A nascent but growing area, Internet ads might get FDA attention before print advertising. Currently, the Internet is guided by principles FDA applies to other media.
FDA Public Health Analyst Nancy Ostrove told Advertising Age the agency is looking at issuing non-binding recommendations, though she would not indicate a timetable.
The American Association of Advertising Agencies as well as publishers have been hoping for priority attention to the "brief summary" requirement in print ads, which make up the bulk of DTC advertising.
"The most important issue out there is cleaning up the brief summary, which is neither brief nor a summary," said John Kamp, Four A's senior VP. "It's not that hard and much more of a significant problem right now.
"The Internet is too complicated and dynamic an issue; the FDA should just follow the rules it has right now," he added.
Spending on DTC drug ads totaled $441.3 million for the first half of this year, according to Competitive Media Reporting; magazines and newspapers accounted for $382 million. Internet DTC drug ad spending is not tracked.
FDA is actively investigating how to create a compromise that will suit the federal agency, marketers, physicians and consumer groups, Ms. Ostrove said.
TOO MUCH INFO?
One Internet issue is the line between labeling and advertising. The agency also is concerned with what consumers take away from the Internet. For example, a consumer seeking a drug's indications may also see financial or pre-clinical data at a marketer's site and possibly glean misleading information about the product, she said.
Further, the agency wonders how other nations might respond to FDA-allowed Internet messages, due to the international nature of the medium.
"We need to carve out some safe harbors," said Ms. Ostrove.
Eventually, FDA hopes to address the brief summary required in print ads to make it more user-friendly and easier for marketers to apply in their ads, she said.
About six months ago, an increasing number of more consumer-friendly messages began getting approvals, although they were not significantly briefer.
"These were not much of a benefit, since many were just as long," said Mr. Kamp, who added that the "major statement" requirement in TV ads remains ill-defined. "You don't know what it really requires."
Pharmaceutical marketers have found it difficult to hit on benefits, risks and contraindications of drugs without diluting the product's message or drawing criticism from FDA or citizens groups. Further guidelines could come for TV advertisements, though nothing is planned immediately from FDA.
In the meantime, Ms. Ostrove said, TV commercials should take their cues from the body copy-not the brief summaries-in print ads for some 70 classes of prescription medications that have been out for more than five years. Those serve as good examples of balance in DTC advertising, she said.
"Our position has always been that for consumers, the brief summary doesn't serve as balance at all," she said. "You need to look within the four corners of