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AACR Cancer Policy Monitor: April 12, 2022

Fiscal Year 2023 Budget is Released

-Marc B. Johnson, MPP

On March 28, the Biden Administration released its FY 2023 budget request, which would provide an increase of $275 million for traditional basic research functions at the NIH as well as $5 billion for ARPA-H. This slight proposed increase, as well as recommendations for worthy initiatives across NIH, would result in some institutes and centers facing financial pressures, including the NCI, which would receive only $6.714 billion, a reduction of $199 million. It is of the upmost importance that NIH and NCI remains the priority for medical research funding.

The president’s budget also calls for noteworthy proposals for the reignited Cancer Moonshot and its goal of reducing cancer death rates by 50 percent over the next 25 years, including investments in precision oncology at the Department of Veterans Affairs and a one-time increase of $20 million for the U.S. Food and Drug Administration’s Oncology Center of Excellence to expedite development of innovative cancer treatments. In addition, in an effort to increase cancer screening and awareness, the budget would provide an increase of $41 million to support the Centers for Disease Control and Prevention’s cancer related screening, prevention, and surveillance programs. The AACR will continue to work with our champions in Congress to build on vital funding increases for NCI in FY 2022 and support NCI’s professional judgement budget for FY 2023, which recommends a total funding level of $7.766 billion. 

Contact your legislators and ask them to prioritize cancer research with a robust increase for NCI for FY 2023.

Appropriations Update

President Biden recently signed the Consolidated Appropriations Act, 2022, which provides funding for federal government agencies and activities through September 30, 2022.

The Fiscal Year (FY) 2022 spending bill provides an increase of more than $2 billion for the National Institutes of Health (NIH) and $353 million for the National Cancer Institute (NCI). This funding increase will allow NCI to reevaluate its FY 2022 interim pay lines to support more groundbreaking research in cancer science and fund additional grants in FY 2023. Last May, AACR President, David A. Tuveson, MD, PhD, FAACR, testified before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies to highlight the funding needs of the cancer research community through NCI, where only one in eight research project grant applications are currently granted NCI funding. The AACR is pleased that Dr. Tuveson’s message was well received and that the needs of the cancer research community were taken into account while crafting this legislation.

The Consolidated Appropriations Act, 2022 also contained important provisions that will drive innovation and improve public health. Congress included $1 billion to provide start-up funding for the Advanced Research Projects Agency for Health (ARPA-H), designed to utilize government support to fund high-risk, high-reward projects to create transformative solutions to better prevent, cure, and treat diseases such as cancer. The legislation also included an important extension of telehealth services, which have improved access to care for patients with cancer throughout the COVID-19 pandemic, and included a statutory fix to ensure the U.S. Food and Drug Administration can regulate any product that contains nicotine, regardless of whether it is synthetic or naturally derived. This provision will allow the FDA to regulate new tobacco products containing synthetic nicotine, which some e-cigarette manufacturers have argued is outside of the FDA’s regulatory jurisdiction.

While the AACR remains grateful for Congress’ support in FY 2022, we will continue to advocate for additional funding in FY 2023 and to increase cancer prevention and screening activities both at the NCI and the Center for Disease Control (CDC) and Prevention, which received only a marginal increase in the FY 2022 bill. The COVID-19 pandemic resulted in nearly 10 million fewer cancer screenings which will lead to more cancers being diagnosed at a more advanced stage. The CDC must have the tools to increase public awareness on the importance of cancer prevention and screening so cancers can be discovered earlier, at a more treatable stage.

National Cancer Institute Director Sharpless Steps Down

-Marc B. Johnson, MPP

Dr. Norman “Ned” Sharpless announced his decision to step down as NCI director, a position he has held since October 2017. In addition to his service as NCI director, Dr. Sharpless briefly served as acting commissioner for food and drugs at the U.S. Food and Drug Administration in 2019, before returning to leadership at NCI. Prior to his appointment as NCI director, Dr. Sharpless, an AACR fellow, served as director of the Lineberger Comprehensive Cancer Center at the University of North Carolina-Chapel Hill. Dr. Douglas R. Lowy will step in as NCI’s acting director effective April 30, 2022.

AACR President David A. Tuveson, MD, PhD, stated that “Dr. Sharpless’ extraordinary leadership at the NCI during the past four years has helped to maintain America’s edge in cancer science. Throughout his time as director, Ned has recognized the value and importance of basic research to advancing translational discoveries, has supported robust funding opportunities for talented young investigators, and has been a passionate supporter of the need to tackle the persistent problem of cancer disparities. Ned’s vision and enthusiasm will be greatly missed as NCI moves forward on many of the important initiatives that President Biden plans to implement through his Cancer Moonshot 2.0 proposal.”

House Subcommittee Takes Aim at Legislation to Increase Diversity in Clinical Trials and Facilitate Biomedical Innovation

On March 17, the House Energy and Commerce Subcommittee on Health held a hearing on “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight.” A central discussion of the hearing was the importance of increasing participation and diversity in clinical trials with two bills that aim to reduce barriers in enrollment, including clinical trials for drugs to combat cancer. 

