FDA to study TV images impact in drug ads.

FDA plans to study whether relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks, the agency announced Aug. 22.

FDA 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.

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.

"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 Sidney Wolfe, M.D., of the consumer advocacy group Public Citizen.

The announcement, posted to FDA's Web site, comes a week after a study published in the "New England Journal of Medicine" (NEJM) suggested the agency's drug-ad enforcement has steadily declined.

According to the authors of the NEJM article, FDA sent 21 citations to drug companies last year for problems with consumer-directed ads, compared with 142 in 1997.

During the same period, drug industry spending on such advertising soared 330%, to $29.9 billion in 2005 from $11.4 billion in 1996. The overall amount spent promoting medicines is 2.6 times what it was in 1996, researchers announced Aug. 15, according to a report from Reuters.

For the new study, Julie Donohue of the University of Pittsburgh Graduate School of Public Health and her colleagues looked at industry data from three market-research firms that track advertising spending by the pharmaceutical industry.

"In 2004, four (FDA) staffers were reviewing such advertisements, even though spending on this form of advertising (and probably the volume of ads to review) had increased by 45%, from $2.9 billion to $4.2 billion," the researchers said.

And while 64% of the ads broadcast on television in 1999 were reviewed by FDA, the ratio had declined to 32% by 2004, Reuters stated.

In addition, in 2002, when then-Secretary of Health and Human Services Tommy Thompson began requiring all warning letters to be reviewed by the FDA's Office of Chief Counsel, the number of letters actually sent to manufacturers dropped by half, the researchers said.

A report from the Government Accountability Office concluded that FDA warning letters often were not sent out until false or misleading ad campaigns had run their course.

FDA's announcement says a study is needed on whether some ads "simply distract consumers from carefully considering and encoding risk information."

Besides looking at how images used in ads affect consumers, FDA will also study how text on the screen can focus or divert attention from audio warnings. FDA says text directing viewers to company Web sites or magazine advertisements can distract viewers from more important audio about side effects. On the other hand, FDA said the repetition of language about risks in text format could help reinforce warnings.

In response to increased scrutiny, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently issued voluntary guidelines for members on promoting drugs to patients. Members include Pfizer, Merck, Wyeth and most other major pharmaceutical companies.

The guidelines recommend companies submit TV ads to FDA for review before broadcast. Drug companies agreed to start paying the agency $80,000 per ad to offset the cost of hiring more drug ad reviewers.

Last month, however, House lawmakers rejected the proposal, recommending that federal money finance the regulatory reviews. The legislators said having drug companies pay salaries of FDA ad reviewers could create potential conflicts of interest.

House lawmakers are slated to meet with their Senate counterparts in September to work out differences between companion bills aimed at increasing FDA's enforcement powers.