Guidelines proposed by FDA for drug risk details in advertising

U.S regulators advised drug and medical device manufacturers to avoid using distracting images and music in their television ads that can decrease viewers’ ability to interpret potential side effects. 

The guidance from the FDA came in response to complaints that drug-makers utilize varying multimedia techniques to downplay risk information presented in ads. The administration suggested guidelines on how the industry should introduce such details adequately in print and broadcast campaigns to better serve the consumer and physicians.

The advice cautions that “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 guidelines note that scenes visually busy including moving camera angles and quick editing "can misleadingly minimize the risks of a product being promoted by detracting from the audience's comprehension." Though the guidelines are not mandatory they suggest the companies should focus on "the messages conveyed by the promotional piece as a whole.”

Prescription drug ads have drawn fire for rushing through or producing distractions when required risk information is conveyed while using the largest percentage of the piece emphasizing the benefits of the drug by using healthy-looking, active and smiling patients. A Schering-Plough Corp ad for allergy drug Nasonex drew criticism at a congressional hearing last year for featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained.

PhRMA senior vice-president Ken Johnson commented that drug-makers "remain committed to producing responsible, balanced promotional materials." Johnson noted that  member companies have voluntarily adopted guidelines calling for risks to be "presented in clear, understandable language without distraction."

Wanda Moebius, spokeswoman for the Advanced Medical Technology Association, which represents Medtronic , Johnson & Johnson and other device makers claims that medical device manufacturers have also adopted voluntary advertising principles saying their industry will “need to present risk information in a manner free from distraction."

Article attributed to firstwordplus.com, forexpros.com, Reuters