Cancer Policy Monitor: April 14, 2026
- White House Releases FY 2027 Budget Request, OMB Releases Funds to NIH
- NIH Director Bhattacharya Addresses Funding Concerns in Congressional Oversight Hearing
- AACR Holds 11th Annual Early-Career Hill Day
- Register Today for the 2026 AACR-AACI Hill Day
- Regulatory Science and Science and Healthy Policy Track Sessions at AACR Annual Meeting 2026
- AACR Annual Meeting 2026: Patient Advocate Poster Symposium: Community Outreach and Engagement
- Join Us at the AACR Annual Meeting 2026: Elevating Patient Advocacy in Cancer Research
- Recording Available: Patient Advocate Forum: Artificial Intelligence in Cancer Research, Care, and Survivorship
- AACR Leads Congressional Briefing on Pediatric Cancer Research and Survivorship
- NIH to Reduce Agency-Directed Funding Announcements and Prioritize Unsolicited Grants
- FDA Releases Guidance Documents on New Approach Methodologies and Flavoring in Electronic Nicotine Delivery Systems
- Oncology Approval Recap
White House Releases FY 2027 Budget Request, OMB Releases Funds to NIH
-Matt Gontarchick
Even as the medical research community celebrates its success in securing funding increases for Fiscal Year (FY) 2026, a new budget challenge is already on the horizon. Released on April 1, President Trump’s FY 2027 Budget Request proposes cuts to federal funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI). The proposed FY 2027 NIH funding level of approximately $41.1 billion for NIH represents a 12% cut from the total FY 2026 level of $48.7 billion. While the latest proposal does not match the severity of the proposed 40% cuts to the agency in FY 2026, it still signifies the challenges facing the biomedical research enterprise and the ensuing uncertainty for researchers and patients. The White House also proposed a $9 million increase to NCI FY 2027 from the currently appropriated level of $7.35 billion.
Following sustained advocacy from the medical research community, Congress rejected the president’s proposed cuts to NIH and NCI. For FY 2026, NIH was appropriated $47.2 billion in base program funding, a $415 million increase from the previous fiscal year. Congress also included language in its FY 2026 spending bill to address other administration proposals by blocking changes to indirect costs and capping the number of forward-funded grants awarded in FY 2026 to the same level approved in FY 2025.
The passage of the final FY 2026 bill in January did not bring an immediate end to NIH’s budgetary concerns. The Office of Management and Budget (OMB) delayed the release of appropriated funds for several weeks until finally agreeing to lift the hold on March 16. As a result of the delay, NIH has reportedly obligated only $5.8 billion so far for FY 2026, compared to nearly $9 billion at the same point in FY 2024. This has slowed the pace of grant awards and research funding.
OMB Director Russ Vought is scheduled to appear before the House Budget Committee on April 15 to discuss the administration’s FY 2027 budget request. Additionally, the House and Senate appropriations committees are expected to begin drafting their own spending bills in the coming weeks.
Advocacy will continue to play a critical role in the FY 2027 appropriations process. As negotiations over spending bills get underway, AACR will continue to advocate for robust, sustainable, and predictable funding increases for medical research. The advocacy community urges Congress to provide at least $51.3 billion for NIH and $7.99 billion for NCI in FY 2027.
NIH Director Bhattacharya Addresses Funding Concerns in Congressional Oversight Hearing
-Matt Gontarchick
NIH Director Jay Bhattacharya assured lawmakers that the agency will distribute its full allocation for extramural grants by the end of FY 2026 at a March 17 oversight hearing. His remarks came one day after OMB released its hold on FY 2026 funding appropriated to NIH.
The House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) convened the hearing in response to concerns over OMB’s delay in releasing funds to NIH and the implications for grant recipients. In addition to pledging that NIH would spend down its allocation by the conclusion of FY 2026 on September 30, Director Bhattacharya assured the subcommittee that all grants will be awarded on the basis of scientific merit.
As noted by Rep. Steny Hoyer (D-MD), NIH saw its workforce shrink by 22% due to a series of reductions in force, voluntary buyouts, and retirements carried out by the Trump administration. Recounting how remaining NIH staff “stepped up” last year to ensure all grant funding was distributed, Bhattacharya said his agency is once again prepared to do the same in 2026. He also shared that NIH has a hiring plan in place, though he did not offer specifics.
