NEW YORK (AdAge.com) -- The FDA's Division of Drug Marketing, Advertising and Communications has sent out letters to 14 leading drug companies requesting them to end what it's calling "misleading" and "misbranded" advertising on search engines such as Google and Yahoo.
In the letters, the FDA asserts, among other things, that the violating ads did not accurately link a branded drug's efficacy claims with its risk information.
The FDA called out nearly every major drug maker, including Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forest Laboratories, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche and Sanofi-Aventis, in addition to nearly 50 drug brands. The letters, which were not warning letters but so-called pre-emptive, untitled letters, requested an immediate end to the ads and written responses from the companies by April 9. Some of the changes will include disassociating a branded drug from the condition it seeks to treat in the search ad's headline, description lines and even URL name.
To date, the FDA does not have specific guidelines for advertising in the digital realm. Instead, it has general guidelines that apply to all media -- namely, that any representations or suggestions about the effectiveness of a branded drug must be accompanied by information about that drug's risks. The FDA said it came across the inappropriate search-engine ads "through our routine monitoring of promotion done on the internet," which includes trolling online or reviewing promotional material it receives, a spokesperson said.
Still, to some insiders, the public finger-wagging seemed just short of a concerted but misguided effort to create a policy statement around search advertising.
"The FDA is of the mind that they don't need to issue guidance specific to digital media because their current regulations cover that," said Mark Senak, senior VP at Fleishman Hillard and author of blog Eye on FDA. "Technically that's true. However, the internet presents a lot of situations that are somewhat nuanced and would lead to question in the mind of any reasonable person. Those questions deserve some answer. Formulating policy by issuing mass warning letters is not a valid way to set that policy or express it."
The FDA does allow drug companies to create "reminder" ads (so long as the drug does not have potentially serious adverse effects) that include the name of the drug to remind consumers it exists. And that's where the 14 drug companies got into trouble. Mr. Senak said they tended to follow a "one-click rule," where if comprehensive drug information was just one click away on the product website, for example, the search-engine ads would be acceptable. "It was one of those things that people did, and because there was no [FDA] action around it, they assumed that it was OK," Mr. Senak said.
At least one pharmaceutical company said it thought it was following the rules. Sanofi-Aventis was called out for improper search ads for its blood thinner Plavix. "Sanofi-Aventis believes that the links were consistent with DDMAC requirements for the provision of risk information," a spokesperson said. "The links went to the product-specific website, which contains the important risk information on the landing page and a link to the full prescribing information."
What about other digital ads?
Sanofi-Aventis said it will work with the FDA to determine the next steps and correct the violating ads. A spokesperson from Pfizer said the company "will make whatever changes are needed to ensure full compliance with the instructions contained in the FDA's communication."
Now that the FDA has taken its stance on search advertising, it's clear that the days of the "one-click rule" are over. But what will happen with other forms of digital advertising -- say, a branded YouTube channel?
Mr. Senak said he doubts that even the FDA knows what to do with all the new-media opportunities out there. "I don't know that the FDA has completely wrapped their head around Web 2.0 policy at the same time we're hurtling ahead to Web 3.0," he said. "There's evidence that they're still figuring this out."
An FDA spokesperson disagreed. "We have address[ed] violative promotion on the internet for years and will continue to do so," the spokesperson said, noting that the agency has evaluated banner ads, promotional videos and product websites. "We look broadly at promotion and address many different promotional vehicles each year. As companies use different promotional vehicles, we will address these if the promotion is violative."