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Cancer Policy Monitor: May 13, 2025

Appropriations Update—President Releases “Skinny” FY2026 Budget Request

Carly McCallie

As expected following a leaked draft in mid-April, the administration released its fiscal year 2026 “skinny” budget request on May 3, outlining deep funding cuts and sweeping structural changes to federal science and health agencies. The proposal calls for reducing the National Institutes of Health (NIH) budget by 40%, slashing funding for the Food and Drug Administration (FDA), and eliminating or consolidating several NIH institutes and centers. A more detailed budget proposal is expected later this month.

The proposed $20 billion cut would shrink NIH’s budget from $47 billion to approximately $27 billion and consolidate its 27 institutes and centers into just eight. Several institutes, including the National Institute on Minority Health and Health Disparities, the National Institute of Nursing Research, and the National Center for Complementary and Integrative Health, would be eliminated entirely. Others would be merged into broader umbrella institutes organized by disease categories or body systems. While the National Cancer Institute (NCI) would not be eliminated, STAT’s recent analysis shows that NCI grant funding has already declined by nearly 10% in 2025, part of a broader $2.3 billion drop in NIH grant awards over the first four months of the year.

In addition to direct funding cuts, the administration has revived its effort to impose a 15% cap on NIH’s reimbursement of indirect research costs. This proposal, blocked in federal court earlier this year, would significantly reduce support for university-based research infrastructure and has drawn strong objections from academic and research institutions across the country.

The FDA would also see a nearly $700 million cut under the proposal, raising concerns about the agency’s ability to review cancer therapies, oversee clinical trials, and meet regulatory timelines amid recent layoffs that affected key personnel involved in the drug and device approval process.

While the NIH and FDA proposals have garnered national attention, they are part of a broader plan to restructure the Department of Health and Human Services (HHS). The administration is seeking to reduce HHS discretionary spending by more than 30% and consolidate multiple agencies and programs into a new entity called the Administration for a Healthy America (AHA). The AHA would absorb select functions from existing agencies, including some related to chronic disease, mental health, and maternal health, but would eliminate many others, including firearm injury research, HIV prevention programs, and services for underserved populations.

Tensions between Congress and the White House have grown in recent days. House Appropriations Committee Chair Tom Cole (R-Oklahoma) has criticized the administration for failing to provide sufficient detail and delaying the release of its full budget. He has also called for the White House to workshop its forthcoming $9.3 billion rescissions package with appropriators before submitting it to Congress, emphasizing the importance of early input and bipartisan collaboration. “We’re in no hurry, but I can get [the cuts] done quicker when the cardinals are involved.”

Signs of bipartisan concern are also emerging in the Senate. During an April 30 Senate Appropriations hearing, Senator Susan Collins (R-Maine) strongly objected to the proposed cap on indirect costs and warned that it may violate existing law. Collins and several of her Republican colleagues reaffirmed Congress’ longstanding bipartisan support for NIH and emphasized the importance of sustained investment in medical research.

The AACR remains deeply concerned about the impact of these proposed cuts on cancer research, scientific discovery, and patient care. The AACR’s advocacy is grounded in the recognition that NIH has long benefited from strong, bipartisan support in Congress, support that has driven decades of progress against cancer and positioned the United States as a global leader in biomedical innovation. The AACR continues to remind lawmakers of that shared legacy, underscoring what is at stake for patients and families and ensuring that federal investment in lifesaving research remains a national priority.

Senate HELP Committee to Hold Hearing with Secretary Kennedy on FY2026 HHS Budget

Carly McCallie

On Wednesday, May 14, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing with U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., to examine the administration’s proposed budget for fiscal year 2026. This marks the first time in over two decades that an HHS Secretary will testify before the HELP Committee on a presidential budget request.

