Don’t judge a book by its cover – or in this case, title.
In November 2009, FDA held a two-day public meeting on the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media to collect input for the eventual development of guidance. That set off a very, very, very long wait.
In December 2011, the agency issued a draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. Because this draft guidance mentioned aspects of social media in this regard, many took it to be the long-awaited social media guidance. Rather, it was a guidance that mentioned social media. In fact, it appeared that FDA was providing guidance over time through a series of publications.
Yesterday, a new draft guidance was put up on the FDA site with the very complex title – Fulfilling Regulatory Requirements for Post-Marketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics. Reading that title, one would hardly know what it is about. It is indeed about how to submit post-marketing submissions of promotional material for FDA review. But importantly, it includes aspects of social media (which is what the phrase “Interactive Promotional Media” includes).
Moreover, the draft guidance gives some insight into FDA’s outlook on the regulation of social media communications on an important question raised during that 2009 public meeting so long ago. It does so by outlining the circumstances whereby manufacturer communications are subject to review, and therefore must be in compliance. These naturally include communications that the manufacturer generates or directs to be generated through an employee or consultant. If there is influence on the use and placement of such material in a third party site, then the site will also have to be reviewed. In other words, one is responsible for one’s own promotional communications, which is logical and unsurprising.
But perhaps the most interesting part of the draft guidance involved user generated content (UGC) that appears on an electronic site about an FDA regulated product. Any UGC developed by a manufacturer, a consultant, an employee or any other person under the manufacturer’s direction and influence, is a communication for which the manufacturer will be reviewed and for which the manufacturer is responsible. “However, a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular). FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.” (emphasis added)
So don’t let the title fool you. With this draft, FDA appears to have clarified how it regards third party generated content with respect to electronic sites. They did it in the context of providing companies with practical information on what must be submitted for review and how it must be done, but this insight, I think, is the real headline.