Peter Pitts, FDA's associate commissioner for external relations, confirmed that guidelines will be issued this week. "The key word is `draft,"' he said. "We're putting these guidelines out for comment and we want input from the industry."
Mr. Pitts said the guidelines could be adopted as soon as 90 days from this week's announcement. The specifications will update the FDA's August 1999 guidelines on DTC marketing.
the brief summary
The draft guidelines will mostly affect print advertising's brief summaries, whereby a one-page ad in a magazine is often followed by a full page of fine print that lists the risks and benefits of taking a drug.
Though some in the industry have suggested the elimination of the brief summary, Mr. Pitts said it would not be eradicated but hinted it would be reduced. "What the FDA wants to accomplish is to make the brief summary more user-friendly," he said. "It's important to us that people need a better way to understand the risk information."
One pharmaceutical company executive who serves as a liaison for compliance and government relations agreed. "The brief summary is not the best way to communicate this information," this executive said, who asked not to be identified. "Based on its own survey, the FDA knows that the number of people who read the brief summary is tiny. How the FDA changes this will be interesting to see. The most extreme thing would be to just eliminate the Patient Information, but I see them reducing it."
That would surely stoke the fires of consumer advocacy groups and politicians, some of whom, such as presidential candidate Sen. John Edwards (D-N.C.), have called for the elimination of DTC ads altogether.
`good first step'
"If it's just reducing the brief summary, it's a good first step but it's not enough," Rebecca Durkholder, director of health policy for the National Consumer's League, said of the new guidelines. "We want to see that ads, broadcast or print, are done so that consumers are better able to comprehend the information."
"Any liberalization of these guidelines will create political havoc," said Doug Wood, executive partner with the advertising law firm Hall Dickler, New York, and general counsel for the Association of National Advertisers. "That's especially true if it's perceived by some that these new [print] guidelines are taking a step back."
As for TV, Mr. Pitts said the FDA plans to ask drug makers to create ads that talk about the condition or disease state, and encourage patients to see a doctor. The unbranded ads would not mention a specific product, although the respective pharmaceutical company could have its name or logo somewhere on the commercial.
"We want to encourage an increase in help-seeking advertising," Mr. Pitts said. "We want to work with the industry and marketing agencies to better understand how to do that."
Mr. Wood said that's something the FDA can't demand. "They can encourage it," he said, "but they can't mandate it."
Most pharmaceutical companies and ad agencies that specialize in healthcare contacted by Advertising Age seemed open to the idea.
But that doesn't mean those that comply will spend more. Two large pharma marketers said that should the guidelines come into play, they will likely convert some branded spots into unbranded ones. Nor will reducing the brief summary seriously hurt magazine publishers, since those pages are generally sold to pharma companies at a loss.
"If this is what the FDA announces, you're not looking at a lot of significant changes in DTC advertising," said one pharma company VP-marketing. "So to comply with a request for some unbranded advertising really gets you back to what DTC is all about. DTC should really be about public health. Over the years, the public health piece of the equation hasn't always been emphasized."