The hearing follows an earlier invitation from HELP Committee Chair Bill Cassidy (R-Louisiana) and Ranking Member Bernie Sanders (I-Vermont), who requested Kennedy’s appearance on April 10, shortly after the Secretary ordered the termination of more than 10,000 federal health employees and announced sweeping structural changes across HHS. That proposed hearing did not move forward because Kennedy did not confirm his attendance, and no formal notice was issued within the required timeframe. The delay drew attention to Kennedy’s previous pledge, made during his Senate confirmation, to appear quarterly before the committee if requested.

The FY26 budget proposal includes deep cuts to domestic discretionary spending, including significant reductions to biomedical research, disease prevention, and regulatory programs. The NIH, CDC, and FDA are among those most affected. All three have experienced major leadership changes in recent weeks, including the departure of several senior officials and institute directors.

While the hearing is officially focused on the FY26 budget, it is also expected to give Secretary Kennedy an opportunity to address his department’s recent reorganization. Chair Cassidy has previously said this topic deserves a full accounting before the committee.

The AACR will be closely monitoring the hearing as part of its ongoing advocacy to protect scientific integrity and ensure sustained federal investment in lifesaving cancer research.

Senate Appropriations Committee Hearing Underscores Urgent Need to Reverse NIH Cuts and Protect America’s Leadership in Biomedical Research

-Carly McCallie

On Wednesday, April 30, the Senate Appropriations Committee held a full committee hearing to examine the growing threat to U.S. scientific progress posed by the administration’s cuts to the National Institutes of Health (NIH) and other key research agencies, with members on both sides of the aisle voicing deep concern about the future of U.S. science and innovation. Lawmakers warned that continued layoffs, grant cancellations, and political interference are already disrupting the nation’s scientific progress and jeopardizing America’s global leadership in medical research and discovery.

The hearing was led by Senator Susan Collins (R-Maine) and Senator Patty Murray (D-Washington), whose bipartisan partnership anchored a forceful examination of the consequences of cutting federal research funding during a time of scientific promise and uncertainty and led a wide-ranging discussion on the future of the NIH, NCI, FDA, and the biomedical workforce.

A Call to Action from the Cancer Research Frontlines

Dr. Barry Sleckman, director of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham and a member of AACR’s Science Policy and Government Affairs Committee, testified about the critical role of federal funding in cancer research, highlighting how Alabama’s only NCI-designated comprehensive cancer center delivers cutting-edge care made possible by NIH and NCI support. He emphasized how this funding enables access to lifesaving treatments across the region. Holding up a photo of nine cancer patients who had once faced terminal diagnoses, he reminded the Committee what’s at stake when clinical trials are delayed or canceled due to instability in funding.

“These patients are young and old, men and women, Black and white—but they are all healthy, happy, and cancer-free. Some have been for more than a decade. This is why we do what we do. And none of it would be possible without the NIH and NCI.”

Warning Signs for American Science

Dr. Sudip Parikh, CEO of the American Association for the Advancement of Science (AAAS), delivered a stark warning about the consequences of underfunding and destabilizing the U.S. scientific enterprise. As a former NIH researcher and Senate appropriations staffer, Parikh brought both technical expertise and policy insight to the hearing. He described how sudden grant cancellations, slowed obligations, and leadership uncertainty are already paralyzing the research community, with young scientists questioning whether to stay in the field.

“The scientific community is in paralysis,” Parikh said, noting that NIH grant funding has already dropped by $2.3 billion in the first months of 2025 compared to prior years. “We can’t let the passive failure to obligate appropriated funds become a way of cutting science by default,” he stated. He also warned that if the proposed cuts go through, “we will have lost the race with China.”

Parikh concluded with a warning: once the system breaks, it cannot easily be rebuilt. “It took generations to build it. . . and if we allow it to collapse, we won’t be able to put it back together next year.”

Rural Research at Risk

Dr. Hermann Haller, president of the Mount Desert Island Biological Laboratory in Bar Harbor, Maine, testified about how federal investment has transformed his rural institution into a nationally respected research center. A physician-scientist and kidney specialist, Haller described how labs like his rely on NIH support not only for research, but to train students and sustain local scientific infrastructure. He warned that the proposed 15% cap on indirect costs would be devastating for institutions without tuition revenue or large endowments. Haller emphasized that the proposed cap would jeopardize not just his institution, but independent research labs across the country—placing lifesaving research at risk.

