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

• 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…