Should FDA show us the search-ad data?

At least one big-time pharma attorney isn't amused by the FDA's recent spate of Internet-search-ad warning letters. Though drug-safety concerns top the list of new-FDA worries for Morgan Lewis FDA/healthcare practice chief Kathleen Sanzo, she's also more than a bit nonplussed by the agency's stance on the search-ad issue.

Sanzo uses Biogen Idec's warning letter to illustrate her point. The FDA objected to this search ad: "Satisfied with your MS medication or looking for something different? Go to www.tysabri.com." Why? The agency didn't like the fact that the ad didn't discuss the fine-print on Tysabri's approved uses and its potential to cause serious side effects, such as the deadly brain infection PML. But Sanzo thinks ads such as this one should be considered along with the websites they reference: "I think if you were a consumer and you saw that [ad], you would go to the website to get more information," she told Investor's Business Daily.

"It's hard to understand the basis on which the FDA took that action," she goes on. "There is no indication the FDA has any data to support its position that consumers stop their searches for drug information when they get the ad that comes up first."

Clearly, we've just begun the debate over FDA's regulation of online pharma advertising and promotion. But even so, it's tough to argue with Sanzo's logic. We'd like to see the FDA's data, too--if it has any.

- read the Q&A from IBD

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