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Publicis Groupe Comments to FDA Social Media Hearings FDA-2009-N-0441-0051.1

Publicis Groupe Comments to FDA Social Media Hearings FDA-2009-N-0441-0051.1

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Published by Dale Cooke
This is the Publicis Groupe's submission to the FDA's Part 15 Social Media Hearings. I was responsible for the section on the 2253 filing requirements.
This is the Publicis Groupe's submission to the FDA's Part 15 Social Media Hearings. I was responsible for the section on the 2253 filing requirements.

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Published by: Dale Cooke on Oct 26, 2010
Copyright:Attribution Non-commercial


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© 2010 Publicis Groupe
Public Comments
Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane / Room 1061Rockville, MD 20852
Publicis Groupe
Docket No. FDA-2009-N-0441 (Federal Register)
Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools
February 28, 2010
Publicis Groupe S.A., the world’s fourth largest communications group, second largest media counsel and
buying group, and a global leader in digital and healthcare communications, welcomes the opportunity toprovide comments regarding the promotion of Food and Drug Administration-regulated medical products
using the Internet and social media tools, in response to FDA’s questions, posted in the
Federal Register 
onSeptember 21, 2009.
For what online communications are manufacturers, packers, or distributors accountable?a.
What parameters or criteria should be applied to determine when third-party communicationsoccurring on the Internet and through social media technologies are subject to substantiveinfluenceb.
In particular, when should third-party discussions be treated as being performed by, or onbehalf of, the companies that market the product, as opposed to being performed independentof the influence of the companies marketing the products?c.
How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?
This is a particularly salient question, given the Federal Trade Commission
’s recent
guidelines, whichnot only require
disclosure of any ―material connection‖
between marketers and endorsers but alsohold marketers liable for any false or unsubstantiated statements made by endorsers in any mediachannel
including social media and other Internet channels. Clearly, both agencies recognize thedegree to which social media both dramatically widen the potential reach of user endorsements andpromotional messages and magnify the difficulty of monitoring and regulating them.
Assuming that FDA’s reference to
―substantive influence‖
represents a potentially broader standardof accountability
than that of strictly ―material connection,‖ Publicis Groupe advocates that
regulated industry, marketing agencies, and media companies adopt the following policies
 If regulated industry, or agencies acting on their behalf, are involved in
the content of the messages or if they have provided
(in cash,goods, or services) to the content creators, they should be deemed to have substantiveinfluence over those messages, which should be clearly and prominently disclosed.If regulated industry
the development of social media or other Internet venues inwhich discussion of their products or the conditions they treat can reasonably be expected tooccur, the funding should be in the form of an
unrestricted educational grant
, preferablyadministered by a
non-marketing function
within the regulated company, and
 of the venue should be by a truly
February 28, 2010 Publicis Groupe Written Comments
Docket No. FDA-2009-N-0441 Page2 of 6 
As social media technologies are evolving rapidly, Publicis Groupe believes it would be bothpremature and impractical for FDA to attempt to provide detailed regulatory guidance as todisclosure format. However, we believe that voluntary adoption by regulated industry of the Word of 
Mouth Marketing Association’s 
 can provide anexcellent basis for enabling FDA to identify communications over which regulated industry hassubstantive influence and to ensure regulatory compliance.Disclosure is, of course, most problematic in short-form social media channels, such as Twitter. The
provides for three brief ―hash tags‖ to disclose material conn
ections of sponsorship(#spon), payment (#paid), and provision of samples (#samp). A similar, though somewhat broader, setof disclosure tags has been developed by staff of a Publicis Groupe affiliate company.
How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) intheir Internet and social media promotion, particularly when using tools that are associated withspace limitations and tools that allow for real-time communications (e.g., microblogs, mobiletechnology)?a.
How should product information be presented using various social media tools to ensure thatthe user has access to a balanced presentation of both risks and benefits of medical products?b.
 Are there data to support conclusions about whether different types or formats of  presentations have a positive or negative impact on the public health?c.
 Are there proposed solutions that may help address regulatory concerns when using socialmedia tools associated with space limitations or tools that allow for real-time communicationsto present product information?d.
How should companies address the potential volume of information shared on various socialmedia sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable?
With respect to questions 2(a)-(c), one of 
Publicis Groupe’s affiliate
companies, is currentlyconducting research on a range of alternative presentations of risk information in banner ads forregulated prescription medications.
February 28, 2010 Publicis Groupe Written Comments
Docket No. FDA-2009-N-0441 Page3 of 6 
One of the key observations in the initial phase of this research is that digital media
and inparticular social media
are consumed differently from offline media and that devices that presentbrief, targeted risk information
in context
with benefit claims and
the user to click throughfor full risk disclosure may be more effective in producing a balanced recall of risk and benefitinformation than
the user with full risk information, as is typical of offline media.
A preliminary report on this research was presented at FDA’s Part 15 hearings on November 13, 2009,
and a full report of a larger-scale follow-on study will be submitted to FDA under separate cover at alater date, following consultation with FDA on study design.Regarding question 2(d) and the requirement to file promotional materials at the time of dissemination, Publicis Groupe believes it is important to recognize a distinction between socialmedia venues established and maintained by independent third parties and venues set up byregulated entities themselves.With respect to
social-media venues, Publicis Groupe recommends
Submission of Templated or Boilerplate Communications
As in other customer-contact channels, many of the topics encountered in social media will berepetitive (e.g., questions or comments about adverse events, off-label usage, what to expectfrom a drug, etc.) and amenable to standardized, templated responses. In these circumstances,it is neither desirable nor, in our view, required for regulated companies to file a distinct 2253submission for each use of these communications.Publicis Groupe recommends that FDA clearly indicate that it is permissible to submit, undercover of Form 2253, templated or boilerplate responses and that the content so submitted cancontinue to be used without requiring additional 2253 submission.This follows existing practice for materials such as call center scripts, direct mail materials,formularies, and other similar pieces containing fixed and variable content. The 2253 submissionitself should indicate what aspects of the content are variable and what types of values canoccupy those locations.For example, a 2253 submission of a templated response to a report of a possible adverse eventmight look like the following:
< social media user 
name>, I work for Pharmacorp, which is the maker of Quelmax.Your comments about <adverse reaction> could be a side effect. You should discussthis with your doctor. You are encouraged to report negative side effects of  prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Having once submitted that paragraph under cover of Form 2253, any employee of the companycould use it without alteration beyond filling in the variable data in a social media forum withoutincurring an additional 2253 filing requirement.
Custom Content
In addition to boilerplate content, there may arise a need to generate custom content. PublicisGroupe believe that it should be permissible for the regulated company to post such content tothe social-media venue and then submit the content to FDA under cover of Form 2253 within 24hours.The sample itself should preferably be a screenshot of the page with the posting(s) with thecontent provided by the pharmaceutical company highlighted (such as by a red box surrounding

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