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- From Ninth Graders to Health Care Elites: A Communications Lesson on the Power of Engagement
- What’s Next in Health Care Part II: Price Transparency – is it the Holy Grail?
- Accountable Health Care: The Silent Health Care Reform
- The FDA Likes Facebook? The AMARC Hysteria
- The Need for a Medical Surge
- Health Care: Now What
- The Real Hospital Quality Measures
- Happy Healthy Weight Week?
- Personalized Medicine – from Complexity to Clarity
- APCO Forum: What’s Next in Food
Tag Archives: off-label
The FDA provided marketers and communicators in the pharmaceutical industry a holiday gift last week by releasing guidelines on how to respond to unsolicited requests for off-label product information. The FDA issued guidelines for both “private” and “public” requests, drawing a distinction between “private” and “public” for the first time. But let’s face it, this is also about social media, so from that standpoint the “public” guidelines are what we really care about. I’ll break out the guidelines in more detail below, but the bottom line is that companies didn’t gain any additional leeway to communicate with the public through social media vehicles. The FDA guidance basically says companies cannot communicate off-label use data or information to the public, but instead must restrict off-label communications to more “private” means.
Posted on Thursday, January 5th, 2012 By David Oarr