“The proposed cap endangers our work and the work of all the other independent research institutions,” he said, “and we will not be able to participate in life-saving research and biomedical breakthroughs.”

The Role of FDA in a Thriving Research Ecosystem

Dr. Cartier Esham, executive director of the Alliance for a Stronger FDA, testified about the critical role of the Food and Drug Administration in translating biomedical research into real-world treatments. Representing a coalition of more than 150 patient groups, professional societies, and industry leaders, she emphasized that innovation in medical research cannot succeed without a strong and well-resourced regulatory agency. Esham warned that proposed funding cuts to the FDA would slow the review of new therapies and undermine the confidence of patients, investors, and small biotech companies working to bring forward lifesaving treatments.

“FDA’s scientific expertise and regulatory capacity are foundational to ensuring that new medical technologies are safe, effective, and accessible,” she said.

A Mother’s Story: “These Moments Aren’t Guaranteed”

Emily Stenson, a mother of three and patient advocate from Washington state, testified about how federally funded cancer research saved her daughter’s life. Her five-year-old daughter, Charlie, was diagnosed with stage 4 germ cell cancer at just three years old. After relapsing, Charlie enrolled in three clinical trials at Seattle Children’s Hospital—studies supported by the National Cancer Institute’s pediatric research programs.

“We faced chemotherapy shortages, anaphylactic reactions, and terrifying setbacks. But because of clinical trials and federally supported research, Charlie is now cancer-free and back to chasing her siblings. These moments aren’t guaranteed. They are made possible because Congress chose to invest in science.”

With Republicans holding the majority in Congress, several GOP senators used the hearing to deliver some of the most direct and consequential criticisms yet of the administration’s biomedical research policies. Their remarks sent a clear message: Protecting the NIH, NCI, and FDA is a bipartisan priority—and a national imperative.

Senator Susan Collins (R-Maine) used the hearing to deliver one of the strongest rebukes to date of the administration’s biomedical research policies. A longtime champion of the NIH, Collins warned that the firing of over 1,000 NIH staff and proposed budget rescissions are threatening the very infrastructure that sustains U.S. leadership in science. “These actions put our leadership in biomedical innovation at real risk and must be reversed,” she said. She also singled out the administration’s effort to cap indirect research costs, saying the plan violates current law. “While some reform of the facilities and administrative system may be merited, these one-size-fits-all caps will be extremely harmful to many institutions,” she warned. Collins noted that China is rapidly advancing in biomedical research and warned that the United States cannot take its global leadership for granted. She also emphasized the human cost of continued instability. “If clinical trials are halted, research is stopped, and laboratories are closed,” she said, “effective treatments and cures for diseases like Alzheimer’s, type 1 diabetes, childhood cancers, and Duchenne’s muscular dystrophy will be delayed or not discovered at all.”

Senator Jerry Moran (R-Kansas) described NIH funding as one of the most hopeful and unifying things Congress provides. “There are few things Congress does that provide as much hope as NIH funding,” he said. Moran, who has long championed steady, bipartisan increases for NIH, emphasized that biomedical research is not just a budget line. It is a commitment to patients, scientists, and the nation’s global leadership in innovation.

Senator Katie Britt (R-Alabama) emphasized the importance of sustained investment in research that saves lives. “Smart investment and continued research is essential to make sure we can save lives,” she said. As a new member of the Committee, Britt is quickly emerging as a strong supporter of the NIH and NCI, reinforcing that the fight against cancer transcends politics and has real consequences for families in every community.

Senator Lisa Murkowski (R-Alaska) shared that her nephew, a college student who wants to study ALS, now questions whether there will be a future for him in science. “He’s not sure if there’s going to be a future in it,” she said, illustrating how uncertainty created by federal funding disruptions is already affecting young people and career decisions.

