© 2010 Publicis Groupe
Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane / Room 1061Rockville, MD 20852
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
onSeptember 21, 2009.
FDA QUESTIONS AND PUBLICIS GROUPE RESPONSES
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
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
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
within the regulated company, and
of the venue should be by a truly