FDA Issues Draft Guidance on Social Media

The U.S. Food and Drug Administration recently took a small step towards providing industry with the long-awaited guidance on how pharmaceutical makers may communicate about their products on social media like Twitter. 

In July, 2012, Congress gave the FDA two years to come up with comprehensive policies on Internet promotion, and FDA has now released for comment the draft guidance document entitled, "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics." It is the first of what is certain to be a series of guidance documents on this subject. 

This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. 

FDA states that a company will be responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm. Such product promotional communications may include firm-sponsored microblogs (e.g., Twitter), social networking sites (e.g., Facebook), firm blogs, and other sites that are under the control or influence of the firm. In determining whether a firm must submit promotional material about its product to FDA, the Agency considers whether the firm, or anyone acting on its behalf, is influencing or controlling the promotional activity or communication in whole or part. Thus, a firm is responsible if it exerts influence over a site in any particular, even if the influence is limited in scope. For example, if the firm collaborates on or has editorial, preview, or review privilege over the content provided, then it is going to be responsible for that content, says the document. 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. For example, if a firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that  the site is subject to submission to FDA to meet postmarketing submission requirements. 

FDA said it recognizes the challenges of submitting promotional materials that display real-time information and thus in the draft makes recommendations for submitting interactive promotional media. The main point of this part of the draft guidance is that marketers don’t always need to obtain FDA pre-clearance on planned tweets or an online posting before it is sent out.  If a firm submits interactive promotional media in the manner described in this draft guidance, FDA intends to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions related to promotional labeling and advertising.

The draft does not address such things as how risks can be communicated within the character-limits of media like Twitter, and  what constitutes acceptable use of hyperlinks. Clearly, more to come.

 

FJC Releases Report on Juror Use of Social Media

Here at MassTortDefense we have observed the many ways in which the evolution and spiking popularity of social media has affected the practice of law.  We are blogging, obviously, can be followed on twitter (@MassTortDefense), and have a presence on Linkedin. On the day Facebook has filed for an historic IPO, it may be a good time to look at the issue of the use of social media by jurors in the courtroom.

The Federal Judicial Center released a report on the topic last week.  At the request of the Committee on Court Administration and Case Management, the Federal Judicial Center conducted a survey of district courts to assess the frequency with which jurors use social media to communicate during trials and deliberations, and to identify effective strategies for curbing this behavior. The results, based on the responses of 508 responding judges, indicate that detected
social media use by jurors is so far infrequent, and that most judges have taken steps to ensure jurors do not use social media in the courtroom. The most common strategy is incorporating social media use into jury instructions—either the model jury instructions provided by CACM or judges’ own personal jury instructions. Also common are the practice of reminding jurors on a regular basis not to use social media to communicate during trial or deliberations, explaining the reasons behind the ban on social media, and confiscating electronic devices in the courtroom.
 

Only 30 judges reported instances of detected social media use by jurors during trials or deliberations. But almost half the judges said they had no good way of knowing whether jurors were using social media.  Nearly 94 percent of the judges who responded to the survey have specifically barred all case-connected use of social media. Judges admit that it is difficult to police jurors, and therefore use of social media is difficult to detect.

Of the types of social media used by jurors, Facebook was ranked as the most common, with instant messaging second.  Twitter lagged behind in this survey.  In most instances, the social media use was in the form of posts about the progress of the case. But the judges reported a handful of attempts by jurors to  “friend” one or more participants in the case. And three reported jurors who revealed aspects of the deliberation process.