awards in coordination with the Office of Management and Budget (OMB). 

For scientific research, the EO states that at least one subject-matter expert must be included in the process, but peer review will no longer have sole authority in funding decisions. Peer review has long been regarded as the gold standard for ensuring that federal grants are awarded based on merit, evidence, and public value. How this new directive will be implemented at NIH and other agencies is not yet clear. Each department must submit a report by September 6 outlining how it will revise its grantmaking terms and conditions in accordance with the order. 

The EO also instructs agencies to include “termination-for-convenience” clauses in grant agreements, granting political officials broad authority to cancel projects that no longer align with shifting priorities. Research leaders warn that this could jeopardize multi-year studies and clinical trials, particularly in fields like cancer where patients depend on continuity. 

Funding priorities are also reshaped. Agencies are told to favor institutions with lower indirect cost rates and to avoid concentrating awards among so-called “repeat players.” Indirect costs support facilities, equipment, and staff that make research possible, from laboratory space to patient services. Critics argue that penalizing institutions with higher indirect costs risks weakening the infrastructure that underpins scientific progress across the country. 

Taken together, these provisions mark one of the most sweeping changes to federal grantmaking in decades. The NIH alone manages tens of thousands of awards each year, a scale that experts say cannot be matched by political offices without slowing the process, undermining rigor, or both. Adding new layers of political review could stall grantmaking, deter investigators from pursuing certain areas of research, and erode confidence in the stability of the federal funding system. 

The executive order has already drawn alarm from across the research community. Experts warn that overriding peer review with political approval would destabilize a system that has made American science a global leader. The addition of “termination-for-convenience” clauses is particularly troubling, since it could mean that clinical trials for patients with no remaining treatment options are halted because of unrelated political disputes. Years of work could be erased, taxpayer dollars wasted, and promising therapies never reach the patients who need them most. 

Agencies are required to submit implementation plans by September 6, and until those are made public, scientists and institutions remain in limbo. What is already clear is that the order marks a profound shift away from the principles of independence and merit that have guided federal research for decades. Its impact could shape how science is funded in the United States for years to come. 

Supreme Court Allows NIH Grant Cuts Targeting DEI and Public Health Research 

-Blake William Rostine 

On August 21, the Supreme Court ruled 5–4 to allow the administration to move forward with canceling more than $780 million in National Institutes of Health (NIH) grants that had been targeted for termination under the administration’s ban on projects tied to diversity, equity, and inclusion (DEI) and certain COVID-19–related efforts. The decision overturns a lower-court order that had blocked the cuts, leaving more than 1,200 research projects without federal support. 

The ruling is not a final judgment on the legality of the cancellations, but it means that affected researchers will not see funding restored while litigation continues. Grant recipients and 16 Democratic-led states have argued that halting studies midstream will cause “incalculable losses in public health and human life,” citing canceled projects on heart disease, HIV/AIDS, Alzheimer’s, substance use, and mental health. Scientists warn that abruptly ending studies destroys data already collected and can derail entire research careers. 

Chief Justice John Roberts joined the Court’s three liberals in dissent. In her opinion, Justice Ketanji Brown Jackson condemned the decision as “neutering judicial review” and forcing plaintiffs into “a likely futile, multivenue quest for complete relief.” She warned the ruling could have “profound consequences,” including shuttered labs and even the euthanasia of animals used in ongoing experiments. 

The administration has defended the cuts as consistent with executive orders banning federal funding for what it calls “DEI” initiatives and “gender ideology extremism.” Solicitor General John Sauer argued that disputes over terminated grants should be heard in the U.S. Court of Federal Claims, which can award damages but is unlikely to reinstate funding in time to save disrupted projects. 

For now, the Supreme Court’s decision leaves thousands of scientists without critical resources and signals a willingness by the justices to defer to the administration on research funding. The broader legal battle will continue in lower courts, but the immediate effect is clear: Hundreds of biomedical studies have been stripped of NIH support, with potentially lasting consequences for patients and public health. 

CDC in Turmoil After Director’s Ouster and Resignations 

-Carly McCallie 

On August 28, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., announced that Centers for Disease Control and Prevention (CDC) Director Susan Monarez was “no longer director” of the agency, less than a month after she was confirmed by the Senate. Monarez, a career scientist with decades of public health experience, had resisted Kennedy’s demands to dismiss senior staff and approve controversial vaccine directives. Her attorneys argue the dismissal was unlawful, as only the president can remove a Senate-confirmed appointee. 

Her removal triggered immediate resignations from senior CDC leaders including Chief Medical Officer Debra Houry, National Center for Emerging and Zoonotic Infectious Diseases Director Daniel Jernigan, and National Center for Immunization and Respiratory Diseases Director Demetre Daskalakis. Collectively, their departures represent decades of expertise in outbreak response, vaccine policy, and disease surveillance. 

