Public Comments

T0: Division of Dockets Management (HFA-305)

Food and Drug Administration
5630 Fishers Lane / Room 1061
Rockville, MD 20852

FROM: Publicis Groupe

IN RE: Docket No. FDA-2009-N-0441 (Federal Register)

Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools

DATE: 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 to
provide 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 on
September 21, 2009.

FDA QUESTIONS AND PUBLICIS GROUPE RESPONSES

1. For what online communications are manufacturers, packers, or distributors accountable?

a. What parameters or criteria should be applied to determine when third-party communications
occurring on the Internet and through social media technologies are subject to substantive
influence
b. In particular, when should third-party discussions be treated as being performed by, or on
behalf of, the companies that market the product, as opposed to being performed independent
of 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, which
not only require disclosure of any ―material connection‖ between marketers and endorsers but also
hold marketers liable for any false or unsubstantiated statements made by endorsers in any media
channel — including social media and other Internet channels. Clearly, both agencies recognize the
degree to which social media both dramatically widen the potential reach of user endorsements and
promotional messages and magnify the difficulty of monitoring and regulating them.

Assuming that FDA’s reference to ―substantive influence‖ represents a potentially broader standard
of 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 creating or

approving the content of the messages or if they have provided compensation (in cash,
goods, or services) to the content creators, they should be deemed to have substantive
influence over those messages, which should be clearly and prominently disclosed.

If regulated industry funds the development of social media or other Internet venues in
which discussion of their products or the conditions they treat can reasonably be expected to
occur, the funding should be in the form of an unrestricted educational grant, preferably
administered by a non-marketing function within the regulated company, and management
of the venue should be by a truly independent entity.

© 2010 Publicis Groupe

 As social media technologies are evolving rapidly, Publicis Groupe believes it would be both
premature and impractical for FDA to attempt to provide detailed regulatory guidance as to
disclosure format. However, we believe that voluntary adoption by regulated industry of the Word of
Mouth Marketing Association’s WOMMA Guide to Disclosure in Social Media Marketing can provide an
excellent basis for enabling FDA to identify communications over which regulated industry has
substantive influence and to ensure regulatory compliance.

Disclosure is, of course, most problematic in short-form social media channels, such as Twitter. The
WOMMA Guide provides for three brief ―hash tags‖ to disclose material connections of sponsorship
(#spon), payment (#paid), and provision of samples (#samp). A similar, though somewhat broader, set
of disclosure tags has been developed by staff of a Publicis Groupe affiliate company.

2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair
balance, disclosure of indication and risk information, postmarketing submission requirements) in
their Internet and social media promotion, particularly when using tools that are associated with
space limitations and tools that allow for real-time communications (e.g., microblogs, mobile
technology)?
a. How should product information be presented using various social media tools to ensure that
the 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 social
media tools associated with space limitations or tools that allow for real-time communications
to present product information?
d. How should companies address the potential volume of information shared on various social
media 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 currently
conducting research on a range of alternative presentations of risk information in banner ads for
regulated prescription medications.

February 28, 2010 Publicis Groupe Written Comments – Docket No. FDA-2009-N-0441 Page 2 of 6
 One of the key observations in the initial phase of this research is that digital media — and in
particular social media — are consumed differently from offline media and that devices that present
brief, targeted risk information in context with benefit claims and engage the user to click through
for full risk disclosure may be more effective in producing a balanced recall of risk and benefit
information than interrupting 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 a
later 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 social
media venues established and maintained by independent third parties and venues set up by
regulated entities themselves.

With respect to third-party social-media venues, Publicis Groupe recommends —

1. Submission of Templated or Boilerplate Communications

As in other customer-contact channels, many of the topics encountered in social media will be
repetitive (e.g., questions or comments about adverse events, off-label usage, what to expect
from 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 2253
submission for each use of these communications.

