Comments Enabled
FDA Guidance on Social Media &
User-Generated Content
An Analysis of FDA Draft Guidance For Industry: Fulfilling Regulatory
Requirements for Postmarketing Submissions of Intera...
FDA released long-awaited draft guidance
governing the use of social media by
pharmaceutical and biotech marketers on
Janu...
Key issues are outlined here.
Do I Own It?

If a company marketing a pharmaceutical or biotech brand exerts
significant influence over a site or online ...
Promotion
rd
on 3 Party Sites
The guidance reaffirms the obvious –

Brand X

@iambrandx

Brand X has Lorem ipsum dolor sit...
The guidance makes it clear that

user-generated content
(UGC) from non-affiliated
users is NOT the
responsibility of the ...
nuts & bolts
Suggested Submission
Procedure & Timing

The final section of the guidance document, Recommendations
for Subm...
nuts & bolts
Company-Controlled Sites

“At time of first display, the firm should …submit in its entirety all sites for wh...
For a third-party site (e.g., Twitter), the firm should initally
submit, as above, the ‘home page’ of the site and the
int...
What’s in a Listing?
2253

Less than we had suspected, frankly. Submitted under 2253 or 2301,
the listing comprises …”the ...
Another notable point

A notable exception

here is that FDA expects to see genuine, unaffiliated
UGC interspersed with pr...
Star Group’s View
The language and content of these recommendations make it apparent to us that

FDA is actively seeking t...
And intent is the key here.
Star Group feels strongly that a good faith
effort to engage in social media and other
interactive promotional media can p...
#TheEnd
Want 2 learn more?
Tim R. Garde
Managing Partner
Star Group / Star Life Sciences
Synegrated Communications
215.875...
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New FDA Social Media Guidelines 2014: Star Group Analysis

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What does the recent draft guidance from the FDA for social media mean for Pharma brands? Find out what Star Life Sciences thinks, then visit us at starlifebrands.com to see more articles with our thinking.

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New FDA Social Media Guidelines 2014: Star Group Analysis