The hearing was cordial overall, with members of both parties raising mutual areas of concern with Bhattacharya, including rising rates of colon cancer among younger Americans and Alzheimer’s disease. However, several Democratic members expressed concern about actions the Trump administration took at NIH over the past year. Subcommittee Ranking Member Rosa DeLauro (D-CT) admonished the NIH director for the termination of grants for ideological reasons in 2025. She also noted that higher rates of multi-year funding have resulted in two thousand fewer grants awarded in 2025. As a result of these changes, DeLauro warned that fewer students are choosing careers in research and that more early-career investigators in the U.S. are pursuing opportunities abroad.
DeLauro also raised concerns about Bhattacharya’s concurrent role as acting director of the Centers for Disease Control and Prevention (CDC), arguing that NIH and CDC are too important for part-time leadership and that the CDC needs a permanent director whose sole focus is restoring the agency.
In contrast, Subcommittee Chair Robert Aderholt (R-AL) spoke positively about Bhattacharya’s tenure at the helm of NIH thus far. Pointing to the decline of public trust in NIH since the COVID-19 pandemic, he underscored the need for the agency to be a proper steward of taxpayer dollars and to fund good research.
In his opening remarks, Bhattacharya stressed his commitment to increasing both reproducibility and the use of human models in research. Noting that a third of NIH’s extramural grant portfolio flows to just 20 institutions, the director pledged to more evenly distribute research dollars across the country. In an exchange with Rep. Stephanie Bice (R-Oklahoma) on this topic, Bhattacharya said the current system “puts its thumb on the scale” in favor of more prestigious coastal universities, to the detriment of institutions in other regions, such as OU Health in Oklahoma.
The issue of caps on indirect cost reimbursements was also raised by Rep. Andy Harris (R-MD), who pushed back on the 15% cap proposed by the Trump administration last year, arguing instead that a cap around 30%, closer to the median rate among institutions, would be a more appropriate benchmark. In its report accompanying the final Labor-HHS spending bill for FY 2026, Congress included language to block the 15% proposal and instead encouraged consideration of alternative reimbursement models.
AACR Holds 11th Annual Early-Career Hill Day
-Matt Gontarchick
20 AACR Associate Members traveled to Washington, D.C., on March 18 to participate in the 11th annual Early-career Hill Day (ECHD). Hailing from 16 states, these early-stage investigators met with more than 50 congressional offices to advocate for sustained and predictable investment in NIH and NCI. They also expressed concerns facing cancer researchers of all career levels, such as the administration’s growing use of multi-year funding mechanisms and proposed caps on indirect cost reimbursement.
The day before their congressional meetings, the ECHD participants heard from a panel of experts including Meghan Mott, PhD, a staff member of the Senate Appropriations Labor-HHS Subcommittee, who imparted her knowledge of the political environment on medical research funding and shared tips on how to advocate effectively for more public investment in NIH. During the dinner program, the early-career researchers in attendance also heard brief remarks from Brad Davidson, PhD, regulatory science and policy analyst, AACR, who offered his perspective on navigating Capitol Hill as a participant in the 2024 ECHD.
As a sign of support, medical research advocates from across the nation participated in a grassroots National Day of Action concurrent to the ECHD. This resulted in email and phone calls to congressional offices in support of strong NIH funding.
Over the course of the day, the ECHD participants had the opportunity to meet in-person with several members of Congress to convey their gratitude for the continued bipartisan commitment to medical research funding. These members included Senator Jon Ossoff (D-GA), and Rep. Troy Carter (D-LA), Rep. Jim McGovern (D-MA), and Rep. Elissa Slotkin (D-MI).
The next ECHD will occur in February or March 2027. The application period will open by this December, and Associate Members are highly encouraged to apply for this unique and rewarding opportunity to advocate on behalf of early-career investigators in Washington, D.C.
Register today for the 2026 AACR-AACI Hill Day
Registration is now open for AACR and the Association of American Cancer Institutes’ (AACI) Hill Day on May 14. 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.
