Currently, there is no language in the new guidelines prohibiting drug companies from using the same celebrity spokesperson and/or the same creative elements in both branded and unbranded ads. That could create the opposite scenario of what the FDA is asking for: more help-seeking, disease-awareness ads that encourage patients to see their doctor rather than mentioning a specific product.
"If this isn't written into the permanent guidelines," said one marketing executive for a pharmaceutical company, "why wouldn't you use the same spokesman or creative backdrop for both kinds of ads?"
The revelation came last week during the Direct-to-Consumer Advertising Draft Guidance Symposium in New York, sponsored by Advance Publications' Parade. A quartet of high-ranking FDA officials formally presented the new draft guidelines for DTC marketing and took questions from an audience filled with more than 200 pharmaceutical company and ad agency executives.
When the question was asked, the FDA officials were at first confused, then flustered and then ultimately chagrined.
"So you're saying, would we object to a help-seeking ad that used the same celebrity as a branded ad? That's an interesting scenario," said Peter Pitts, the FDA's Associate Commissioner for External Relations. "I don't know."
"That gets kind of tough," said Thomas Abrams, the FDA's Director of the Division of Drug Marketing, Advertising and Communication, who also did not answer the question.
now an issue
The FDA is seeking public comment over the next 90 days before the draft guidelines become permanent, "and you can bet now that they'll talk about this," said another pharmaceutical VP-marketing. "I mean, let's face it. If you take a Cindy Crawford ... and stick her in front of Niagara Falls or the Grand Canyon ... in unbranded and branded DTC ads, even the village idiot is going to make the connection between the disease and the specific product."
A similar tactic was tried three years ago when Merck and Co. hired 1976 Olympic gold medal winner Dorothy Hamill to pitch Vioxx, its anti-arthritis drug. In a campaign from Omnicom Group's DDB Worldwide, New York, Ms. Hamill appeared in both branded ads for Vioxx and unbranded ads for the disease osteoarthritis.
Part of the problem is that the FDA's new guidelines requesting more unbranded ads may go unheeded, said Andrew Schirmer, exec VP-managing director of Interpublic Group of Cos.' McCann HumanCare.
"If you're a pharmaceutical company and you have a 20% market share of a product, are you going to do an unbranded ad that ends up helping the guy that has 60% of the market?" Mr. Schirmer asked. "I don't think so."