Wednesday, April 01, 2009

FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!

If you were taken in by my FDA-social media guidance April Fool's post (see here), you were not alone. Many other savvy people were also fooled.

Within minutes of posting a notice on Twitter, hundreds of visitors flocked to Pharma Marketing Blog to read the amazing news. Hundreds are still visiting while I write this.

The fake press release I posted was even copied and uploaded to other blogs, including the Medical Sales Recruiter blog: see "FDA sounds off about Pharma/Medical and their use of Social Media: Youtube, Twitter, etc." and Drug Wonks too!

Many people are also e-mailing me asking if it's true because they can't tell if it's an April Fool's joke or not!

Why do so many people want to believe?

It's about time is why!

And the time may be near! The FDA may actually issue such guidance in the near future -- no kidding this time!

Regulatory executives from several pharmaceutical companies have been meeting and discussing guidelines on how the drug industry can take advantage of social media for marketing and other healthcare communications purposes. The FDA has been involved as well! I was told this several weeks ago by a regulatory person in attendance at an industry conference.

But you don't have to take my word for it. You can read about it here: "Key Headline From Waggener Edstrom Webinar: Pharma Working With FDA On Social Media Marketing Guidance"

The same story was repeated in the April issue of MM&M.

What's the next step?

Call to Action: Bring More Stakeholders Into the Discussion!

I believe that more stakeholders need to be involved in the discussion of social media pharma marketing guidelines and best practices. I'm talking about ad agencies that work for pharmaceutical companies, patient advocates, healthcare professionals, social network site owners, etc.

The FDA did it right in 1996 when brought in all these stakeholders -- including me -- for a two-day public hearing on FDA AND INTERNET: ADVERTISING AND PROMOTION OF MEDICAL PRODUCTS (find the minutes here).

In his opening remarks to that hearing, Bill Schultz, who was Deputy Commissioner at the time, said "With the increased popularity of the Internet, it's not surprising that questions would begin to be raised about how the laws pertaining to drug and device advertising apply to the Internet. FDA has no question but that they do apply and, in fact, the Agency has issued a number of warning letters during the past six months. But we also recognize that the Internet raises some new and important and very different issues regarding the regulation of promotion."

Well, it's deja vu all over again! I bet the current people in charge of the FDA don't realize there was such a public meeting.

Next week I am hosting a invitation-only roundtable discussion entitled "Overcoming Barriers to Pharma's Engagement in Social Networks." It's a special event primarily for members of the ePharma Pioneer Club. At least a dozen people will be participating, including several pharma people. I am also inviting Jean-Ah Kang from the FDA and a representative from PhRMA to attend.

If you are interested in attending (openings are limited), fill out the ePharma Pioneer Club membership form and let me know.

Maybe we can get the ball rolling a little faster on this issue!

Should FDA Convene a Public Hearing on Use of Social Media by Pharma?
[Click here for background.]

This survey presents you with several different procedures the FDA could use to develop guidance for the use of social media for the promotion of drugs and other medical products it regulates. These are:
  1. Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
  2. FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
  3. FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
  4. If FDA solicits public comments -- no matter in what fashion -- it should publish ALL the comments it receives.
Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.


  1. Anonymous3:39 PM

    I have been a loyal follower of Pharma Marketing Blog but I have to tell you that I do NOT appreciate your April Fools gag. You operate in a highly connected industry that moves very rapidly and you have embarrassed me (and I'm sure many others) who have put out trust in you... as we blogged, tweeted and otherwise eagerly shared this blog post with others, tarnishing our own reputations with the pale of poor judgment. It is just those sorts of loyal subscribers that make your success possible by pointing the rest of the world to your blog -- and you basically threw mud in our faces for your own jollies. Yes, aren't you clever! And your response: a "Don't hate me" cartoon. How about a sincere apology with an acknowledgment of the responsibility that comes with blogging about serious topics and your responsibility to those that make your success possible.

  2. I do apologize that many people did not realize this was a prank designed to raise awareness of an important issue.

    I had thought that the phrase "way cool" attributed to an FDA staff person PLUS the links would have given it away.

    Unfortunately, a few people did not catch those hints.

    I do not believe, however, that anyone should be embarrassed. When I make mistakes I admit them. Last year I got caught in an April Fool's joke that did NOT include hints. I just modified my post, admitted I was duped and moved on.

  3. Anonymous4:33 PM

    Dear Anonymous (2:39 PM) -- I have to assume your post is also an April Fools joke. No one could take themselves so seriously. It was a good -- well designed -- prank. The industry will survive. Your valuable reputation will somehow be restored over time. Go home get some rest -- you've had a long and stressful day.

    Dear John -- You got me. I liked it. I saw it first from Peter and thought wow! When I couldn't find a guidance or a press release on the FDA site I though something was fishy. I forwarded it to one colleague as an FYI and then sent a follow-up. I think my reputation is still intact.

  4. Anonymous5:16 PM

    Dear Anonymous (3:33), Reputations ebb and flow... thanks for your concern about mine! John's, I would submit, has taken a downward tick because John is a blogger on a serious topic at an important moment of convergence in an industry that's undergoing significant transformation. This wasn't an informal email or a random post on a form... it was the deliberate written testimony of a trusted journalist (or was it?)

    Regarding whether the prank was "well designed" I would say yes... well designed to dupe professionals who are otherwise pressed for time in a fast moving digital world and who rely on a relatively small set of trusted sources for serious treatment of the industries in which they operate. A "way cool" at the end of the sixth paragraph and a couple of faux links at the end does not constitute a well crafted prank unless that prank was intended to dupe. I suspect that John duped a lot of people in a short amount of time and that is why he revealed his hoax so quickly... i.e., to stop the bleeding. If that's right, then I'm right... i.e., his post wasn't so transparent and some other "serious" professionals got caught up.

    Regarding taking my job (and John's blog) seriously -- guilty as charged. I will continue to take my job seriously. I will be more careful about what I read from John -- after all, there is no shortage of information sources out there.

  5. Anon (4:16)

    You ALWAYS should be careful about what you read, but more careful about what you share as a trusted source.

    For every person who felt as you do (there were only 2 by my count), there were many in very high up industry positions who checked the ultimate source (ie, FDA) BEFORE they got too excited. And when they found out they were duped, they smiled. At least a couple have gotten back to me and said it made them think about the issue and wanted to know what they could do.

    This is more than journalism! I am involved and engaged with my audience and I have a mission, which I hope is evident. The spoof helped me fulfill my mission. Sorry for the eggs that got broken in the process.

  6. Anonymous5:51 PM


    Thanks for the lecture on being a responsible reader; I really needed that. Your fatal flaw in my case was that you used the exact same press release ID that the FDA used, i.e., P04-12. When I started reading your original post I immediately searched for an FDA article that used that reference number and found it. While it's not a phone call to the FDA it was my brand of due diligence to make sure that there was an actual press release. Hoping back to your blog I continued reading. I honestly thought I was supporting you by referencing your blog in my twitter post but later realized I had made the mistake of not considering you'd try to dupe me.

    I realize that it's April Fools Day and that you were doing what fools do to other fools on that day. But that I and others were caught unaware only means that you made fools of us. Good for you but that's not what I'm looking for in a trusted industry source. Your mission statement says: "focused on issues of importance to pharmaceutical marketing executives." Note that "importance" and "executives" suggests that pranks should be carefully administered.

  7. Anonymous6:00 PM


    Notice that you essentially said, "You should be careful about what you read but be even more careful before you trust anything that I write."

  8. Anonymous6:02 PM

    Some see broken eggs... I prefer to see an omelet. John -- don't let the stick in the muds get you down.


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