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Cancer Policy Monitor: July 14, 2026

AACR Calls on Research Community to Oppose OMB’s Proposal on Federal Grantmaking

The American Association for Cancer Research (AACR) issued a statement and call to action on Tuesday, June 30, opposing a proposed rule from the White House Office of Management and Budget (OMB) that would substantially revise how federal grants are awarded and managed. AACR warned that the proposal, titled “Regulation for Federal Financial Assistance,” would pose a major threat to the National Institutes of Health (NIH) and its mission to accelerate progress for patients with cancer and hundreds of other diseases.

While OMB has said the proposed revisions are intended to improve transparency, accountability, oversight, and stewardship of taxpayer resources, AACR argued that many provisions would instead increase administrative complexity, create uncertainty for grant recipients, reduce transparency in funding decisions, and undermine the merit-based review processes that have long guided federal research investments.

AACR highlighted several provisions of particular concern to the cancer research community and the broader medical research ecosystem. These include expanded authority for political appointees to review and potentially override expert assessment of scientific merit; new authority to suspend or terminate active awards based on changing political priorities; additional barriers to international scientific collaboration; restrictions that could affect cancer disparities research; and limits on activities essential to scientific publication, conference participation, and dissemination of research findings.

The statement noted that the current framework for federal research funding through agencies such as NIH and the National Cancer Institute has helped fuel transformative advances in cancer prevention, detection, treatment, and survivorship. AACR warned that if the rule is finalized, it would weaken the federal research grant system that has supported U.S. leadership in cancer research and medical science for decades.

As part of its call to action, AACR urged its more than 66,000 members to submit comments opposing the proposal before the July 13 deadline. AACR also called on stakeholders to contact their members of Congress and urge them to exercise their authority to prevent implementation of provisions that could undermine scientific independence, restrict collaboration, disrupt dissemination of research, and threaten progress against cancer and other diseases.

OMB Director Testifies at Congressional Hearing and Faces Questions on OMB’s Proposal on Federal Grantmaking

The same day AACR issued its statement and call to action opposing the Office of Management and Budget’s proposed grantmaking rule, OMB Director Russell Vought appeared before the House Appropriations Subcommittee on Financial Services and General Government for an oversight hearing.

While the proposed rule was not the central focus of the June 30 hearing, it surfaced in several exchanges that echoed concerns raised by AACR and others in the medical research community. Lawmakers questioned Vought about the rule’s implications for scientific merit review, NIH-supported research, active grant termination, implementation challenges, and delays in making congressionally appropriated funding available to agencies.

The proposed rule came up against a broader backdrop of congressional concern about OMB’s role in implementing federal funding decisions. Subcommittee Chair Dave Joyce (R-OH) emphasized in his opening statement that Congress and OMB must work together to ensure federal funds are used as Congress intended, even when the administration disagrees with the intent of certain programs. Subcommittee Ranking Member Steny Hoyer (D-MD) tied that concern more directly to the proposed grantmaking rule, warning that federally funded scientists and researchers could be at risk because of what he described as a political litmus test over a historically nonpartisan, peer-reviewed process.

The most direct discussion came from Full Committee Ranking Member Rosa DeLauro (D-CT), who argued in her opening statement that the proposal would subject federal funding to political tests rather than evidence, science, and merit. DeLauro warned that promising cancer treatments and Alzheimer’s research could lose support for reasons unrelated to scientific merit, calling the proposal “cancel culture for cancer research.”

During questioning, DeLauro asked Vought whether OMB would grant a 45-day extension of the comment period for the 412-page Notice of Proposed Rulemaking. Vought declined to commit to an extension, though he acknowledged that the volume of comments OMB has received would take time to review.

DeLauro also pressed Vought on why OMB or political officials would be better positioned than physicians, researchers, and other experts to judge the merits of an NIH clinical trial. Vought responded that OMB would not formally review every Notice of Funding Opportunity and said grant determinations would be made by policy officials at the agencies. DeLauro pushed back, citing language in the proposal that she said would require senior political appointees, rather than career scientists and program officers, to conduct pre-issuance review of discretionary grants before they are awarded and would prohibit those officials from routinely deferring to peer review recommendations.

