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Cancer Policy Monitor: September 13, 2022

President Biden nominates Monica Bertagnolli, MD, to be the next NCI Director 

On August 10, 2022, the AACR issued a press release that applauded President Biden’s nomination of Monica M. Bertagnolli, MD, as director of the National Cancer Institute (NCI). 

“Dr. Bertagnolli brings impressive qualifications to this vital position, including her background as a top-tier physician-scientist and much-admired professor,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “Her appreciation for the value and importance of basic research to advancing translational discoveries, as well as her commitment to ensuring that such treatment innovations reach patients in all populations across the United States, will ensure that the NCI continues to lead the way in programs aimed at improving health, preventing cancer, and reducing the incidence and mortality from this devastating disease.” 

Bertagnolli is the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard Medical School, and a professor and member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber/Brigham and Women’s Cancer Center. She is a renowned surgical oncologist who specializes in the research and treatment of gastrointestinal malignancies. An AACR member since 1996, Bertagnolli is currently a member of the AACR’s Tumor Microenvironment Working Group and Women in Cancer Research membership group. She has also served as chair and committee member on numerous award and grant review committees for the AACR. 

“I offer my heartfelt congratulations to Dr. Bertagnolli on her appointment as the next NCI director,” said AACR President Lisa M. Coussens, PhD, FAACR. “The AACR looks forward to collaborating with her in support of the NCI’s many initiatives, including increasing diversity in cancer research, furthering education and training of the cancer research workforce, improving funding across the cancer continuum, and working together with NCI-designated cancer centers to solve the biggest problems in cancer.” 

Appropriations Update from Capitol Hill

Marc B. Johnson, MPP

The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) released its funding bill for Fiscal Year (FY) 2023 on July 28. The bill would provide a total of $46.95 billion in base funding for the National Institutes of Health (NIH), an increase of $2 billion. Of the total provided for NIH, $7.2 billion would be provided for the National Cancer Institute (NCI), an increase of $291 million. These funding levels would be considerably lower than the House bill, which would provide NIH and NCI with increases of $2.5 billion and $466 million, respectively. The Senate bill would also provide $1 billion for the Advanced Research Projects Agency for Health (ARPA-H), which is identical to the FY 2022 funding level. In addition, in the Senate bill, ARPA-H would be based within NIH, whereas the House bill has it as a stand-alone agency within the Department of Health and Human Services (HHS).

On July 20, the House passed six out of the 12 appropriations bills, which did not include the LHHS appropriations bill.  With the House and Senate in recess until September, it is likely the final agreement on FY 2023 appropriations will not be finalized before the end of the fiscal year on September 30.  A continuing resolution will have to pass to fund the government while negotiations continue to finalize FY 2023 appropriations.

Join the Rally for Medical Research National Day of Action on September 14

The 10th Annual Rally for Medical Research will be held Wednesday, September 14, bringing patients, caregivers, researchers, clinicians, and other advocates together for meetings with congressional offices in support of funding for NIH. You can join them by participating in the National Day of Action , also on September 14. Take a moment to contact your members of Congress that day via email or social media and tell them why federal funding for medical research is so important for you, your family, and friends. Find out more about messaging and tools that you can use to contact your members of Congress by visiting the Rally for Medical Research website.

Register for the AACR Cancer Progress Report Policy Briefing on September 21

The Cancer Progress Report 2022 is a cornerstone of the AACR’s educational and advocacy efforts. The 12th edition of this report details how cancer develops, the importance of early cancer detection, provides insights on how to support all patients with cancer and highlights the importance of biomedical research in improving the quality of life for every cancer survivor. The report also underscores the necessity of unwavering bipartisan efforts from Congress to maintain the progress made against cancer. This includes supporting robust, sustained, and predictable funding for the NIH, NCI, FDA, and Center for Disease Control (CDC). 

The AACR Cancer Progress Report 2022 will be officially released during a policy briefing on Wednesday, September 21, from 12 – 1:30 p.m. ET. Register to attend in-person. The policy briefing will also be live streamed. Register for the live stream.

Learn more about the Cancer Progress Report and view the 2021 edition of the report.

15th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and The Medically Underserved

Join us September 16-19 at the AACR Science of Cancer Health Disparities Conference for programs highlighting the power of patient advocacy and community engagement. Wenora Johnson, Fight Colorectal Cancer, will deliver the patient advocate keynote followed by sessions addressing cultural literacy and increasing diversity in clinical trials.  Learn more.

Establishment of ARPA-H Is Gradually Progressing While Location of Headquarters Remains Up for Debate in Congress

Matthew Gontarchick

On June 22, the House voted 336-85 to advance Rep. Anna Eshoo’s H.R. 5585, the Advanced Research Project Agency-Health Act.  Meanwhile, the Senate’s authorizing legislation on ARPA-H is included in S. 3799, the PREVENT Pandemics Act, which the Health, Education, Labor, and Pensions (HELP) Committee advanced on March 10. The Senate is not expected to take action on this measure until later in the fall.

