An article in today's Washington Post -- "Drug Firms Jockey for Space Online" -- sent EyeonFDA blogger Mark Senak on a "fantastic rant" (HT @brianreid) against FDA's "fundamental lack of understanding of how people use the Internet for healthcare and therefore does not understand how to regulate it" (see "Fact or Fiction - FDA Has a Policy on Social Media?").
The question is: Is the FDA media agnostic or not?
"If drug companies or others working on behalf of drug companies wish to promote [their products] using social media tools, FDA would evaluate the resulting messages as to whether they comply with the applicable laws and regulations." said Karen Riley, a spokeswoman for the agency. "Our laws and regulations don't restrict the channels that prescription drug companies choose to use for disseminating product promotional messages."
"That is the same line they fed me during my podcast with DDMAC in March," said Senak, "which turned out to be inaccurate when they issued the 14 untitled letters on search engine ads. They are still sticking to their story - but take a whole dose of caveat emptor if you want to rely on it."
But I contend that the 14 letters do NOT contradict the line that FDA "fed" to Senak, who apparently got hooked.
Senak asks: "Does risk information need to be included in a search engine ad that names the drug and what it is for when the placement of the risk information is no differently handled than in a print ad?" Apparently, Senak believes a search engine Adword should be treated exactly the same as a print ad -- everyone knows you have to click the adword to see the risk information just like you have to turn the print page to see the full risk information.
But Senak misses an important point: the main promotional piece of a print ad -- what you see BEFORE you turn that page -- contains a "brief statement" about risks; Adwords don't.
FDA guidance on communicating risk says this:
"For a piece to be accurate and non-misleading, risk information should be included in the main part of a piece. If the omission of risk information in any part of a piece makes that part of the piece false or misleading, the problem cannot be corrected simply by including the risk information in a separate part of the piece [my emphasis]. To be comparably prominent to benefit information, risk information should generally appear in the same parts of the piece as the benefits."
You will note that the FDA does not say "print piece" and this example, which can equally apply to Adwords or display ads ("pieces") on the Internet.
In the post "Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance," I point out that you may not like that the FDA views an Adword as the "main piece" of a promotion, but there it is.
I agree, however, that the FDA should come out with SPECIFIC guidance for Internet ads just as it has done for TV and print. If the rules are the same, point that out with examples. Don't leave it up to imaginative marketers to interpret the tea leaves from "media agnostic" guidance.