WOMMA to Take Role in FDA Public Hearing on Social Media

We have waited a long time. Those with a proclivity for social media and a passion for more empowered patient care are speculating vigorously about the FDA Public Hearing on Nov. 12 and 13. Will there be a sea of change in regulatory perspective on social media, merely incremental steps towards change, or no change at all?

The key question behind the others is this: what is the public health advantage in allowing industry to have a greater presence in social media? If companies are able to more assertively promote their brands in uncontrolled settings, will patients really benefit? Many members of the Word of Mouth Marketing Association believe that changes in FDA guidelines are important for these reasons:

The healthcare and pharmaceutical industries should listen to the dialogue of patients and physicians online so companies can more effectively understand their issues and reflect those issues in brand communications. Current adverse event reporting requirements make listening to patients and physicians cumbersome at best.

The industry funds and supports disease education initiatives of non-profit patient groups. These groups provide an invaluable service in helping patients understand, cope with and treat disease. But, in the social media setting, non-profits have not kept pace with evolving social media options because they lack the resources and industry support is tenuous. These groups would be able to do more to help patients if companies understood exactly what they can and cannot do in this setting and were able to sponsor more open discussions.

Emerging brevity-driven technologies are proving to be cost-effective for clinical trial recruiting, drug adherence and disease prevention. Yet, tweeting and texting do not allow for full disclosure of risk/benefit information. The current guidelines for fair balance are not feasible in today’s 140-character world. We need new rules so these technologies can be used to solve some crucial healthcare issues.

Because of the power of the consumer online, we have a new ethics meter for evaluating corporate behavior. Companies and executives that overstep the bounds are outed quickly. Most industries have recognized this and are changing the way they communicate with the consumer. The healthcare industry is behind the curve and continues to push messages out in a one dimensional way. By engaging more in social media, companies may finally learn the benefits of having an open and honest conversation with the healthcare consumer vs. aggressively marketing to them. Imagine, FDA having another watchdog in tracking industry behavior!

WOMMA is taking an active role in this hearing. Two WOMMA members—John Bell, the president of WOMMA and managing director at Global 360° Digital Influence Practice at Ogilvy Public Relations Worldwide and Melissa Davies, healthcare research director, online division, for Nielsen Online—will represent WOMMA and present during the hearings.

Kathy Baughman, co-chair of the healthcare and Pharma task force and principal at ComBlu will be available for questions. WOMMA will provide attendees at its Summit 2009 a recap of the hearings and will live broadcast the recap for all to participate.

Finally, WOMMA member companies will have an opportunity to submit their comments to WOMMA during the FDA’s public commentary period after the hearing.

What will unfold at the hearing? Here are some predictions:

The hearing will burst open the unrealistic requirements relating to AE reporting online and show that there are better and more efficient ways to gather safety and surveillance data.

The power of social media to affect patient care will also be center stage. Social media sites that have become gathering places for people with diverse diseases will show that patients convening and conversing creates a healthy dialogue about disease and improves health motivation and treatment effectiveness. These sites may also stress the importance of industry involvement (and funding) in allowing communities of interest to flourish.

A hearty debate will center on how involved industry should be on these sites in correcting misinformation or presenting its point of view. Some patient advocates and social media sites will argue that blogs, chats, discussion boards are not the place for industry and should be left to scientific advisory boards and other less biased sources.

There will be a debate about the one click rule and fair-balance and what needs to be part of a “teaser” ad to ensure patients or physicians are not misguided.

There will be tough questions asked by the FDA about industry’s intentions in social media. FDA will push industry on whether or not drug marketing online is beneficial to society and whether consumers and patients—who have a lack of trust in the industry—will support a greater presence of healthcare companies in social media.

So, will this event create an opportunity for the WOM industry to get across the value of industry involvement? Yes, most definitely. But others with divergent points of view will have their 10 minutes too. Will the arguments open the doors to greater industry participation? WOMMA, as a leader in social media and a top marketing industry trade association will continue to engage its membership as these issues evolve and reinforce the evolution of ethical and responsible word of mouth practices in healthcare just as the organization has in the broader consumer marketing world.

Ann Moravick is president of Rx4good and co-chair of WOMMA’s Healthcare and Pharma Task Force.