While there is strong bipartisan support for both legislative proposals to authorize ARPA-H, significant differences between the House and Senate bills will have to be resolved. First, both bills differ on the placement of ARPA-H within the federal government. The House bill stipulates that ARPA-H be a separate agency within HHS, which supporters say will allow the new agency to maintain a level of independence necessary to carry out its mission. In contrast, the Senate’s legislation aligns with the administration’s preference of placing ARPA-H within the organizational structure of NIH. According to HHS Secretary Xavier Becerra, placing ARPA-H within NIH will allow the new agency to focus on developing breakthroughs from day one by delegating administrative functions to the parent agency.

There are also differences in where the headquarters of the new agency should be physically located. While both measures say that the new biomedical research agency should not be physically located on the NIH campus in Bethesda, Maryland, the Senate bill goes a step further by banning the agency from being located in the Washington, D.C., area.

Since the Biden administration officially created ARPA-H with the signing of the FY 2022 omnibus appropriations bill in March, biotechnology industry leaders and public officials have launched lobbying campaigns to promote their respective states and regions as potential headquarters locations. Among the states who have been jockeying for ARPA-H are Illinois, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, and Texas. Many of these campaigns are leveraging their respective state’s life sciences communities and proximity to airports and universities. 

The Biden administration is likely to hold off on selecting a headquarters for ARPA-H until Congress comes closer to finalizing its authorizing legislation and until an inaugural ARPA-H director is announced. ARPA-H is currently being managed by Adam Russell, PhD, who is serving as the acting director to administratively establish the agency. In addition, given the likelihood that future ARPA-H leaders and projects managers are likely to travel throughout the nation to work on research projects, the significance of the new agency’s headquarters may be limited, and ARPA-H could also utilize a hub or remote work structure that would place project managers closer to the projects they will manage.

Finding Drug Information with FDA Product Labeling

In 2018, the FDA Oncology Center of Excellence (OCE) partnered with Deloitte to update labeling information for long-standing off-patent oncology drugs through an initiative called Project Renewal. In collaboration with AACR and several other stakeholders, Project Renewal has successfully developed a repeatable process for evaluating published literature to inform labeling updates, increased awareness of labeling and its importance to end-users, and educated stakeholders on the regulatory science behind labeling.

Recently, Project Renewal developed a video describing how to find and use drug labeling to make informed clinical decisions for patient care. The Drugs@FDA site is a free FDA resource that provides healthcare providers and patients with the most up-to-date labeling for all FDA approved drugs. To learn more about Project Renewal, please visit the Project Renewal website.

FDA Faces Financial Cliff as User Fee Reauthorization Deadline Approaches 

Nicholas Warren, PhD 

The U.S. Food and Drug Administration (FDA) receives slightly less than half of its $6 billion annual budget through user fees collected from drug and device manufacturers. Since 1992, in legislation enacted every five years, Congress has authorized FDA to collect these fees to hire additional staff for product reviews. In exchange, FDA guarantees products will be reviewed on defined timelines.  

This June, the House passed H.R. 7667, the Food and Drug Amendments of 2022, by a vote of 392-28 that would fully reauthorize FDA user fee programs. The bill also includes provisions designed to increase diversity in clinical trials and improve the Accelerated Approval pathway. A separate version advanced through the Senate HELP Committee in June, but does not appear to have enough support to pass the full Senate. The Senate bill lacks the additional provisions on clinical trial diversity included in the House bill, but has a separate provision that grants FDA additional authority to regulate diagnostic tests. A third bill introduced in July by Sen. Burr (R-NC), ranking member of the Senate HELP committee, lacks the additional provisions on clinical trial diversity or diagnostics and focuses only on reauthorizing the user fee programs.  

Reauthorizing the User Fee Agreements by the September 30 deadline is vital to prevent layoffs of thousands of FDA employees and enable the hiring of staff for emerging areas like cell and gene therapies. FDA needs robust staff to continue reviewing drugs and devices on standard timelines, and inspecting manufacturing facilities for safety issues to preserve momentum against deadly diseases like cancer. The timing and final language of a reauthorization bill remains unclear. For any bill to become a law, identical language must be agreed upon by both the House and Senate. Bipartisan leaders from the House Energy and Commerce Committee, Reps. Pallone (D-NJ) and McMorris Rodgers (R-WA), have urged the Senate to quickly pass the House bill before the authorization expires. Congress could also pass a short-term extension of the current user fee agreement to provide additional time for negotiation. However, this would prevent FDA from starting any new initiatives to improve efficiency.  

AACR Patient Advocate Forum on The Transformative Potential of Biomarkers

The recording is now available for on-demand viewing of the August 23 AACR Patient Advocate Forum on biomarkers. Moderated by Dr. Ann Barker from the Ellison Institute, panelists Jill Feldman, Steven Averbuch, Josh LaBaer, and Laura van ‘t Veer discussed how biomarkers are changing research and care to benefit patients with cancer. Watch Now