While most GOP members voiced strong support for NIH, not all were aligned. Senator John Kennedy (R-Louisiana) pressed witnesses about indirect cost reimbursements, questioning whether federal rates should be capped. In response, Dr. Sudip Parikh explained that these funds are not overhead luxuries but essential supports for safety, compliance, and clinical trial infrastructure.

Senator Collins noted that the hearing was the first in a two-part series. A second hearing, expected in May, will call administration officials to testify about the budget cuts, staffing reductions, and policy decisions already impacting the NIH, FDA, and broader biomedical research ecosystem.

Just two days after the hearing underscored bipartisan alarm over the state of U.S. biomedical research, the administration released its FY26 budget proposal, a sweeping plan that would slash discretionary funding for the Department of Health and Human Services by 26%. The proposal includes nearly $18 billion in cuts to the NIH, a $3.6 billion cut to the CDC, and significant reductions across the Department of Health and Human Services. The budget would eliminate several NIH institutes, consolidate others, and reshape agency priorities around the “Make America Healthy Again” agenda. The timing and scale of these proposed cuts reinforce the urgency of the April 30 hearing and the importance of continued bipartisan oversight and advocacy in the critical weeks ahead.

The AACR submitted a statement for the record to the Committee for the hearing urging Congress to reject the administration’s proposed cuts and recommit to strategic, bipartisan investment in biomedical science. The statement highlighted the long history of bipartisan support for the NIH and NCI, underscored the risk of losing a generation of early-career scientists, and called for at least $51.3 billion for the NIH and $7.934 billion for the NCI in FY2026. The AACR emphasized that progress in the fight against cancer is not guaranteed—it depends on predictable funding, a stable research environment, and continued commitment across party lines.

Read the AACR’s full statement for the record.

As the leading voice for the cancer research community, the AACR continues to advance robust and strategic advocacy efforts to protect the NIH and NCI, defend scientific integrity, and sustain progress against cancer. Throughout the past several months of funding freezes, grant cancellations, and administrative interference, the AACR has been working with lawmakers on both sides of the aisle to ensure that the voices of researchers, clinicians, and patients are heard. Through direct engagement with Congress, coalition leadership, public testimony, and national advocacy events like the AACR-AACI Joint Hill Day (May 21–22) and Rally for Medical Research Hill Day (September 17–18), the AACR is working to turn bipartisan concern into action that protects patients, researchers, and the future of lifesaving science.

A Wake-Up Call for the Nation: 60 Minutes Spotlights the Consequences of NIH Cuts  

-Carly McCallie

On April 27, 60 Minutes aired a sobering segment highlighting the devastating toll that recent cuts to the National Institutes of Health (NIH) are taking on patients, researchers, and the future of American science. Featuring former NIH Director Dr. Francis Collins, the story gave a national audience an unflinching look at how political decisions are reverberating across the medical research ecosystem and putting lives at risk.

Dr. Collins, who led the NIH under Presidents Bush, Obama, and Biden, underscored the gravity of the moment: “You can’t just go in and decide, ‘I’m going to shut those [clinical trials] down and maybe I’ll try something else.’ Those are people’s lives at risk.” He also revealed that NIH scientists had been barred from speaking publicly, describing his decision to retire as necessary in the face of an “untenable” environment. His remarks echoed what the cancer research community has been warning for months. These cuts are not abstract; they are halting progress, dismantling infrastructure, and endangering patients who depend on scientific innovation.

The segment detailed the scope of the damage. More than 1,300 NIH employees have been fired, over $2 billion in research grants have been canceled, and clinical trials for Alzheimer’s, cancer, and other life-threatening conditions have been delayed or abandoned. A leaked budget proposal from the administration calls for a 40% cut to the NIH, roughly $20 billion. This would be the most severe proposed rollback in the agency’s history. That same draft includes plans to consolidate the NIH’s 27 institutes and centers into just eight and eliminate several, including those focused on nursing research and minority health.

