A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0

At the bottom of this posting is a podcast with the FDA on Web 2.0 and pharma, making it an important posting for anyone connected with communications by pharmaceutical companies - advertisers, regulatory and legal departments and marketing whether in the U.S. or not.

As a highly regulated industry, the pharmaceutical industry has been highly reticent about participation in Web 2.0 though social and digital media to reach out to patients, physicians and other stakeholders. But there are many moving parts that, taken together, really demand the digital presence of the pharmaceutical industry or risk brand dilution:

• The Communications Revolution - First, traditional means of communications are changing rapidly.  Broadcast and print journalism that offers pre-packaged news to broad audiences do not offer the consumer the ability to pick and choose the news he or she can use. Broadcast and print are often aimed at the lowest common denominator. Socially, large institutions have lost the trust of the general population and there is a drive and an ability in the digital realm to pick and choose news and news sources as well as topics from sources that you trust - with the added feature that you as the consumer are also a participant in dialog, rather than old world news that was a one-way street.  There is also a speed to digital to which traditional media cannot match.  A blogger, for example, has no editor traps to run through which, while it might be a two-sided coin, certainly means that the blogger is more fleet of pen.  The bottom line here is that there has been a huge and continuing shift to new and social media for both news and conversation.  People no longer just read news, they are now more active in spreading it.  Meanwhile, revenues in traditional journalism are down, papers are declaring bankruptcy, paring down issues or going completely digital.

• The Policy Environment- Second, for pharmaceutical companies, the policy environment is poised to change, significantly altering two main routes of communication to patients - one being Direct-to-Consumer (DTC) and one being the relationships that pharmaceutical companies develop with prescribers through their professional medical societies and through direct marketing.  As Congress moves to reform these areas, the only alternative for pharmaceutical companies is to communicate with both of these audiences in the digital environment.  

• Patients Seek Information Online - According to the Pew Internet and American Life Project, not only do people use the Internet to seek information about healthcare options, but people with chronic illnesses are more likely to access and act on information they get from the Internet.   If people are going to that space for Web 2.0 communications and the pharmaceutical industry is only up to Web 1.0, well - then they are leaving their brand to be shaped by almost entirely by outside forces.  And one need only look at the proliferation of medical on-line sources and communities such as Medpedia, Wikipedia, Sermo and Physician Connect to know that the conversation has moved.    

Despite the crushing amount of incentives to go digital, the pharmaceutical utilization of social media and Web 2.0 has been hobbled by regulatory concerns that participation might necessarily trigger FDA action in the form of a warning letter.   There have been a few pioneers in the space, but the majority of pharmaceutical firms are not engaged and sit paralyzed as control over their brands ebbs away into the ether.

To date, FDA and the Division for Drug Marketing, Advertising and Communications (DDMAC)has been relatively quiet on the subject.  While the agency has a number of guidances on a wide variety of topics, there is nothing on this topic.  In such a vacuum, many have made assumptions about the use of social media and for many, any time the subject comes up - it is a non-starter.

To help to begin to clarify the situation, it seemed like a good idea to sit down with FDA to get some of their thinking about Web 2.0  The result is the following podcast with Dr. Jean Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development.  

 

There was no expectation, of course, that the FDA was going to issue a guidance in the context of a podcast, but it did seem important to start getting some definition to the environment where there has largely been only speculation.  So I began by asking about the appropriateness of social media engagement by  pharmaceutical companies; about the nature of multi-media releases; about the real fear among many companies that if they generate and post original materials that they may later be changed by others; about the FDA's plans and how companies can get help in making their own.  

 

Obviously, understanding the complete FDA point of view about Web 2.0 and pharmaceutical companies is going to be a process, not an event.  A comprehensive set of answers to the many outstanding questions cannot be gotten in one sitting.  But this is a good beginning for gaining some insights into this most important communications, marketing and regulatory issue.  

The podcast runs 15 minutes, but it will be time well-spent.

By the way, I absolutely expect waves of love for this...

 

Download this podcast

Comments

[John Mack]

Where's the podcast?

[Ali Kuru]

It would be great if we had a chance to download the podcast directly in a common format like mp3.

[Paul Vogelzang]

Where can we find the podcast? Need an MP3 file.

[Mark Senak]

You should be able to download the podcast into mp3. If you are having trouble viewing, your adobe flash may not be up to date. Or try viewing through a different browser.

