Leaders from NIH, FDA and other organizations call for innovations in treatment development to help smokers quit
October 15, 2024
Media Advisory
Tuesday October 15, 2024
The commentator stresses the importance of involving all stakeholders to reduce smoking and smoking-related diseases.
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A new comment in the Annals of Internal MedicineLeaders from the National Institutes of Health and the U.S. Food and Drug Administration highlight opportunities and recommendations to encourage urgently needed innovation in research and development of smoking cessation therapies. They provide a brief update on the regulatory framework for smoking cessation treatment, as well as an overview of innovative therapeutic targets and research gaps. The authors emphasize the importance of active collaboration among clinicians, academia, industry, public health, patient advocacy groups, and other stakeholders.
Nearly 500,000 Americans die each year from smoking, including more than 28 million adults in the United States. Although most smokers say they want to quit, fewer than 10 % actually succeed.
These gaps are addressed by the authors of this commentary, who also make recommendations on how to fill them. FDA 2023 Guidance on Nicotine Replacement Therapy. The authors emphasize the importance of incorporating meaningful endpoints into smoking cessation studies, in addition to abstinence. Clinically meaningful reductions in smoking, for example, are important, particularly if they increase the likelihood of quitting.
They also highlight the need for more research on e-cigarettes. This includes studies on their long-term health effects and toxicology. They also discuss initiatives currently underway at the NIH, FDA, and other organizations that seek to promote innovative research on smoking cessation. This includes groups that have historically been underrepresented.
This comment will be published in advance. Joint FDA-NIH Public Meeting on Smoking Cessation PrioritiesThe event will take place on Monday, October 21, between 9 a.m. and 4:30 p.m. EDT. Register for the event here.
The article below provides more information about the item.
H Warraich, et al. The NIH/FDA Perspective on Innovations in Smoking Cessation Treatment. Annals of internal medicine. DOI: 10.7326/ANNALS-24-02318 (2024).
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- Wilson Compton, MD, deputy director of the National Institute on Drug Abuse, NIH
- Brian King, Ph.D. Director of the FDA's Center for Tobacco Products
The National Institute on Drug Abuse: NIDA is part of the National Institutes of Health of the U.S. Department of Health and Human Services. NIDA is responsible for the majority of the world's research on substance abuse and its health effects. The Institute offers a broad range of programs to improve policy, advance substance abuse research, and inform practice. Visit NIDA for more information about its programs and services. www.nida.nih.gov.
The National Institutes of Health: The NIH is the medical research agency of the U.S. Department of Health and Human Services. It includes 27 institutes and centers. The NIH, the nation's medical research agency, is a component of the U.S. Department of Health and Human Services. It is responsible for conducting basic, translational, and clinical medical research and investigating causes, treatments, and cures. Visit the NIH for more information about its programs and services. www.nih.gov.
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