The program also drew national attention to proposed caps on facilities and administrative (F&A) cost reimbursement. Critics have attempted to frame these costs as wasteful overhead, but universities warn that reducing them would severely compromise their ability to conduct research. As Dr. Collins explained, more than 80% of the NIH’s budget flows to institutions across the country, supporting laboratories, core facilities, compliance infrastructure, and research personnel, especially early-career scientists. Stripping this support would cripple discovery and erode America’s research capacity from within.

But this is not just a research crisis; it is a human one. 60 Minutes profiled Beth Humphrey, a 68-year-old grandmother diagnosed with Alzheimer’s and participating in an NIH-funded clinical study now in jeopardy. “When that hope of a possible treatment is taken away,” she said, “you’re left with nothing but the disease.”

The story also featured Kristin Weinstein, a PhD candidate at the University of Washington studying cancer and autoimmunity. With hiring freezes and funding uncertainty, she and her family are now considering leaving the United States to continue her work abroad. A recent Nature survey found that 75% of U.S. scientists are contemplating relocation, and other countries are actively recruiting American talent in response.

As Collins emphasized, NIH-funded research does more than save lives—it drives economic growth. “Every dollar that NIH gave out in 2024 to a grant is estimated to have returned $2.46 just in a year,” he said. Yet even with that level of return on investment, the agency remains in the crosshairs of aggressive downsizing. Newly confirmed NIH Director Dr. Jay Bhattacharya has said the proposed cuts represent “the beginning of a negotiation,” but has not outlined a clear plan to maintain research continuity. Meanwhile, new NIH directives have raised additional concerns, including potential grant ineligibility for institutions with DEI programs or certain foreign policy positions, prompting further alarm about politicization of funding decisions.

With canceled grants, eroded institutional support, and growing uncertainty about the NIH’s direction, the future of American science hangs in the balance. This national broadcast should serve as a call to action. Advocates must continue to speak out, educate lawmakers, and mobilize the public. The future of cancer research, and the lives of millions, depend on it.

The AACR remains committed to protecting the integrity of science, preserving robust federal investment in medical research, and ensuring continued progress for patients. As challenges to NIH funding and stability continue to grow, the AACR continues to work alongside policymakers, partner organizations, and the broader research community to advocate for policies that support discovery, innovation, and improved outcomes for all those affected by cancer.

New NIH Acting Directors Named Amid Reorganization and Uncertainty

-Carly McCallie

On April 25, the National Institutes of Health (NIH) announced six new acting directors to lead key institutes, many of them stepping in to fill roles left vacant by recent terminations and reassignments under the administration’s sweeping reorganization of the Department of Health and Human Services (HHS).

The appointments come in the wake of a large-scale reduction-in-force that affected more than 1,200 NIH employees and eliminated or reshuffled leadership across multiple institutes and centers. These changes are part of a broader restructuring effort outlined in a draft budget proposal that would consolidate the NIH’s 27 institutes and centers into just eight, with plans to eliminate four entirely, including the National Institute of Nursing Research (NINR) and the National Institute on Minority Health and Health Disparities (NIMHD).

Despite the uncertainty surrounding the future of these institutes, the newly appointed acting directors bring deep institutional knowledge and longstanding NIH experience to their roles:

  • Courtney Aklin, a clinical psychologist and former acting associate deputy director of the NIH, will lead the NINR.
  • Alison Cernich, a neuropsychologist and deputy director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development since 2019, will now serve as its acting director.
  • Monica Webb Hooper, previously deputy director of the NIMHD, will step in as acting director of the NIMHD, taking the helm as the administration continues to defund health disparities research and projects linked to diversity, equity, and inclusion.
  • Andrea Beckel-Mitchener, who played a key role in the NIH BRAIN Initiative, will serve as acting director of the National Institute of Mental Health.
  • Carolyn Hutter, known for her leadership on The Cancer Genome Atlas and most recently director of the NIH’s Office of Strategic Coordination, will lead the National Human Genome Research Institute.
  • Jeff Taubenberger, a virologist recognized for sequencing the 1918 influenza virus, will now lead the National Institute of Allergy and Infectious Diseases. He replaces Dr. Jeanne Marrazzo, who was placed on administrative leave after succeeding Anthony Fauci in 2023.

