Healthy Skepticism Library item: 15698

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Richwine L.
UPDATE 1-US warns of TV drug ads' distracting music, images
Reuters 2009 May 26
http://www.reuters.com/article/governmentFilingsNews/idUSN2651619920090526

Full text:

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
(SGP.N) 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 (PFE.N),
GlaxoSmithKline PLC (GSK.L) 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 (MDT.N), Johnson &
Johnson (JNJ.N)and other device makers.
Schering-Plough spokeswoman Julie Lux said the company
reviews all its promotional material “to ensure it complies with
FDA regulations.”