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​​Cancer Policy Monitor: Aug. 1, 2017     

NIH Funding Update from Capitol Hill     

The healthcare reform debate has dominated headlines – and the Senate’s time – in recent weeks.  Congress has yet to agree on a formal budget resolution, casting doubt on the appropriations timeline in what has become a very packed legislative calendar.  Still, fiscal year (FY) 2018 spending bills have been advancing through the committee process in both the House and the Senate. 

On July 19, The House Appropriations Committee approved the draft FY 2018 funding bill on Labor, Health and Human Services (HHS), Education and Related Agencies with Committee members voting along party lines, 28-22. The bill includes a $1.1 billion funding increase for the National Institutes of Health (NIH). House Appropriations Committee Chairman Rodney Frelinghuysen (R-NJ) stated, “This bill reflects Republican priorities to cut spending and focus investments in programs our people need the most – public health and medical research, biodefense, fundamental education, and proven programs that increase job growth, for example.”  While Democrats support increased NIH funding, they objected to the Republican proposal to cut $5 billion from overall non-defense discretionary funding for FY 2018 as compared to FY 2017.     

The Senate’s time has largely been consumed by attempts to pass health care reform legislation.  Still, in recent weeks senators have begun to mark up appropriations bills. The Subcommittee on Labor, HHS, Education and Related Agencies – which has jurisdiction over the NIH – has been working on its mark-up, but it appears that it will not be brought forward until September. 

In FY 2018, sequestration returns under the Budget Control Act of 2011. Therefore, for Congress to ignore the lower spending caps imposed by the law, it will need to reach a new budget agreement soon. “Raising the caps,” as it is referred to, becomes very important if the NIH and NCI are to receive the robust funding increases necessary. Ultimately, there will either be a Continuing Resolution (CR) to keep government funded after Sept. 30, or Congress will reach a new bicameral, bipartisan budget deal in the coming months. Given the dwindling number of legislative days between now and Sept. 30, a short-term CR is increasingly likely. 

Take a minute today to callemail, or tweet your members of Congress and urge them to support robust, sustained, and predictable funding increases for the NIH and NCI. You can also send a Thank You Note to members who voted in favor of a $2 billion increase for the NIH in FY 2017.

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Key FDA Legislation Makes Its Way Through Congress      

Action is pending on legislation to reauthorize the Food and Drug Administration’s (FDA) collection of user fees, and the AACR continues to monitor legislative activity that would impact FDA’s regulatory authority over tobacco products. 

FDA Oversight of Tobacco Products

On July 12, the House Appropriations Committee approved a FY 2018 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies appropriations bill that would greatly weaken the FDA’s oversight of tobacco products.

One rider included in the bill would require the FDA to exempt many cigars, including some large, premium, cheap, and flavored cigars from oversight. A second provision in the bill would change the "grandfather date" under the 2009 Family Smoking Prevention and Tobacco Control Act and would allow cigars, e-cigarettes, and other tobacco products to escape a crucial first-step review by the FDA. This would make it easier for new products to stay on the market before the agency determines the public health risk and how, for example, flavors are being used to attract kids. The AACR, along with many other organizations, signed on to a letter opposing these riders. Representative Nita Lowey (D-NY) offered an amendment to strike the grandfather date provision and cited this sign on letter in her arguments. Unfortunately, the amendment failed by a vote of 22-30.

These provisions are not new to the House FDA appropriations bill, but the development comes as the Trump administration has delayed enforcement of the new FDA rule and the e-cigarette industry is hopeful that efforts to roll back the Obama administration’s regulations will advance both as legislation and through several pending lawsuits. On July 20, The Senate Appropriations Committee approved its FY 2018 bill for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies without the riders attached. 

On the non-legislative front, the FDA announced on July 28 a new comprehensive plan to lower nicotine in cigarettes to a non-addictive level. “Addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA's strategy for addressing the devastating addiction crisis that is threatening American families,” said FDA Commissioner Dr. Scott Gottlieb in an announcement. "We may be able to reach a day where the most harmful products are no longer capable of addicting our kids."

The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) seeking input on the potential public health benefits and any possible unintended consequences of lowering nicotine in cigarettes, such as potentially opening up a black market for cigarettes with higher nicotine content.