Other questions focused on implementation. Rep. Marie Gluesenkamp Perez (D-WA) asked whether agencies were already aligning with the proposed rule before it is finalized and whether OMB is developing artificial intelligence tools to flag grants that do not align with administration priorities. She also raised concerns that restrictions on conference costs and the proposed elimination of fixed amount awards and subawards could increase administrative burdens for smaller and rural organizations. Vought said OMB does not want to create unnecessary burden and that the public comment process is intended to help OMB better understand implementation concerns.

The hearing also previewed how the administration is defending the proposal. Rep. Michael Cloud (R-TX) argued that the rule would add safeguards for taxpayer dollars and help agencies address problematic grants. In response, Vought cited NIH funding involving the Wuhan Institute of Virology as the administration’s clearest example of why it believes agencies need authority to cancel grants midstream. Vought said the proposal would not be “anti-science” and that peer review would remain part of the process.

DeLauro later connected the grantmaking proposal to broader concerns about delayed federal spending. She asked whether OMB had made all congressionally appropriated funding available to agencies so they can obligate and spend the funds Congress has already provided. Vought said OMB was working through that process “expeditiously” but acknowledged that not every apportionment had been completed.

The hearing underscored why both public comments and congressional outreach are important as OMB considers the proposed rule. Comments submitted before the July 13 deadline will help ensure that detailed concerns and real-world examples from the cancer research community are included in the formal administrative record. At the same time, members of Congress need to understand how the proposal could affect the cancer research community and the broader medical research ecosystem that supports progress for patients, particularly if options for addressing the rule after it is finalized prove limited or complicated.

While the comment period closed July 13, discussion of the proposed rule and its potential impact is likely to continue as the administration reviews stakeholder comments and determines next steps in the rulemaking process.

House Appropriations Committee Approves FY2027 NIH Spending Bill

–Matt Gontarchick

The National Institutes of Health (NIH) would receive a roughly $100 million increase under the Fiscal Year (FY) 2027 Labor, Health and Human Services, Education, and Related Agencies appropriations bill approved by the House Appropriations Committee on June 9. The bill advanced by a 34-28 vote and would provide targeted increases for biomedical research even as the overall Labor-HHS allocation is below the FY 2026 enacted level.

Under the bill, NIH would receive $47.316 billion in base program funding, while the National Cancer Institute (NCI) would receive $7.462 billion, a $110 million increase from its FY 2026 level. The bill would also provide $420 million for the Centers for Disease Control and Prevention’s cancer programs and $1.5 billion for the Advanced Research Projects Agency for Health.

The bill includes a manager’s amendment to limit forward-funding of extramural grants in FY 2027 to the level awarded in FY 2025. The biomedical research community supports such guardrails because forward-funding multi-year awards ties up future-year funding upfront, leaving fewer dollars available for new grants each year.

The committee rejected an amendment from Rep. Rosa DeLauro (D-CT), ranking member of the Labor-HHS Subcommittee, who advocated to stop implementation of the Office of Management and Budget’s proposed “Regulation for Federal Financial Assistance” rule, which AACR and other research organizations also are actively opposing. The amendment failed on a largely party-line vote, with Rep. Mike Simpson (R-ID) the only Republican on the committee to vote in favor.

Next steps for the Labor-HHS appropriations bill remain uncertain in the Senate, where topline spending levels remain unresolved. The Senate has not yet released its FY 2027 Labor-HHS bill, and continued disagreements over spending levels could complicate efforts to reach a final agreement. The American Association for Cancer Research urges lawmakers to provide $51.3 billion for NIH and $7.99 billion for NCI in FY 2027.

