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Cancer Policy Monitor: November 14, 2023

Congressional Update

–Matthew Gontarchick

On October 25, 2023, the House of Representatives elected Rep. Mike Johnson (R-LA) to be speaker of the House, capping off a contentious 30-day period that saw the enactment of a 45-day continuing resolution (CR) and a historic ouster of Johnson’s predecessor.

Congress narrowly averted a government shutdown October 1 when then Speaker Kevin McCarthy (R-CA) struck a deal with House Democrats on a CR to keep the federal government open through November 17, thereby providing lawmakers additional time to either complete Fiscal Year (FY) 2024 appropriations or enact another CR to allow negotiations for FY 2024 spending to continue further.  To reach an agreement with Democrats, McCarthy’s CR dropped so-called “poison pills,” or partisan policy riders that had previously been holding up the Fiscal Year (FY) 2024 appropriations process. Examples of poison pills include a ban on funding for a federal firearms registry as well as stopping the implementation of a rule to ban discrimination in health care settings. After Congress enacted the CR, President Joe Biden signed the measure into law just hours before FY 2023 funding was set to expire.

The CR ensures that government funding continues through November 17 at FY 2023 levels, which means the allocation for the National Institutes of Health (NIH) will remain at $47.5 billion. While more favorable than a government shutdown, a CR and the general uncertainty surrounding federal appropriations is disruptive for members of the biomedical research community who rely on NIH-funded grants and will delay new research initiatives. 

Throughout the FY 2024 appropriations process, calls from the biomedical research community to increase funding for NIH have been met with considerable resistance. In July 2023, the House Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education, and Related Agencies approved a spending bill for FY 2024 that would cut NIH funding by $2.8 billion. In contrast, the Senate Appropriations Committee approved $49.22 billion in NIH funding for FY 2024, a slight increase from the current FY 2023 level.

McCarthy’s decision to work with Democrats on a 45-day CR sparked anger among a group of conservative House Republicans who were urging McCarthy to drastically cut federal spending. This dissatisfaction with the speaker culminated in a motion to vacate that forced a House floor vote on whether McCarthy should continue to control the speaker’s gavel. McCarthy ultimately failed to win enough votes to remain in his post, marking the first time in history that the House voted to remove a speaker.

For the following three weeks, the House Republican Conference approved three nominees for speaker before finally settling on Rep. Johnson, who had been serving as the conference’s vice chair. First elected to Congress in 2014, Johnson was elected the 56th speaker of the US House of Representatives for the remainder of the 118th Congress by a 220-209 vote. 

Prior to his election to the speakership, Johnson shared his plans to avoid a shutdown and continue the FY 2024 appropriations process. In a letter to his House Republican colleagues, he outlined a schedule up until November 17 for the House floor to consider all eight remaining FY 2024 spending bills. In the likely scenario that Congress fails to enact a final FY 2024 spending agreement by the November 17 deadline, Johnson proposed a CR through January 15 or April 15, 2024, to allow more time to negotiate and prevent members from feeling pressure to reach a spending agreement before Congress begins its holiday season break December 14.

More details about the remainder of the FY 2024 appropriations process are likely to unfold soon. As Congress adjusts to a new speaker, the AACR remains committed to working with lawmakers to ensure robust, sustained, and predictable funding increases for NIH.

Dr. Monica Bertagnolli Confirmed as NIH Director by the Senate Following Bipartisan Vote

-Blake William Rostine

On November 7, 2023, the Senate voted to confirm Dr. Monica Bertagnolli as the new Director of the National Institutes of Health (NIH). The final vote was 62-36, with a handful of Republicans joining Democrats in approving her nomination. She will replace the current Acting Director Dr. Lawrence Tabak.

A surgical oncologist and former director of the National Cancer Institute (NCI), Bertagnolli was nominated for NIH Director by the Biden administration in May 2023, a decision that was applauded by leading doctors, advocates, and research organizations, including the AACR. During her distinguished tenure at NCI, Bertagnolli worked to advance the Biden administration’s Cancer Moonshot and has undertaken efforts to pool resources from various sectors to bring clinical trials to more Americans.

In the leadup to her confirmation, on October 25, the Senate Health, Education, Labor, and Pensions (HELP) Committee voted to advance Dr. Bertagnolli’s nomination. This action followed a much-delayed confirmation process, including HELP Committee Chair Bernie Sanders’ (I-VT) refusal to hold a hearing on Bertagnolli until the Biden administration committed to address prescription drug pricing reform. 

