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The Social Media Playground: What if FDA Says Pharma Can’t Play?

Guest Blogger

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The industry is waiting with bated breath for guidance from FDA on the use of the Internet and social media for promotion of pharmaceutical products. When can we expect it and what will it mean?

When Can We Expect It?

As recently as June, FDA was quoted in print as saying they were "still on track" to have guidelines issued by end of 2010. In an exclusive report issued in September, Reuters reported the same timeline. But last month, fellow pharma blogger Mark Senak attended the Food and Drug Law Institute Advertising and Promotion Conference held in Washington, D.C., and sat through several presentations from DDMAC. Mark subsequently blogged "FDA could not say for sure that it would happen by the end of the year, but that was the goal. They also stated that while they were planning more than one guidance document, they couldn’t say how many." Then the BioJobBlog took it all one step further with the headline "FDA Guidance on the Use of Social Media May Not Be Complete Until 2012!"

So? It’s anybody’s best guess as to when they will be issued. (Should we start a Vegas pool and place bets? Who’s in?!) I don’t think FDA even knows when they will be done. Maybe by end of 2010 (I’d be surprised) ... maybe sometime in 2011 (more likely) ... maybe not until 2012 (a possibility). So where does that leave the industry? What if Pharma Can’t Play?

What if FDA says pharma can’t "play in the social media playground?" It’s a scary thought, but it’s possible that guidance could be so restrictive for brand promotion that it makes no sense at all to participate in what should be a two-way conversation.

Then we’d pretty much be in the same place as where we are now, wouldn’t we?

What We Do Know - Our Baseline:

  • They’re Online. We know patients and professionals are online and using mobile devices seeking information, talking to others about health and medicine.
  • Space Limitations. We know there are (and likely always will be) real limitations around the use of fair balance in space-limited channels such as Twitter, search ads, text messaging, and sharing tools.
  • Content Control. FDA will always hold pharma responsible for content that it controls. What’s somewhat debatable is whether pharma is also held responsible for content that is out of its control. (For example, what search engines display in organic results, content that is shared and then edited by the user, and that gray area of comments posted on a pharma-sponsored Facebook or YouTube channel.) But we know for what pharma controls, pharma is held accountable, as noted in the recent FDA letter concerning Facebook social sharing.
  • AE Reporting. Pharma is still responsible for reporting AEs - that, too, will never change. This week FDA reminded us all of this by issuing a warning letter to Actelion concerning its failure to follow postmarketing AE reporting requirements for three of its drugs.
  • With our Without. We know, also, that there are still ways we can reach patients and professionals, with or without social media. Read on ...
What We Can Still Do - With or Without Guidance:
  • Listen In. Everyone says it but it’s worth saying again ... social "listening" is always a great place to start, and FDA surely can’t have a problem with it as long as AEs are monitored and reported and other existing SOPs are followed. Monitoring social media provides information, insights, and a wealth of information not found anywhere else. I’m still amazed at how many pharma companies aren’t doing this in an organized manner yet. Of course, the trick is to integrate human analysis with automated ones so that the information you glean is actually helpful and actionable.
  • Corporate Approach. What seems the safest, most widespread, and perhaps most appropriate use of social media is at the corporate level. Corporate initiatives support the company brand and reputation — not a product. See this (now one year old, but still useful) graph on who’s tweeting from a corporate perspective.
  • Customer Service. There’s an opportunity to look at customer service and even medical information providers in a new way. Product specialists could reach out to help answer online queries in channels not owned by the pharma company. Nurses could seek out patients with questions and concerns and help them. Perhaps the conversations would need to be taken offline or one-on-one, but this could be explained, and the effort would be appreciated. (These days, that’s practically an expectation from consumers)
  • Unbranded Approach. Unbranded product promotion, though recently under new fire from FDA, is still safer ground than branded promotion. The industry is in a position to be able to provide disease support, tools, and education that others can’t. Recently, sanofi-aventis’ launched a new diabetes Facebook page. The effort received accolades from blogger Rich Meyer, who isn’t shy about telling it like he sees it when it comes to critiques. Read his review to see what he liked about it. [Full disclosure: this was my agency’s project and sanofi-aventis is our client]
  • Back to Basics. I expect that FDA isn’t going to outright ban certain means of outreach such as search engine marketing, banner advertising, email, or good old fashioned Web sites. These are all still viable, proven means of reaching professionals and patients online. Social media could certainly extend and enhance these efforts, but honestly if we must, we can do without it.
  • True Transparency. Why not help explain to customers, in clear language, the difficulties pharma faces in speaking with them in an open forum? Maybe something like this. I got a sense from most of the "ePatients" at the ePatient Connections Conference last week that they at least have a basic understanding of the challenges the industry faces when trying to communicate with them. I think they witnessed that there are people in the industry who are trying like heck to be able to do more, for the right reasons. It might help for others to better understand that as well.

The Moral of the Story?

What if FDA says pharma can’t play in the social media playground, or can do so in only a very restricted manner? I guess the moral of the story is not to fret too much about FDA guidance on social media. Nobody has a crystal ball on when guidances will come and what they will be. Meanwhile it shouldn’t prevent the industry from trying new things within the confines of what we currently know. And it won’t be the end of the world if guidance ends up being one of those "geez, I wish we hadn’t asked for it" results.

I use the word playground for fun — but I don’t mean to imply that pharma should treat social media as a playground, as John Mack pointed out in this post with the social media crisis management maxim, "Social media: not your children’s playground anymore."

If social media is the playground and FDA is the playground monitor, we still must sit and wait for playground rules. But even without those rules, we know we can’t throw rocks ... and that we must play well with others!

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