Tag Archives: public request

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.