by Cheryl K. Olson, Sc.D.

TPPI studies are studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.

So sayeth the FDA in Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. This is the FDA’s most recent (October 2020) guidance to industry on how to be successful when submitting a modified risk tobacco product application (MRTPA), premarket tobacco product application (PMTA), or substantial equivalence report (SE Report).

Perception is one key to being successful in your product application or report according to the FDA.

New FDA guidance can look scary: 20 more pages of rules to follow and things to go wrong!

Fear not, for this is a stress-relieving map to some key but wobbly steps to FDA approval. One critical takeaway is that while FDA guidance is non-binding legally, you should view it as absolutely binding scientifically. If you ignore their scientific guidance, you increase the risk of the FDA not granting your tobacco product market authorization.

Think of this draft guidance as a chance to sit down for coffee with some FDA scientists and overhear their shop talk. Or a window into their thoughts as they smile or frown while paging through the behavioral research parts of your application.

I’ll go over specific aspects of that behavioral research advice in future papers. Let’s start with the FDA’s overall approach to TPPI studies (helpfully spelled out in section IV: Overall Approach) and what it reveals about how their reviewers think and ways to win them over.

Fly Flags of Credibility

This section of the guidance gives some diplomatically phrased warnings. First:

We recommend applicants conduct studies using best practices specific to the study design and method employed that have been either (1) written or published by well established social or behavioral scientific organizations (e.g., the American Psychological Association), or (2) written by authors who have demonstrated scientific expertise in the type of method or design (i.e., have published studies using the method or design in peer-reviewed journals). Adhering to best practices improves the validity of the data collected and the conclusions drawn from those data….

In other words, don’t wing it. For example, I often mine best practices from peer-reviewed publications that include authors who work for FDA, CDC, or HHS. Publications from the National Academies Press or the Cochrane Database of Systematic Reviews are also great resources.

Be prepared to justify every aspect of your research design and statistical analysis, and to show how it’s been used in similar situations. I’ve seen and written about multiple instances in which companies raised the ire of the FDA by submitting “scientific” studies that were viewed by its panels as little more than modified marketing studies. This is an extremely expensive and time consuming mistake.

Second, we recommend that applicants select appropriate study personnel for TPPI studies. Appropriate study personnel may include study personnel involved in the design, implementation, and analysis of the TPPI study who have sufficient formal education, training, and experience in conducting social or behavioral science research to ensure the study designed and conducted appropriately. Study personnel should be able to recognize and address features of a TPPI study that could introduce bias or compromise the validity of the study results (e.g., poorly worded measures, failure to “blind” study personnel and participants to condition assignment or study hypotheses). Using appropriate study personnel helps ensure that the data and analyses are scientifically valid. [p. 5]

Translation: Don’t try to do it all in-house. We at FDA like hearing from people who think like us, with similar training and expertise. Don’t make us talk about science with your market research people; they’re simply not credible.

Another way to look at this: By describing up front the reputable studies that guide your TPPI study program, and the experienced scientists you’ve hired to run it, you’re flying flags of credibility. The FDA folks can give a sigh of relief, and settle in comfortably to review the particulars of what they know will be well-thought-out research worthy of their attention.

Learn more about how we use perception and behavioral studies to create a sound regulatory strategy.