Register Now: 14th Annual Rally for Medical Research

The 14th Annual Rally for Medical Research will be held September 16-17, 2026, in Washington, D.C., bringing together patients, advocates, researchers, clinicians, and partner organizations from across the country to urge Congress to make funding for the National Institutes of Health (NIH) a national priority.

Launched in 2013, the Rally has grown from a single day of advocacy into an annual nationwide movement calling for robust and predictable NIH funding. This year’s Rally comes at a critical time for the medical research advocacy community, as the White House has proposed a 12% cut to NIH in its FY 2027 budget request.

A participant training and advocate reception will be held September 16, followed by the Rally Hill Day on September 17, when participants will meet with congressional offices to share why sustained NIH funding is essential to advancing medical research, supporting clinical trials, and improving health for patients and families.

Public support for federal investment in medical and cancer research remains strong. A 2025 AACR survey found that 89% of voters favor the federal government using taxpayer dollars to fund medical research, and 83% favor increasing federal funding for cancer research.

Register for the Rally and reserve a room in the hotel block before the September 9 deadline. Please contact Rally organizers with any questions.

AACR Releases Fourth Edition of Cancer Disparities Progress Report on Capitol Hill

–Blake William Rostine

On June 24, AACR held a Capitol Hill briefing to mark the release of the fourth edition of the AACR Cancer Disparities Progress Report, a biennial report first published in 2020 that examines the unequal burden of cancer in the United States and identifies policy opportunities to ensure that advances against cancer benefit all patients.

The briefing brought together members of the cancer research, patient advocacy, and policy communities to discuss the report’s key findings and implications for federal policymakers. Attendees heard from patient advocates featured in the report, as well as experts who discussed the structural, social, environmental, and biological factors that contribute to disparities in cancer incidence, diagnosis, treatment, survival, and quality of life.

The report highlights both meaningful progress and persistent challenges. Since 1991, the overall cancer death rate in the United States has declined by 35%, translating to more than 4.8 million fewer cancer deaths and a growing population of more than 18.6 million cancer survivors. The report also notes encouraging reductions in some cancer disparities, including narrowing gaps in overall cancer mortality between Black and white populations and in cervical cancer mortality between Hispanic and white women.

At the same time, cancer disparities remain a major public health challenge. According to the report, Black and American Indian or Alaska Native individuals continue to have the highest overall cancer death rates of all U.S. racial or ethnic groups. Residents of rural counties are more likely to be diagnosed with and die from colorectal cancer than residents of metropolitan or urban counties, and cervical cancer death rates are higher among women living in persistent-poverty counties.

The report also underscores the importance of continued federal support for cancer disparities research. An AACR survey of cancer disparities researchers found that 93% of respondents have been affected by recent federal policy changes, with many reporting disruptions to funding applications, ongoing research projects, grant support, study personnel, and collaborations. More than half of respondents reported that they have partially shifted away from disparities-focused research or are seriously considering changing their research focus.

The report calls on policymakers to sustain and strengthen federal investments in cancer disparities research, including robust funding for NIH, NCI, and CDC; support data collection initiatives and cancer surveillance systems; ensure that cancer therapies are evaluated in the populations in which they are meant to be used; and expand equitable access to cancer prevention, screening, genetic testing, follow-up care, and clinical trials.

The briefing can be viewed and the entire Cancer Disparities Progress Report 2026 can be accessed online.

NIH Seeks Input on Proposal to Cap the Number of Grants Per Investigator

–David Zahavi, PhD

The National Institutes of Health (NIH) has issued a request for information on a proposal to cap the number of simultaneous Research Project Grants (RPGs) that an individual investigator may hold as a principal investigator or multiple principal investigator. In the June 8 notice, NIH said the proposal is intended to improve stewardship of taxpayer dollars, support workforce sustainability, and distribute funding across a larger number of investigators in order to maximize scientific productivity and innovation. NIH is seeking public comment on whether the cap should be set at two, three, or four RPGs per investigator and for recommendations on implementation. Comments are due August 3.

