FDA Issues Draft Guidance on Social Media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FDA two years to come up with comprehensive policies on Internet promotion, and FDA has now released for comment the draft guidance document entitled, "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs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This draft guidance is intended to describe FDA’s current thinking about how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf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.

 

New Blog Worth a Look

My colleagues  Andrew Carpenter, Scott Kaiser and Gregory Wu at Shook Hardy have handled an amazing array of class actions.  To share some of that experience, they have launched the Missouri & Kansas Class Action Blog to provide up-to-date information about federal and state rulings in class action decisions arising in these particular jurisdictions.  And I am sure they will touch on MDLs, and other types of aggregate and complex litigation in state and federal courts. 

Definitely worth a look for all our readers who are interested in class action law.

Last Chance to List Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Might I also suggest you think about the Point of Law blog?

Recommend Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Might I also suggest you think about the Mass Tort Litigation Professors' Blog? Another worth a look is the FDA Law Blog.  And of course Abnormal Use.

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ABA's Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Might I also suggest you think about Lowering the Bar, the humorous blog of my colleague Kevin Underhill? wide ranging, funny, a welcome break from the serious side of the law.

Another worthy of consideration is the Drug and Device Law blog, of my former colleagues Jim Beck, Steve McConnell, et al. Comprehensive, pithy, timely, opinionated. Well deserved winner of several awards. 

 

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ABA Journal Searching for Top Blawgs

The ABA Journal is embarking on its annual quest to identify the top law blogs.  The criteria and form are here, if any of our wonderful readers are inclined to identify MassTortDefense as one that you read regularly and think other lawyers should know about. 

Friend-of-the-blawg briefs are due no later than Aug. 9, 2013, says the Journal.

Can't say being selected would make up for losing that student council election in 8th grade, but it would surely help!

In a later post I will note a couple other blogs that I think are very worthy of your consideration.


 

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"You Like Us; You Really Like Us!"

As evidenced by the badge to the left of this post, I am excited to announce that the humble MassTortDefense blog has been selected as one of the LexisNexis Top 25 Torts Law Blogs of 2011.

More info on the criteria used by the LexisNexis Litigation Resource Community to select their  Top 25 Tort Law Blogs of 2011 is available here, but it is clear their list includes blogs with a wealth of information for tort law practitioners, with timely news items, practical information, expert analysis, frequent postings, and helpful links to other sites. 

MassTortDefense is proud to be included, and grateful, as always, for our faithful readers.

 

ABA To Select Annual Best Blogs

Ok, so it is not the Oscars or the Emmys, and to my children it ranks well behind the Kid's Choice Awards, but to those in the blogosphere it is noteworthy that the ABA is working on its annual list of the 100 best legal blogs, and they want your advice on which "blawgs" you think they should include.

Here is the link to the form to tell the ABA  your thoughts, but keep your remarks pithy—you have a 500-character limit.

Friend-of-the-blawg briefs are due no later than Sept. 9, 2011.

While we would not be unhappy to be nominated, if any readers think us worthy, may we make a suggestion that you consider commenting on the Drug and Device Law Blog; and the Mass Torts Professors Law Blog; and Overlawyered.com; as well asPoint of law.com; and the Consumer Class Action Litigation blog, among the many worthy sites.

 

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