FDA User Fees

On July 12, the House passed bipartisan legislation that would reauthorize the Food and Drug Administration (FDA) to collect user fees for drugs and medical devices and streamline some elements of the review process. The full Senate has not yet taken up the legislation, though the Senate Committee on Health, Education, Labor and Pensions (HELP) marked up a very similar bill in May. Passing this legislation is a top priority for Congress because the fees collected from manufacturers fund the positions of FDA staff required to review and approve new treatment applications. Without the timely passage of the legislation, thousands of these employees could receive layoff notices. FDA Commissioner Scott Gottlieb sent an email to staff expressing his confidence that the legislation would be passed ahead of the Sept. 30 deadline and that it was not anticipated that pink slips would be issued. The Senate will likely take up the reauthorization bill as soon as it is done with health care reform legislation.  

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AACR Cohosts Congressional Briefing on Progress in Immuno-oncology      

On July 19, the AACR partnered with the Society for Immunotherapy of Cancer (SITC) to host a congressional briefing titled “Progress in Immuno-Oncology: Delivering Hope and Clinical Benefit to Cancer Patients.” The briefing was moderated by AACR President-elect Elizabeth M. Jaffee, MD and featured Stefanie Joho, a colon cancer survivor who benefitted from immunotherapy and is now a cancer research and patient advocate. The expert panel of speakers included Lisa Butterfield, PhD, Steven Rosenberg, MD, PhD, Bernard A. Fox, PhD, and Daniel Chen, MD, PhD.

The speakers discussed the promising advances being made in the field of immuno-oncology, as well the challenges that remain in bringing these beneficial treatments to more patients. Panelists also highlighted the critical role of NIH funding in making discoveries possible, and noted the importance of partnerships between government, academic research institutions, and the private sector in bringing advances to patients. The remarks were well received by an audience of around 100 hill staffers and members of the cancer community. Following the briefing, several of the speakers participated in a Facebook Live event on Capitol Hill where they discussed some of the key takeaways from the event. 

For those who were unable to attend the event, a video of the briefing in its entirety is av​ailable on the AACR’s YouTube channel. You can also check out photos from the event.

Stay tuned to our Congressional Briefings page for information on future AACR events on Capitol Hill.

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Joint FDA-AACR Workshop Explores Questions in Immuno-oncology    

On July 20, the AACR and FDA cohosted the third Dose Finding Workshop. Co-chaired by FDA’s Dr. Amy McKee and AACR President-elect Dr. Elizabeth Jaffee, the workshop, attended by more than 680 participants including nearly 200 in person, was divided into three sessions: Immuno-oncology (IO) Overview – Scope of the problem; Key Translational and Design Questions for IO Agents; and, Considerations for Dose Selection of IO Combination Products.

This third dose finding workshop comes on the heel of two successful FDA-AACR Oncology Dose Finding Workshops in 2015 and 2016. A recent article in The Cancer Letter reported that 803 clinical trials currently testing PD-1 and PD-L1 drugs had over 160,000 slots for adult patients. As more checkpoint inhibitors (ICIs) enter the market, additional trials will seek to combine these products with standard of care therapies, novel small molecules, targeted antibodies, and other biologic therapies such as vaccines and engineered T-cells. Patient and dose selection of oncology drugs will be of critical importance, as recent approvals of immune ICIs and early, promising readouts from studies combining ICIs with chemotherapy, targeted therapy, and other immuno-oncology agents will put enormous pressures on the current clinical trial infrastructure of the U.S. and the international community.

Slides and other materials from this workshop will be posted on this page in a few weeks. Only slides from presenters who have given permission will be included. Some presenters have opted not to have their slides posted. Read the speaker bios.

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Charting the Future of Cancer Health Disparities Research    

Leading national cancer organizations have released a joint position statement to guide the future of cancer health disparities research. The statement represents a unified strategy by the American Association for Cancer Research (AACR), the American Cancer Society (ACS), the American Society of Clinical Oncology (ASCO), and the National Cancer Institute (NCI) to foster cooperation across the cancer research community to ensure that all patients – regardless of social demographics, socioeconomic status, or the communities in which they live – benefit from cancer research. 

“The AACR is committed to eliminating cancer health disparities, and we hope that the recommendations put forward through this unprecedented collaboration will promote cooperation among all stakeholders in the cancer disparities research community to ensure that research-driven advances benefit all patients, regardless of their race, ethnicity, age, gender, socioeconomic status, and community in which they live,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR.

