Bonus Content: Christopher Russell

In a 45-minute video recording posted as part of the bonus content of the September Global Tobacco and Nicotine Forum in Seoul, South Korea, Christopher Russell, director of Russell Burnett Research and Consultancy of Glasgow, U.K., described a type of study that manufacturers of new tobacco products can conduct to demonstrate the cigarette-switching and smoking reduction potential of their products.

Russell started by outlining the risks associated with smoking and the importance of reducing smoking prevalence and smoking-related harms.

Then, in a presentation largely looking at the U.S. and the Health Risk Investigations section of the Food and Drug Administration’s system of premarket tobacco product applications (PMTAs), which require the submission of substantive amounts of data and information, he focused on the requirement to demonstrate the impact of a new tobacco product on tobacco use behavior among current tobacco users.

The FDA, he said, had recommended that an applicant manufacturer conduct an Actual Use Study (AUS) but had not provided any formal guidance on how to design and conduct such a study in respect of a new tobacco product. Russell therefore spent some time describing how pharmaceutical manufacturers carried out AUSes in support of applications to change the marketing status of a drug from prescription to nonprescription and followed that up by describing how a PMTA applicant might take some of the key principles and design elements from such a drug-switch AUS and apply it to an AUS for a new tobacco product aimed at assisting adult smokers completely to switch or substantially to reduce their cigarette smoking when using a new product in everyday settings. He described four core principles that underpin how an AUS should be designed and conducted and on the objectives that new tobacco product AUSes had focused to date.

Russell referenced a number of studies conducted primarily by the major tobacco manufacturers, Philip Morris International, Altria and Reynolds American. And he briefly described the design and key results of two of these studies, one involving a heated-tobacco product and another involving a nicotine pouch.

In summary, Russell said the AUSes that had been completed to date showed they could provide near to real-world evidence that new tobacco products can serve as complete or substantial substitutes for combustible cigarettes for many adult smokers, so demonstrating the utility of this behavioral study design for providing the FDA with reliable and robust real-world information about the likelihood that if a new tobacco product were to be authorized for marketing, it would be used by adult smokers and that those adult smokers using the product in question would ultimately, in the short term to medium term, completely switch to using the product or, if not completely switch, substantially reduce the number of cigarettes they smoke while continuing to use the product, hopefully on a path to complete abstinence from cigarettes.

Finally, Russell outlined a number of factors that manufacturers should have in mind when considering undertaking AUSes, including the company’s internal and external expertise capacity; the time required to design and conduct a study; the timing relative to the proposed PMTA; scientific engagement with the FDA’s Center for Tobacco Products; the possible availability of a robust, reliable alternative; the cost of the study and the cost of a lost opportunity.