According to NIH, relatively few investigators hold large numbers of RPGs, and capping simultaneous awards could free up funding for additional researchers and potentially broaden access to NIH support, particularly for early-career scientists. The agency framed the proposal as part of a broader effort to strengthen the biomedical research workforce and rebalance funding across the extramural research ecosystem. However, the proposal was met with mixed reactions across the research community. Some science policy experts view the idea as a potentially meaningful way to spread funding more broadly and reduce the concentration of grants among a small subset of highly funded investigators. Others, however, have raised concerns that a blunt cap could unintentionally penalize productive collaborative scientists, disadvantage investigators leading large multi-project efforts, or create new administrative complications without addressing deeper structural problems in the NIH funding system. Critics have also cautioned that the proposal arrives at a moment of broader instability in the biomedical research enterprise, including declining success rates and uncertainty surrounding NIH funding priorities.

For the cancer research community, the proposal raises important questions about how NIH can best balance support for established, high-capacity research programs with the need to expand opportunities for early-stage investigators and sustain a diverse pipeline of cancer researchers. The RFI signals that NIH is moving forward with another significant shift in grantmaking policy, and researcher feedback is needed to help shape how future funding is distributed across institutions, laboratories, and career stages.

Medicaid Work Requirements Could Threaten Cancer Patients’ Access to Coverage and Care

–David Zahavi, PhD

A new federal Medicaid work requirement could create significant new barriers to insurance coverage for people with cancer, despite lawmaker assurances that cancer patients would not be affected by implementation of the 2025 reconciliation bill, also called the “One Big Beautiful Bill”. On June 1, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule implementing a statutory requirement that certain adults enrolled through Medicaid expansion complete at least 80 hours per month of work, education, or community engagement activities to maintain coverage. States must fully implement the requirement by January 1, 2027, though the rule takes effect on July 31, 2026, and allows states to begin outreach and implementation planning immediately.

The law included a series of exceptions for certain vulnerable populations, including those who are “medically frail.” which included individuals with “a serious or complex medical condition.” However, the CMS ruling narrows how states may apply the “medical frailty” exemption and imposes additional reporting and verification requirements. Under the new CMS rule, a cancer diagnosis itself will not qualify an individual for an exemption, and they instead will only be exempt if they prove their condition “significantly impairs” their ability to comply with the work requirement. Patient advocates argue that this standard will force some cancer patients, including those in active treatment or dealing with debilitating side effects, to repeatedly prove they are too sick to work, while others may feel compelled to keep working 80 hours per month to avoid losing their Medicaid coverage. Because implementation is left up to the states, the specific processes, documentation, and rules will vary significantly depending on where patients live.

In addition, the rule also changes how patients can establish that they qualify for a medical frailty exemption. For an initial implementation period of one year, states may allow beneficiaries to self-attest that they meet the exemption. But beginning in 2028, CMS will phase out that flexibility and require additional documentation for many patients seeking an exemption. Patients will be forced to navigate a two-step process: They would first confirm they are undergoing active treatment and then provide clinical documentation proving their treatment or side effects explicitly prohibit them from working the required hours. For cancer patients, that shift would mean obtaining physician letters, medical records, or other paperwork to demonstrate that their condition significantly impairs their ability to meet the work requirement. Removing the self-attestation option will create new administrative burdens not only for patients already navigating treatment and recovery, but also for already overburdened oncology practices and other providers that may be asked to complete forms and certify patients’ medical status in order to help them maintain coverage.

The CMS ruling would place cancer patients on Medicaid at increased risk of losing access to lifesaving care because of administrative red tape. Research shows that access to Medicaid is associated with better survival for children and young adults with cancer. Implementation of the Medicaid work requirements is estimated to cause 3 million to 7 million expansion enrollees to lose coverage by 2028, underscoring the scale of coverage disruptions cancer patients could face if states do not take aggressive steps to minimize administrative barriers. CMS must revise the rule and give states greater flexibility to protect patients with serious illnesses such as cancer, including by allowing broader self-attestation and less burdensome documentation requirements.

