On Friday, November 12th, Melissa Davies, Research Director at Nielsen, and I will present on behalf of WOMMA during two sessions with the FDA. These are part of the long-awaited FDA foray into considering new guardrails for health products marketers in social media. Pharma, one of a few heavily regulated industries, has stepped cautiously into social media over the past few years. Still, pharam is not as paralyzed as some would suggest. Dose of Digital maintains a great list of pharma social media activities from Twitter to communities.
WOMMA has just gone through a productive year with the FTC that culminated recently with the FTC Guidelines on Endorsements and Testimonials.We will have a follow up session with the FTC at this year's WOMMA Summit in November.
Ultimately, WOMMA wants to protect the consumer and the trust that brands can build with consumers if they use social media well. Consumers increasingly expect brands to engage and be available in social media. Brands value third party word of mouth as one of the most trusted sources for opinion and purchase decision. Brands and consumers want to connect in socila media. And we have to do it right or the basic premise beneath WOM - trust - will crumble. We also want to empower marketers to productively engage within social media. Pharma has been held back in part because of their fear of additional regulations or actions.
The FDA's 5 Questions
The FDA has set up a listening session on November 18 and 19. The agenda is full of marketers and each of us has a 10-minute slot to help inform the FDA's 5 questions.
It is not clear yet if these are even the right 5 questions. Still, in respect to the FDA and the simple principle that we have to start somewhere, I am grateful that they opened their doors. You can review the FDA's Notice of Public Hearing here.
Here are the 3 questions we plan to address with a quick summary of our POV:
Question #1: For what online communications are manufacturers, packers, or distributors accountable?
In today’s social Web marketers and consumers alike are flocking to third party sites and platforms both to be where consumers are and to garner legitimate third-party mentions that corroborate their products’ benefits or around a topic related to a disease or condition. The power of word of mouth means that marketers want influencers/bloggers to experience their topic, product, or service that relates to a brand and then share about it authentically.
WOMMA has an aggressive POV on what is proper disclosure both in spirit and actuality. Aligned with the recent FTC Guidelines, we see the opportunity for marketers to not only practice ‘full disclosure’ of any and all material connection between brand and influencer/blogger, but also to strongly encourage those influencers to do their part to properly disclose. As with the FTC Guidelines, it doesn't take payment to define a material connection. Marketers are better off disclosing any type of material connection whether they be travel expenses for a health blogger, technology support on an unbranded community, or even the snacks at a tweetup. Disclose and let the consumer judge credibility.
Question #3: What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
Social media is defined by conversations and a hyper-democratized approach to publishing. Brands and marketers want to connect more directly with customers to better understand their needs and build a stronger relationship. In addition, brands want to ensure that the full story behind products are shared outside their Web sites. They want to be where consumers are spending their time and that is increasringly across the social web.Can pharma marketers be allowed the opportunity to comment on blogs and message boards – completely transparent about their identity and interests – to help keep the information about medical products as clear as possible? Most pharma marketers do not feel empowered to comment or "fact correct" as the historic FDA guidelines might interpret that as a new instance requiring advertiisng or labeling information. Imagine if every comment required that full page disclaimer you see in print ads. Conversely, we must not require an unsupportable burden - the requirement to "story-correct" across the vastness of social media. Like the FTC Guidelines, the marketer must focus their energy on keeping their own communications accurate and encouraging and even enforcing accuracy from any influencers they proactively outreach to.
The challenge with health care information is to allow for this conversational interaction while always putting the full story behind products and services front and center. No blog comment field or Tweet will sustain the full content of a product Web site. We may need to allow pharma a consistent "one-click" solution where marketers can comment and link back to the full body of a product insert.
Question #5: Specific to Adverse Events Reporting
One of the biggest effects of social media is the new opportunity for brands to hear what consumers are saying in public discussions about products, services and issues important in their lives. Smart marketers have adopted “big ears” to make sure they listen and respond to customer concerns.
The historic and important requirements around adverse events reporting have held many health care marketers back from listening to consumers. How the intent of adverse events reporting actually applies when a patient posts a product experience in Twitter with no contact information in their “bio” or exactly when an adverse event is established over the course of several blog posts is not clear. We need to find a clearer way of recognizing an adverse event and then reporting it that does not hold back a marketer from listening to what consumers are saying in the public space.
Outcome of the Hearings
The real solution may lie in the FDA establishing clear principles and then encouraging the industry to define exact practices as we are doing at WOMMA in relation to the FTC Guidelines. Can the FDA really hope to define the exact nature of a url or how to balance their historic need to approve marketing claims with the non-stop, real-time nature of a twitter-ized social Web? Will this type of detailed regulation help or hold innovation back? We need principles that protect the consumer but do not curb marketers from innovating.
If you are in DC for the hearings, stop by Ogilvy on Thursday night. WOMMA, LiveWorld and Ogilvy will be hosting a post-hearing Tweetup to recap what we heard that day. RSVP Here