Regulatory Science and Science and Healthy Policy Track Sessions at AACR Annual Meeting 2026
There is still time to register for the AACR Annual Meeting 2026, which will take place at the San Diego Convention Center in San Diego, California, on April 17-22 with an option for virtual attendance. A major highlight of the Annual Meeting is the Regulatory Science and Policy and Science and Health Policy Tracks, 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 some of these important sessions by following the links below.
*All times are listed in Pacific Time (PT):
Saturday, April 18
- 8-9:30 a.m.: Dose Optimization in Early-Phase Oncology Trials: Implementing the Vision of FDA’s Project Optimus
- 10-11:30 a.m.: Advancing Patient-Centered Clinical Trials: Bringing Trials to Patients and Patients to Trials
- 12:30-2 p.m.: Where Expedited Pathways, Innovation, Safety, and Patient Access Collide: A KRAS Case Study
- 2:30-4 p.m.: Contextual Challenges in Interpreting Performance of Blood-Based Early Cancer Detection Tests
Sunday, April 19
- 1-2:30 p.m.: Approaches to Drug Development for Rare Malignancies
- 3-4:30 p.m.: Researcher Town Hall: Navigating Policy Challenges and Securing Funding
- 4:30-6 p.m.: Modernizing Nonclinical Safety Assessment in Oncology Product Development: Current Progress and Future Directions
Monday, April 20
- 10:15-11:45 a.m.: Strengthening the Oncology Trial Ecosystem Through Operational and Regulatory Innovation
- 12:30-2 p.m.: Cancer Prevention and Screening: Exploring Policy Solutions
- 2:15-3:45 p.m.: Advancing Early-Phase Pediatric Cancer Trials to Turn Promising Agents into Actionable Evidence
- 4-5:30 p.m.: Power in Numbers: Leveraging Adult Data in Pediatric Cancer Drug Development
Tuesday, April 21
- 12:30-2 p.m.: Code Meets Cure: Navigating the Regulatory Landscape of AI in Oncology Drug Development
AACR Annual Meeting 2026: Patient Advocate Poster Symposium: Community Outreach and Engagement
The Patient Advocate Poster Symposium, taking place on Sunday, April 19, from 3-5 p.m., will highlight the role of patient advocates and community partners in advancing cancer research and improving cancer care. The session will feature posters showcasing community outreach and engagement initiatives that strengthen trust, improve understanding of research, and ensure that studies reflect the needs and priorities of patients.
By bringing together patient advocates, community members, researchers, and health care professionals, the symposium will explore how collaborative partnerships can help address the complexities of cancer care and accelerate the translation of research into meaningful benefits for patients.
Learn more online.
Join Us at the AACR Annual Meeting 2026: Elevating Patient Advocacy in Cancer Research
Patient advocates play a critical role in advancing cancer research and improving patient outcomes. The AACR Annual Meeting 2026 offers a wide range of opportunities for advocates to engage with leading scientists, clinicians, policymakers, and fellow advocates through educational programming, networking events, and interactive sessions focused on patient-centered research and care.
The meeting will also feature the Patient Advocate Partners Pavilion and Lounge, which provides complimentary exhibit space for patient advocacy organizations and a central gathering place for advocates to connect, collaborate, and recharge throughout the Meeting.
Together, these programs and resources reflect AACR’s commitment to integrating patient perspectives across the cancer research continuum and fostering collaboration that accelerates progress for patients.
Learn more online.
Recording Available: Patient Advocate Forum: Artificial Intelligence in Cancer Research, Care, and Survivorship
On March 24, AACR convened a virtual Patient Advocate Forum titled “Artificial Intelligence in Cancer Research, Care, and Survivorship: Current Status and What’s Next.” The forum explored how artificial intelligence is being used to analyze complex data, identify patterns, and accelerate discoveries across cancer research and clinical care.
The discussion highlighted areas where AI‑driven research is showing the most promise and examined how these scientific advances may translate into improvements in cancer prevention, early detection, treatment, and survivorship. Speakers also addressed key challenges, including data quality, bias, transparency, and equitable access, and emphasized the importance of incorporating patient advocate perspectives to help guide responsible research and implementation.
