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Most marketers who have anything to do with promoting pharmaceutical products or medical devices have the upcoming FDA hearings at the top of this minds heading into next week.  With less than 7 days to go until the hearings, all the presentations have been submitted to the FDA, the anticipation is rising and conversation online about the hearings from speakers, attendees and online watchers (the hearings will be live webcast) is rising.

Ogilvy is among the organizations slated to speak at the hearings, and we have several activities planned around them beyond speaking - including hosting a “tweetup” the evening after the first hearing in our Washington DC office for anyone interested in coming and having an informal chat about how the day went and implications for our industry. In preparation for this moment, here are 5 things anyone in the industry should expect to come from the hearings, as well as some initial information you should know:

1. What is the format of the hearing? The entire hearing consists of short introductory remarks by the FDA followed by a series of 15 or 10 minute presentations by approved speakers. There are about 60 approved speakers and on Thursday they will all focus on answering the first four questions from the FDA hearing notice, and Friday morning will solely focus on “question #5′ which is about adverse event reporting online. Friday afternoon will continue general comments. Each presentation will be specifically cut off at the time alloted and the FDA panel hearing these presentations may choose to ask questions during a speaker’s alloted time.

2. What is the timeframe for the FDA to act on comments? The format of the hearings is that the FDA will begin by LISTENING to people from the industry and presumably take those voices into account in order to create guidelines for marketers to use the web and social media for promotion. By most estimates, these guidelines will not be finalized until the end of 2010 - so if you are expecting a magic fix or list of rules to come out of the meetings this week, you should reset your expectations.

3. Who will be speaking at the hearing? More than 50% of the 60+ speakers who will be participating in the hearings come from industry groups such as agencies (Ogilvy fits in this group) or consultants. Clearly we care because these discussions matter to our business, but we are also often the most directly involved parties in executing marketing activities that will be governed by the policies that the FDA determines, so this makes sense. There are a handful of us, however, who are planning to share our voice from industry WITHOUT forgetting about the patients and what they want. Though there may not be many patient advocacy groups, we happen to believe it is the role of responsible marketers and agencies to keep these patients (and healthcare professionals as well) at the center of thinking because they are the ultimate audience for these marketing activities. See an evolving list of links to presentations published ahead of time by speakers here >>

4. How can you participate/attend virtually? Over 800 people tried to RSVP to attend and only about 300 were selected based on a first come first serve basis. This means there is a lot of interest in the hearings beyond those who will be able to physically be in the room. To help, there are a number of ways that you can participate in the conversation virtually beyond just tuning into the live webcast. Ignite Health has created an online community that most participants of the hearing are part of at http://www.fdasm.com/. This will be frequently updated throughout the hearing and is a valuable resource for anyone who wants to track the conversation from the hearing in real time. Most content will include the keyword/hashtag “#fdasm.” I plan to be live tweeting and blogging from the hearing, as well as many other attendees.

5. What is Ogilvy’s point of view? Our point of view on a top level with regards to this hearing is that brands wanting to use the web and social media for promotion desperately need some guidance because without it they are constantly in a state of panic or ignorance about what they should and should not do. Both of our presentations address this fact, and the first introduces a new model that we believe in for how this could be tracked by the FDA. Our full slides are available on our team Slideshare account at http://www.slideshare.net/ogilvypharma and will be published on this blog shortly.