The FDA may be having problems handing down its social media commandments. But it's playing enforcer just the same.
Last week, the agency hosted a webinar promising to illuminate the guidelines it's drawing for pharma's online chit-chat. As BioWorld notes, people really wanted to see the light. Many people, in fact--so many that the event filled up.
But when it came time for the clouds to part, FDA experienced technical difficulties. Registered guests couldn't log on. The slide presentation crashed. After trying to fix it on the fly, FDA resorted to audio-only. By the end of the event, the slides were back up, but the audio "was intermittent and unintelligible," BioWorld notes, "similar, some would say, to the FDA's message on social media as a whole."
Meanwhile, FDA was just as busy--and perhaps a bit clearer--when it issued a couple of missives to trespassing companies. As Medical Marketing & Media reports, the agency's Office of Prescription Drug Promotion last week slapped Gilead Sciences ($GILD) for its Google AdWords efforts. Not to leave out Facebook ($FB), the agency scolded Zarbee's Naturals for "liking" and commenting on Facebook posts about its products.
The offending Gilead promo, which featured its Viread treatment for hepatitis B, managed to step on several of the agency's social media mores. In fact, the third word in the ad--prevention--was a problem in itself. The drug is approved for hep B treatment, not prevention.
Then there were the drug's names. Its brand was mentioned as part of two URLs, but never featured on its own, and capitalized. The drug's generic name, tenofovir disoproxil, didn't make an appearance at all.
And then there was the whole risk-benefit disclosure. As you'll recall from the FDA's new guidelines on such disclosures, the agency wants both, even in space-limited venues. So, when Gilead raised Viread as a treatment option for the disease--and didn't mention any of its risks--that ran afoul of the risk-benefit framework.
With its Zarbee's scolding, the FDA shed some light on its Facebook preferences. The agency sees a "like" on the social media site as an endorsement of the post or comment in question. Zarbee's "liked" several consumer testimonials, and the FDA saw that as promotional.
"I've been battling either bronchitis or pneumonia for the last 18 days and have tried everything," stated one comment later "liked" by Zarbee's (as quoted by the FDA in its letter). "[Y]our Children's Cough Syrup and mucus relief got rid of...my hoarseness [sic]...[m]y throat and chest are beginning to feel so much better..."
What's worse for Zarbee's, that promotion was immediately a no-no; its supplements aren't FDA-approved to treat pneumonia or bronchitis. (Or anything else, for that matter, but that's a separate issue.) Ditto, we assume, for any off-label likes, but you probably knew that already.
As case studies go, these two communications from FDA aren't bad teachers. As MM&M notes, the Gilead AdWords mishap basically shows how not to use the format if you're a drugmaker. And the slap at Zarbee's, supplement maker or no, offers pharma additional incentive to be careful with the "Like" button.
Brave enough to give the FDA's direct-to-pharma communications a try? The FDA did post the slides from its ill-fated webinar, along with a Q&A that addresses some of the webinar participants' questions.
- check out the agency's posted Q&A (PDF)
- read the BioWorld post
- get more from MM&M
- here's the Time article
- see the FDA's webinar slides (PDF)
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