• by Dale Cooke , April 11, 2014

Last year, I wrote in a Marketing:Health column, “The primary challenges for makers of prescription products with adopting social media are operational.” I emphasized three sets of challenges: adverse event reporting, responsiveness, and FDA filing requirements.

I am pleased to report that the Food & Drug Administration, through its first social media guidance has provided significant help for the makers of prescription medicines to address two of these three hurdles. Specifically, FDA’s guidance provides a clear path for companies who want to engage in social media to be responsive, while meeting their FDA filing requirements.

First, a word about the requirements. Makers of prescription drugs, biologic, and veterinary medicines (but not medical devices!) are required to submit all of the materials they use to promote their products prior to use.  So, before any TV spot airs, Facebook page is launched or print ad is circulated, the FDA receives a copy of the material. They submit that material under cover of form 2253; hence, the filings are called 2253 submissions.

For traditional static materials, this requirement has been easily met. However, industry has been concerned that meeting this requirement would hinder the ability to be responsive to real-time conversations. Imagine a phone conversation where the person on the other end of the line had to fill out a form before speaking. That could make for a lot of paperwork, but not much conversation.

That’s where the new guidance comes in. In the first of several planned guidances for release this year, FDA tackles this issue head-on and provides a viable framework for regulated industry to engage in real-time conversations. Rather than mandating that every statement be submitted prior to use, FDA sets out the very reasonable stance that industry can fulfill its 2253 filing requirement by providing FDA with a list of every location where they are participating in social media conversations. 

So long as the conversations themselves are publicly accessible, industry is not required to provide their conversations via 2253 submissions. Every 30 days, FDA wants industry to update the list (adding and deleting venues as appropriate).

For restricted access venues, such as a private forum for registered healthcare professions (HCPs), FDA also set out a framework that enables real-time interaction while meeting their 2253 filing requirements. Again, FDA wants industry to submit a list of locations where real-time conversations are taking place, but because FDA can’t guarantee access to the private venues, FDA is requiring that industry also submit screenshots of the conversations themselves indicating which aspects of the conversation were owned by industry.

For both scenarios, regulated industry is seeing FDA taking a very measured approach to remove some of the most significant hurdles to participating in the social media channels where both consumers and HCPs and now discussing their health and the possible treatments for their health conditions.

With more guidance to come, industry should welcome the general direction FDA is moving. There are challenges to taking advantage of the latest technology to provide health information to people when and where they need it, but those challenges can be overcome, and industry should be pleased to see the agency providing a framework for doing so compliantly.