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 in August that 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.
FDA has, in the past, slapped ads like those for Lilly's 2005 “Videogame” spot for Strattera, in which the agency said distracting visuals competed with the presentation of risk information.
The announcement came on the heels of a study published by The New England Journal of Medicine (NEJM) that suggests that ad enforcement at the agency is on the decline.
According to the report, total spending on DTC 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, from 142 in 1997 to 21 in 2006, reflecting either better compliance—due perhaps to the voluntary PhRMA code—or worsening FDA oversight.
PhRMA SVP Ken Johnson said in a statement that the group “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 has not kept pace, 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.
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.