In our mad rush to start off our new careers (mine as an independent consultant and Shwen as a social media thought leader for Edelman), I want to ensure folks that we haven’t forgotten that we are hosting a presentation for MM&M’s Virtual Summit on May 24th.

In the rather ambiguously entitled session “We’ve got your social media guidelines right here!”  we thought we’d cover some of the digital and social media activities  pharma companies could be doing NOW, despite a lack of (formal Internet and Social Media) Guidelines from the the FDA.

But as we started developing our slides and materials it suddenly struck us — is this REALLY what people want to hear?  Are we answering the questions people want answered?  If we put together a fantastic presentation, will people EVEN CARE???

Rather than second guess what people are looking for, we thought we would instead eat a bit of our own dogfood and ask you — our potential audience — to submit the questions YOU want answered in this session on what social media activities companies could be doing today.   We would then address the crowdsourced presentation (Well, ok, I guess the presentation won’t be crowdsourced, but the questions will be.  Anyway, you get the idea…)

So with that in mind, please let us know what questions you’d like answered.  (Keep in mind, now that Shwen and I are no longer working directly for our corporate pharma overlords organizations, so we may be a wee bit more free in what we can say in response…

Don’t be shy — please submit your questions in the comments field below and we hope to see you at the virtual summit!

THANKS!

Thanks to my friend Mark Senak (of Eye On FDA blog) for breaking the news/story late last night (DEC 20th) that the FDA has announced a delay on the issuance of Internet and Social Media Guidance, that was originally planned for release by the end of 2010 (or at least part of it).

According to Mark, an email was sent by the Center for Drug Evaluation and Research (CDER) announcing the following:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

• Responding to unsolicited requests
• Fulfilling regulatory requirements when using tools associated with space limitations
• Fulfilling post-marketing submission requirements
• On-line communications for which manufacturers, packers, or distributors are accountable
• Use of links on the Internet
• Correcting misinformation

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

You may recall that this all started with the FDA Open Forum to address Internet and Social Media guidance in NOV 2009. Over the course of the year since then, general  chatter and bits of information that were revealed at various conferences where the FDA presented, etc. (e.g. see Pharma Marketing Blog, NOV 1st, 2011) suggested that the FDA was planning to release guidelines: (1) by the end of 2010, (2) in a modular format, and (3) that would not address Adverse Event issues initially.

While many have been skeptical about the timing and some even had countdown clock widgets installed on their blogs , I believe many were holding on to a glimmer of hope that something would at least give us an indication for what to expect. In fact, I was at a recent conference in NYC, where an attendee asked a speaker from CDER if they could even just confirm a general date/timeline for when to expect the guidelines. So…I guess that’s what we have for now–a vague sense of what to expect. I guess we’ll just have to wait and see what happens in Q1, 2011.

Also see other commentary on this issue:

• Scrooge FDA Delays Laying Social Media Guidelines Golden Egg: Why?

*UPDATED: Day 1 & 2 Hearing Summaries and Resources

The next 2 days (NOV 12-13) marks a VERY significant occasion in the history of social media in pharma. By that, of course, I mean that it’s the kick off to the FDA Open Hearing on Internet and Social Media — the first of it’s kind since 1996! Of course, it was just “Internet” back then — social media didn’t exist as we know it today.

The biggest irony of this meeting on INTERNET and SOCIAL MEDIA is that there’s no wifi connection or cell phone reception (the meeting room is 2 floors underground), so no one there will be able to live tweet/blog the meeting, but at least it’s an open forum. Whatever the case, those of us watching the live webcast will be live-tweeting (because we have wifi! ) using the hashtag #FDASM, so look out for those.

Click image for live webcast on NOV 12-13

There’s already been bevy of write-ups and resources surrounding this, so rather than write my take on it, I’m going to point to several of these so that you can get a variety of viewpoints and information…

In case you haven’t already heard, the two big pieces of news in the Social Pharmer world (over the last couple of weeks) both have to do with the FDA…

FDA Launches Official Twitter Feed
Firstly, the FDA launched it’s official Twitter feed on Sept 11th: @FDA_Drug_Info. You can find their Twitter information page here, which includes information on “Available Twitter Feeds” (I’m guessing that means they’re planning more than one Twitter feed in the future) and associated disclaimers. Not surprisingly (I guess), their disclaimer states “We are not able to respond to replies or direct messages. Please do not reply to tweets with any private, personal, or proprietary information. Send questions, comments to: druginfo@fda.hhs.gov or call 1-888-INFO-FDA“, which means that — for them — Twitter is merely another channel for disseminating information via one-way communications — not a medium for interaction or conversation.

While social media “purists” may call this heresy, I think it’s a reasonable initial approach (though they did launch FDArecalls a few months back) and even encouraging that they have at least taken the first step to try it out for themselves. However, others may refer to it as the Irony of Ironies, since we are all painfully aware of the fact that industry guidelines (currently) DO NOT exist for even the Internet, let alone social media. We’ll see how things evolve in the near future.