According to the statement, cancer health disparities are pronounced and well documented. Medically underserved populations, including racial and ethnic minorities and individuals of lower socioeconomic status, experience worse cancer outcomes. As the organizations discuss, disparities are driven by a range of multilevel patient, community, and structural factors, including sociodemographics, health care access, lifestyle factors, and biological and genetic differences. While understanding of underlying causes of cancer disparities is growing, emerging and increasing cancer disparities among some populations continue to create new challenges – requiring a deeper understanding of the multilevel, interrelated causes and how to effectively address them, according to the organizations. 

The position statement was developed following a summit held by the groups, which brought together experts in clinical cancer research, epidemiology, public health, and health care policy, as well as patient advocates, to discuss the current state of cancer health disparities research and identify top priorities in the field. 

Research Needs and Priorities

​​​The joint statement, published simultaneously today by the four co-authoring organizations, outlines the following top research needs and priorities:

Defining and improving data measures and tools for cancer disparities research: Patient data are often incomplete, inaccurate, or overly-simplified and usually do not consider many social and community factors. Cancer disparities research is limited by a lack of comprehensive, consistent data on factors that impact disparities in cancer care and patient outcomes, including a patient’s social status and demographics, community and lifestyle factors, and biology and genetics, as well as by widespread variation in data collection methodology.

Addressing disparities in cancer incidence: Eliminating disparities in cancer incidence requires advancing knowledge of biological and environmental determinants of cancer incidence disparities, including a greater understanding of the role of genetics in contributing to higher cancer risk among certain populations.  

Addressing cancer survival disparities: Currently, the interplay between system-level, biological, social, and environmental factors is often inadequately accounted for in cancer research. Counteracting growing disparities in cancer survival requires a more complete picture of the range of factors involved and how to track, identify, and address them.  

Improving community engagement in cancer research: Poor translation of innovation in cancer care into health care systems in diverse communities has hampered the impact of innovative treatments and precision medicine advances on underserved patient populations. Ensuring that all patient populations benefit from advances in cancer care requires stronger community engagement in cancer research. 

Redesigning cancer clinical trials to acknowledge and address cancer disparities: Recruitment and retention rates in cancer clinical trials are lower for some patient populations. Since clinical trials are the foremost means of generating reliable evidence on efficacy of treatments and patient care methods, changes to the clinical trials system are needed to improve the generalizability and applicability of clinical trial findings and better inform the care of underrepresented patient groups.​

Recommendations

The statement provides a series of recommendations to address each of these outlined needs, with a particular focus on guiding investments in cancer health disparities research. In addition to specific recommendations in each of these areas, the statement also includes broad action items that can be taken to further the field of cancer research disparities as a whole, based on the current landscape and existing priorities. 

Investigators, research sponsors, and research publications should insist on the use of the highest-quality data measurement tools and the most granular data for conducting cancer disparities research. 

Establishment of a health disparities research network and multiple consortia to gather relevant patient contextual data and biospecimens are needed to effectively inform cancer disparities research that examines the multilevel factors involved in causing cancer disparities. 

Best practice strategies should be designed and utilized to engage underserved populations in research studies and ensure they are informed of clinical trial opportunities. 

Researchers should be adequately trained in community engagement research tactics, and academic promotions should appropriately account for time needed to conduct community engagement research. Expectations for the possible need for funding beyond funding cycles should be made for community engagement research. 

Cancer treatment systems should ensure real-time monitoring of patient experiences to understand how patients are being treated and intervene when care and outcomes disparities are identified. 

“Charting the Future of Cancer Health Disparities Research: A Position Statement from the American Association for Cancer Research, the American Cancer Society, the American Society of Clinical Oncology, and the National Cancer Institute,” was published July 24 in Cancer Research.

This joint statement is the latest example of the AACR’s longstanding commitment to addressing cancer health disparities, often in association with the AACR Minorities in Cancer Research Council (MICR). In September, the AACR and MICR will host the 10th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved in Atlanta. Learn more about the AACR and MICR’s work in this area​.

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AACR President Urges Congress to Maintain Robust NIH Funding    

As president of the American Association for Cancer Research (AACR), Michael A. Caligiuri, MD, is a strong advocate for the federal funding that has powered significant advances in understanding and treating cancer.

In recent weeks, as several members of Congress pushed back against funding cuts proposed by President Trump, Caligiuri, who is also the director of The Ohio State University Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, wrote an op-ed for The Cancer Letter.

“If the NIH, NCI, the FDA, and other vitally important scientific agencies are to receive the resources that are necessary to drive advances across the clinical cancer care spectrum and save an increasing number of lives from cancer,” Caligiuri wrote, “it’s going to require that Congress negotiate a bipartisan budget deal to raise the discretionary budget caps for FY 2018.”

