Cancer Policy Monitor, November 8, 2022
- AACR and ASCO Publish Updated E-Cigarette Policy Statement
- FDA and DOJ File First First-Ever Injunction Against Illegally Marketed Tobacco Products
- FDA and AACR Welcome a New Class of Oncology Educational Fellows
- REGISTER NOW! Virtual Patient Advocacy Forum: Revolution in Cancer Clinical Trials
- Applications Open for 2023 AACR Early-Career Hill Day
- Extension of Public Health Emergency Is Welcome News for Cancer Patients
AACR and ASCO Publish Updated E-Cigarette Policy Statement
-Nicholas Warren, PhD
In 2015, the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) published a joint statement expressing concern about a sudden increase in the use of electronic nicotine delivery systems (ENDS), including e-cigarettes, as well as the lack of regulation over these products. Between 2012 and 2014 the National Youth Tobacco Survey (NYTS) reported a dramatic 400 percent increase in ENDS use among middle and high school students. Youth ENDS use peaked in 2019 with an estimated 27.5 percent (4.1 million) high school students using ENDS regularly. Youth ENDS use declined in 2020 and 2021 impacted by greater awareness, fewer in-person interactions, and new laws restricting tobacco product sales to individuals 21 years or older. However, in 2022, the NYTS reported a 24 percent increase compared to 2021 in the number of high school students (2.1 million) using ENDS. This demonstrates how challenging addressing youth ENDS can be, following decades of persistent reductions of tobacco product use. AACR and ASCO are especially worried that ENDS are a gateway to nicotine addiction and subsequent transitions to smoking, which is the single largest preventable cause of cancer.
This October, the AACR and ASCO published an updated joint policy statement detailing new evidence about the impacts of ENDS on early steps in cancer development and calling for urgent actions to protect public health. Critically, the statement called for complete prohibition of all non-tobacco-flavored products that contain nicotine, because flavors are a major driver of youth ENDS use. The 2022 NYTS found that 85 percent of middle and high school students who used ENDS vaped flavored products, and that fruit flavors were the most popular. Additional recommendations included: taxing all nicotine-containing products that reduce overall tobacco use; funding increases for evidence-based awareness campaigns and cessation resources; limiting tobacco sales to locations where minors are not allowed; improving insurance coverage of evidence-based cessation therapies; stopping predatory advertising practices; reducing the addictiveness and appeal of tobacco products through product standards; and increasing transparency of the U.S. Food and Drug Administration (FDA)’s tobacco review processes.
Promoters of ENDS had billed these products as an alternative method to help adults quit smoking. However, very limited data regarding efficacy exists, and all major U.S. health authorities to date have concluded there is insufficient evidence for using ENDS to help with smoking cessation. A major contributing factor is that, to date, no ENDS manufacturer has applied to FDA to develop an ENDS product as a cessation therapy, a prerequisite for conducting clinical trials in the United States.
Smoking cessation is the most effective action a person who smokes can take to improve their health and reduce cancer risks. The new ENDS statement emphasizes the importance of providers advising their patients on the use of FDA-approved tobacco cessation therapies such as behavioral counseling, varenicline, and nicotine replacement therapies including gums, patches, and lozenges to improve chances of successfully quitting tobacco. Additional initiatives led by the Centers for Disease Control and Prevention, FDA, and National Cancer Institute have helped millions of Americans quit tobacco or prevented initiation.
The joint ENDS statement update also identified several research needs to better understand ENDS and cessation therapies. Research needs include effective strategies for ENDS cessation; studies to understand the long-term health impacts of ENDS; how ENDS and other tobacco products interact with anticancer therapies and impact cancer outcomes; and randomized clinical trials comparing ENDS to FDA-approved smoking cessation therapies.
AACR will continue advocating for evidence-based policies to reduce tobacco-related cancers.
FDA AND DOJ FILE FIRST-EVER INJUNCTION AGAINST ILLEGALLY MARKETED TOBACCO PRODUCTS
-Nicholas Warren, PhD
FDA has slowly ramped up pressure on illegally marketed tobacco products in recent years and now has taken the historic step of seeking court orders to force six companies to cease operations this October in collaboration with the Department of Justice. All six companies manufacture and sell electronic nicotine delivery systems (ENDS) and failed to submit premarket tobacco product applications (PMTAs) to FDA, a requirement of the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA). This is a powerful action to hold companies accountable for failing to follow tobacco regulations and comes as the 2022 National Youth Tobacco Survey found a 24 percent increase in ENDS use by U.S. high school students.
