This Monday, April 14, was the deadline for comments on the FDA’s social reporting guidance, titled Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. This guidance, as reporting in January, held a lot of direction regarding firms’ responsibilities on social channels as well as the actual reporting issues. We have reviewed the comments from the 16 participating firms and grouped the comments to see what the overall direction is from industry to the FDA.
Types of Firms Commenting
There were a total of 16 firms of four types that commented on the guidance, which seemed a bit low, especially for the amount of buzz the draft guidance. In total they presented 77 pages of commentary on the FDA’s draft. The firm types were:
The associations were speaking for pharmaceutical and other healthcare companies, so it is possible that some of the individual firms declined to comment because their voices were rolled into the Associations’ but this can create the impression that they are not interested.
Even more interesting was that digital agencies were represented by two firms, Klick Health and Evolution Road. The other three agencies were specialized patient outreach groups that were lobbying to ensure that healthcare companies retain the ability to engage with their constituents.
Types of Comments
We grouped the comments into the main themes being expressed. Naturally, there is some interpretation and “poetic license” used when doing this, but this represents our understanding of the issues being brought forth and their ranked importance:
For those familiar with the guidance the comment types are probably fairly understood, however short descriptions are:
|Ads||Advertisement placement and how control over that placement might be interpreted to create unwarranted ownership for the firm|
|Agency||Issues relating to agents of the firm such as employees or paid speakers and when their comments should be interpreted as speaking for the firm (and when they should not)|
|Anonymous Comments||Issues relating to when a commenter is anonymous|
|Answering Questions||The ability of a firm to answer questions online and how much monitoring of conversations should be expected|
|Bloggers||Interpretation issues surrounding the firm’s interaction with bloggers and where the line is regarding editorial control and agency|
|Browsers||Issues surrounding the provision of links and how those links will be viewed|
|Ceasing Usage||The reporting of a channel when the firm is no longer using or reviewing it|
|Context||Related to ads, above, and the reporting of contextual pages close to ads when the firm has control over the ad placement|
|Editing Comments||Questions relating to how the maintenance of comments on social sites will be interpreted as relating to firm ownership of the UGC|
|Editorial Control||Questions relating to the overbroad definition of control in the guidance|
|Editorial Influence||Questions relating to the overbroad definition of influence in the guidance|
|First Use||Suggestions on how channels can be reported on first use|
|Hashtags||Questions about hashtags, relates to link guidance, below|
|Limitation to Promotion||Discussion around the FDA’s mandate and an undue expansion of its regulatory scope when discussing social channels not relating strictly to promotion|
|Link Guidance||Comments on the expected upcoming link guidance|
|Monitoring||Questions relating to how long firms should monitor discussions that are on 3rd party sites|
|Overstepping Authority||Discussion around the FDA’s mandate and the overbroad language in the guidance that implies that it has more regulatory scope than is actually true|
|Providing Content||Questions relating to the provision of content to 3rd parties such as bloggers and the expectation that the firm is not automatically expected to assume responsibility for the 3rd party’s posts|
|Public Definition||The definition of “public” versus “private” channels for reporting purposes|
|Reporting Schedule||Comments on the suggested reporting schedule and options for more flexibility|
|Reporting Scope||Questions relating to the number and type of sites reported|
|Unique Nature||Comments that ask the FDA to remember the unique nature of social media compared to more traditional forums|
|Widgets||Questions about social media content being used in places other than the channel itself|
We also charted the number of different topics that each firm brought forward. The ranking is:
So now we wait. We hope that the FDA moves relatively quickly on the full guidance now that it has responses from the interested parties from industry.