Using a Label Comprehension Study for Nonprescription Drug Products

by | May 12, 2021 | FDA User Experience Study, Genetic Testing, Survey Methodology, User Comprehension

Over-the-counter drugs and direct-to-consumer genetic tests need to stand alone: here’s how the FDA ensures label comprehension. 

At SoundRocket, we have spent some time talking about the #SoundScience that is associated with FDA user comprehension studies. These studies are designed to ensure people who have direct-to-consumer (DTC) genetics tests for medical purposes, such as genetic health risk (GHR) or pharmacogenetics tests, can understand the meaning of their results on their own (i.e.: without a healthcare provider) based on the materials provided.

User comprehension studies emerged in recent years associated with marketing authorizations for DTC tests at the FDA, however, they are simply an evolved version of a familiar evaluation study referred to as a label comprehension study. 

Label comprehension studies have been conducted for decades to ensure that inserts (i.e.: labels) for nonprescription (i.e.: over the-counter) drug products include clear information on safe and appropriate use, which can be “read and understood by the ordinary individualon their own. To measure this, comprehension is evaluated in individuals with normal literacy and those with low literacy.  

In 2010, the FDA issued a guidance document, which provides specific recommendations on how to implement label comprehension studies. In it, they address general principles regarding study design, objectives, population makeup, and statistical considerations and data analysis. 

The document reviews the overall process. Label comprehension studies begin iteratively, using a combination of qualitative research and pilot testing to refine the drug label and tweak the study questionnaire, in preparation for the larger comprehension study. The larger study uses a combination of quantitative and qualitative data to measure, and ultimately prove to the FDA, an acceptable comprehension level. 

We use the same phased approach for user comprehension studies. 

While the FDA guidance document explores elements of questionnaire design, they caution, it is best to consult experts in questionnaire design when conducting these studies since ‘wording, question structure, and question sequence may significantly affect the validity and interpretability of the data collected’. 

With loads of experience in survey methodology and creating questionnaires, this comes easy to us. Stay tuned for a closer look at questionnaire design considerations for label and user comprehension.

Read the full guidance document or contact us directly to discuss your label or user comprehension study needs with a genetic test FDA expert. 
Currently, the FDA only regulates true direct-to-consumer (DTC) genetic tests, which have no health care provider involved either before or after testing. Consumer-initiated, physician-mediated genetic tests are considered lab developed tests (LDTs), which currently do not require FDA oversight. 


Our Study Design

Our study was designed to simulate the experience of an everyday person who is considering doing a health-related genetic test. For this reason, we only reviewed website contents presented to a consumer before ordering a test. By limiting our data collection to pre-test content, instead of digging around or contacting the companies to fill in missing data points, gaps in public-facing information that consumers use to make ‘informed’ decisions were revealed.  

Also, while a genetic counselor supervised the project, a research assistant (RA) conducted most of the website investigations. The RA was familiar enough with genetics and genetic testing to understand and identify the information presented on the websites, but has not had the clinical exposure that might create bias from knowing how specific tests work “behind-the-scenes”. 


To Sum Up

We set out to understand the landscape of health-related consumer genomics testing from the public perspective. By limiting our research (by design) to public-facing pre-test website content, we could not complete our data collection as set out in the protocol. However, this uncovered an important observation: consumer genomics websites are highly variable in content, readability and ease of use. 

This begs the question, if we can’t find basic test information on a consumer genomics website, how does a consumer have enough information to make an informed choice about testing? 

Stay tuned for Part 2 in this series, where we will dig into our study findings and reveal our most interesting observations.  



As experts in FDA user comprehension studies for consumer genomics companies seeking 510(k) clearance, we are interested in how everyday people access and understand health content that is meant for them. If you need help optimizing your consumer-directed health communications, we’ve got the in-house expertise and experience to meet your needs. Let’s chat

About the Author

Scott D. Crawford

Scott D. Crawford is the Founder and Chief Vision Officer at SoundRocket. He is also often found practicing being a husband, father, entrepreneur, forever-learner, survey methodologist, science writer & advocate, and podcast lover. While he doesn’t believe in reincarnation, he’s certain he was a Great Dane (of the canine type) in a previous life.