The appointments were announced internally via email from the NIH Executive Secretariat, which described the new leaders as “distinguished colleagues” and encouraged staff to welcome them to their roles. However, the long-term futures of several of these institutes and their acting directors remain unclear as the administration moves forward with its “Make America Healthy Again” agenda, led by HHS Secretary Robert F. Kennedy, Jr.

The proposed NIH reorganization would centralize key administrative functions and shift scientific priorities to align with political directives, including increased funding for autism research and a renewed focus on chronic disease, while sidelining longstanding agency initiatives in behavioral health, infectious disease preparedness, and health equity.

The AACR remains deeply concerned about the continued erosion of scientific leadership and the growing uncertainty facing intramural and extramural research communities. As new acting directors take on expanded responsibilities during this period of upheaval, their ability to sustain critical research infrastructure and support early-career scientists will be vital to preserving the agency’s capacity to deliver breakthroughs that improve and save lives.

Policy and Regulatory Sessions from the AACR Annual Meeting 2025 Now Available for Streaming

The AACR Annual Meeting 2025 brought together more than 22,000 scientists, clinicians, advocates, and policymakers from 81 countries for five days of groundbreaking science and critical dialogue. With hundreds of sessions spanning the latest in cancer biology, clinical trials, and public policy, this year’s meeting underscored both the momentum of scientific discovery and the mounting challenges confronting the research community. To ensure attendees can catch up on what they missed or revisit the most impactful moments, registrants have access to all recorded sessions through on-demand streaming until October 31, 2025.

The track featured the following sessions:

  • Bridging the Gap: Ensuring a Broad Representation of Patients in Cancer Clinical Trials
  • Rising Rates of Early-Onset Cancers: Understanding the Shift and Exploring Solutions
  • What Defines the Gold Standard for Validating Blood-based Cancer Tests?
  • Cancer Research at a Crossroads: Sustaining Progress Against Cancer for the Benefit of Patients
  • Regulatory Trends Shaping the Future of Cancer Drug Development
  • Molecular Tumor Profiling for Pediatric Oncology
  • Implementing Multi-Regional Clinical Trials (MRCTs) for Cancer Research in an Evolving World
  • Modernizing Performance Statistics for Clinical Validation of Blood-based Cancer Screening Tests

While many sessions focused on regulatory frameworks, diagnostics, and clinical trial innovation, Cancer Research at a Crossroads addressed a broader and more urgent concern: the fragility of the biomedical research system itself and what is needed to sustain progress for patients. This session brought together researchers, former federal leaders, early-career scientists, and patient advocates for a candid discussion about the growing instability across the biomedical research enterprise. Panelists included then AACR President Dr. Pat LoRusso, former NIH Director Dr. Monica Bertagnolli, former NCI Director Dr. Kimryn Rathmell, Dr. John Wherry of the University of Pennsylvania, Dr. Cody Wolf of the University of Virginia, former NBC correspondent and breast cancer survivor Kristen Dahlgren, and leukemia and lymphoma survivor Dr. Larry Saltzman.

Dr. LoRusso opened the session by reflecting on both the extraordinary momentum in cancer research and the mounting challenges facing the systems that support it. She pointed to halted trials, hiring freezes, and growing pressure on how science is framed as signs of broader instability. “The science is not failing. Researchers are not failing,” she said. “It is the system we rely on that is faltering.” Most critically, she reminded attendees what is at stake: “Behind every delay, every cancellation, and every missed opportunity is someone whose life might depend on what we discover next.”

