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Pronouncing its two-year test of direct-to-consumer drug advertising a success, the Food & Drug Administration has opened that door permanently.

It's also given print media a big boost in the process.

In issuing final guidelines to marketers that want to use broadcast advertising for prescription drugs, the FDA had few revisions to the temporary rules, though it intends to look closely at whether related print ads detailing drug side effects have adequate reach and readability.


The FDA said brochures aren't an adequate substitute for print advertising for those disclosure purposes.

"FDA generally believes that a sponsor has not provided adequate access to the product's labeling when the print component . . . is highly targeted or made only narrowly available and the product is broadly advertised in broadcast media," said a question-and-answer document accompanying the new guidelines.

"FDA intends to monitor the availability of print advertisements . . . [and] may request that sponsors provide . . . information about reach, frequency and total number of exposures of both the broadcast and associated print advertisements."

The Magazine Publishers of America and Newspaper Association of America complained that drug marketers had given print short shrift in the rush to use broadcast ads following the August 1997 temporary guidelines. Last year, $664.4 million was spent on DTC ads, according to IMS Health.


In some cases, drug marketers -in order to run broadcast ads without disclosures by running print ads with the disclosures- ran the required print ads in magazines with limited reach. Also, they ran magazine ads that were nothing but disclosures listing, leaving them virtually unread if not unreadable.

"This is a very good job by the FDA. They took a lot of our comments into account," said Rita Cohen, VP-government affairs for the MPA. Paul Boyle, the NAA's VP-government affairs, said his group was "very pleased."

Neither would offer any estimate of the potential ad gain by the FDA position, though some print media executives have suggested such a change could be considerable.

Dick Porter, exec VP-general manager, TV Guide Media Sales, said the change might encourage drug marketers to use print more broadly.

"I think it's smart for all of us to be concerned about all demographics in this country, especially when it comes to drug information," he said. "To have upper-income whites have access to more information about drugs than other demographics-I think that's an untenable position."


A drug industry ad executive, however, suggested the change would have a limited effect.

"I don't think there's going to be any significant shift of funds," said Matt Giegerich, president of CommonHealth's Quantum Group, Parsippany, N.J., the main agency for Schering-Plough Corp.'s Claritin. "It might affect some marketers that were interpreting the draft guidelines loosely. Most marketers with significant spending were using a balanced campaign in print and broadcast."

Aside from the reach and frequency concerns the FDA expressed, it also said drug marketers broadcasting messages in Spanish have to run their print ads in that language as well.

The agency said print ads have to be more than just a small-type listing of side effects.

"FDA believes that it is critical to have additional product information available in print, especially for audience members who are particularly sensitive to privacy issues in seeking out information," the agency said. "It is important that these sources of information be prominent . . . A display ad with graphics is more likely to be easily found than straight text . . . FDA therefore recommends that sponsors consider . . . including more than just a brief summary and a 1-800 number."

"If you are on [NBC TV show] 'Friends' and you are [doing print] advertising in Guns & Ammo and Boy Scouts Today, it doesn't mean your message is broadly disseminated," said Nancy Ostrove, branch chief for the FDA's Division of Drug Marketing & Advertising.

While the agency provided few specifics, Ms. Ostrove said she also would have a concern about print ads running for one week while the TV buy is longer-term.


The FDA, which was urged by some groups to cut back on DTC advertising, instead gave the Rx strategy a strong endorsement.

"FDA is unaware of any data supporting the assertion that the public health or animal health is being harmed or is likely to be harmed by the agency's actions in facilitating consumer-directed broadcast advertising," the agency said in the question-and-answer document. "No rigorous evidence has been presented to demonstrate that DTC advertising has had any of the hypothesized ill effects."

Ad groups were thrilled with the final guidelines.

"It's great news," said John Kamp, senior VP of the American Association of Advertising Agencies. "Not only didn't they roll back broadcast rules, but they clearly defended the value of advertising for consumers."

The decision is "an important reiteration" of the value of direct-to-consumer advertising," said Dan Jaffe, exec VP of the Association of National

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