Thursday, October 29, 2009

Social Media Best Practices for Pharma Are Needed, Whatever Happens at FDA

Many pharma eMarketing pundits and FDA policy wonks out there are already predicting that nothing much will come out of the upcoming public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!").

Rich Meyer, blogger over at World of DTC Marketing, says "So what do I expect from the FDA open hearings? A lot of self promotion ... the fact that they are having these hearings communicates a lack of understanding of how people are using the Internet for health information."

Meyer predicted several months ago that the FDA would never have such a hearing in the first place. Now that there is a public hearing scheduled and a public comment process underway, Meyer does not believe that DTC marketing as we know it will change. He may be right about that, but there will be some changes.

First of all, the mere fact that there will be a public hearing where approximately 62 people will be making presentations (see list-in-progress here), will lead to an increased awareness among the public of how the pharma industry may be tapping into social media to influence patients and physicians. Whenever the public becomes aware of potential problems, Congress is not far behind. And when Congress starts investigating, the pharma industry rolls out another set of voluntary guidelines for best practices.

Of course, the FDA could also issue regulatory guidelines for use of social media for Rx promotion. The jaded among us think that it may be years before that happens, if ever. I, however, believe the FDA already has some kind of draft guidelines in the works that it will publish before the end of 2010 (see "Expect FDA Social Media Draft Guidance Before End of 2010"). As I said before, this is NOT your father's FDA -- case in point: Jean-Ah Kang, special assistant to DDMAC director Thomas Abrams, picks up the phone when you call. She also sent out the e-mail invitation to speakers at 2:07 AM! That's dedication!

After the 1996 FDA public hearing on the Internet, a bunch of presenters -- including patient advocates -- got together to form the Internet Healthcare Coalition, a non-profit grassroots organization that created the eHealth Code of Ethics. Pharmaceutical companies were involved in that effort and it received much media attention.

So, a lot can happen as a result of FDA's public hearings: Increased public awareness, congressional investigations, new regulatory guidance, voluntary industry guidelines, codes of ethics, and perhaps even new regulations. These are significant changes that cannot be ignored.

Pharma marketers also cannot long ignore the lure of social media, whatever form it takes in the future.

Although, according to polls, a majority of consumers out there do not trust pharmaceutical companies, there are millions of patients who have been helped by the industry. Many of these are patient advocates involved in social media and they want conversations with pharma companies. They want to partner with pharma companies and vice versa. But there needs to be "rules" or "best practices" for carrying on these conversations.

I don't have the answers, but I am enjoying the questions and responses to the questions I am receiving from readers who have taken my survey (see here). I have reviewed one set of answers having to do with adverse event reporting and social media. I made this presentation (pdf) of the results at the recent ePatient Connections 2009 conference in Philadelphia this week. You can also read this article in the October, 2009, issue of Pharma Marketing News: "Social Media Adverse Event Reporting Safe Harbors." Use the discount code SM222 to get it FREE.

1 comment:

  1. I love pharma. Seriously. The realist in me, however, is perplexed by an industry with unparalleled expertise in legal, regulatory and advocacy development not motivated to issue its own voluntary guidelines for using social media. This isn’t a new medium, from chat rooms to Second Life to Twitter, we’re talking about years with which to study, master and then train others on “fair balanced and appropriate use of these channels.”

    As thrilled as people are by the upcoming #FDASM meeting—myself included as I’ll be attending in person—there should be shared disappointment in PhRMA, BIO, Coalition for Healthcare Communications (among others), not to mention the individual companies, for not preparing working industry guidelines for using social media.

    Would we still need the #FDASM? Most definitely. Would said working guidelines need to be revised? No doubt about it, hence the qualifier “working guidelines.” But, for a prideful industry—renowned for carving out its own destiny—to hold back on drafting good faith guidelines combines passive resistance with head in the sand avoidance.

    I hope @pharmaguy John Mack is correct and we’ll have “published draft guidelines from the FDA before the end of 2010.” Question is to the industry at large, how do we proceed until then, or will we have more of the same fiddling for the next 13 months?

    Marian Cutler
    www.twitter.com/mariancutler

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