Fair Balance: Hiding in Plain Sight

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  • 02/18/2014
The FDA says, “Lengthy lists of drug side effects recited in TV ads are so baffling they may cause consumers to overlook the worst harms of the medicine.”

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.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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