  1. 1. Comments Enabled FDA Guidance on Social Media & User-Generated Content
  2. 2. An Analysis of FDA Draft Guidance For Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics January 2014 Access the FDA Draft Guidance Here
  3. 3. FDA released long-awaited draft guidance governing the use of social media by pharmaceutical and biotech marketers on January 13, 2014. While far from exhaustive, the document contains, among other things, specific new guidance on the use, documentation, and submission of social media and similar channels that entail the use of user-generated content. 3
  4. 4. Key issues are outlined here.
  5. 5. Do I Own It? If a company marketing a pharmaceutical or biotech brand exerts significant influence over a site or online service, that firm has a responsibility to submit the entire current contents of the site or service. The definition of influence is the key. Merely buying advertising space on the site does not trigger ‘ownership’ responsibilities; the firm is still responsible for proper submission of the advertising materials given to the site, of course. Dictating or negotiating preferable placement of such advertising constitutes influence of the sort that triggers ownership responsibilities. We interpret this guidance such that, for instance, simple selection of an expensive, prominent placement is permissible without submission of the entirety of the surrounding content; purchase of such a placement contingent on its appearance next to an editorial column by a prominent KOL would trigger the requirement. While this does not constitute a bright-line rule, we believe that this guidance will suffice in most conceivable contemporary instances. 5
  6. 6. Promotion rd on 3 Party Sites The guidance reaffirms the obvious – Brand X @iambrandx Brand X has Lorem ipsum dolor sit amet, consectetur adipiscing elit. Pellentesque eget velit eu magna dignissim commodo ut a est. brandx.com Free health screenings may be in your area this month including BMI, blood pressure & more! Learn more http://ow.ly/sSzaM The winter games are starting soon! What’s your favorite winter sport? Did you know our iPad app brings a virtual Brand X store right to your living room. Try it today! http://ow.ly/sjEfm the marketer is responsible for regulatory submission of promotional communications via services like Twitter, Facebook, etc. The guidance also makes clear that the firm is responsible for submitting such communications as tweets from sales reps or other employees, blogs or microblogs maintained by employees or contractors, etc. Thus, the company’s social media policy should prohibit dissemination of promotional content–even an innocuous tweet about MOA–from employees unless specifically requested. Mittens or gloves – what’s your go-to way to keep your hands warm when temperatures drop? Share your best savings tips and we’ll RT our favorites! We’ll go first – always scheck our website for the best tips on preventing... 6
  7. 7. The guidance makes it clear that user-generated content (UGC) from non-affiliated users is NOT the responsibility of the firm, and need not be submitted. This applies to third-party sites and, potentially, brand sites, if they have a forum or similar venue for display or dissemination of user-generated content. While not addressed in this guidance, it should not be construed that such guidance frees the firm from established responsibility in regard to reporting of adverse events, if identifiable adverse events are asserted or suggested via UGC. Promotional communication IS your responsibility Good times with good people!! @7oasis @jazminsisters @thebrucewaynne #BRANDX #HBK… http://instagram.com/p/jaflwBy12H/ UGC - Not your responsibility Free health screenings may be in your area this month including BMI, blood pressure & more! Learn more http://ow.ly/sSzaM #projecthealth #BrandX Mittens or gloves – what’s your go-to way to keep your hands warm when temperatures drop? #BrandX 7
  8. 8. nuts & bolts Suggested Submission Procedure & Timing The final section of the guidance document, Recommendations for Submitting Interactive Promotional Media, is a real eye-opener. One can easily imagine the onerous regulatory submission burden an active brand Twitter or Facebook account could generate. FDA lays out a series of simple recommendations for pharmaceutical marketers. 8
  9. 9. nuts & bolts Company-Controlled Sites “At time of first display, the firm should …submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301.” For example, if a brand site is adding a comments feature, resubmit the entire site, and include the new feature, with annotations to indicate its function(s). the firm need only supply an updated listing of the site via form 2253 or 2301, every 30 days. The details of the listing are Thereafter, provided on the following page. 9
  10. 10. For a third-party site (e.g., Twitter), the firm should initally submit, as above, the ‘home page’ of the site and the interactive page(s) within said site. Implementation of this portion of the guidance will depend largely on the third-party site in question. Here, once again, the burden for ongoing regulatory submissions comprises submission of an updated listing, every 30 days, via form 2253 or 2301. nuts & bolts Third-Party Sites 10
  11. 11. What’s in a Listing? 2253 Less than we had suspected, frankly. Submitted under 2253 or 2301, the listing comprises …”the non-restricted sites for which the firm is responsible or in which it remains an active participant and that include interactive or real-time communications.” There is no requirement for a visual representation of the interactive communications. The listing includes only the site name, URL, and date range, along with a cross-reference to the most recent submission of the site. Better yet, multiple sites may be submitted under a single form. Our interpretation is that all appropriate properties or sites for a given brand can be submitted under a single 2253. Furthermore, we do not believe this necessitates monthly updates to inventory/control numbers. 11
  12. 12. Another notable point A notable exception here is that FDA expects to see genuine, unaffiliated UGC interspersed with promotional messages. It is not necessary to ‘clean up’ the site at submission as reviewers expect to see, for example, user-generated tweets interspersed with branded tweets on a brand’s Twitter page. Of course, any inappropriate UGC should be removed per site moderation policy, but that is not a matter FDA intends to exert particular influence over. is the case of restricted sites, like sites that require a password (to post comments, anyway). In this case, FDA wants to see the whole site, but again, recognizing the realities of ‘real-time’ content, FDA requests only that such submissions be made every 30 days. 12
  13. 13. Star Group’s View The language and content of these recommendations make it apparent to us that FDA is actively seeking to empower use of social media and other ‘real-time’ interactive promotional media. While the guidance is not binding, FDA has stated that it will exert enforcement discretion around the key items described in this document. We feel that the risk exposure associated with pharmaceutical and biotech brands’ use of social media networks, blogs, forums, etc. is substantially less than in the past. The guidance presented is actionable and, on its face, reasonable. As ever, FDA has avoided being overly specific in some definitions, as a hedge against future actions that violate the intent of this guidance.
  14. 14. And intent is the key here.
  15. 15. Star Group feels strongly that a good faith effort to engage in social media and other interactive promotional media can pay substantial dividends when deployed as part of an integrated communications strategy to reach members of key target audiences. This good faith effort includes: • Content strategy for key audiences • lear value proposition for people C to engage with brand and its reps • Well-defined success metrics • Moderation policies and staff • Transparency • Flexible approach from all stakeholders Star believes the quality of flexibility to be vitally important to success. The tools of the trade will evolve over time, and it is important that marketers evolve as well, while preserving core principles like transparency, respect for the audience, and timeliness of response. This kind of ongoing and transparent conversation with patients, physicians, caregivers, etc. is new for pharmaceutical marketers. A willingness to learn from mistakes – and to make these mistakes in the first place – is paramount to success in this realm. 15
  16. 16. #TheEnd Want 2 learn more? Tim R. Garde Managing Partner Star Group / Star Life Sciences Synegrated Communications 215.875.4313 (l) 215.815.0075 (m) tgarde@stargroup1.com stargroup1.com starlifebrands.com ©2014 Star Group Communications, Inc.

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