In the guest-editorial, Caligiuri urged Congress to take four necessary step to ensure proper funding for biomedical research, including cancer research:

  • Continue to support robust, sustained, and predictable growth for the NIH budget by providing an increase of $2 billion for the NIH in FY 2018, for a total funding level of $36.2 billion;
  • Ensure that funding designated through the 21st Century Cures Act for targeted initiatives such as the Beau Biden Cancer Moonshot Initiative is fully appropriated in FY 2018;
  • Increase the FDA budget in FY 2018 to $2.8 billion, an $80 million increase above its FY 2017 level, and fully fund the FDA Oncology Center of Excellence, to ensure support for regulatory science and to accelerate the pace of development of medical products that are safe and effective; and
  • Negotiate a bipartisan budget deal to raise the discretionary budget caps for FY 2018 and beyond, which would allow our nation’s policymakers to continue to invest in priority areas, such as biomedical research funded by the NIH.

Read the guest editorial in its entirety.

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Congressman Tom Cole to Speak at the Rally for Medical Research    

Congressman Tom Cole (R-OK), chairman of the House Labor-Health and Human Services-Education Appropriations Subcommittee, will speak at the Rally for Medical Research Hill Day breakfast. Register today for the fifth annual rally to join advocates in Washington, D.C., Sept. 13-14, in support of funding increases for the NIH.

Registration is now open and all interested advocates of biomedical research are invited to register. We have reserved a block of rooms at the rally headquarters hotel, the Grand Hyatt Washington, at a negotiated rate. Reserve your room today!​​

For those unable to travel to D.C. in person, there will also be a National Day of Action Sept. 14, when advocates will be able to contact their senators and representative from anywhere in the United States to urge support for the National Institutes of Health. Save the date and sign up here for the National Day of Action. We will then send you a reminder email with everything you need on Sept. 14.

Stay up-to-date on by visiting the rally website, Facebook, and Twitter pages.

Interested in becoming a Sponsoring Organization for the 2017 Rally for Medical Research Hill Day? Learn more!

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Save the Date: Second FDA-AACR Workshop on Liquid Biopsies    

Date: Oct. 10, 2017. Time: 8:30 a.m. - 5 p.m.

Location: Renaissance Downtown Hotel, 999 9th St NW, Washington, DC 20001

Purpose: As a noninvasive method to detect genetic alterations in tumors, analysis of tumor-derived cell-free DNA (cfDNA) in plasma holds much promise for improving cancer diagnosis and monitoring as well as drug development. This technology is advancing quickly, being incorporated into numerous drug development programs, and likely to be rapidly incorporated into clinical care.

Theme: Technology has evolved to enable the development of tests that can detect signs of cancer in blood and other bio-fluids. Although liquid biopsies are an exciting development, this technology presents with a set of unique regulatory concerns, particularly in establishing analytic and clinical validity. This session will build upon a July 2016 U.S. Food and Drug Administration-AACR co-sponsored workshop on liquid biopsies and will examine the regulatory challenges in adopting this technology for early detection, disease monitoring, and the potential use as surrogate end point markers for drug development.

SESSION I: Cancer Liquid Biopsies: State of the Science

SESSION II: Liquid Biopsies for Early Detection

SESSION III: Liquid Biopsies in Cancer Drug Development and Clinical Use

SESSION IV: Liquid Biopsy Test Development

See the draft agenda.

Workshop Co-chairs:

  • AACR:
    • Carlos L. Arteaga, MD, AACR past president (2014-2015); Donna S. Hall chair in breast cancer research; professor of medicine and cancer biology, Vanderbilt University associate director for translational/clinical research; director, Breast Cancer Program; director, Center for Cancer Targeted Therapies; director, Vanderbilt-Ingram Cancer Center Research Network, Vanderbilt-Ingram Cancer Center
    • Pasi A. Jänne, MD, PhD, AACR Regulatory Science and Policy Subcommittee member; director, Lowe Center for Thoracic Oncology; scientific director, Belfer Institute for Applied Cancer Science; senior physician, Dana-Farber Cancer Institute and professor of medicine, Harvard Medical School
  • FDA:
    • Julia Beaver, MD, Director (acting), Division of Oncology Products 1, Office of Hematology and Oncology (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Gideon Blumenthal, MD, Deputy Director (acting), Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Reena Philip, PhD, director, Division of Molecular Genetics and Pathology (DMGP), Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH), FDA

Sign up to receive updates about this workshop, including information about registration for in-person or webcast participation.

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