[Fard Johnmar]

Excellent work Mark. I look forward to listening to the podcast.

[Denice Wroe]

Thank you for your professional, well prepared, and comprehensive interview with Dr. King. She was a great interviewee as well. I felt she explained the positions clearly and with obvious knowledge and insight into the process.

[Ward Tongen]

Fantastic stuff! A transcript of this podcast could help spread the word. A little ham-handedness goes a long way. ;-)

[Fabio Gratton]

I really appreciate you doing this -- as it's great to start this dialogue. I was really hoping that we could get a simple answer to the question -- if a pharma company launches/creates a social network (say for ADHD), with no branding whatsoever (call it ADHDConnect for sake of arguement)-- no links to products (but clear statement that Pharma X owns it) -- and the public starts to discuss and post comments about products (on label, off label, adverse events, etc...) -- what is the DDMAC's stance? Certainly, if it's off-label there can be a pre-post moderation process that "rejects it" based on terms of site. If it's an adverse event, assuming that there is sufficient info to follow-up, then the pharmaco could and should -- that should simply be spelled out in the terms of the site AND people should be required to provide enough information for a follow-up to take place. But beyond that, would the fda/ddmac have any other issues? Would they be OK with this provided these conditions? Can we find out? THANKS AGAIN FOR THIS!!!

[D.Loosbrock]

Agreed. Great beginning to what will likely be a long conversation with FDZ/DDMAC.

Agree that the AE reporting questions must be addressed and would be a great follow-up to your initial conversation.

Personally, I think that the users (potentially consumers) sharing the potential AE-related content should have the option of "reporting" the AE to the FDA or Pharma or not, this would take some of the burden off of the manufacturers and reduce the litigation risk... but this would need to be sanctioned by the FDA. This may be a personal issue of mine, though, because I feel like HC consumers need to take more of an active role in their own health and wellness, rather than laying that burden at the feet of the healthcare providers, pharma and biotech companies. Empower the consumer to decide if the issue they are blabbing about is worthwhile enough for them to report. Get the consumer engaged... that's what I say.

Just some thoughts... Thanks again for the interview!

Danielle
Ann Arbor, MI

[Rob Halper]

Fantastic, Marc! Incredibly timely.

Rob
jnjhealth

[Rob Halper]

Mark (sorry I called you Marc last time, I'm too used to emailing Marc Monseau!) When I heard Dr. Kang talking about the 21CFR314.....forms for VNR's and SMR approvals, my ears glazed over! Does the FDA make a distinction between branded content produced for you tube and produced for network television dissemination - while that medium still exists! Depending on how long that approval process takes, I can't see realistically how you can produce timely branded video for you tube.

[Mark Senak]

Rob - Yes I agree. I think it is clear that FDA has not thought everything out so that it is practicable. However, there were some good elements in there I thought, particularly with regard to material that is changed subsequently by others. But yes, some of what they offer here is not practical when considering the speed with which so much of what occurs in Web 2.0 - there is clearly going to have to be an evolution of thought here and FDA has some catching up to do on the regulatory front as far as Web 2.0. But this, for now, represents what they are willing to say on the issue.

[Rob Halper]

It was a great interview and very helpful in gaining insight into their thinking.

Rob

[Robert Kadar]

Regarding Pharmaceutical brand advertising online on social networking and health sites and whether a pharma company faces a risk from a "third party" posting a comment, Jean Ah Kang, Special Assistant to Tom Abrams at DDMAC seems to be saying that a pharma company is NOT at risk if a user posts a negative comment or adverse effect. Mark, is there a way you can get clarification on this point? It's a big one.

Thanks,

Robert Kadar
CEO
Good Health Advertising
www.GoodHealthAdvertising.com

[R.J. Lewis]

Great job Mark... the iceberg just calved and the melting has begun!

You are absolutely correct that this will be "...a process, not an event...", but this is certainly a great starting point.

[John]

Much love, much love. Interesting. So howcome the FDA then went and crushed everybody's search marketing? What they don't acknowledge is that these formats don't support fair balance due to limitations - has to be one click way or another solution.

[Melissa Davies, Nielsen Online]

Mark, thanks for sharing this great interview. We all know that the immediacy of social media and Web 2.0 really stretches the boundaries of how companies have traditionally communicated in this regulated world. Let's hope this acknowledgement is just the start of more guidance to come.