FDA Calls for Open Hearing on Social Media and Internet
Speaking of evolution…

In a surprise announcement last week (SEP 18th), the FDA filed a Notice of Public Hearing “…to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools“. The hearing will be held on NOV 12-13, 2009 in Washington, D.C. Here’s more from the notice…

FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription  drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.

While this announcement may be surprising to many, it’s been something that folks like John Mack have long asked for and discussed over the course of the last few months (it was also a big topic at the Social Pharmer Unconference earlier this year), as social media started to rise in popularity within the industry.

As you can imagine, the announcement has also drawn a lot of interest and chatter from the Social Pharmer crowd and here are some links to what are being said around it:

1. Ignite Blog: BREAKING NEWS: The FDA calls for a public hearing to discuss promotion of FDA-regulated medical products using the Internet and social media tools (NOTE: this is where I heard it first)
2. Pharma Marketing News: Pharma Influence Over 3rd-Party Conversations in Social Media
   
3. Eye on FDA: FDA to Hold Part 15 Hearing on Social Media and Pharma – Finally!
4. Walking the Path Blog: Why Non-Pharma Marketers Should Care About the FDA Public Hearing on Drug Promotion & Social Media
5. Impactiviti Blog: Coming Up: A Big Week in Pharma Social Media

If you’re interested (and you should be) in following the conversation on this topic, the hashtag that has been established is #fdaSM. And if you’re thinking about playing a more active role in this, you should (1) read and take John Mack’s survey, (2) read Mark Senak’s blog on “What Companies Should Do Between Now and The Part 15 Hearing on Social Media“, and (3) register to attend the event in NOV at regulations.gov — see “How To Register for FDA’s Part 15 Meeting on Social Media” for help.

So, the big news on DEC 3rd was the announcement by the FDA and WebMD about their “new partnership to inform and educate tens of millions of Americans”.

According to the press release…

The U.S. Food and Drug Administration and WebMD today announced a collaboration that expands consumers’ access to the agency’s timely and reliable important health information. This joint effort reflects the FDA’s emphasis on using innovative, technology-based strategies to carry out its foremost mission, which is to promote and to protect the public health…

The partnership includes:

• A new online consumer health information resource on WebMD.com (www.webmd.com/fda): Consumers can access information on the safety of FDA-regulated products, including food, medicine and cosmetics, as well as learn how to report problems involving the safety of these products directly to the FDA. In addition, WebMD will bring the FDA public health alerts to all WebMD registered users and site visitors that request them. The cross-linked joint resource will also feature FDA’s Consumer Updates—timely and easy-to-read articles that are also posted on the FDA’s main consumer Web page (www.fda.gov/consumer).
• The FDA contributions to WebMD The Magazine: FDA Consumer Updates will also be featured at least three times a year in WebMD’s bimonthly magazine, which reaches nearly nine million consumers. The magazine is distributed to physician office waiting
  rooms across the country.

As soon as the news broke on Wednesday (DEC 3rd) morning, it was quickly picked up on the Twitterverse and plenty of discussions erupted around the topic of this new relationship.

On the one hand, people were encouraged by the fact that the FDA was finally reaching out and “fishing where the fish are” — i.e. not expecting consumers to come to the FDA website to find important FDA-regulated product info, but to proactively publish info where consumers already typically turn to (i.e. WebMD). After all, and through their own admission, “The FDA Web site currently receives approximately 6 million visitors per month, most of which are representatives of regulated industry“, meaning that it’s not the average consumer, but mainly organizations that are regulated by the FDA (e.g. pharma, device manufacturers, etc.) that visit their website.

On the other hand, there’s also a concern about the “fairness” of a relationship between the FDA and a for-profit, pharma-sponsored organization. I mean, I have absolutely nothing against WebMD and I’m all for the for increasing public awareness by using consumer channels to engage them, but doesn’t an exclusive partnership with a for-profit company seem a bit like a bit of an endorsement?

Here’s a portion of the Memorandium of Understanding (MOU) between the FDA and WebMD that disclaims their endorsement — for some strange (suspicious?) reason, the PDF has disappeared from the FDA website at the time of posting this blog:

Focusing on point #2, there is an obvious and intentional purpose NOT to imply an FDA endorsement of the “product, service or Web site”. However, since no other health portals have the same arrangement with the FDA, wouldn’t the public perceive it that way? And wouldn’t such a relationship/partnership imbue an added level of trust and inherent promotion associated with WebMD, leading to increased traffic and, ultimately, financial gain?

Would this be similar to having a single sponsor for a CME event, instead of a multi-sponsored event? Isn’t the big reason for having multiple sponsors to show impartiality towards a specific organization?

Is it just me? Am I reading too much into this?

