Godot Finally Arrives: At Long Last, FDA Issues Draft Guidance On Submissions For Interactive Social Media

By Jeffrey N. Wasserstein & Delia A. Stubbs –

For years, those of us who followed FDA’s attempt to provide guidance related to social media felt like Vladimir and Estragon from Samuel Beckett’s Waiting for Godot.  FDA initially promised guidance by the end of 2010.  But, like Godot, the guidance never came.  On January 13, after years of anticipation by industry, Godot finally made a cameo appearance as FDA issued a draft guidance titled, “Fulfilling Regulatory Requirements for Postmarketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  Unfortunately, much as Vivian Mercier described Waiting for Godot as “a play in which nothing happens, twice,” FDA’s guidance dances around the issues that industry has been asking and focuses primarily on process rather than substance.  Specifically, FDA addressed how and when a company is required to submit promotional materials that appear on social media platforms to FDA. 

Enforcement and Scope 

Generally, companies are required to submit promotional materials to FDA at the time of initial dissemination.  Promotional labeling relating to prescription drugs for humans are submitted on Form FD-2253.  FDA recognized that compliance with postmarketing submission requirements poses unique difficulty for “real time” communications (e.g., blog posts, comments on a website, and twitter feeds), namely, the requirement that the firm submit specimens of promotional material “at the time of initial dissemination.”  Guidance at 2.  FDA, thus, stated its intent to exercise enforcement discretion “due to the high volume of information that may be posted within short period of time” if the firm “submits interactive promotional media in the manner described in the guidance.”  Id. at 2.

The draft guidance applies to human prescription drugs, prescription and OTC veterinary drugs, and FDA-approved biologics, but does not apply to veterinary biological products regulated under the Virus-Serum Toxic Act.  Id. at 1, n. 3.  Nevertheless, as FDA’s draft guidance briefly touches on when a firm may be responsible for the content of certain social media, which may have enforcement ramifications regarding provisions of the FDCA act unrelated to submissions (e.g., off-label promotion), medical device companies likely should also pay close attention to the draft guidance. 

Influence and Control: What Qualifies

FDA stated that “in determining whether a company is “accountable” for a promotion, it will look to whether the firm or anyone on its behalf “is influencing or controlling” the product promotion or communication.  Guidance at 2.  FDA clarified that “[a] firm is responsible for product promotional communications on sites that are owned, controlled, created influenced or operated by, or on behalf of the firm.” Id. at 3.  Control, according to the Guidance, is more than mere ownership. “[I]f the firm collaborates on or has editorial, preview or review privilege over the content provided then it is responsible for that content.”  Id. at 3, 4.  Moreover, “[a] firm is responsible for promotion on a third-party site if the firm has any control or influence on the third-party site, even if that influence is limited in scope.”  Id. at 4 (emphasis added).  By way of example, FDA stated “when a firm provides on its product website an online forum that gives users the opportunity to post comments about the use of its product . . . the firm is responsible for submitting to FDA the product website.”  Id. at 3-4.  Also, “if [a] firm make suggestions on the placement of its promotional messages on an independent third-party site, the firm is responsible for submitting to FDA the promotion along with the surrounding pages to FDA.”  Id. at 4.  However, “[i]f a firm that provides mere financial support (e.g., through an unrestricted educational grant) and has no other control or influence . . . it is not responsible for the content on that site.”  Id. at 4.  Likewise, “[i]f a firm is merely providing promotional materials to a third-party site, but has no control over placement of those materials within the site” and no other control of the site, the firm is responsible only for and required to submit the content that it passed on to the site.  Id. at 4. 

This is a fairly expansive view of control.  While one might agree that having input or editorial rights over the material provides some level of control, it is hard to see how having preview or review privileges, without the concomitant right to alter the content, equals control.  If a Web-based publisher of medical content agrees to give a prescription drug advertiser preview rights without allowing them to alter the content, it seems a mere courtesy rather than a degree of control.

Also, FDA stated that a firm is responsible for content “generated by its employees or any agents acting on behalf of the firm who promote the firm’s product.”  Id. at 4.  Thus, “if an employee or agent of a firm, such as a medical science liaison or paid speaker (e.g., a key opinion leader) acting on the firm’s behalf, comments on a third-party site about the firm’s product, the firm is responsible for the content its employee or agent provides.”  Id. at 4.  Also, a “firm is responsible for the content on a blogger’s site if the blogger is acting on behalf of the firm.”  Id. at 4.  Likewise, a firm is responsible for and required to submit a “comment made by a sales representative on an independent third-party site about a product’s release mechanism” and “a blog to FDA that is maintained by the firm’s representative and about the firm’s product.”  Id. at 5.

FDA also addressed sock puppetry, although it did not use that term (it would have amused us if it had).  Sock puppetry is online deception, where one pretends to be someone one is not, generally in order to praise the actual person or to anonymously disparage another.  FDA recommends that a regulated company clearly disclose its involvement on social media sites through the use of the company’s name or logo as part of the communication or site.  Employees or third parties acting on behalf of the company should likewise identify their affiliation with the company.

Perhaps to assuage concern about broad-based liability, FDA comforted (we use that term lightly) that “a firm is generally not responsible for user-generated content (“UGC”) that is truly independent of the firm (i.e., is not produced by, or on behalf of, or promoted by the firm in any particular).  Id. at 5.  It specified that it “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.”  Id. at 5. While informative, to some limited extent, this does not address the issue of whether a regulated company would need to correct misinformation or off label discussions placed on site or platform controlled by the company.  Like our friends Vladimir and Estragon, we’ll have to keep waiting for that issue to be addressed.

What Do Firms Have to Submit and How

In general, FDA’s draft guidance requires firms to submit “at the time of initial display” the “entirety of sites for which it is responsible” including interactive and real-time components contained therein.  Id. at 6.  FDA’s draft guidance suggests that it is referring here, to sites over which it has review authority or other dominion or control, as discussed above.  See id.  With respect to UGC, FDA stated its preference that firms “allow FDA to view and interact with the submission in the same way as the end user” through the use of such tools as “working links” but, in the alternative, indicated it will accept screenshots.  Id. at 6.  Likewise, for third-party sites, “where the firm’s participation is limited to user-generated content, a firm should submit the home page, the interactive page, and the firm’s first communication, at time of initial display.”  Id. at 6.

FDA will then permit a firm to update its submission monthly via the provision of list of relevant sites or screenshots of relevant content, depending on whether the site is unrestricted (in other words, whether FDA has access to it).  Id. at 6.  For unrestricted sites, FDA will permit a firm to submit an updated listing of the sites in which it remains an active participant.  Id. at 7.  No screenshots of content are required.  Id. at 6.  For restricted sites, however, FDA clarified “screenshots or other visual representations of the site should be submitted monthly.”  Id. at 7.  Otherwise, for submissions related to restricted sites, FDA clarified “[f]irms should submit all content related to the discussion (e.g., all UGC about the topic) which may or may not include independent UGC.”  Id. at 7.

Written comments on the draft guidance may be submitted within 90 days.