The first, H.R. 6584, the DEPICT Act, would require applicants to report to the FDA on clinical trial enrollment targets by demographic subgroup and make a Diversity Action Plan to detail outreach and engagement strategies the sponsor will use to meet these targets. It would also require FDA to publish an annual report analyzing the data collected and measuring progress for improving diversity in clinical trials. A second bill, H.R. 5030, the DIVERSE Trials Act, would require FDA to issue guidance on decentralized clinical trials to better allow demographic and geographic diversity in enrollment. By permitting remote collection and assessment of data and utilizing tools such as telemedicine, the bill would address some of the burdens that too often create barriers against patient enrollment. Both bills were discussed favorably, and markups are expected in the coming months.

The hearing also included debate of efforts to propel biomedical innovation through H.R. 5585, the ARPA-H Act, and H.R. 6000, the 21st Century Cures 2.0 Act. Both bills would authorize ARPA-H, providing statutory structure and authority for the new agency to complement the funding it received in the FY 2022 omnibus spending bill. The 21st Century Cures 2.0 Act also contains provisions that would increase diversity in clinical trials, expand telehealth services under Medicaid, CHIP, and Medicare, and expand collaboration between FDA and CMS to speed delivery of new discoveries. The AACR will continue to monitor these bills as they progress through Congress. 

U.S. Adult Smoking Rates Dropped to Historic Low

-Nicholas Warren, PhD

Cigarette smoking rates among U.S. adults peaked in 1964 at approximately 40 percent. Since the 1964 Surgeon General’s report on smoking, numerous effective tobacco control policies have been implemented and led to significant declines in the number of Americans who smoke, such as advertising bans, excise taxes, restrictions on smoking in public, and insurance coverage of evidence-based cessation therapies. A new report from the U.S. Centers for Disease Control and Prevention has found the downward trend of cigarette smoking rates continued in 2020, reaching a new historic low of 12.5 percent of U.S. adults. For comparison, 14 percent of U.S. adults smoked cigarettes in 2019. Additionally, overall tobacco product use decreased from 20.8 to 19.0 percent of U.S. adults between 2019 and 2020. The report found continued disparities in tobacco use with disproportionately higher smoking rates among men, non-Hispanic American Indian and Alaskan Native adults, people living in rural areas, households with incomes less than $35,000, sexual and gender minorities, adults without health insurance, and adults living with disabilities.

Reducing the use of tobacco products is an essential part of the AACR’s mission to prevent and cure all cancers. The AACR will continue to advocate for additional policies to reduce the public health impacts from tobacco.  

AACR Partners with St. Jude Children’s Research Hospital to Increase HPV vaccination rates, End HPV Cancers

-Calais S. Prince, PhD

Human papillomavirus (HPV) is extremely common as approximately 13 million teenagers and adults in the United States become infected with the virus every year. The Centers for Disease Control and Prevention report that more than 42 million people are currently infected with HPV, which can cause six types of cancer including cervical, vaginal, vulvar, anal, penile, and oral/throat cancers. Of those millions, more than 200,000 will be diagnosed with cervical pre-cancer and nearly 36,000 men and women will be diagnosed with HPV cancers this year.

The HPV vaccine is safe, effective, and provides long-lasting protection against HPV cancers. HPV vaccinations can be administered to children as young as nine years old and are recommended for everyone up to 26 years old and some adults aged 27 to 45 years. Unfortunately, HPV vaccination rates in the United States are lower than the Healthy People 2030 goal of 80 percent. In 2020, only 59 percent of children aged 13 to 17 years old in the United States were vaccinated against HPV. Children living in rural areas are less likely to be vaccinated when compared to children living in urban areas and vaccination rates for adults are variable across states.

There is an urgent need to increase awareness of HPV vaccine effectiveness in preventing cancer. The AACR partnered with the St. Jude Children’s Research Hospital HPV vaccination campaign “Path to a Bright Future” to provide critical support in the fight against HPV cancers. The program launched in March 2022 with a series of virtual seminars addressing topics related to HPV cancer prevention such as addressing inequities in vaccination coverage, improving vaccination coverage, and engaging with survivors of HPV cancers to discuss the importance of normalizing HPV vaccination discussions.

The AACR will continue to promote evidence-based, relevant, and appropriate policies to support equitable and timely administration of HPV vaccinations for everyone.

Patient Advocate Roundtable: COVID-19 and Cancer

Patient advocate perspectives are critical to understanding and preparing for the long-term impact of COVID-19 on cancer care and research. The AACR Covid-19 and Cancer Taskforce Chair, Dr. Tony Ribas, recently sat down with leading patients advocates to gain their insights on the pandemic to inform the AACR Report on COVID-19. Watch Now.

Patient Advocate Forum Topics for 2022

We are pleased to announce the schedule and topics for the AACR Patient Advocate Forum 2022 series. These forums invite leaders from patient advocacy, academia, industry, and health care communities to discuss pressing topics and the latest discoveries in cancer research. Registration is now open for all Forums. Learn More.  

Reducing Racial Disparities in Cancer Outcomes

The same urgency and cooperation triggered by the racial disparities in the Covid-19 death rate and the enrollment of people of color in Covid-19 vaccination trials are needed to reduce disparities in cancer deaths. TheAACR joined leaders at the HBS Kraft Precision Medicine Accelerator summit to identify strategies for enrolling patients in cancer research. Read More.