Having said all that, an interesting element in this scenario is that, according to their general Co-branding Agreement...

• Co-branding arrangements are not exclusive. Entering into a partnership agreement does not restrict FDA from participating in similar initiatives with other public or private agencies, organizations or individuals…
  
• Both parties agree that information FDA provides to co-branding organizations shall be public domain material. FDA shall have full rights to reuse the content for all FDA purposes, and the right to share with other collaborators or requestors.

In other words, the content that the FDA publishes on WebMD is not exclusive to WebMD — they can choose to publish it with another partner and it also belongs to the public domain, so anyone can repurpose the content. As someone on twitter said, “…so WebMD is just acting as the aperture through which FDA content can be repackaged and distributed“?

There’s also a bunch of other criteria that need to be adhered to as a partner, including the following for content display:

• FDA Consumer Health Information should be easily distinguishable from non-FDA content. Placement of FDA Consumer Health Information on the Web or in printed publications should be clearly identified as such. Examples of clearly identifying FDA Consumer Health Information would be placing this information in a box and/or using a distinct color to distinguish it from non-FDA content, and/or otherwise clearly distinguishing the non-FDA content via an adequate disclaimer statement.
  
• Printed and online pages containing FDA Consumer Health Information must be free of advertisements to avoid implying FDA’s endorsement or support for a particular product, service or Web site.

So, I’m not really sure where I finally stand on this…

Don’t get me wrong… I really like the idea that the FDA is reaching out to engage consumers in the “consumer playground” (as opposed to the old “build it and they will come” approach). But if reach is the key objective, why not partner with the top 10 health portals to give an even greater reach — just think about the Revolution Health and Everday Health merger for numbers!

I also saw another suggestion on Twitter that it “…would maybe have been better done if they’d just done open source code for updates or offered RSS feed link to all? (already there)“. Indeed, why not just create a news/media feed or even a YouTube channel that can be distributed to ALL health portals, blogs, etc. At least, in that format, not only can specialized groups select relevant information, but viral distribution will also be inherent to the system, PLUS the FDA can then collect the usage data themselves (i.e. not reliant on the individual organizations to provide them the usage statistics/analytics, etc.).

It’ll be interesting to see how this evolves going forward. The way the MOU and Co-Branding Agreement is written, it does appear that the FDA has plans to grown beyond a single partnership and I sincerely hope they do. The more they can openly engage with consumers through channels where consumers are already consuming health-related content, the closer we will get to an informed and educated patient population.

Great concept!

But as for execution, I personally feel that for an organization that preaches impartiality — particularly when it comes to organizations that have a financial interest (and traffic = $$$ for a health portal) — a relationship with a for-profit company that provides a potential advantage to that company over other organizations in the same industry could be perceived as somewhat biased and unfair.

What do you think?

Let’s face it – at this stage, many of these corporate efforts – particularly in the healthcare field — don’t quite match what you or I do when we use Facebook or Twitter or engage with others online… While I would argue that what is being done is a good start, it nonetheless begs the question – why not more?

Take the case of what we had to think through as we developed THIS little ‘ole blog.

In addition to our well-known consumer products, Johnson & Johnson also sells prescription medicines and medical devices — which are highly regulated products. That’s where things become complex. Among the many considerations we had to take into account as we tried to move from simply broadcasting messages to engaging in conversations, we had to sort out how we would handle comments that could include reports of adverse events (which legally must be reported to the FDA — something we routinely do) – and could include a discussion of so-called “off-label” or unapproved uses of our products, which we do not support or encourage.

Ultimately, the decision was reached, right or wrong, to create a comments policy that would encourage comments that would be “on topic” – as well as to not allow comments that could get us into legal or regulatory trouble…

Clearly there need to be some measures put into place to mitigate the risk of legal or regulatory liability. However, the more hurdles that are put into place, the less credible, useful or open those online efforts become, and in the end you may be left with something that could be criticized as being more akin to a traditional, one-way communications effort.

And so what we have ended up doing in many cases is take some small steps to get more comfortable with getting involved. We are also making sure we have processes in place to handle adverse event reports and that we have responsible people involved who can respond quickly to questions.

At the same time, projects like JNJBTW and the Johnson & Johnson health channel on YouTube are giving us some great experience.

I think Marc has really said it perfectly, in terms of where we are today with the adoption of social media in the healthcare industry (you can read my response to Marc at the bottom of the post here).

It’s a real conflict of interest, as this industry tries to engage in a conversation with it’s customers — both consumer and professional — without overstepping the gray boundaries that it is regulated by. But as more and more companies in the industry start to push forward with new social media initiatives (such as YouTube, Facebook, and Twitter), the momentum will build, we’ll get more, and ultimately establish better boundaries and processes for operating in this space.

As for right now, like Marc says, we’ll take small steps and get great experience — the most important thing, is that we need to at least try!