The TCA specifically requires companies to submit PMTAs for any new tobacco products that were not already on the market as of February 2007. In 2016, FDA used authority under the TCA to classify ENDS as tobacco products, thus subjecting ENDS, including e-cigarettes, to PMTA review processes. The TCA requires manufacturers to provide sufficient evidence to prove to FDA that their products are “appropriate for the protection of public health.” More than eight million PMTAs have been submitted for ENDS products since 2020. Thus far, FDA has granted Marketing Orders for a small number of PMTAs, but the vast majority were found to lack sufficient evidence to meet the protection of public health standard. Dozens of PMTAs for very common products are still pending decisions by FDA and those products can remain on the market in the meantime.
While FDA has issued nearly 300 warning letters to ENDS manufacturers for illegally selling more than 17 million products in 2021 and 2022, many illegally marketed products can still be purchased online or in stores. The six manufacturers subject to injunctions were among those who received warning letters and represent the first time FDA has ever used this authority. This promising development suggests a shift in FDA’s enforcement strategy that could finally remove many predatory nicotine-containing products that appeal to youth from the market.
FDA and AACR Welcome a New Class of Oncology Educational Fellows
-Tristen V. Tellman
In October 2022, the AACR and the FDA welcomed a new class to the FDA-AACR Oncology Educational Fellowship. This year’s class is comprised of 18 U.S. fellows and two international fellows who are passionate about oncology drug development and the regulatory review process. This fellowship, now in its third year, is designed to promote scientific progress through the exchange of scientific knowledge in oncology education, collaborative learning, and research. Throughout the course of the year-long fellowship, fellows will participate in educational sessions led by experts from the AACR and the FDA Oncology Center of Excellence and cover topics including expedited pathways, clinical trials design, and precision oncology among many others. Additionally, fellows will be invited to participate in mentoring and networking opportunities and attend two in-person activities, the AACR annual meeting in April 2023 and an onsite visit to the FDA. We look forward to working with these outstanding early-career investigators!
REGISTER NOW! Virtual Patient Advocacy Forum: Revolution in Cancer Clinical Trials
Join us November 29 for a free virtual forum to review the standard features of the traditional or gold-standard randomized clinical trials and discuss innovative trial designs that are changing the way new treatments are developed for patients with cancer. Learn more and register.
Applications Open for 2023 AACR Early-Career Hill Day
The AACR is now accepting applications for its 2023 Early-career Hill Day, which will be held in-person in Washington, D.C., March 1-2. This annual event provides 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 Wednesday, November 30, 2022.
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].
Extension of Public Health Emergency Is Welcome News for Cancer Patients
Health and Human Services (HHS) Secretary Xavier Becerra extended the public health emergency (PHE) for an additional 90 days on Thursday, October 13. This marks the 11th time HHS has extended the PHE since the declaration was first made in January 2020.
The extension of the PHE is crucial because it ensures flexibilities related to telehealth will continue for some time. Under the PHE, Medicare can cover more than 80 telehealth services for seniors, including virtual check-ins and audio-only visits. The PHE also allows for the waiver of Medicare’s geographic site origination requirement for telehealth and reimbursement.
Telehealth flexibilities under the PHE are of particular importance to cancer patients, who are especially vulnerable to COVID-19. Since the start of the pandemic, cancer patients have utilized telehealth for pretreatment screening, nontreatment visits, and follow-up visits. These virtual interactions have reduced cancer patients’ risk of exposure to COVID-19 and eliminated transportation barriers to medical services.
While the impact of telehealth on cancer outcomes has yet to be determined, early evidence suggests patients approve of telehealth as a means to connect with their care team for non-treatment visits. Additionally, several major National Cancer Institute-designated cancer centers have publicly reported significant increases in telehealth utilization during the pandemic. However, serious gaps remain in the equitable adoption of telehealth. For instance, cancer patients living in underserved areas may not have access to the devices and broadband internet necessary to access telehealth.
Telehealth waivers and flexibilities granted under the PHE are currently set to expire 151 days after the end of the PHE on January 11, 2023, and it remains unknown if the Biden administration will further extend the PHE. At the conclusion of the 151-day period, Medicare will no longer provide reimbursement for telehealth services, leaving patients and providers who have enjoyed telehealth services for years in a state of uncertainty. Several legislative proposals have been introduced to extend Medicare coverage of telehealth services, including a bill that passed the House earlier this year that would extend telehealth coverage for two years. However, Congress has yet to pass legislation to address the coming telehealth cliff.
The AACR is keenly aware of the significance of telehealth services for cancer patients. In the Report on the Impact of COVID-19 on Cancer Research and Patient Care published earlier this year, the AACR urges Congress to deliver a permanent extension of Medicare-approved telehealth services. To address disparities in the implementation of telehealth, the AACR urges lawmakers to provide more support for high-speed broadband to reach underserved areas.