The session made clear that the future of cancer research is at a tipping point. The scientific breakthroughs of today are built on decades of sustained investment, public trust, and a stable research environment. That foundation is now showing serious cracks. Without action, the consequences will be measured not just in lost opportunities, but in lives. Progress depends on more than discovery. It depends on protecting the institutions, policies, and people that make that discovery possible. At this critical moment, the cancer research community must speak out, show up, and do everything it can to ensure that science continues to move forward for the patients who are counting on it.

Tobacco Control Takes a Big Hit in April 1 Reductions in Force

-Brad Davidson, PhD

As part of an April 1 Reduction In Force (RIF), which brought the total number of Department of Health and Human Services (HHS) employees cut since January 2025 to 20,000, critical governmental tobacco regulatory bodies were weakened or eliminated. These offices, namely the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP), and Centers for Disease Control and Prevention (CDC) Office of Smoking and Health (OSH) have helped contribute to a precipitous decline in smoking and vaping. For example, according to CDC data, youth smoking hit its lowest level ever recorded in 2024 at 1.8%, and youth e-cigarette use has continued to decline since its 2019 peak.

The FDA CTP typically performs premarket review of tobacco products seeking to enter the market, enforces tobacco advertisement restrictions, and runs public health efforts to prevent youth uptake of smoking, among other roles. Recently, the FDA’s “The Real Cost” smoking and vaping prevention programs were lauded as a success by an FDA news release, highlighting that it prevented nearly 450,000 youth from starting to use e-cigarettes between 2023 and 2024. However, the CTP was significantly remodeled on April 1 after the removal of top officials such as Brian King, director of the CTP, and Matthew Farrelly, director of the CTP Office of Science. Others were also removed, including some that supported the successful “The Real Cost” campaign as well as tobacco enforcement workers.

The CDC OSH was the lead federal agency for comprehensive tobacco prevention and control. Some of the main priorities of the OSH included measuring tobacco use in the U.S. to encourage policy development, financially supporting state and federal tobacco control programs, educating the public about the dangers of tobacco products, and helping tobacco users quit. A recent success of the CDC OSH was that their education campaign, “Tips From Former Smokers,” spurred 16 million smokers to make a quit attempt. This office was entirely eliminated. If this office does not return, states will face significant funding cuts to their tobacco control efforts, it will become more difficult to track tobacco use trends, and smokers will lack support in their attempts to quit.

The full extent of the layoffs is not yet clear and plans to rebuild these offices have not yet been revealed. Some congressional representatives, led by Dick Durbin (D-IL), have indicated in a letter to leaders at HHS that these changes will “make Americans sicker and cause more tobacco-related deaths, diseases” and have requested an explanation of the scope of and reasoning behind the changes.

FDA Center for Biologics Evaluation and Research Is Under New Management 

-Brad Davidson, PhD 

Vinay Prasad, MD, has been chosen to lead the FDA Center for Biologics Evaluation and Research (CBER), which oversees the regulation of medical products including vaccines, cell therapies, and gene therapies. He takes over as CBER director weeks after the resignation of former CBER director Peter Marks, MD, PhD, who left the agency over concerns about the future of vaccine policy within the U.S. Department of Health and Human Services (HHS). Prior to his role at the FDA, Prasad was a professor of epidemiology and biostatistics at the University of California, San Francisco and trained in hematology and medical oncology at the National Cancer Institute and National Institute of Health. He is a prolific creator of scientific content, having written over 500 articles and two books while running multiple blogs and a podcast.    

