• by Dale Cooke , February 10, 2012

In December, the FDA released the first of its long-awaited social media guidances. The collective response from industry was a shoulder shrug.

So, where do we go from here?

To appreciate how momentous this non-event was, we need to recount briefly the path we’ve taken.

In March 2009, the FDA issued the infamous 14 letters to more than 40 brands for improper marketing via search engine paid advertising.

In May 2009, the FDA released a draft guidance about presenting risk information. In more than 20 pages of discussion, there was no mention of search engine marketing or social media and only three brief mentions of websites. The guidance did have a section called “Considerations of Format.” But to the amazement of many, the FDA thought it was sufficient for that section to have only two subsections for Print and Non-Print Promotions, as if TV ads, mobile apps, websites, and social media could all be lumped under “Non-Print Promotions.”

In September 2009, the FDA announced that it would hold hearings to learn more about the unique challenges associated with social media and the Internet. At those hearings, held in November, the FDA was told repeatedly by all interested parties that there was a need to clarify fundamental issues about how to present risk information in space limited contexts and other issues associated with social media.

Following the hearings, the FDA began publicly announcing its intention to develop social media guidance and even included an item called “Promotion of Prescription Drug Products Using Social Media Tools” on its 2010 agenda of guidances being developed, though 2010 ended with nothing being released.

In July 2011, the FDA released a guidance on the closely related topic of mobile apps and how they would be regulated.

Then, in December, the FDA finally released its first social media guidance.

The most important fact about the FDA’s first social media guidance is that it is not a social media guidance at all. Instead, the FDA issued a guidance about responding to requests for off-label information and included certain aspects of social media within that discussion.

This is a major step forward in that the FDA is actually discussing the Internet and social media as part and parcel of its discussion of regulated communications, but it also represents a significantly scaled back expectation of what’s coming. All mention and discussion of a grand, all-encompassing social media guidance has disappeared. That item from the 2010 agenda has been removed.

And although the 2012 guidance agenda has not yet been published, it is highly unlikely that a major statement on the use of social media as a whole will be added. Instead, we’re likely to see more of what we have seen—piecemeal, slow advances whose scope is limited.

In this respect, one other development offers tantalizing prospects. In late January of this year, the FDA released a final guidance on the product name usage and prominence. That guidance had been in draft for 13 years. The final version included major revisions with direct impact for social media and other space-limited contexts.

Perhaps the FDA is signaling via the inclusion of social media in discussion of issues relating to off-label marketing and its finalization of a draft more than a decade in waiting with implications for social media, that we will see more discussion in other finalized guidances.

The most intriguing prospect in this regard is the 2009 draft guidance on presenting risk information mentioned earlier. The FDA does not release a schedule for releasing final versions of guidances, but it does not take a wild leap of the imagination to see in the offing a finalized guidance with a revised section on “Considerations of Format” that includes “Social Media and Other Space-limited Contexts” added.