On October 18, the Senate HELP Committee held a hearing to give committee members an opportunity to question Dr. Bertagnolli. During this hearing, Bertagnolli testified that expanding diversity in clinical trials and research staff are two of her top priorities. Bertagnolli also acknowledged the “transformative power of research to produce results that save lives,” and stated that if NIH funding is reduced, the medical research community will miss out on important scientific opportunities. She was also questioned by Sanders and Ranking Member Bill Cassidy (R-LA) about drug pricing clauses and march-in rights (with Sanders in favor and Cassidy opposed). She did not commit to a specific stance on march-in rights. 

While Sanders praised Bertagnolli, he stated: “I think this is a moment where we need leadership with the NIH which is really prepared to take on the greed of the pharmaceutical industry.” He joined five Republican members of the Committee in voting “no” on Dr. Bertagnolli’s nomination. Despite this, Sanders remarked that he had “not asked any member of the Committee to follow [his] vote.” While Bertagnolli’s hesitation to commit to specific steps to reduce drug prices ultimately lost her Sanders’ vote, it likely helped her earn bipartisan support; Republicans on the committee, including Ranking Member Cassidy, expressed appreciation for her “respect [for] Congressional authority.” 

The Committee voted 15-6, with Republican Sens. Markwayne Mullin (R-OK), Rand Paul (R-KY), Mike Braun (R-IN), and Ted Budd (R-NC) joining Sanders in voting against Bertagnolli’s confirmation.  

An AACR member since 1996, the AACR celebrates Bertagnolli’s confirmation and looks forward to her new role as NIH Director. 

Final Rules to Prohibit Menthol Cigarettes and Flavored Cigars Sent to White House for Review

-Calais Prince, PhD

In October 2023, the Food and Drug Administration (FDA) submitted final rules for review to the White House Office of Management and Budget that would ban menthol cigarettes and flavored cigars. Previously, in April 2022, the Center of Tobacco Products (CTP) at FDA published two proposed product standards to prohibit the manufacturing, distribution, and sale of menthol cigarettes and flavored cigars.

Every year, cigarette smoking is responsible for more than 480,000 premature deaths in the United States. Although the number of people who smoke cigarettes has fallen to historic lows, smoking remains a preventable cause of premature death and the proportion of people who smoke menthol cigarettes has been increasing. Menthol and other flavors in cigarettes, as well as flavors in cigars, increase smoking initiation, cigarette use, and nicotine dependence. Between the years 2000 and 2021, the sale of all cigars more than doubled, which was driven by inexpensive, small, flavored cigars.

The new regulatory action by FDA on menthol cigarettes and flavored cigars is an incredibly important step towards significantly reducing tobacco-related disease and death. The AACR will continue to support CTP in its efforts to use data-driven population-based strategies to end tobacco-related diseases and mortality.

FDA Issues Proposed Rule to Regulate Laboratory-Developed Tests as Devices

-Rukiya Umoja, PharmD

Laboratory Developed Tests (LDTs) are diagnostic tests developed by pathology laboratories, including those at cancer centers, and certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. FDA has historically contended that LDTs are in vitro diagnostics (IVDs), which it regulates as medical devices under the Federal, Food, Drug, and Cosmetic Act (FDCA), but used enforcement discretion to exempt LDTs from the regulatory process since 1976. Over the past four decades, LDTs have grown from simple lab tests to advanced assays, some of which are sold commercially. This has led to increased concern within the FDA. In 2014, the agency proposed a regulatory framework, which included several exemptions related to academic medical centers. The American Association for Cancer Research (AACR) supported the framework with a public comment. However, the draft guidance was never finalized after various stakeholders requested further public discussion. 

In 2018, Congress introduced bipartisan legislation called the Verifying Accurate, Leading-edge IVCT Development Act (VALID Act) that would reclassify LDTs as in-vitro clinical tests (IVCTs), and would establish a new risk-based framework for regulation. The VALID Act was also met with heightened stakeholder concern and has not been passed by Congress. While Congress continues to debate potential LDT legislation, FDA maintains that LDTs have become more complex and have documented many cases of inaccurate or ineffective tests.

On September 29, 2023, FDA announced a proposed rule that, if finalized, would classify all LDTs as medical devices, regardless of who developed the test. FDA also introduced a phasing out of the enforcement discretion policy over a four-year period, with the aim of quickly gathering data about LDTs that could threaten public health and safety.

FDA estimates this rule could generate annual health benefits averaging $44 billion over 20 years. The benefits include reduced costs from eliminating unnecessary lab tests, and potential savings from fewer health care system expenses. On the other hand, the agency also quantified annual regulatory costs, including laboratory compliance and FDA expenses, averaging $11 billion.

