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Cancer Policy Monitor: June 14, 2022

AACR President Submits Testimony in Support of Increased Federal Investments in Medical Research

The AACR is actively engaged with Congress in support of increased investments for the National Institutes of Health (NIH) and National Cancer Institute (NCI) for Fiscal Year (FY) 2023.  In May, AACR President, Lisa M. Coussens, PhD, FAACR, provided testimony before the House Appropriations Committees in support of at least $49 billion for NIH and $7.766 billion for NCI.

Dr. Coussens highlighted the role of cancer research in the significant reductions in cancer mortality over the last 30 years and called on Congress to prioritize medical research investments in the FY 2023 appropriations process. Specifically, Dr. Coussens noted that the percentage of research grant applications that NCI can fund, referred to as the success rate, was only 13% in FY 2021.  This low success rate leaves well-reviewed science unfunded and has an adverse impact on the financial and career security of cancer scientists, in particular early-career researchers. 

Dr. Coussens’ testimony comes on the heels of NIH Acting Director Dr. Lawrence Tabak and several Directors of NIH Institutes testifying before the House and Senate Appropriations Subcommittees on Labor, Health and Human Services, Education, and Related Agencies on the Biden administration’s FY 2023 funding priorities for the NIH.  The President’s budget proposed $49 billion in total funding for the NIH, of which its base budget would receive a marginal increase of approximately $275 million. Within the total funding proposed for NIH, the budget would provide $5 billion for the Advanced Research Projects Agency for Health (ARPA-H) to target high-risk, high-reward research designed to drive medical and health breakthroughs.  If enacted, the budget request would result in a cut of $199 million for the National Cancer Institute (NCI) as well as 11 of the 27 other Institutes and Centers. 

At both the House and Senate hearings, the Congressional committee leaders expressed support for the creation of ARPA-H but were unanimous in their assessments that its funding should not come at the expense of base funding for NIH.  House subcommittee markups, the process of debating and amending legislation, are expected to start in mid-June with the goal of full committee markups beginning in late-June. 

Dr. Coussens testimony before the House and Senate can be found here.

AACR RELEASES CANCER DISPARITIES PROGRESS REPORT 2022

-Marc Johnson, MPP

The AACR Cancer Disparities Progress Report 2022 was released on June 8 with a virtual congressional briefing. This report features the latest research on the underlying causes of cancer disparities in racial and ethnic minorities and other medically underserved populations and includes a Call to Action with steps policymakers should take to eradicate cancer disparities. The report was developed by preeminent cancer researchers and reflects the AACR’s longstanding commitment to eliminating cancer disparities through research, education, science, and public policy.

At the congressional briefing, AACR CEO Margaret Foti, PhD, MD (hc), and AACR President Lisa M. Coussens, PhD, FAACR, welcomed the audience. Lisa A. Newman, MD, MPH, of NewYork-Presbyterian/Weill Cornell Medical Center and chair of the Steering Committee for the report provided a keynote address and was joined by Steven Patierno, PhD, of the Duke Cancer Center and Mariana C. Stern, PhD, of USC Norris Comprehensive Cancer Center who spoke to the contents of the report. The briefing also included cancer survivor perspectives from Mathew Knowles, PhD, MBA, Marlena Murphy, and Sandra Morales. Congresswoman Brenda Lawrence (D-MI) and Senator Shelley Moore Capito (R-WV) highlighted the need to increase federal funding for research and public health agencies that reduce cancer disparities and the importance of investing in medical research. 

For more information about the report or to view the briefing, please click here.

June is National Cancer Survivor Month: Take Action for Cancer Survivors

Thanks to cancer research, there are currently 16.9 million cancer survivors in the United States. The AACR celebrates survivors and encourages individuals touched by cancer to learn more about the science of survivorship and discover how research can save lives. Throughout the month, we will be sharing survivorship stories, posting educational sessions, and inviting the community to take action on behalf of cancer survivors. Join us on social and #CelebrateSurvivorship. Learn more.

Brian King, PhD, MPH, Appointed to Direct FDA Center for Tobacco Products

-Nicholas Warren, PhD

After serving for nine years as the director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), Mitchell Zeller, JD, retired this April. In May, Brian King, PhD, MPH, was announced as Mr. Zeller’s successor to lead CTP. Dr. King has served at the U.S. Centers for Disease Control and Prevention (CDC) since 2015. As the deputy director of research translation at the CDC’s Office on Smoking and Health, Dr. King played a key role in addressing the youth e-cigarette epidemic and supporting smoking cessation efforts. During the COVID-19 pandemic, Dr. King served as the chief science officer for the CDC’s pandemic response as well as the executive editor of Morbidity and Mortality Weekly Report. These experiences will be invaluable during a critical time at CTP as it seeks to finalize prohibitions on menthol cigarettes and flavored cigars, as well as complete review of e-cigarette products.

