The Food and Drug Administration is studying whether disclosure limited only to serious side effects would improve consumer understanding, according to an agency document. To cover lesser side effects, the FDA proposed simply adding a line about “potential additional risks.”
“Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks,” the FDA said in its document.
The FDA plans to survey 1,500 study participants about ads with varying ranges of side-effect disclosure, and then measure their understanding of risk.
The underlying problem is that risk information is hidden in plain sight by not being in plain English. Risk information is neither designed nor delivered to be user-friendly. At present it is designed to be “in compliance.” And that has to change.
When it comes to DTC print ads, the joke inside the FDA (and in many regulated industry review offices) is that the Brief Summary is like the Holy Roman Empire – it is neither brief nor a summary. So, when it comes to TV ads, hopefully the agency is asking the right questions. Fair Balance and Adequate? “Fair” for whom and “Balanced” how? Adaquate Provision? Doesn'tlook like it.
Working together, the FDA and industry can make a difference. DTC can be a more potent, precise, and persuasive tool on behalf of the public health. And rather than rubbing the lamp and wishing, we need to burn the midnight oil and work harder to make it a reality—because an educated consumer is not only a better customer, but a more compliant and adherent patient.