The upheaval has drawn bipartisan concern on Capitol Hill. Senator Bernie Sanders (I-Vermont), ranking member of the HELP Committee, has called for a bipartisan congressional investigation into Kennedy’s handling of the agency. Senate HELP Chair Bill Cassidy (R-Louisiana) has already urged postponement of the CDC’s vaccine advisory panel meeting, warning that its legitimacy is in question following Kennedy’s installation of vaccine skeptics. Senator Susan Collins (R-Maine), who chairs the Senate Appropriations Committee, said Monarez’s firing and the exodus of CDC leaders “will not be easily remedied.” 

The controversy is also expected to dominate Kennedy’s appearance before the Senate Finance Committee next week, where members from both parties are preparing to press him on vaccine policy, the forced departure of Monarez, and the broader stability of the CDC. Finance Committee Democrats have signaled they plan to highlight how the administration’s actions could undermine trust in public health and delay care. Republicans, meanwhile, are divided: some echo concerns about scientific integrity, while others remain aligned with Kennedy and the White House. 

Together, these developments suggest that congressional oversight of the administration’s health policies will intensify in the weeks ahead, with the CDC crisis now a central point of contention in the broader appropriations and health policy debates. 

In the midst of the turmoil, Kennedy has made a series of remarks questioning vaccines and floating unscientific theories, including suggesting he can identify children with “mitochondrial challenges” by sight. Critics say such rhetoric underscores how scientific judgment is being sidelined in favor of ideology. Outgoing CDC official Demetre Daskalakis confirmed that Kennedy has not been briefed by CDC experts on major outbreaks such as measles, flu, or COVID-19 before issuing policy decisions. 

Kennedy has appointed Jim O’Neill, his deputy and longtime ally, as acting CDC director. While O’Neill has past experience in public health policy, colleagues note he is unlikely to challenge Kennedy’s directives. Confirming a permanent successor through the Senate could prove difficult in the wake of the Monarez controversy. 

Former HHS officials and public health leaders have issued stark warnings that the agency’s diminished capacity threatens both current health needs and preparedness for future pandemics. More than 750 current and former federal health employees signed a letter calling Kennedy “an existential threat to public health.” 

The upheaval at the CDC is part of a wider pattern of uncertainty across federal health agencies under Secretary Kennedy. From NIH funding delays to executive orders altering grantmaking, the disruption is creating real risks for the research community. For cancer science in particular, continued progress depends on stable institutions and reliable federal partners. The events of recent weeks underscore how fragile that stability has become. 

Opportunities for Patient Advocates at the AACR Annual Meeting 2026

The AACR is now accepting applications for the 2026 Scientist↔Survivor Program® (SSP) and the Advocate Partners Pavilion, which will be held during the AACR Annual Meeting in San Diego, California, April 17-22, 2026. 

The SSP is a pioneering initiative that connects cancer patient advocates with leading cancer researchers to foster collaboration, education, and dialogue. Through this immersive experience, advocates gain a deeper understanding of cancer science and contribute their perspectives to the research community. 

Selected participants will engage in customized educational sessions, attend scientific presentations, and collaborate with scientists and fellow advocates throughout the meeting. For more information and to apply, please visit the application page. 

In addition, applications are also open for the Advocate Partners Pavilion, an exhibit space that showcases the work and resources of advocacy organizations during the AACR Annual Meeting. Apply online. 

Questions may be directed to [email protected]. 

REGISTER for FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development  

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and the AACR are hosting a hybrid workshop titled “Approach to Novel Oncology Endpoint Development” on Thursday, September 11, 2025, at the Hilton Alexandria Old Town in Alexandria, Virginia. 

This workshop will bring together leading experts from the FDA, academia, industry, and patient advocacy to examine evolving approaches to endpoint development in oncology drug trials. As cancer research progresses and therapeutic strategies become more targeted, there is an increasing need to reconsider traditional clinical endpoints and define new ones that better reflect meaningful outcomes for patients. 

In-person registration is now closed. We welcome you to join us online by registering for virtual attendance. For more details, visit the workshop website. 

FDA Releases Guidances on Clinical Development in Oncology: Radiopharmaceutical Dosing and Approaches to Overall Survival Assessment 

-Brad Davidson, PhD  

On August 19, the FDA released two draft guidance documents recommending best practices for the clinical development of oncology drugs—one outlining dosing approaches for radiopharmaceutical therapies (RPTs), and one outlining approaches for the analysis of Overall Survival (OS) as a clinical trial endpoint. The FDA has had a long history of regulation and community outreach leading up to each of these guidances.  

Approaches to Assessment of Overall Survival in Oncology Clinical Trials 

OS is the gold standard endpoint in oncology trials, reflecting both therapeutic efficacy and safety, and it is often the primary endpoint of registrational trials seeking to generate FDA approval of an anti-cancer drug product. However, in settings where the disease is indolent or survival time is expected to be long, the amount of follow-up needed to adequately assess OS can be impractical. Other issues with the assessment of OS include difficulties interpreting its relevance in single-arm trials, in trials with significant crossover, and in trials where subsequent therapies are not well standardized or monitored, among others. Given its importance but also acknowledging these difficulties, the FDA recommends collecting OS data in all trials, even if only as a secondary endpoint or as a safety endpoint. This is especially relevant since certain therapeutics have recently received accelerated approval on the basis of early efficacy endpoints but were later shown to have OS detriments, leading to subsequent removal from the market.  