The agency is seeking specific input on several aspects of the proposed rule, including exempting certain LDTs from premarket review, the possibility of a longer phaseout period for smaller laboratories, and the applicability of a different policy for laboratories associated with academic medical centers. The public comment period is open until December 4, 2023. To learn more, FDA is hosting a webinar, October 31, to provide an overview of the proposed rule and describe the phaseout period.

FDA and AACR Welcome a Fourth Class of Oncology Educational Fellows

-Nicholas Warren, PhD

In October 2023, the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) welcomed the fourth class of FDA-AACR Oncology Educational Fellows. This year’s class is comprised of 21 early-career scientists and physicians who are passionate about creating new and better treatment options for patients. Over the next year, fellows will learn directly from AACR experts and FDA officials about the regulatory process, how to design successful clinical trials, and critically analyze issues that affected past drug approvals. Topics including expedited regulatory pathways, clinical trial designs, dose optimization, trial diversity, and precision oncology among many others will be covered through lectures and small group discussions. Additionally, fellows will have the opportunity to participate in mentoring and networking opportunities at the AACR Annual Meeting in April 2024 and an onsite visit to the FDA White Oak Campus to conduct a mock meeting of the Oncologic Drugs Advisory Committee. We look forward to working with these outstanding early-career investigators!

Applications Open for the 2024 AACR Early-Career Hill Day

The AACR is now accepting applications for its 2024 Early-career Hill Day, which will be held in Washington, D.C., February 26-27. This annual event provides a valuable opportunity for AACR Associate members to learn about the advocacy process by taking their message directly to members of Congress in support of federal funding for cancer research at the National Institutes of Health (NIH) and National Cancer Institute (NCI).

Participants will receive training on advocacy and the federal appropriations process prior to the Hill Day. Please visit this page for more information and to apply for one of the limited spots to attend and network with your fellow early-career Associate members.  The deadline to apply is Thursday, November 30, 2023.

Potential applicants who are not already AACR Associate Members can find more information about membership. There are no annual dues for Associate members. Any questions may be directed to [email protected].

ARPA-H Announces Launch of Health Innovation Network, ARPANET-H

– Benjamin Krinsky, PhD

On September 26, the Advanced Research Projects Agency for Health (ARPA-H) announced the launch of ARPANET-H, a nationwide network of three regional hubs to pursue innovation in biomedicine and health care delivery. Each hub will focus on a different aspect of health innovation by fostering partnerships between public and private organizations (including nonprofit organizations and industry) with the shared goal of accelerating the deployment of new medical technologies and novel strategies to improve health outcomes for people across the country.

The Customer Experience Hub of ARPANET-H, headquartered in Dallas, Texas, will concentrate its efforts on health care access and equity issues. These activities may include diversifying participation in clinical trials, human-centered design and prototyping of new health devices, and exploring novel health care delivery systems to reach underserved populations. This hub is managed by Advanced Technology International (ATI), a private firm that has historically specialized in managing public-private partnerships to advanced Department of Defense research and development projects.

Based in Cambridge, Massachusetts, the Investor Catalyst Hub will work to enhance research and commercialization activities to advance new therapeutics and other medical breakthroughs. The hub will endeavor to foster further collaborations among multiple sectors, including industry, venture capital, government, and academia, with an emphasis on expanding these partnerships across the country to include minority-serving institutions and nonprofit organizations in both rural and urban areas. The Massachusetts hub is managed by the firm VentureWell, which focuses on areas including promoting entrepreneurship among academic researchers and commercialization of medical technologies.

The third hub, the Stakeholder and Operations hub, will be located in the Washington, D.C., area. The exact location and management of this hub will be announced later in 2023. This hub will help to coordinate ARPA-H activities, drawing on its proximity to federal agencies and other institutions.

Each hub will draw on expertise and resources from “spokes,” research and health organizations located across the country. This model is designed to expand the impact of each hub and enable engagement with stakeholders in different communities throughout the U.S.

ARPA-H was initially authorized in the fiscal year (FY) 2022 Consolidated Appropriations Act. Inspired by the Defense Advanced Research Projects Agency (DARPA), the mission of ARPA-H is to catalyze transformative breakthroughs in health and medicine. With a current appropriation of $1.5 billion, the agency has begun to fund projects in several areas of biomedical research and development, including efforts to improve early detection and treatment of cancer.

APPLICATIONS OPEN FOR THE 2024 AACR ANNUAL MEETING SCIENTIST↔SURVIVOR PROGRAM

The AACR is accepting applications for patient advocates to enroll in the Scientist↔Survivor Program® at the AACR Annual Meeting 2024. This unique educational program provides an opportunity for patient advocates to learn and discuss the latest findings in cancer research, regulatory science, and health science policy. Participants are accepted through a competitive application process. Learn more about the program.