After Delay, FDA Publishes Results of the National Youth Tobacco Survey

–Brad Davidson, PhD

The FDA Center for Tobacco Products (CTP) published its analysis of the 2025 National Youth Tobacco Study (NYTS), showing that tobacco use in youth continued to hit new historic lows year over year in 2025. Only 7.2% of all middle and high school students reported current tobacco use during the evaluated period, with 5.2% reporting the use of e-cigarettes and 2.6% reporting use of combusted tobacco products such as cigarettes. While this is incredible news, more remains to be done, as even these small percentages mean that 2 million youth are still using these harmful products. A concern raised by the report is that nicotine pouch use among youth rose between 2022 and 2025, although it still remains overall low at 1.7%.

This report comes during a strange time for the tobacco control and enforcement community, where there have been significant disruptions due to reductions in force and cuts at federal agencies. While most of the cuts have been restored, with the CDC Office on Smoking and Health level funded in Fiscal Year 2026 and expected to receive similar funding in 2027, and the over 200 FDA CTP staffers who were removed from their roles returning to their posts after legal action by a coalition of state attorneys general, expectations for federal tobacco control agencies remain uncertain. The release of these NYTS results illustrates this. In a typical year, FDA would have issued a press release including analysis of the results of the NYTS months ago, instead of quietly uploading the data from the NYTS onto their website without any notification to the public and allowing external organizations with potential biases to be the first to report and analyze the results. Strong support for continued monitoring of tobacco use habits in youth, such as the NYTS, will be necessary for realizing further public health gains, as despite these strong results and similar decreases in adult tobacco use, it still remains the number one cause of preventable cancer and death in the United States.

HHS Launches Operation TrIAlBlazer to Advance U.S. Leadership in Early-Stage Clinical Research

–Brad Davidson, PhD

The U.S. Department of Health and Human Services (HHS) announced a cross-agency effort known as Operation TrialBlazer to “restore America’s leadership in clinical research, remove unnecessary barriers, and bring more clinical research and investment back to the United States,” said HHS Secretary Robert F. Kennedy, Jr. According to the plan, China’s global share of phase I trials and total number of clinical trials surpassed the U.S.’ in 2021 and 2024, respectively. Australia has also become widely regarded as an ideal location to perform phase I trials. This development is due in no small part to fast trial startup timelines and excellent economic conditions for running trials in these countries. Under the plan, agencies such as the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) have planned significant actions to address these disparities and improve U.S. competitiveness for global clinical trials. For example, FDA released a Request For Information to aid in the development of a pilot program that is aimed at shortening the Investigational New Drug (IND) process, thereby getting drugs into early-stage trials faster. On FDA’s webpage related to Operation TrialBlazer, they also highlight a new guidance on using quantitative systems pharmacology (QSP) modeling for dose selection in first-in-human trials. Both FDA documents are open for comment, with the comment period closing for the Expedited IND program on July 22 and for the QSP modeling guidance on July 24.   

FDA Oncology Center of Excellence Releases 2025 Annual Report

–Brad Davidson, PhD

The FDA Oncology Center of Excellence (OCE) 2025 Annual Report shares a retrospective on the steady progress made during a turbulent year for the agency. Notably, OCE completed or contributed to 70 approval decisions and held 1,277 meetings with sponsors. Among these approvals, 11 were for pediatric cancers, and nine of the 17 novel products approved this year were for orphan-designated indications. The report also highlights the OCE’s continued and significant efforts to collaborate and communicate with the oncology drug development community through 33 workshops or other similar events as well as the release of nine guidance documents and 46 scientific journal articles. Angelo DeClaro, MD, acting director of the Oncology Center of Excellence, also emphasized the ongoing importance of streamlining programs such as the Assessment Aid and Real-Time Oncology Review programs and international collaboration through programs such as Project Orbis in his Director’s Message. You can find the report online.

