Wednesday, March 11, 2009

Report from CBI's eMarketing Forum: Taking on the AE Boogey Man

I attended a few more presentations this morning at CBI's 8th Annual Forum on eMarketing for the Pharmaceutical Industry in Princeton, NJ. I missed FDA's presentation on its use of Web 2.0 Communication Channels for Public Health, but I don't think I missed much if I expected to discover from the FDA what is permissible for drug companies to do within those channels.

Jonathan Richman -- an ePharma Pioneer Club member -- pointed out that the FDA can use social media, but pharma companies cannot (see "FDA Uses Social Media, But You Can’t"). Actually, not only can the FDA use social media, it can also do it in a way that violates its own regulations! For example, the FDA is free to post a video about a new drug that they approved WITHOUT including fair balance information! An example is shown below.

It used to be that every time a government official spoke at these conferences they would start off with a little joke: "We're from the government and we're here to help you." I don't think the FDA speaker mentioned that today.

Nevertheless, when the FDA is doing more than pharma companies with social media, "we need to figure out how to get in there," said Stacy Reese, Associate PRA Director at AstraZeneca. She spoke on "Managing the Risks Associated with Online Discussions." Although she did not actually tell the audience how to manage the risks, she did a great job pointing out what the risks are and presented some interesting scenarios to consider.

Specifically, Reese spoke about adverse event reporting (AER) and off-label promotion, the two scariest boogey men that pharma faces in its quest to engage in social media marketing.

[BTW, Reese included a disclaimer that her comments do not represent the views of AstraZeneca and she suggested that each company should determine the best approach to social media that meets its specific business needs.]

Regarding AER, Reese compared a real life sales rep/doctor conversation about an adverse event to a similar conversation held online via a discussion board. Obviously, the sales rep is obligated to report the conversation. While there is no recording or written record of the live conversation, in the case of the discussion board, the conversation is recorded and archived. But how much of it does the FDA require to be submitted on Form 2253?

Although I may not fully understand the distinction, it's questions like these that keep pharma regulatory people awake at night.

The main takeaways from Reese's presentation are (1) there are many social media marketing issues that need to be addressed, and (2) pharma companies must develop standards that tell them how to address these issues before they get too deeply involved. It appears that AZ has thought it all through and has its standards in place. If only they could share them with the rest of us.

What's needed is for a meeting of the minds to mull over all the scenarios mentioned by Reese and decide what the best practices should be. At the table should also be representatives from vendor companies that offer services to pharma as well as patient advocates.

It would also be nice if the FDA were also involved. Unfortunately, the FDA may attend such meetings as an observer, but it won't say whether or not any "best practices" developed will pass regulatory muster. As was pointed out at the conference by several attendees, the FDA can only tell you what you are doing wrong and unless it issues specific "guidance," the agency remains mum about what is the right thing to do when engaged in social media marketing.


  1. Anonymous12:47 PM

    Thanks for the meeting update John. I guess I am not completely tracking with folks that say we (the industry) can’t engage in social media. We can… we have! The concerns around AE reporting and off-label promotion are valid, but (with some level of calculated risk taking) these concerns can be appropriately addressed. Also, I don’t feel that we must wait for FDA guidelines on the topic to take the first step… that could take forever. In fact, if you recall, I think it took more than fourteen years for the FDA to issue guidance on television advertising after the first ad ran in 1981… and after a 2-3 year moratorium (somebody keep me honest on that). It would not be uncommon for the industry to move forward in an area of new media prior to official guidance by the FDA. For example, there are definitely no FDA guidelines for films or documentaries, but we did that! That said, I think we have learned some valuable lessons on things not to do when going into unchartered waters. Social media should not be a testing ground for bypassing the basic guiding principles set forth by the FDA. In fact, when launching programs that broke new ground (when I was on the corporate side) we always took the guidance a step further just to be safe. As an industry, we need to tap into our knowledge and experience with these guiding principles to find solutions that will address the FDA’s concerns when speaking about a product. But then again… I am just a PR guy. I would love to hear from the regulatory folks on this.

  2. Anonymous9:22 AM

    Funny thing, this being the season of St. Patrick’s day and all. I was born and raised a traditional Irish Catholic, by two Irish Catholic parents who had Irish Catholic parents. I can vouch for myself and my 7 brothers and sisters that we never got ANY guidance on how to do that stuff that magically causes babies to appear. Even in the 70’s and 80’s when sex education began to be taught in school, we got a note from home that we were to be kept out of class. I’m from a family of ten (8 kids and 2 parents) and I now have a 5 year old, 6 year old, 7 year old and an 8 month old (all boys by the way, and they're half-Italian and half-Irish). It’s kind of amazing how this thing seems to just keep happening. Without a lick of guidance, and heavy doses of disdain and hell-mongering, we Irish Catholics seem to make babies with the utmost proficiency. Funny how things like that happen.

    So anyway, happy St. Patrick ’s Day Mike and John. I can’t help but to think that this whole social media controversy is a lot like procreation. It can be done, it will be done, with or without guidance. But, and this is a great big “but,” your social media offspring are a lot like your real-life offspring. They need a lot of care, often come with wide variance in sound planning, and as they grow up, they’re joyous, temperamental, and have a tendency to get into trouble without proper care and rearing. As a regulatory professional, blogging, twittering, facebooking, chatting, texting, and youtubing down the e-river all make me weary. It seems to me that what people seem to want is for FDA to somehow come out and change the standards for how companies can communicate about their regulated products. The tension lies in the fact that social media, at its best, is innovative, creative, ubiquitous, authentic and unscripted. You still have to apply FDA advertising and labeling requirements to social media. You can wait for a guidance from FDA, but no guidance is going to change that. In fact, be careful what you wish for. A guidance will likely result in standards that will stifle innovation. We’ll all become what we are, creatures of habit seeking safe places. Look at DTC ads. Its really hard to break out of the same old creative patterns, because you have to comply with an FDA guidance document that creates a structure that everyone feels safe with (and then becomes the subject of ridicule in every sketch comedy show on TV).

    But again, Happy St. Patrick’s Day. Doing two-way social media or doing social media with an authenticity that the community expects requires companies to treat it like a living breathing thing. People have to be fully engaged in all of the details of all of the issues. Accept the inevitable and come up with realistic, thoughtful, and defensible ways of addressing issues. It can be done, it will be done, it has been done, it is being done. I do think, as well, that people in industry probably also have unrealistic expectations of any “guidance” from FDA. Also, there's the big abstract question of what "it" really is in all these conversations, but that's for another day.


  3. Not only is FDA not following their own rules, but they are vague and non-committal in providing direct to agencies and pharmaceutical companies on marketing guidelines. The most recent example are the warning FDA warning letters that went out. A spokesperson from sanofi-aventis has an interesting position on this at href= ""If anyone is interested in seeing the actual letters from FDA, here is the link: href=""I'm seeing a lot of seminars on social media, SEO/SEM, but nobody really providing direction or guidance on how to market in this highly regulated environment, with very fuzzy guidance from FDA.

    So, I put together a seminar sponsored by DMA and the HCMA. We were able to reach the FDA and get some form of guidance from them. We'll be in San Fancisco May 21 discussing these issues. Anyone is welcome to attend and you can sign up at href=""

    If you can't afford the trip, or have a conflict, just shoot me an email at and I'll be happy to either send you an output of the meeting, or dialogue over email so nobody misses out.


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