Watch the recording online.
AACR Leads Congressional Briefing on Pediatric Cancer Research and Survivorship
-David Zahavi, PhD
On February 26, AACR held a congressional briefing, in partnership with St. Baldrick’s Foundation and St. Jude Children’s Research Hospital, on Capitol Hill to highlight the ongoing need for sustained pediatric cancer research and the needs of pediatric cancer survivors.
The congressional briefing, “Ensuring Sustained Federal Support for Pediatric Cancer Research and Survivorship,” showcased the impacts of congressional investments in pediatric cancer research as well as discussed issues related to pediatric cancer survivorship. The congressional briefing convened acclaimed researchers, patient advocates, and National Cancer Institute representatives to educate Capitol Hill on how bipartisan congressional support for federal funding and key legislation can significantly advance pediatric cancer research, drug development, and improve the lives of pediatric cancer patients and their families. The panel of speakers connected robust federal investment and federal programs to tangible improvements in outcomes for children with cancer and highlighted opportunities to improve pediatric cancer survivorship.
A recording of the briefing is available online.
NIH to Reduce Agency-Directed Funding Announcements and Prioritize Unsolicited Grants
-David Zahavi, PhD
In a significant shift in federal biomedical research policy, NIH is moving away from agency-directed funding mechanisms and placing greater emphasis on unsolicited grant applications. Unsolicited grants, also known as investigator-initiated research, are funding applications developed by scientists based on their own original ideas rather than responding to a specific targeted request from NIH. The change signals a reorientation of NIH’s role from actively steering research priorities through targeted announcements to relying more heavily on the scientific community to define the direction of biomedical research.
NIH Notices of Funding Opportunities (NOFOs), previously referred to as Funding Opportunity Announcements or FOAs, have long served as a primary tool for NIH to direct research funding toward priority areas. NOFOs articulate specific scientific needs, highlight underserved populations, ensure attention to emerging or underfunded fields, and provide review criteria. However, recent data suggest a dramatic reduction in the use of NOFOs. NIH issued an average of approximately 780 such announcements each year between 2016 and 2024, but that number fell sharply to about 73 after Trump took office in 2025 and is now down to fewer than a dozen in early 2026. This amounts to a decline of over 90% in funding calls and reflects a broader policy pivot away from agency-directed science.
The shift toward investigator-initiated research is reinforced by recent administrative changes aimed at reducing barriers to submission of unsolicited grants. In late 2025, NIH eliminated requirements for letters of intent and removed prior approval requirements for large unsolicited applications exceeding $500,000 in direct costs. NIH has said the changes are intended to streamline the application process and encourage broader participation and has framed the reforms as part of a larger effort to “bring greater clarity, consistency, and focus” to its funding ecosystem while prioritizing “the most meritorious science.” On NIH webpages outlining the move to reduce the number of overall NOFOs, it says the “majority of applications to NIH are investigator-initiated” and that this is “a proven, efficient model.” The move away from agency-directed funding amid other ongoing NIH policy shifts indicates a larger transformation of NIH’s funding model towards the research community playing a more central role in identifying scientific opportunities.
For the cancer research community, the diminished use of targeted funding announcements raises several concerns. Historically, NIH-directed strategic and specific funding initiatives have played a significant role in advancing prevention, diagnosis, and treatment. These announcements have been critical for advancing research in areas that may not attract sufficient investigator-initiated attention, such as rare cancers, cancer health disparities, and survivorship. Moreover, funding announcements have been important for coordinating large-scale, multidisciplinary efforts across multiple institutes. NIH has previously maintained a balance between unsolicited grants and targeted funding announcements to ensure both innovation and strategic direction. A dramatic reduction in NOFOs risks less visible research priorities receiving diminished support.
NIH Director Bhattacharya has argued that prioritizing unsolicited grants could enhance innovation by allowing scientists greater freedom to pursue novel ideas unconstrained by agency-defined priorities. As NIH implements these changes, the long-term effects on the biomedical research ecosystem will remain uncertain. Key questions include whether the reduction in agency-directed funding will lead to gaps in critical research areas, how the shift will affect early-career investigators, and how grant review will be impacted.
