Back in June in a posting about the new (relatively) live streaming capability brought to use by Periscope. The app, acquired by Twitter prior to its launch early in 2015, allows you to live stream content from where you are to your followers who can provide commentary – and to allow your Twitter followers to see it afterwards, including the comments. Periscope, in essence, allows you to be your own reporter. In the June posting, I talked about how it might be used to film AdComm outcomes and that it had great utility in healthcare for developments and announcements at medical meetings.
But would a pharma company use Periscope? Are there special regulatory concerns that might be in play given this particular digital venue? Here are thoughts on each question.
So are pharma companies using Periscope? You bet.
I checked out this list of the top 25 pharma companies by global sales. I found that 10 of them – or 40 percent of the top 25 pharma companies – appeared to have established Periscope feeds and some of them are even following the Eye on FDA Periscope feed (thank you!). They ranged in the size of followership from 0 (though for each of these, I became a follower so now they have at least 1 follower) to 717. I have heard of at least one company holding an event using their Periscope feed.
Which brings us to the second question – are there concerns that regulatory might bring up associated with Periscope use?
What if a company were running a broadcast of a patient group at a medical meeting and someone mentioned an off-label use? What if they stated something that was misinformation about the product? What if they mentioned an adverse event?
So what if someone mentioned an off label use or other misinformation during a pharma Periscope session? Of course, FDA/OPDP does not issue platform specific guidance documents. But in the June 2014 Draft Guidance document (page 5) on correcting misinformation, FDA had this to say about third party content on a company hosted site when they provided an example:
“A firm hosts a discussion forum about its drug or devices’ FDA-approved use on its corporate website and does not participate in the discussion, but it does monitor the forum for profanity and obscenity. The forum includes an overarching and clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for the information that is posted by an independent third party and can, if it so chooses, correct misinformation according to this guidance.”
This might seem to suggest that a third party speaking on Periscope session – analogistic to the corporate website in this case – might convey misinformation and the company would not be responsible – as long as the company were not participating in the interview and was able to communicate a conspicuous statement that the firm was not creating or prompting this content. Or it might not.
Following that example, FDA also states:
“However, a firm’s control over, involvement with, or influence over a product-related communication, even when generated by a third party, may result in the firm being responsible for the information as a promotional communication. Thus, firms might be responsible for UGC that they solicit or influence, regardless of the forum.”
So perhaps if a company asked for an interview with a specific entity, as opposed to benign broadcasting of such an interview by a third party (with a disclaimer), responsibility might ensue.
That is as it pertains to misinformation. Regarding an adverse event – that is one of the five question areas raised in the 2009 public hearing about which we have had no guidance from FDA. We would only know by further FDA explanation, usually through the issuance of untitled letters, which OPDP has issued only rarely this year. In the meantime, it is up to individual companies to decide how, and if, to proceed.