From the Floor of the FDA Social Media Hearing
I’m sure I’m not the only one waiting with anticipation to see what will come out of the current FDA Hearing on Social Media. The very fact that this meeting is taking place puts the FDA under pressure to issue some coherent guidance on how pharma companies can and should be engaging in dialogue with patients and physicians online and how to address the issues around adverse event reporting. We’re fortunate enough to have a colleague at the hearing and below is her update from yesterday’s session. The updates are also being posted www.HealthieRForum.com
HealthieRForum Exclusive: From the Floor of the FDA Social Media Hearing
Nicole Preiss-Riley, Senior Vice President in Ruder Finn’s Healthcare practice, is onsite at the FDA hearing on social media. Based on the sessions from the first half of the day, here’s what she has to report:
Presenters were asked to focus their remarks on five key questions:
1. For what online communications are manufacturers, packers or distributors accountable?
2. How can manufacturers, packers or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications?
3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
4. When is the use of links appropriate?
5. How should adverse event reporting be addressed online?
Thus far, presenters have selectively responded to questions rather than answering each one of the five as part of their respective comments – much of the discussion has focused on the unique character of social media and the value it provides to both providers and consumers.
It’s clear that the pharmaceutical and medical device companies are eager to work with the FDA to determine parameters for working within the social media sphere as well as a plan for implementing those guidelines. However, the question has been raised repeatedly as to what product-related information companies should be responsible for conveying.
Much of the commentary has focused on moderated sites (i.e., WebMD) that have discrete editorial roles. What has not yet been addressed with any robust discussion is the broader social media landscape of bloggers and opinion-based Web sites.
How this type of content can or should be regulated has not been touched yet. One independent blogger who is scheduled to present at the hearing tomorrow said, “It’s been a good meeting so far. Based on what’s been said, I hope the FDA will come up with guidance within the next year.”
Tags: FDA, healthcare, HealthieRForum, Nicole Preiss-Reley, social media, social media hearing
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