Policy Matters: January 2018
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FDA’s New Regulatory Framework for Tobacco and Nicotine: the Role of Medicinal Nicotine
In the U.S., the FDA plays a key role in tobacco control and prevention. In July 2017, the agency announced a new, comprehensive regulatory plan and framework aimed at further reducing tobacco-related disease and death in the U.S. The underlying philosophy of this new approach is the recognition that nicotine-containing products fall along a spectrum of risk, with combustible cigarettes being the most harmful way of satisfying a craving for nicotine. In contrast, medicinal nicotine replacement therapies (NRTs), such as skin patches, gum, and lozenges, are considered safe enough to be sold over the counter (OTC) as smoking cessation aids. Despite their OTC status, however, they are still less widely available than the most harmful products on the market – cigarettes. FDA aims to change that dynamic, and to that end recently announced the formation of a Nicotine Steering Committee to evaluate and modernize FDA’s approach to the development and regulation of medicinal nicotine.
On December 12, 2017, the Duke-Margolis Center for Health Policy convened a public workshop to discuss the role of medicinal nicotine in addressing the tobacco epidemic as well as the key policy issues that FDA will need to address as part of their broader efforts. The event featured a keynote address by FDA Commissioner Scott Gottlieb followed by a panel discussion which included Mitch Zeller, the Director of FDA’s Center for Tobacco Products, along with key leaders from the public health, addiction, and advocacy community. Several key themes emerged from the discussion, including the need to encourage new product development and innovation, as well as the importance of making existing products more effective through evidence-based labeling changes, improved communication to the public, and more effective support for patients trying to quit.
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Duke University’s Fuqua School of Business has expanded its healthcare offerings with a 19-month online master in quantitative management degree in health analytics. The program curriculum will combine business, analytics, and health sector institutional training. Fuqua and the Duke-Margolis have been in active discussions about this new, innovative program and look forward to working together in the future.
Fuqua will be hosting a virtual information session on January 22, 2018.
Register here.
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New Collaborative to Advance Regulatory Use of Real-World Evidence
Duke-Margolis is forming a
new collaborative to advance policy development related to the regulatory acceptability of real-world evidence (RWE). The Collaborative will engage major stakeholders to help advise and guide high priority efforts aimed at improving the development and use of RWE, with the express aim of informing and supporting the FDA as it works to meet RWE milestones as established in the 21
st Century Cures Act and the sixth Prescription Drug User Fee Act (PDUFA VI).
The RWE Collaborative will consist of
an advisory group that will include senior representation from medical product developers, payers, research groups, providers, patient networks, and regulators and will steer working groups and contribute to the Collaborative’s recommendations.
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Duke-Margolis Launches Initiative to Improve Health Care for Serious Illness
The Duke-Margolis Center for Health Policy, funded by the
Gordon and Betty Moore Foundation, is launching an initiative to investigate how accountable care approaches can improve care for people with serious illnesses, which is a next step in the Center’s work on accountable care. In partnership with
Leavitt Partners, the project will identify promising practices and practical operational guidance that organizations could implement.
Read More
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Patrick Conway Joins Duke-Margolis Advisory Board
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Margolis Seminar
The Margolis Seminar, held from noon-1:30 pm every other Friday, is a venue for sharing work in process and expertise across Duke University and with the Duke-Margolis team in Washington, DC. If you are interested in being added to the mailing list, please contact
Hilary Campbell.
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Medicine Grand Rounds
Medicine Grand Rounds are held every Friday at 8 am in Duke University Hospital Room 2002.
Ziad Gellad, MD, MPH, will present
"Innovating for Value: How to Improve Quality, Lower Costs, and Save Ourselves" on January 19, 2018.
Webcast is also available: learn more
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Sponsored by the Duke University School of Nursing
Thursday, February 15, 2018, 3:00 – 5:00 p.m.
Location: Christine Siegler Pearson Building, Room 1014
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February 5, 2018 - 9:00 am to 4:30 pm
February 7, 2018 - 9:00 am
February 15, 2018 - 9:00 am to 4:15 pm
March 8, 2018 - 9:00 am to 4:00 pm
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Awards, Honors and Presentations
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Greg Daniel, PhD, RPH, will be a panelist on the Plenary Market Access Panel at Phacilitate Cell & Gene Therapy World 2018 Conference on January 22.
Minahil Shahid, a 2017-2018
Margolis Scholar and first-year student in the MPP program at the
Sanford School, has been selected for the
Quality & Innovation Scholars Program (QISP), a six-month long interdisciplinary, team-based practicum opportunity in healthcare quality improvement. The QISP scholars will complete didactic training in quality improvement, and will then be matched with a faculty mentor, and will participate in an ongoing quality improvement project. The scholarship is awarded by the Institute for Healthcare Improvement (IHI) Open School at Duke.
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Making a Difference in Real-World Bioethics Dilemmas
The Greenwall Foundation is requesting proposals for the Spring 2018 cycle of its bioethics grants program, Making a Difference in Real-World Bioethics Dilemmas, to support research to help resolve an important emerging or unanswered bioethics problem in clinical care, biomedical research, public health practice, or public policy. Our aim is to fund innovative projects that will have a real-world, practical impact. Letters of intent are due January 8, 2018 by 11:59 pm ET, for projects to begin on or after July 1, 2018.
Learn More
RFP for Research on Effects of Affordable Care Act
This Russell Sage Foundation initiative will support innovative social science research on the social, economic and political effects of the Affordable Care Act. We are especially interested in funding analyses that address important questions about the effects of the reform on outcomes such as financial security and family economic well-being, labor supply and demand, participation in other public programs, family and children’s outcomes, and differential effects by age, race, ethnicity, nativity, or disability status.
Learn More
CTSI Population Health Improvement Awards
The Duke CTSI Community Engagement Population Health Improvement Awards program aims to engage community and academic partners in collaborative research that promotes novel ideas to improve community and population health. Duke CTSI, home of the National Institutes of Health’s Clinical and Translational Science Award at Duke, will provide approximately $200,000 for direct costs to support pilot awards that can be used to either a) develop new community-research partnerships or b) foment already existing community and research partnerships that aim to develop and test effective solutions to improve community and population health. These partnerships and innovations can originate from community stakeholders or from Duke research partners but they must involve both community and research collaborators.
Level 1: Seed Awards of $1,500
Level 2: Co-development awards of up to $25,000
Level 3: Advanced Partnership awards of up to $25,000
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Interesting Project? Funding Opportunities? News and Events? Awards and Honors?
Policy Impact? Op Eds?
We're looking for ways to highlight your accomplishments and share information.
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