Dr. King also has a long-standing relationship with the AACR by participating in Annual Meeting sessions, congressional briefings, and advising the AACR Tobacco Products and Cancer Subcommittee in an ex officio capacity. Of note, he served as a panelist during the AACR congressional briefing on “E-Cigarettes and Nicotine Addiction: A Potential Public Health Crisis for Youth and Young Adults” which highlighted the growing rates of youth e-cigarette use, evidence about health impacts, and gaps in knowledge for this rapidly evolving landscape. The AACR looks forward to working with Dr. King to eliminate all cancers caused by tobacco use.

Congress Working to Reauthorize FDA User Fees by the September Deadline

-Nicholas Warren, PhD

In Fiscal Year 2021, the U.S. Food and Drug Administration (FDA) received 54 percent ($3.3 billion) of its budget from discretionary funds appropriated by Congress, and 46 percent ($2.8 billion) from fees paid by companies to cover most costs associated with regulatory review of their products. Following several months of delays, FDA successfully completed negotiations with stakeholders on the next round of user fee agreements in March. Congress is now working to reauthorize these user fee agreements before the current authorization expires on September 30.

On May 18, the House Energy and Commerce Committee voted 55-0 to advance H.R. 7667, the Food and Drug Amendments of 2022, its legislation of the user fee package. This legislation now awaits consideration before the full House of Representatives. In addition, the Senate Health, Education, Labor, and Pensions (HELP) Committee unveiled a draft version of the senate user fee agreement proposal. The Senate HELP Committee is expected to markup its draft in June.

There are several policy provisions proposed in the House bill pertaining to cancer research or drug development, including:

  • Requiring late-stage clinical trials to have diversity action plans to improve representation of racial and ethnic minorities.
  • Granting FDA authority to require post-approval trials if it determines a drug or device sponsor failed to achieve adequate representation in pre-approval trials.
  • Requiring FDA to examine pandemic-era clinical trial flexibilities and if any should be incorporated moving forward.
  • Allowing drug and device developers to skip animal testing before starting human studies by using cell culture, computational, or other in vitro experiments to assess safety and efficacy.
  • Strengthening FDA’s authorities regarding the Accelerated Approval process, and increased requirements for sponsors following an Accelerated Approval

In comparison, the current Senate draft lacks policy provisions related to diversity in clinical trials and the Accelerated Approval process, but does include additional provisions that grant FDA more authority to regulate in vitro clinical tests, dietary supplements, and cosmetics. Notably, the Senate version includes the entirety of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, S. 2209, which creates a new application, review, and approval pathway for laboratory developed tests, including for cancer diagnostics. It is unclear whether Congress will ultimately pass one of the current proposals, or a new version with compromises on the different policy provisions. House leadership has expressed hope to pass a final agreement before the August recess.

FDA Oncology Center of Excellence Panel Discussion Spotlights Cancer Awareness, Equity in Cancer Treatment

-Calais Prince, PhD

On June 16, the FDA Oncology Center of Excellence (OCE) national public health initiative, Project Community, will launch the second annual National Black Family Cancer Awareness Week. The goal of National Black Family Cancer Awareness Week is to increase cancer clinical trial awareness and to encourage participation in national genetic databases for cancer research. The opening event, National Black Family Cancer Awareness Week: Engaging the Generations, will be a public panel discussion focusing on how to improve the quality of life for patients with cancer and cancer survivors. Invited speakers will be from across the federal government, academia, patient advocacy organizations, community-based groups, and the pharmaceutical industry.

Learn more information and find the link to register for this event.

AACR Forum on Brain Cancer Highlights a Glimmer of Progress and Calls for Further Collaboration

In honor of National Cancer Research Month and Brain Tumor Awareness Month, the AACR convened a panel titled Brainstorming for Brain Tumor Cures. The panel, a joint venture between AACR’s journal Cancer Discovery, and Science Policy and Government Affairs office featured Drs. Chetan Bettegowda, Michelle Monje, Roel Verhaak, and advocate Andrew Kaczynski. Learn more.

FDA-AACR Oncology Educational Fellowship Application Period Open

The FDA-AACR Oncology Educational Fellowship provides early-career cancer researchers and clinical fellows with a greater understanding of oncology drug development and regulatory review. Applications are being accepted now until August 15, 2022. Learn more.

AACR Virtual Patient Advocate Forum: Science of Survivorship

As of 2019, more than five percent of the US population is living with a history of cancer. Researchers are exploring evidence-based strategies to improve survival and quality of life for patients with cancer. Please join us on June 28 at 1 p.m. ET/10 a.m. PT. Learn more.