Looking Back Down the Road – What Have We Learned from FDA on Regulation of Digital Media?

So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms.  It seemed like a good time to produce a recap on where we are – and where we aren’t – with respect to social media.

• March 2009 – It’s the Not the Medium, It is the Message – In April 2009, representatives from the Office of Prescription Drug Promotion (OPDP), then called the Division for Drug Marketing, Advertising and Communication (DDMAC) sat down with me to do a podcast to provide their thinking into how promotional speech would be regulated on these new platforms.  At the time, the thinking seemed to be that existing regulatory guidance was sufficient – that if you couldn’t say it in print or broadcast, you couldn’t say it in social media.  In short, the attitude was – it is not the medium, it is the message.  While that sounded simple and direct, in fact, the very nature of the Internet and social media platforms raised very specific questions that were unique to digital media – which quickly became apparent the following month.
• April 2009 – The 14 Untitled Letters and the One Click Rule – In a seeming contradiction to “It’s Not the Medium, It is the Message” message FDA then issued 14 untitled letters to companies primarily for a failure to include risk information in banner ads on the Internet.  Banner ads had been a widespread practice in the world of prescription product promotion because of belief in the “one-click rule” – meaning that if risk information were one click away from copy that mentioned a product name and indication, then it was permissible.  Turns out the “one-click rule” was not a rule at all.  The takeaway however was clear – FDA laid out its first “guidance” on the Internet and social media by enunciating the tenet that when you have a drug name and indication present in promotional language, the risk information cannot be anywhere else but in the same place and cannot be incorporated by reference or included by link.  The FDA action resulted in a New York Times Headline – “FDA Rules on Drug Ads Sow Confusion as Applied to Web”.
• September 2009 – FDA Announces Public Meeting on Internet and Social Media – Apparently upon reflection FDA came to realize it is not just the message, it is the medium after all that begs some unique regulatory questions and announces in the Federal Register that it will hold a two-day meeting on the “Promotion of Food and Drug Association-Regulated Medical Products Using the Internet and Social Media Tools” to be held in Washington, D.C. (ironically in a room without a WiFi connection).
• November 2009 – Two Day Public Workshop – FDA holds a two day meeting that had full attendance and participation by many pharmaceutical companies.  The meeting was patterned to answer a series of questions:  (1) For what online communications are manufacturers, packers, or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, post marketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and finally (5) Questions specific to Internet adverse event reporting.  The docket for this topic was open to receive comments through February 2010.
• July 2010 – Agency Issues an Untitled Letter Involving Facebook – In what has been the only regulatory action involving social media as a medium, OPDP issued an untitled letter regarding a Facebook share function based in part on the fact that the share function conveyed the drug name and indication without the risk information – again another version of the “one-click” rule – not really providing any new insight into the parameters discussed at the November 2009 meeting, but reinforcing the principle that wherever goeth the name and indication also must goeth the risk information.
• December 2011 – FDA Issues Draft Guidance that Mentions Social Media – After a long, long period of silence, FDA finally issued a draft guidance that mentioned social media in its context, prompting some to believe this was the long-awaited social media guidance.  Rather, it was a guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” which included what to do if the request came via digital media platforms, but provided little insight into FDA’s actual outlook on any of the questions raised during the 2009 public meeting.
• Also in December 2012 – An Interesting Non-OPDP Warning Letter – FDA sent a Warning Letter to a manufacturer of an animal drug product that involved a social media communication. In this case, among other things that concerned FDA, the manufacturer “liked” a posting on their Facebook page that carried a claim by a third party, indicating a human had taken the product and experienced satisfactory results.  This perhaps indicates that a “like” – as an endorsement of the content that would be violative if the manufacturer had said it and one could extrapolate from this that a “re-tweet” of a comment that would contain a violative claim would also be an issue for FDA.
• January 2013 – Another Non-OPDP FDA Warning Letter May Tell Us Something About Search – In the context of a letter citing other violations, one thing FDA noted in this non-OPDP Warning Letter was that by typing in specific medical conditions into the search engine on the site, the results included products which were not approved for the treatment of that condition.  “In addition, typing the word ‘cancer’ or ‘diabetes’ into your product search field located on your website brings up your products… implying your products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.”  This at least raises some questions about optimization issues.
• January 2014 – FDA Issues a Draft Guidance on Post-Marketing Submissions Involving Social Media – It is perhaps telling that FDA issued a guidance about how to do post-marketing promotional submissions involving social media without ever having issued any guidance about use of social media, but that is what happened.  Here FDA gave the most insight it has ever given on the topic.  As mentioned last week, it was perhaps most notable for what it seemed to indicate regarding third party sites and third party commentary on a company owned site.

By staging the 2009 hearing, as it did, with specific questions being asked in a specific order FDA lent the altogether reasonable impression that the agency would answer these questions in the same order the form of a guidance document. That has not happened. Instead, we are getting puzzle bits to place back into the construct of the discussion.

If you go back to the questions, one can see that these events tell us some of the answers – from use of links to how third party material is regarded.  We will hopefully see more about correcting material of third parties, more on the appropriate use of links, about optimization – something not contemplated in the hearing – and more direct guideline as to how the agency is regulating these rapidly evolving media.  After four years, we are informed, but not fully.