Publicis Groupe recommends that FDA clearly indicate that it is permissible to submit, under
cover of Form 2253, templated or boilerplate responses and that the content so submitted can
continue 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 submission
itself should indicate what aspects of the content are variable and what types of values can
occupy those locations.

For example, a 2253 submission of a templated response to a report of a possible adverse event
might look like the following:

< social media user’s name>, I work for Pharmacorp, which is the maker of Quelmax.
Your comments about <adverse reaction> could be a side effect. You should discuss
this 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 company
could use it without alteration beyond filling in the variable data in a social media forum without
incurring an additional 2253 filing requirement.

2. Custom Content

In addition to boilerplate content, there may arise a need to generate custom content. Publicis
Groupe believe that it should be permissible for the regulated company to post such content to
the social-media venue and then submit the content to FDA under cover of Form 2253 within 24
hours.

The sample itself should preferably be a screenshot of the page with the posting(s) with the
content provided by the pharmaceutical company highlighted (such as by a red box surrounding

February 28, 2010 Publicis Groupe Written Comments – Docket No. FDA-2009-N-0441 Page 3 of 6
 the post). This would make clear that the regulated entity is taking responsibility solely for the
content in the post.

The 24-hour timeframe for submitting posts is both reasonable for companies to achieve and
accomplishes the intent of the regulation to ensure that FDA has the information it needs to
protect the public health by taking action to prevent companies from disseminating false and
misleading information.

Submission could easily be accommodated either by email with attachments of the screenshot
and a Form 2253, or FDA could set up a web portal for uploading these samples. Only minor
modifications to the existing Form 2253, such as including the URL of the forum and the time of
the posting, would be necessary to make a form customized for these submissions.

Please note that, in making these recommendations for regulatory compliance, Publicis Groupe
neither advocates nor discourages participation by regulated companies in social-media venues.
It would be entirely at the discretion of individual companies to determine how much or in what
manner, they are willing to participate and how many employees they might choose to empower
to communicate on behalf of the company in these venues.

3. Information Provided

For custom posts, companies should be required to submit the URL for the venue where posted
and the time of the posting, in addition to providing the sample of the posting itself.

This would enable FDA to monitor reaction to these posts and would not put an undue burden on
industry.

For boilerplate posts, which are not being submitted de novo each time they are used, it would
place an undue burden to keep track of every individual posting and there is no practicable way
to update or append the information to the original 2253 filing, without requiring multiple
resubmissions. Instead, companies should include a list of social media forums where they
anticipate using the messages. That would enable FDA to monitor community reaction without
placing an undue burden on industry.

For social media venues established by industry, Publicis Groupe recommends —

1. Submitting the Venue Itself

Industry should be required to submit the shell (e.g., web page design, user interface, safety
information, disclaimer language on the site, etc.) just as they do for any other electronic
communication. And any time that shell undergoes substantial changes, it should be submitted
again.

2. Information Provided

In addition to the standard information required on the Form 2253, the URL for the location of the
venue should be provided and information about the nature of the discussion (moderated vs.
unmoderated, archiving/purging procedures, etc.) should be submitted.

3. Posts to the Venue

All of the same requirements outlined above for posts to a venue maintained by a third-party should
apply to posts to a forum hosted by industry. This includes the requirements to indentify which
posts are generated by industry, and for which industry is thus accountable.

February 28, 2010 Publicis Groupe Written Comments – Docket No. FDA-2009-N-0441 Page 4 of 6
3. When is the use of links appropriate?
a. The agency is interested in any comments about the appropriateness of various techniques
regarding the use of links (including between various social media tools) and data or research
about whether or not users find these approaches to be misleading.
b. Should parameters be established for links to and from Web sites?
c. In addition, the agency is interested in any data or research concerning the frequency with
which users actually click on different categories of links (e.g., banner ads, links within Web
sites, sponsored links, organic search result links) to get additional information about
products.

