On December 5, 2018, FDA will hold a public hearing to discuss its efforts to eliminate youth e-cigarette and other tobacco product use. One of the objectives of the hearing is to obtain the public’s perspectives on whether there is a need for drug therapies to support youth e-cigarette cessation. In particular, FDA seeks to explore the appropriate methods and study designs impacting the development of such therapies, as well as safety and efficacy issues.
FDA states that it has determined that a public hearing is the most appropriate way to ensure public engagement (including members of the medical and research fields, pharmaceutical and tobacco industries, and public health stakeholders) on this issue. Although FDA welcomes all feedback on any public health, scientific, regulatory, or legal considerations related to this topic, the Agency has provided specific questions on which it solicits stakeholder feedback and comments. We summarize some of these questions below.
Questions for Commenters
- How might the factors driving e-cigarette use among youth (which are likely different from those in the adult population) impact the need for drug therapies for e-cigarette cessation among youth?
- What youth age groups, patterns in tobacco use, and clinical features (level of addiction, etc.) might characterize the population of youth e-cigarette users who would likely benefit from the use of such drug therapies? What types of products (prescription vs. over-the-counter, etc.) might be useful?
- What approaches could be used to overcome barriers to research, including scientific, clinical, and societal factors that could affect the conduct of clinical trials?
- What methods and study designs are appropriate for assessing drug therapies for youth e-cigarette cessation?
- How can data available from the adult experience with smoking cessation be extrapolated for this purpose?
- While this hearing is focused on the topic of e-cigarette use among youth, FDA also welcomes comments regarding the potential need for drug therapies to support cessation of other tobacco products, including combustible products (i.e., cigarettes or cigars) and smokeless tobacco products.
The public hearing will be held from 9 a.m. to 5 p.m. on December 5, 2018 at the FDA White Oak Conference Center. Presenters must register by November 23, 2018, and attendees must register by December 3, 2018. We encourage stakeholders and industry to submit written comments on this important issue; the comment period opens after the public hearing and ends on January 2, 2019.