Prasad has a significant history of disagreeing with FDA decisions on topics including COVID vaccine and oncology approvals in the name of increased scientific rigor and transparency. He has long spoken out against the use of surrogate endpoints in clinical trials in favor of overall survival, an endpoint that is the traditional gold-standard indicator of patient benefit. Recently, Prasad participated in the public comment portion of a meeting of the FDA Oncology Drug Advisory Committee (ODAC), where the committee recommended the use of minimal residual disease (MRD) as a surrogate endpoint to support accelerated approval of therapeutics for multiple myeloma. In contrast, Prasad indicated that he did not think that this decision was appropriate. He posited that multiple myeloma is not a setting that should be considered for accelerated approval due to its long median survival time of ~10 years, and that the use of MRD as an endpoint would lead to the approval of active but toxic agents. He specifically called out some CAR-T cell therapies, which he now presides over, as rushed to FDA approval and marketed without thorough validation. He is an advocate for the use of randomized controlled trials (RCTs) as the vehicle for drug approval, and has particularly stressed the importance of appropriate control arms and post-progression treatment within RCTs. He is also a past critic of precision oncology approaches, downplaying the benefits they provided to patients with cancer.    

However, surrogate endpoints are being used more and more frequently in the approval of cancer drugs. This has helped spur innovation and improved some patient outcomes by allowing for the earlier approval of drugs that treat serious and life-threatening conditions. Additionally, running flexible trials, not always with randomized controls, has helped provide therapeutic options for patients with rare diseases. Precision oncology drugs also now constitute the majority of drugs approved for oncology indications and have provided significant patient benefit. The interplay between the current regulatory environment and Prasad’s views will be critical for drug development in the coming years.    

NCI Annual Report Highlights Decline in Cancer Deaths

-Matt Gontarchick

Cancer death rates decreased 1.7% annually for men and 1.3% annually for women between 2018 and 2022, according to latest edition of the Annual Report to the Nation on the Status of Cancer. First published in 1998, this annual report from the National Cancer Institute (NCI) tracks both short-term and long-term trends in cancer as well as rates and trends for the most common cancers.

Between 2018 and 2022, the report found that 12 of the 19 most common cancers in men and 14 of the most common cancers in women saw decreases in mortality, with the death rate for lung and bronchus cancer in both men and women dropping the most. However, during this period, death rates for cancers of the pancreas, bones, and non-melanoma skin cancer grew in men, while women saw higher death rates for cancers of the liver and uterus. Both men and women also saw a higher death rate for cancers of the oral cavity and pharynx.

The report also found a decline in mortality rates for pediatric cancer. From 2001 to 2022, cancer death rates declined by an average for 1.5% each year for children. Among adolescents and young adults, mortality rates for cancer decreased by 2.9% from 2001 to 2005, while remaining steady from 2020 to 2022.

Of note, this year’s report is first to assess the impact of the COVID-19 pandemic on cancer diagnoses. Due to disruptions to the health care system, the rates of late-stage cancer diagnoses increased slightly in 2020 and then decreased slightly in 2021. In particular, the months of March, April, and May saw the lowest rates of new cancer cases in 2020. Among men, new cases for colon cancer and melanoma saw the largest drops in 2020, while thyroid, stomach, and lung cancers saw the most prominent declines in new cases among women that year.

Oncology Approval Recap

Between March 29 and April 24, the U.S. Food and Drug Administration (FDA) granted four new oncology approvals, all for cancer immunotherapy agents.  

  • Penpulimab-kcqx was approved with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) and for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based therapy and at least one other prior line of therapy as a single agent. This application was granted fast track designation, breakthrough designation, and orphan drug designation.
  • The combination of nivolumab with ipilimumab was approved for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma. This is the ninth indication for the combination of nivolumab with ipilimumab, and the seventh for nivolumab in a first-line setting. This application was granted orphan drug designation. 
  • The combination of nivolumab with ipilimumab was approved for patients older than 12 years of age with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). This review was conducted under FDA’s Project Orbis framework for concurrent review of oncology drug products among international partners, including the Brazilian Health Regulatory Agency (ANVISA), the Israel Ministry of Health (IMoH), and Health Canada (HC).
  • Nivolumab was converted from accelerated approval to traditional approval as a single agent for patients older than 12 years of age with MSI-H or dMMR metastatic CRC that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan treatment. This review was conducted under FDA’s Project Orbis framework for concurrent review of oncology drug products among international partners, including ANVISA, IMoH, and HC.