FDA reveals tough new stance on ads at DTC NationalFood and Drug Administration officials delivered a "heads up" to DTC advertisers that the agency will be taking a tougher line on drug ads. "We're going to be taking a much closer look at the way information is being presented" in drug ads, said Kathryn Aikin, social science analyst on the research team of the FDA's Division of Drug Marketing, Advertising and Communications, speaking at the DTC National Conference in Boston this morning. Aikin said the agency is "very concerned about the direction DTC is taking," particularly with regard to viewers' appreciation of the balance of risks and benefits of drugs.
Aikin urged advertisers to consider the "overall impression" of an ad on the viewer, and outlined areas of concern to the FDA. Risk information, she said, is not being communicated clearly. DDMAC will be examining the prominence and amount of risk information, censuring ads with too much as well as those with too little.
"Risk information can be too much or too technical," said Aikin, adding that the agency is also concerned with distracting visuals during presentation of risk information. She cited a Zyrtec ad which showed a cute dog cavorting in a park while the announcer ran through the risk information. The speed of delivery and placement of risk information in broadcast ads will also be considered. Aikin said, "Think education instead of car-leasing information." Hyped-up statements of efficacy, implied off-label uses and overblown, "scary" depictions of a disease are other no-nos.
"This is not just coming from us," said Aikin, citing Congressional pressure. Melissa Moncavage, DTC review group leader at DDMAC, said that while the agency has no plans to revisit the broadcast guidance, a guidance on fair balance is in the works. Moncavage said that the number of broadcast ads submitted to DDMAC rose from 474 in 2003 to 628 in 2004, while the total number of final promotional pieces submitted climbed to 42,190 in 2004 from 38,081 in 2003. Of those, 7,972 pieces in 2004 were consumer promotions, compared to 6,059 in 2003.