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.
4 Comments
As long as you ensure internal AE and REMS policies are followed, nothing should prevent pharma companies from listening to or engaging in social media. Social media is just another channel (This is what FDA said in the last hearing).
We are seeing a significant up-tick in customer interest ever since we released our “compliance ready” social media platform. Companies are taking the next steps to integrate our platform into internal AE/REMS processes so that there are no issues of compliance when it comes to exploiting the power of social media.
Siva Nadarajah VP, Product Strategy and Development Semantelli Corp.
http://www.semantelli.com
“Compliance Ready, Life Sciences Specific Social Media Platform enhancing CRM, Market Research, Drug Discovery and Competitive Intelligence”
So the DDMAC division of FDA blanketed the industry a year & a half ago with missives about various online communications being inappropriate. The industry flung up its hands & said they didn't know what the rules were, because guidance has never been updated for the digital age. FDA eventually admitted this was true & they were working towards a certain deadline. And now here we are.
FDA has essentially abrogated its responsibilities to the industry & the public.
Thanks for the update. Though I'm not justifying the delay, I think it points to the complexities of figuring out best practices in the emerging and ever-evolving digital landscape. I spent 1 1/2 days last week at a conference focused on the legal implications of social media, and they admittedly could only scratch the surface.
Readers may be interested in a blog post I've written about social media policies that goes beyond FDA compliance issues. It's called "Social Media Policies: Necessary but not Sufficient" and can be accessed via tiny.cc/SMinOrgsPolicyPost (need to add http).
Courtney Hunt Founder, Social Media in Organizations (SMinOrgs) Community
Yes, the FDA has been slow to enter the realm of social media.
Still, as slow as that process may be, the relationship between the FDA and social media is always evolving. For those interested, here's a related article on what the future may bring for the relationship between social media and the FDA. It's split into four parts, and may provide a deeper understanding of the issue at hand.
://goo.gl/EBMMK (with 'http' in front)