The FDA's promotional police plan to address social media links for pharma again this year. Maybe.
That is, the issue is on the agency's annual agenda of "new and revised draft guidances CDER is planning to publish during calendar year 2016." And the item specifically states that the FDA plans to look at the "use of links to third-party sites," according to the guidance document.
Still, it's a "maybe," because, as Eye on FDA blogger Mark Senak pointed out, that same item was listed in almost exactly the same way on 2014's agenda. In 2014, it read simply "use of links"; last year's agenda added a reference to "third-party sites."
"[I]t probably pays to think of this list as more aspirational," Senak wrote in an email interview. "Particularly when it comes to digital media, FDA has been slow to develop guidance. It is not clear what the contents of this guidance would be. … The use of links has been partially addressed in other guidance and actions."
When asked about the new agenda and the social-media item, an FDA spokeswoman told FiercePharmaMarketing, "We continue to work on this guidance, but I don't have any information about specific timing."
Kim Kardashian issued a corrected social media post for Diclegis with the hashtag "CorrectiveAd" on Instagram.
However, don't expect--or wait for--a big overhaul, was the advice to pharma from social media compliance expert Joanna Belbey. The Office of Prescription Drug Promotion (OPDP) has made it clear in the past year with warning and untitled letters that links are not acceptable substitutes for listing benefits and risks together in any digital media, she said.
Most recently, in July the FDA slapped a warning letter on drugmaker Duchesnay and its anti-nausea brand Diclegis, for a sponsored Instagram post by reality star Kim Kardashian. The main problem was that Kardashian used a link to the risks and side effects rather than spelling them out in the post. Kardashian had to spell out the risks in a corrective post, as part of FDA-required reparations.
It wasn't the only time the FDA made known its thinking on links. In April 2009, OPDP sent 14 letters to companies regarding 45 different brands for the use of links in banner ads. What's left to spell out? "It is not obvious to me what would be contained in a separate document now on links," Senak says, "nor has there been any indication from the agency of which I am aware."
Belbey posited that the new agenda item simply "may be about providing a bit more guidance or more examples." However, she added that regardless of the outcome on new link guidance, "Pharma firms need to continue to follow the spirit of the law. And the spirit of the law is to be fair and balanced and to list in equal measure the risks and benefits."
Belbey also works with other regulated industries, such as financial services, where similar risk-and-benefit rules apply in marketing communications, including social media. Belbey said she advises clients to make decisions about communications following the fair and balanced guidelines and then document what they're doing. That way, if a company does receive a letter, they can retrace steps and provide reasons and thinking regarding marketing materials.
- check out CDER's 2016 guidelines
- read RAPS' 2014 article with similar guidance
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