The FDA is planning to launch a study into whether positive, upbeat or relaxing images appearing in DTC TV ads may also distract viewers from warnings about drug risks and potential side effects.
The agency said it plans to examine how 2,000 people react to DTC drug ads, in an effort to determine whether they have a positive impression of products despite audio warnings about potential side effects.
The announcement, posted today to the FDA's Web site, comes on the heels of a study published last week by The New England Journal of Medicine (NEJM) that suggests that ad enforcement at the agency is on the decline.
According to last week's NEJMreport, total spending on DTC advertising in the US increased from about $1 million in 1996 to $4 billion in 2005.
The article however noted a dramatic dip in the number of FDA regulatory actions regarding DTC advertising in recent years, from 142 in 1997 to only 21 in 2006, reflecting either better industry compliance—due perhaps to the voluntary PhRMA code—or worsening FDA oversight.
PhRMA senior vice president Ken Johnson, said in a statement that the trade group representing the industry, “looks forward to the opportunity to fully review FDA's proposed consumer comprehension study of DTC broadcast ads.”
The level of FDA staffing dedicated to review of DTC advertising has not kept pace with the recent increase in DTC advertising, authors stated. From 2002 to 2006, DTC advertising was the target of one third to one half of drug promotion violation letters sent by the FDA. Most violations involved DTC advertising that minimized risks or exaggerated effectiveness.
As most companies begin ad campaigns within a year of drug launch, any mandatory restrictions on consumer advertising, such as a DTC moratorium, would be a major shift for most marketers, the researchers added.