FDA Releases Multiple Documents on New Approach Methodologies

–Brad Davidson, PhD

In April 2025, FDA released a Roadmap to Reducing Animal Testing in Preclinical Safety Studies, outlining the agency’s stepwise approach for reducing animal testing in preclinical safety studies where scientifically appropriate. In a new article in JAMA, FDA highlighted the steady progress made in the last year towards this goal. Among the steady stream of accomplishments are increased collaboration between FDA and the NIH, including a co-sponsored workshop with international regulatory partners, formalization of the Innovative Science and Technology Approaches for New Drugs (ISTAND) program as a pathway for the validation of new approach methodologies (NAMs), and the release of multiple guidance documents highlighting how FDA intends to apply NAM principles during regulatory review.

The newest addition to these guidance documents released in late May 2026, specifically outlining how NAMs can be implemented across oncology pharmaceuticals. Traditionally, one-month and three-month repeat-dosing studies in animals proceed clinical development of a given therapeutic. This guidance indicates FDA’s willingness to consider and recommendations for alternative approaches to replace the three-month study. The guidance also makes it clear that any specific approach must be tailored to the therapy at hand, and each proposal of alternative approaches will be considered on a case-by-case basis. The guidance can be read online and is open for comment until July 30, 2026.

FDA-AACR Oncology Educational Fellowship: Apply Now!

The FDA-AACR Oncology Educational Fellowship is a program for early career cancer researchers and clinicians designed to increase their experience with oncology drug development and the regulatory review process through targeted educational activities and interactions with experts from AACR and the FDA Oncology Center of Excellence.

Over the course of one year, fellows will participate in virtual educational events on topics to include, among others: INDs, NDAs/BLAs, expedited pathways, clinical pharmacology, biostatistics, clinical trial design, companion diagnostics, novel endpoints, and precision oncology. Fellows are also provided with travel and lodging assistance to attend two in-person events: the AACR Annual Meeting and a capstone event known as Project ODAC Odyssey at the FDA White Oak Campus. The application period for the 2026-2027 edition of the fellowship opened on June 15 and will close on August 3. Learn more and apply.

Oncology Approval Recap

–Brad Davidson, PhD

Between May 29 and June 25, FDA approved five new indications for cancer therapeutics:

  • Palbociclib was approved in combination with trastuzumab and endocrine therapy, with or without pertuzumab, for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
  • Sacituzumab govitecan-hziy was approved in two new first-line indications for triple-negative breast cancer (TNBC). Namely, it was approved a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 targeting immunotherapy, as well as in combination with pembrolizumab for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1. Review of the related application was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration (TGA), Isreal’s Ministry of Health, the Brazilian Health Regulatory Agency, Health Canada (HC), and Switzerland’s Swissmedic.
  • Capivasterib was approved in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation naïve or sensitive prostate cancer. 
  • Belzutifan was approved in combination with pembrolizumab for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate-high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Review was conducted under Project Orbis in collaboration with TGA and HC. This application was granted priority review.

Applications open: Scientist↔Survivor Program® 2027

AACR is now accepting applications for the 2027 Scientist↔Survivor Program® (SSP) which will be held during the AACR Annual Meeting in Orlando, Florida, April 2-7, 2027.

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. 

Questions may be directed to [email protected].

National Cancer Survivor Month 2026 Highlights

AACR recognized National Cancer Survivor Month by highlighting how research advances care and quality of life for people who have faced cancer. AACR remains committed to survivorship research that supports survivors during and after treatment. Learn more.

To extend this focus, AACR has made select Annual Meeting 2026 on-demand recordings on advances in cancer survivorship available to the public. This work also aligns with the continued patient advocate support for the Lainie Jones Comprehensive Cancer Survivorship Act of 2026, which seeks to improve survivorship care by addressing unmet needs across diagnosis, treatment, post-treatment recovery, and long-term health.

Watch the AACR Annual Meeting 2026 Advances in Cancer Survivorship Sessions: