Industry Comments on Draft FDA Guidance

Several leading drug manufacturers have worked to shed light on serious issues with the social media guidance issued earlier this year by the U.S. Food and Drug Administration.

Readers may recall the draft guidance was intended to describe FDA’s current thinking about how manufacturers and distributors can fulfill regulatory requirements for postmarketing submissions
of interactive promotional media for their FDA-approved products.  A number of industry members have submitted formal comments

PhRMA and its member companies highlighted two fundamental concerns with the Draft Guidance. First, the Draft Guidance assumes that a biopharmaceutical manufacturer can be held accountable for content written by third-parties on third-party web sites if the company merely somehow "influences" the third-party. This premise is overbroad and is inconsistent with the FDCA. Put simply, third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA‘s authority to regulate promotional labeling or advertising. Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance.

WLF echoed the latter concern. noting serious problems with the Draft Guidance at Section IV (entitled, "Factors Considered in Determining Postmarket Submission Requirements for Interactive Promotional Media"). The Draft Guidance's basic premise seems to be that everything a manufacturer posts on-line: (1) qualifies as "promotional" material; (2) falls within FDA's statutory purview; and (3) is not protected from FDA regulation by the First Amendment. Those premises are 
demonstrably incorrect. Accordingly, agency policy in this area ought to begin with guidance
regarding where FDA draws the line between speech that it is and is not permitted to regulate.
The Draft Guidance brushes aside such concerns and seems to indicate that FDA intends to regulate everything that a manufacturer says regarding its products on social media sites.

It will be interesting to see how the FDA reacts to these valid comments.

 

FDA Issues Draft Guidance on Social Media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.

 

 

Facebook Groups and Class Actions

Plaintiffs have sued the Procter & Gamble Co. in a proposed national class action, alleging that  new Pampers diapers containing “Dry Max” technology is causing rashes and "chemical burns" in some infants. See Clark, et al. v. Procter & Gamble Co., No. 10-301 (S.D. Ohio, 5/11/10). Plaintiffs seek reimbursement for the cost of diapers, as well as for alleged medical expenses and treatment.  The plaintiffs allege that P&G knew or should have known that the diapers with Dry Max technology could harm kids' bottoms. They assert causes of action for breach of implied warranty of merchantability, breach of  implied warranty of fitness for a particular purpose, violation of consumer fraud acts, negligence, unjust enrichment, and strict liability.  Then came word that the Consumer Product Safety Commission would review consumer complaints regarding Pampers with the new Dry Max technology.

P&G notes that the Dry Max technology is a significant innovation in diapers. The Dry Max technology allows the diapers to be thinner and lighter, but still absorbent.  The Proctor & Gamble website notes the safety of the diapers  for babies, and the heavy testing -- the product is one of the most tested diapers in the company's history. To date, there have been in excess of two billion diaper changes using the new product, with only a handful of rash complaints, none of which were shown to be caused by the type of materials in the product. In fact, the company has received fewer than two complaints about diaper rash for every one million diapers sold, which apparently is average for the diaper business and does not deviate from the number of calls received prior to Dry Max.

It is hard to imagine that common issues will predominate over the individual issues arising from causation and injury, in the putative class action. Diaper rash is very common, and sometimes severe, regardless of the diaper used. At any given moment, more than 250,000 babies will experience a serious rash. Disposable diapers in fact have helped reduce the incidence of rash by more than 50 percent since they were first introduced in the 1960s because they pull wetness away from a baby's skin. It is very common for long-time consumers of child care or personal care products to correlate a change in product style or design with an adverse effect.

What is most interesting for our readers, perhaps, is the fact that this litigation was apparently spurred by the social networking site, Facebook, where some parents have been blaming the new diapers for rashes.  This has spread not only word of the incidence of a possible problem, but also the non-scientific, non-expert attribution of causation.  Here, for example, there have actually been very few complaints to the CPSC, but the CPSC said the on-line activism was part of what has prompted them to examine the alleged diaper issues.

Sites like Facebook give consumers a bigger platform to voice their opinions and find other similarly situated individuals, and product sellers need to realize how that can spur litigation. Social media alone do not produce litigation, of course.  But from a potential liability standpoint, the social networking sites are becoming a new resource for plaintiff product liability  attorneys.   Facebook provided plaintiff attorneys potential access to thousands of product users documenting their experiences with the product.  Some even have posted relevant photographs. The diaper Facebook group apparently grew to more than 10,000 members. Such Internet activity can include product users talking about the possibility of litigation and searching for attorneys. Some members of the plaintiff bar have used on-line media to communicate with potential clients, and identify ideal class representatives.  

Defense lawyers need to recognize they can research and learn from plaintiffs' on-line activities, as well, particularly before the involvement of plaintiff attorneys. Discovery requests for
Facebook profiles, forensic examinations of computers, or, at proper times, third-party requests directly to the social networking site, may be part of their arsenal.  There may be information about named class representatives, or the class in general. After litigation is filed, some class members continue to participate in Facebook groups.  People will say things in that informal environment that they might not say in a deposition.

Of course, several advisory ethics opinions remind litigators that rules of professional responsibility apply when accessing social networks for case purposes. Contacting parties or witnesses through a “friend request” must be done in accordance with the applicable Rule of Professional Conduct.