WASHINGTON — Federal regulators plan to study whether relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks.
The announcement, posted Tuesday to the Food and Drug Administration's Web site, comes a week after a study published in the New England Journal of Medicine suggested the agency's drug-ad enforcement has steadily declined.
The FDA says it plans to study how 2,000 people react to television drug ads to determine whether they have an overwhelmingly positive impression of products despite audio warnings about potential side effects.
The Pharmaceutical Research and Manufacturers of America did not immediately respond to a request for comment. The industry trade group has repeatedly said that TV ads are an important way for patients to learn about diseases and treatments.
Drug companies are legally required to present a balanced picture of a drug's benefits and risks in promotions. But critics charge that the images of smiling and relaxed couples and families featured in ads overshadow audio warnings about possible complications.
One ad for Eli Lilly & Co.'s impotence drug Cialis features a middle-aged couple returning from a shopping trip while smooth jazz plays in the background. Toward the ad's end, a male voice lists common side effects, including headache, back pain and muscle aches.
"If advertisers were really interested in getting information about drug risks out, they'd show pictures of those problems, but you almost never see that," said Dr. Sidney Wolfe of the advocacy group Public Citizen, which frequently criticizes drug industry marketing.
According to the authors of the NEJM article, the FDA sent 21 citations to drug companies last year for problems with consumer-directed ads, compared with 142 in 1997. During that same period, drug industry spending on such advertising soared 330 percent, to $29.9 billion in 2005 from $11.4 billion in 1996.