WASHINGTON (Reuters) - Television ads for drugs and medical devices should avoid distracting images and music that can reduce viewers’ comprehension of potential side effects, U.S. regulators advised in guidelines proposed on Tuesday.
Advertisements also should use similar type styles and voice-overs when conveying benefits and risks, the Food and Drug Administration said.
The guidelines follow complaints that manufacturers use various techniques in their widely seen television ads and other promotions to downplay risks while emphasizing potential benefits.
Leaving out or minimizing side-effect information is the most frequent violation the FDA cites in letters to companies complaining about misleading promotions.
The draft guidelines advise manufacturers on how to present risk information adequately in print and broadcast promotions to consumers and doctors without running afoul of federal regulations. The guidelines are not mandatory.
The advice covers techniques ranging from the use of contrasting colors to highlight information, the location and timing of risk details and other factors that can influence how well viewers understand a product.
Prescription drug ads have drawn fire for portraying healthy-looking, active and smiling patients while explaining benefits and then rushing through or providing distractions when required risk information is conveyed.
At a congressional hearing last year, a Schering-Plough Corp ad for allergy drug Nasonex drew criticism for featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained.
In the new guidelines, the FDA said busy scenes, frequent scene changes and moving camera angles “can misleadingly minimize the risks of the product being promoted by detracting from the audience’s comprehension.”
The FDA also warned against speeding up an announcer’s description of risks. “If risk information is considerably more difficult to hear and process than benefit information because it is presented at a much faster pace, the piece will not convey an accurate impression,” the agency said.
Reviewers will consider “the net impression conveyed by all the elements of a piece. For this reason, manufacturers should focus not just on individual claims or presentations but on the messages conveyed by the promotional piece as a whole,” the guidelines said.
Groups representing drug and medical device makers said they were still reviewing the FDA guidelines.
Drug companies “remain committed to producing responsible, balanced promotional materials” and have adopted voluntary guidelines that say risks “should be presented in clear, understandable language without distraction,” said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America. The group represents Pfizer Inc, GlaxoSmithKline PLC and other drugmakers.
Medical device manufacturers also have adopted voluntary advertising principles that include “the need to present risk information in a manner free from distraction,” said Wanda Moebius, spokeswoman for the Advanced Medical Technology Association, which represents Medtronic, Johnson & Johnsonand other device makers.
Schering-Plough spokeswoman Julie Lux said the company reviews all its promotional material “to ensure it complies with FDA regulations.”
The FDA guidelines were posted on the agency's websitehere.
Reporting by Lisa Richwine, editing by Dave Zimmerman and Matthew Lewis
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