February 26th, 2014
FDA: Long Drug Warnings Hide Risks
By Conan Milner
Agency proposes simple, serious, warnings in drug ads
Pharmaceutical marketing has had a profound effect on America’s growing prescription drug appetite. Now regulators worry that advertising may cause consumers to miss the biggest risks.
The U.S. Food and Drug Administration (FDA) is reconsidering what regulators call the “major statement”—an obligatory list of side effects and health hazards that accompany each pharmaceutical ad. The major statement serves to balance the slick sales pitch with the risks associated for a particular drug, and hopefully leads the consumer toward an informed decision. According to an FDA announcement, “The major statement is often too long, which may result in reduced consumer comprehension.” The concern is that ads, which drone on about dry mouth, nausea, and skin irritation, may distract consumers from the most serious risks, such as suicidal thoughts, heart attack, or stroke.