The moment you have all been waiting for has been delayed... again. For the second time in four months, the FDA has apparently postponed plans to issue widely anticipated guidance on social media. The guidance was initially expected last December and then rescheduled for release in the first quarter of this year, which was presumably to have occurred this month (back story).
Now, though, the FDA is delaying again, according to (PR Week). We asked the FDA last night for some clarity about timing and received this response: "It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or 'Good Guidance Practices' (GGPs), which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic."
In other words, the FDA appears unwilling to commit to a timetable and there is only one day left in this year's first quarter. Nonetheless, the agency insists there is a commitment here. "Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities. Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources," the statement reads.
Meanwhile, the agency adds the following issues will be addressed: "responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet and correcting misinformation...We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued."
The uncertainty about a timetable for releasing guidance only adds to the greater uncertainty about the use and development of social media as an industry tool as companies grapple with unanswered questions and a lack of uniformity. Of course, one can always Tweet about their frustration.