By Lisa Seachrist

Washington Editor

WASHINGTON - The FDA issued its final guidance concerning direct-to-consumer (DTC) broadcast advertising, making slight changes to the rules that have been in effect since August 1997.

However, for the first time, the agency highlighted the importance of the potential benefits of DTC for consumers while stating there were no data for the potential risks of such practices.

"They made very subtle changes to the existing guidance," said John Kamp, senior vice president for the American Association of Advertising Agencies. "The news is they stayed the course. And, in response to critics of DTC, they said there is no evidence of negative public health effects. That is a significant thing. They concede that DTC is a good thing."

Dan Jaffe, executive vice president of the Association of National Advertisers, concurred with Kamp's assessment, noting, "We think this was an important step because they solidified the actions they have already taken."

FDA, however, pointed out that while some have claimed that DTC would result in benefits to consumers and others have argued that such advertising would endanger the public health, neither side had offered any hard evidence for its position. That has since changed.

Nancy Ostrove, branch chief for the FDA's Drug, Marketing, Advertising and Communication Branch, pointed to a Prevention Magazine and Time Inc. survey over the past two years that indicated 13 percent of respondents had discussed a condition with their physicians that they had never discussed before a television ad opened an avenue to communication.

"The agency has always felt that the potential was there for direct-to-consumer advertising to benefit consumers," Ostrove said. "But, there was no data in the past to support such claims. Having 13 percent to 14 percent of patients discuss new conditions with their doctors is a benefit."

In addition, that survey suggested DTC enhanced compliance by patients already on the advertised drug by reminding them to refill their prescriptions. Ostrove noted that may very well be a benefit from DTC in conditions that are undertreated, such as high cholesterol, osteoporosis and depression, because patients become aware there are treatments available.

Ostrove also noted there aren't any good data on how physicians feel about DTC or any health risks associated with the advertising.

That's not to say the FDA is pleased by all facets of broadcast DTC. The agency served notice to the pharmaceutical and biotechnology industries that they will be closely monitoring the broadcast ads to ensure they are backed up with appropriate print ads.

In order to broadcast an advertisement for a drug, ads must refer to a number of different sources in which consumers can receive more detailed product labeling information. They can include a toll-free number, referral to a print advertisement, referral to a health care provider or to an Internet web page address. That is called the "adequate provision requirement," which is designed to ensure people have several different sources of product labeling information.

The agency noted that recently it has become common to launch widespread broadcast advertising campaigns and refer people to limited-circulation periodicals. The FDA noted "that a sponsor has not provided adequate access to the product's package labeling when the print component of its adequate-provision approach is highly targeted or made only narrowly available and the product is broadly advertised in the broadcast media."

"We will be monitoring this and may even be requesting information on the reach, frequency, and total number of exposures of both the broadcast and associated print advertisements," Ostrove said.

The advertising community still has unresolved issues with the guidance as it stands, particularly with the number of side effects the agency requires them to mention during a broadcast.

"We have always thought the rules require more disclosure than is necessary - it just causes confusion," Jaffe said. "We'll continue to try to work for more patient- and consumer-friendly information."

Nevertheless, the requirements to list data on side effects and publish product labeling information are unlikely to deter pharmaceutical advertisers.

"We've all sort of seen DTC advertising level off since the spurt of growth after the 1997 rule change," Kamp said. "I presume there will be an increase with the new drugs, especially the biotechnology drugs, as they come out."