Linking is, of course, fundamental both to the architecture of the web and to its transformational
power, providing not only a navigational model but a new paradigm of user choice in which the depth
and sequence of information consumption, as well as the context of other information to which it is
compared and contrasted, is in the hands of the user of information, not the presenter. As such, the
concept has represented a conceptual conundrum to regulatory agencies since the emergence of the
World Wide Web nearly two decades ago. If marketers cannot control how their information is
consumed, how can they be held accountable for how it is presented? Questions virtually identical to
the ones listed above were posed by FDA at their first Part 15 Internet hearings in 1996.

While broad, philosophical consideration of the nature of links and the issues surrounding them is
beyond the scope of these comments, Publicis Groupe believes that links to regulated-industry
websites from independent, third-party sites are beyond the control of industry and thus beyond the
scope of regulation. Links among regulated-industry websites present, for an entirely different set of
reasons, few regulatory issues, since both the originating and destination sites will have been subject
to internal legal/regulatory review and submitted to FDA at time of launch. The issue, then, goes to
links from regulated-industry websites to external, third-party sites, particularly those that may
contain off-label information.

Regarding links from websites primarily intended for consumers, we note that many
regulated-industry sites already provide links to external sites, such as the Partnership for
Prescription Assistance, medical associations, and patient advocacy groups. Typically,
consumers clicking on these links are presented with a dialog box which they must click to
confirm that they are leaving the company site and linking to a site not controlled by the
company, for whose content the company is not responsible. Provided that such links are to
reputable third-party sites and do not link directly to pages containing off-label information,
we believe this practice represents a positive contribution to public health and should be
allowed to continue.

Regarding links from websites intended for healthcare professionals, we believe that with
appropriate precautions to ensure that users actually are healthcare professionals or
―healthcare entities‖ (hospitals, professional medical organizations, formulary committees,
and health plans) links can be offered even to off-label information, provided that standards
analogous to those enunciated by FDA in its Good Reprint Practices guidance are met

4. Questions specific to Internet adverse event reporting.

a. How is adverse event information from these sources being received, reviewed, and processed?
b. What challenges are presented in handling adverse event information from these sources?
c. What uncertainties are there regarding what should be reported from these sources to meet
FDA adverse event reporting obligations?

Publicis Groupe believes that the Internet in general, and social media in particular, provide valuable
new pharmacovigilance tools which have the potential both to improve public health and, through
more timely discovery of potential adverse events in postmarketing experience, to reduce regulated
companies’ exposure to product-liability claims.

February 28, 2010 Publicis Groupe Written Comments – Docket No. FDA-2009-N-0441 Page 5 of 6
 Publicis Groupe companies have extensive experience in developing standard operating procedures,
back-end systems, and training programs to automate monitoring, triage, and escalation of
potentially reportable AEs to our clients.

We should note, however, that in eight years of conducting social media monitoring on behalf of our
clients we have found reportable AEs (i.e., those containing all four elements of reportability:
identifiable patient, identifiable drug, identifiable adverse event, and identifiable reporter) to be
extremely rare. To a large degree this is because the majority of condition-related social media
venues have anonymous identity models for their members, making the reporter effectively
unidentifiable, even by those companies that maintain a ―best efforts‖ policy to identify and contact
reporters.

We note that some social-media venues, such as Craigslist, employ an anonymous-reply mechanism
that allows other users to contact them privately without disclosing their identity. We believe that
social-media venues in which there is significant discussion of prescription medications and the
conditions they treat would make a significant contribution to public health and drug safety by
employing such a tool.

Thank you again for the opportunity to share Publicis Groupe’s experience and point of view in the context
of these comments. We hope that they will prove useful to FDA in advancing its mission of public health and
in formulating guidance for industry in this important emerging sphere of healthcare communication.

Prepared by: Bruce Grant

February 28, 2010 Publicis Groupe Written Comments – Docket No. FDA-2009-N-0441 Page 6 of 6