In a new guidance, Approaches to Assessment of Overall Survival in Oncology Clinical Trials, the FDA highlights considerations for the analysis of OS when it is not a primary endpoint. Many of the recommendations outlined therein are in line with those proposed at a 2023 workshop jointly organized by the FDA, AACR, and the American Statistical Association and a corresponding manuscript on the use of OS as an endpoint in oncology clinical trials. These recommendations include considerations for the design of clinical trial protocols and use of design elements that can impact the interpretation of OS, including interim analysis plans, unequal randomization, and crossover. It also details considerations for the statistical analysis plan of trials seeking to meaningfully measure OS, including the importance of pre-specification, justification for the timing and length of follow-up as well as analysis timepoints, accounting for intercurrent events, and consideration of assumptions made during sensitivity analyses. The guidance also specifically highlights recommendations for the assessment of harm using OS data and the assessment of OS in trial subgroups, among other topics.  

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development 

RPTs are similar to external beam radiation therapy (EBRT), the typical radiation therapy that cancer patients receive, in their mechanism of action and their ability to be targeted to specific organs but are administered similarly to systemic drug therapies, such as targeted therapies. This means that when determining an optimized dose for RPT therapies, characteristics of both EBRT and systemic therapies apply. While the dosing paradigm for classic EBRT is well established—the maximal dose up to normal tissue tolerances—optimized dosing for systemic therapies has been a source of intense scrutiny. In 2024, the FDA released guidance on dosing for systemic therapies, highlighting that the maximum tolerated dose (MTD) is unlikely to be the most optimized dose for modern targeted oncology drugs, as lower doses may have similar efficacy with less toxicity than higher doses. However, this relationship is not clear for RPTs, meaning that it is not currently known whether using MTD is the optimal approach for dose-finding for RPTs. In the new guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, the FDA outlines that neither MTD nor normal tissue tolerances alone should be used to determine doses selected for RPT trials, instead recommending the use of a totality of data, including other datatypes as well.  

One specific point of concern with dosing for RPT therapies is the potential for radiation toxicities to build up in organs that the therapies are targeted to over time, potentially superseding the typical ERBT-derived normal tissue tolerance, and whether such a dose might actually still be optimized for RPTs. To mitigate the safety concerns associated with such a potentiality, the new guidance specifically calls out how higher doses of RPT should be tested in populations with greater risk for cancer-specific mortality first to decrease the risk of patients experiencing long-term toxicities from treatment, and that previous radiation treatment should be a consideration when determining patient eligibility and overall dose levels for RPT trials. Additionally, because the onset of radiation toxicity can be delayed by years after exposure, drug sponsors must continue to monitor patients for at least five years after their last dose of experimental RPT therapy. Additional considerations for dosimetry, trial design, safety monitoring, and enrolled patient populations can be found in the guidance.   

Comments can be placed online for both the OS guidance and radiopharmaceutical dosing guidance until October 20.  

Notice of Upcoming PCORI Funding Announcement    

The Patient-Centered Outcomes Research Institute (PCORI) intends to issue a PCORI Funding Announcement (PFA) on December 2, seeking to fund high-impact, patient-centered comparative clinical effectiveness research (CER) projects led by researcher and community partnerships to focus on advancing care and outcomes across different phases of the cancer care continuum. PCORI is particularly interested in submissions that address the following Special Areas of Emphasis: 1) Addressing barriers to recommended cancer screening and timely follow-up in the general population and among individuals at high risk of cancer; 2) Improving the delivery of patient-centered, evidence-based care during cancer treatment, and/or 3) Addressing the post-treatment, follow-up care needs of cancer survivors. 

The purpose of the preannouncement is to provide additional time for potential applicants to identify collaborators, obtain patient and other partner input, and develop high-quality proposals. Details regarding the announcement and funding opportunity are available online. 

Oncology Approval Recap  

-Brad Davidson, PhD  

 Between July 25 and August 28, the U.S. Food and Drug Administration (FDA) granted two approvals for novel oncology products, both through the accelerated approval process.  

  • Zongertinib received accelerated approval for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activation mutations who have received prior systemic therapy. This review used the Real-Time Oncology Review program, and this application was granted priority review, breakthrough therapy designation, and fast track designation.  
  • Dordaviprone received accelerated approval for patients 1 year of age and older with diffuse midline glioma (DMG) harboring a H3K27M mutation with progressive disease following prior therapy. This protease activator is the first and only therapy approved for recurrent H3K27M mutant DMG. This application was granted priority review and received orphan drug, rare pediatric disease, and fast track designations.