FDA to study impact of shorter DTC risk list
Abbreviating risk information is courting a regulatory slap, but the FDA is now exploring if providing too much risk information in DTC ads interferes with just how much information viewers are able to absorb.
The plan is to see if addressing fewer risks may not just be OK, but if it helps patients better understand the risks that are described.
For anyone thinking this could mean fewer collateral pieces: The study is also testing whether telling viewers to check out other sources for unaddressed risks prompts them to do so.
To find out, researchers will show viewers one of four ads for real products, and the ads will vary by the amount of information provided, such as a full disclosure of risk with advice to seek out additional information, a shortened list with advice that not all risks have been addressed or a short risk list with no indication that there is more to it.
The disclosed risks are ones the regulator calls "serious" or "actionable." The FDA defines actionable in a Federal Register Q&A about the study as a condition a patient may be aware of or can recognize, such as an allergy or physical symptom, and which a patient can resolve through efforts like ceasing medication or medical help. The FDA defines serious in this same Q&A as items that would be covered in a warning label.
This is just one component of the DTC space the FDA is and has looked into. The regulator is also assessing how and if patients understand aural compared to print information and how repetition affects drug perception.