FDA Releases Guidance Documents on New Approach Methodologies and Flavoring in Electronic Nicotine Delivery Systems
-Brad Davidson, PhD
In March, the U.S. Food and Drug Administration (FDA) released two draft guidance documents that may broadly impact the ongoing development of products relevant to cancer. First, FDA released a guidance titled Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk that discusses FDA’s updated considerations for potential authorizations of flavored electronic nicotine delivery systems (ENDS), such as e-cigarettes. In order to authorize a tobacco product, FDA must determine that it is “appropriate for the protection of the public health,” requiring that the benefits to those who smoke combusted cigarettes outweigh the risks to non-users, particularly youth. The potential benefit for smokers would be derived from switching completely to e-cigarettes, away from combustibles, while the risks for youth and other non-users are derived from a product’s potential to entice initiation of tobacco use. Flavored products have been directly linked to youth e-cigarette initiation and continued use but may also present an attractive smoking cessation tool for smokers. While this may complicate the benefit-risk balance, up until this point, only e-cigarettes with tobacco and menthol flavoring have been authorized by FDA to be sold in the United States. Flavored products with candy, fruit, or spice flavorings are instead commonly sold illicitly. While a recent release of data for 2025 from the National Youth Tobacco Survey shows that e-cigarette use has continued to decline among youth, youth use, especially of flavored products, remains a present danger.
This new guidance indicates that the risk to youth of flavored products varies by the flavor, stating that sweet flavorings have the greatest appeal, and therefore the greatest evidentiary burden to show their appropriateness. It also states that if a flavor is shown to have lower youth appeal, positing spice, coffee, or tea flavors, that the product may be more likely to be appropriate for the public health. The guidance continues to highlight potential study designs that could determine youth appeal to flavored products. Overall, this guidance appears to open the door to marketing authorization for certain flavored e-cigarettes, which had traditionally been denied.
FDA also released a guidance titled General Considerations for the Use of New Approach Methodologies in Drug Development to discuss the use of new approach methodologies (NAMs) for toxicologic studies in regulatory filings and their validation. The advancement of NAMs, which include complex in vitro, 2D in vitro, in chemico and in silico studies, has been a priority of the Administration, with FDA emphasizing their utility in preclinical safety studies.
This guidance outlines that the use of NAMs in regulatory filings seeking drug approval does not need to be limited to formally validated or qualified methods in order to be considered by FDA as part of safety and toxicology studies. It continues to set general principles for the validation of NAMs, which would enhance any technique’s interpretability and therefore potential weight in regulatory decision-making. In short, validating a NAM requires defining a specific context the NAM will be used in and what question it seeks to answer, its relevance to human biology, the technical methodology of the assay, and the purpose the assay is fit for. By defining these parameters, FDA is encouraging the use of NAMs by providing clear expectations to be met by sponsors when designing and implementing NAMs as part of their drug development program.
The guidance on flavored ENDS is open for comment until May 11, while the NAMs guidance is open for comment until May 18.
Oncology Approval Recap
Between February 27 and March 26, the FDA issued three new approvals for oncology drug products as well as three conversions for other indications of these products from accelerated to traditional approval.
- Relacorilant was approved in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
- Nivolumab received traditional approval in combination with doxorubicin, vinblastine, and dacarbazine for patients 12 years and older with previously untreated stage 3 or 4 classical Hodkin lymphoma (cHL). Nivolumab was also converted to traditional approval after receiving accelerated approvals in 2016 and 2017 respectively for adults with relapsed or refractory cHL after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, as well as after three or more lines of systemic therapy which includes autologous HSCT. Review of the new approval was conducted under Project Orbis with international partners including the Israeli Ministry of Health, Australian Therapeutic Goods Administration, Health Canada, and Swissmedic. This application was also granted priority review and orphan drug designation.
- Teclistamab received traditional approval in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Additionally, a 2022 accelerated approval for teclistamab as a monotherapy in adults with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody was converted to a traditional approval. This application participated in the FDA Commissioner’s National Priority Review Voucher pilot program and the Real-Time Oncology Review pilot program. This application was also granted priority review, and review was conducted under Project Orbis in association with international partners including Health Canada and Swissmedic.