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

8/8/2019 Publicis Groupe Comments to FDA Social Media Hearings FDA-2009-N-0441-0051.1

1/6

2010 Publicis Groupe

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 worlds fourth largest communications group, second largest media counsel andbuying 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 FDAs questions, posted in the Federal RegisteronSeptember 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 substantiveinfluence

b. 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 Commissions 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 FDAs reference tosubstantive influence represents a potentially broader standardof accountability than that of strictly material connection, Publicis Groupe advocates thatregulated industry, marketing agencies, and media companies adopt the following policies

If regulated industry, or agencies acting on their behalf, are involved in creating orapproving 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 substantiveinfluence over those messages, which should be clearly and prominently disclosed.

If regulated industryfunds 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 managementof the venue should be by a truly independent entity.


2/6

February 28, 2010 Publicis Groupe Written Comments Docket No. FDA-2009-N-0441 Page 2 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 ofMouth Marketing AssociationsWOMMA Guide to Disclosure in Social Media Marketingcan 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. TheWOMMA Guideprovides for three brief hash tags to disclose material connections 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.

2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fairbalance, 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 ofpresentations 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 regulatoryrequirements to submit promotional materials to FDA as applicable?

With respect to questions 2(a)-(c), one ofPublicis Groupes affiliate companies, is currentlyconducting research on a range of alternative presentations of risk information in banner ads forregulated prescription medications.
http://womma.org/ethics/disclosure/Social-Media-Marketing-Disclosure.pdfhttp://womma.org/ethics/disclosure/Social-Media-Marketing-Disclosure.pdfhttp://womma.org/ethics/disclosure/Social-Media-Marketing-Disclosure.pdfhttp://womma.org/ethics/disclosure/Social-Media-Marketing-Disclosure.pdf


3/6


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 engage the user to click throughfor full risk disclosure may be more effective in producing a balanced recall of risk and benefitinformation than interrupting the user with full risk information, as is typical of offline media.

A preliminary report on this research was presented at FDAs 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 ofdissemination, 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 third-partysocial-media venues, Publicis Groupe recommends

1. Submission of Templated or Boilerplate CommunicationsAs 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 can

occupy 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 users name>, I work for Pharmacorp, which is the maker of Quelmax.Your comments about could be a side effect. You should discussthis with your doctor. You are encouraged to report negative side effects ofprescription 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.

2. Custom ContentIn 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


4/6


the post). This would make clear that the regulated entity is taking responsibility solely for thecontent in the post.

The 24-hour timeframe for submitting posts is both reasonable for companies to achieve andaccomplishes the intent of the regulation to ensure that FDA has the information it needs toprotect 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 screenshotand a Form 2253, or FDA could set up a web portal for uploading these samples. Only minormodifications to the existing Form 2253, such as including the URL of the forum and the time ofthe posting, would be necessary to make a form customized for these submissions.

Please note that, in making these recommendations for regulatory compliance, Publicis Groupeneither 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 whatmanner, they are willing to participate and how many employees they might choose to empowerto communicate on behalf of the company in these venues.

3. Information ProvidedFor custom posts, companies should be required to submit the URL for the venue where postedand 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 onindustry.

For boilerplate posts, which are not being submitted de novo each time they are used, it wouldplace an undue burden to keep track of every individual posting and there is no practicable wayto update or append the information to the original 2253 filing, without requiring multipleresubmissions. Instead, companies should include a list of social media forums where theyanticipate 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 ItselfIndustry should be required to submit the shell (e.g., web page design, user interface, safetyinformation, disclaimer language on the site, etc.) just as they do for any other electroniccommunication. And any time that shell undergoes substantial changes, it should be submittedagain.

2. Information ProvidedIn addition to the standard information required on the Form 2253, the URL for the location of thevenue 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 VenueAll of the same requirements outlined above for posts to a venue maintained by a third-party shouldapply to posts to a forum hosted by industry. This includes the requirements to indentify whichposts are generated by industry, and for which industry is thus accountable.


5/6


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 researchabout 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 Websites, sponsored links, organic search result links) to get additional information aboutproducts.

Linking is, of course, fundamental both to the architecture of the web and to its transformationalpower, providing not only a navigational model but a new paradigm of user choice in which the depthand sequence of information consumption, as well as the context of other information to which it iscompared and contrasted, is in the hands of the user of information, not the presenter. As such, theconcept has represented a conceptual conundrum to regulatory agencies since the emergence of theWorld Wide Web nearly two decades ago. If marketers cannot control how their information isconsumed, how can they be held accountable for how it is presented? Questions virtually identical tothe 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 isbeyond the scope of these comments, Publicis Groupe believes that links to regulated-industrywebsites from independent, third-party sites are beyond the control of industry and thus beyond thescope of regulation. Links among regulated-industry websites present, for an entirely different set ofreasons, few regulatory issues, since both the originating and destination sites will have been subjectto internal legal/regulatory review and submitted to FDA at time of launch. The issue, then, goes tolinksfrom regulated-industry websites to external, third-party sites, particularly those that maycontain off-label information.

Regarding links from websites primarily intended for consumers, we note that manyregulated-industry sites already provide links to external sites, such as the Partnership forPrescription 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 thecompany, for whose content the company is not responsible. Provided that such links are toreputable 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 beallowed to continue.

Regarding links from websites intended for healthcare professionals, we believe that withappropriate precautions to ensure that users actually are healthcare professionals orhealthcare entities (hospitals, professional medical organizations, formulary committees,and health plans) links can be offered even to off-label information, provided that standardsanalogous to those enunciated by FDA in itsGood Reprint Practicesguidance 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 valuablenew pharmacovigilance tools which have the potential both to improve public health and, throughmore timely discovery of potential adverse events in postmarketing experience, to reduce regulatedcompanies exposure to product-liability claims.
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htmhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htmhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htmhttp://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm


6/6


Publicis Groupe companies have extensive experience in developing standard operating procedures,back-end systems, and training programs to automate monitoring, triage, and escalation ofpotentially reportable AEs to our clients.

We should note, however, that in eight years of conducting social media monitoring on behalf of ourclients 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 beextremely rare. To a large degree this is because the majority of condition-related social mediavenues have anonymous identity models for their members, making the reporter effectivelyunidentifiable, even by those companies that maintain a best efforts policy to identify and contactreporters.

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

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

Prepared by: Bruce Grant

Documents

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