To prep for our latest Webinar, I thought it best to go straight to the source. Now, finding plenty of information hypothesizing the administration’s stance on web content publishing was pretty easy, but I wanted to dig a little deeper.
Yes compliance people, I called the FDA.
Connecting with Shelly L. Burgess, Public Affairs Specialist at the FDA, proved very fruitful. In an email I received from her, Burgess first lead me to the administration’s Guidance for Industry: Consumer-Directed Broadcast Advertisements Questions and Answers.
While this document provides clear direction for traditional media broadcasting (and we’ll get into this a bit more in our Webinar), it only skims the surface regarding web content.
In that same email, Burgess explained, “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.”
Despite Burgess’s statement, I wouldn’t sit back and assume these guidance policies are that far off. The FDA has been sending out Warning Letters and Notice of Violation Letters to Pharmaceutical Companies since 1997. With the expansion of Pharmaceutical and Biotech firms’ presence online, more recent letters (over the past several years) are targeting marketing campaigns “broadcast” via websites and social media platforms.
But wait, there’s more! On November 12 – 13, 2009, the FDA held the: Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. From that hearing, the FDA gleaned information to identify issues they need to address in their forthcoming policy.
Now, as much as I would like to continue on this vein, I feel most comfortable letting Mark Middleton and Bruce Crain use the Webinar to take the conversation from here. Wouldn’t you rather see compliance challenge scenarios, along-side solutions in action, instead of reading a never-ending blog post about them? I thought as much. I know I would.
So, I’ll close with an invitation to join us on November 10 at 9:00 a.m. PST. “See” you then!