November 2009

Kurt Mueller
Executive Vice President
Roska Digital Advertising FDA Social Media
215-699-9200, ext. 123
www.RoskaDigital.com Hearing Summary
kmueller@RoskaDigital.com
http://blog.roskadigital.com
http://twitter.com/roskadigital

For now it would appear we are left to police ourselves, form our own guidelines and give our best
effort to do right. The findings and ideas consolidated in this point of view article are offered in an
effort to encourage more companies and marketers to become responsibly involved in social
media so that we have a stake in shaping the final guidelines.

As for the FDA, I would encourage restraint. Allow technology and innovation to take root. If
allowed to experiment and innovate, many of your questions will be answered, resulting in better
doctor-to-patient dialogue, a safer online environment for social discussion, and better
health outcomes.

Having spent the past 2 days listening to 69 speakers present more than 77 presentations, 5 key
takeaways emerged from the proceedings.

1. The resonating theme across both days boiled down to transparency. To maintain credibility and
trust we as an industry must be absolutely transparent with respect to our involvement and
influence over content we substantially control or unduly influence.

2. All presenters supported the present best practices being used today as the standard by which we
should adhere until further guidance is issued by the FDA.

3. It remains unclear the degree to which a company must monitor 3rd party websites in which it
inserts corrective information (or sponsors the insertion), and for how long.

4. Digital media is here to stay, and there are ways we can facilitate link strategies and foster access
to user generated content (UGC) in responsible ways.

5. What consumers really need is a holistic approach to new guidelines where the identification and
reporting of AEs is radically simplified, and health literacy is improved.

On the following pages I expand on these key takeaways and put them into the context of 5 core
questions posed by the FDA.

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At the FDA public hearing November 12-13, 2009, speakers and presentations were rotating so quickly –
and PowerPoint presentations transitioning at such a quick pace – that little time was left for the FDA to
ask more than a handful of questions (and even less time to engage in meaningful dialogue).

One thing, however, is clear. With the issuance of

Hensley Evans from IMC2 may have the recent FDA warning letters pharmaceutical
characterized the proceedings best, companies and marketers alike are wary of getting
calling them into the social spaces without clear guidelines
from the FDA.
“more of a monologue than a dialogue.”
Though no specific guidelines emerged from the
hearings, several ideas and potential best-practices
were offered that will serve well those who venture into the social spaces. These ideas can be best
segmented according to the 5 questions the FDA sought answers to as part of the hearings.

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

The theme resonating across all presentations in answer to this question included the same key word –
transparency. To maintain credibility and build trust and confidence, we as an industry must be absolutely
transparent with respect to our involvement and influence over content.

We are (or should be) accountable for any website, online property, or 3rd party content for which we:
• Were the sole sponsor or originator
• Paid for or substantially subsidized
• Exhibited significant influence
We should not be accountable for:
• Policing the entire Internet
• Content that has been superimposed without permission (for example comment postings using
Google Sidewiki)
• 3rd party content that has been created and posted without the knowledge of, and no involvement
from, the sponsor company

On the surface the above appears to be a straightforward,

commonsense approach to social accountability for “The Plavix site has been hijacked
company/sponsor involvement in social media on the by Sidewiki.”
Internet. However, without specific approved guidelines –Jamie Peck, Rosette
from the FDA, many companies are reluctant to enter
the space.

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 “We have significantly avoided social media because of a lack of FDA guidance...fear of
warning letters. [Example] if we insert a post at the top of a Sidewiki to provide correct
information....are we then responsible for all comments in the Sidewiki?"

–Michele Sharp, Eli Lilly

Question 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)?

Companies and marketers alike maintained the position that the medium in which we communicate today is
radically different from print, television, or other broadcast media, and the FDA guidelines intended for those
media cannot be appropriately applied to today’s electronic communications platforms.

Virtually all speakers supported the present best practices used today as the standard by which we should
adhere, until further guidance is issued from the FDA.

For Rich Media Banners or Media Allowing Multi-dimensional Functionality:

• Utilize scrolling technology to display brief important safety information (ISI) and product information (PI)
• Insert links that support the ‘1-Click Rule’ to provide access to the full PI and ISI
For Character Limited Media (paid search text ads, microblogs, etc.):
• Insert links that support the ‘1-Click Rule’
• Ensure destination pages clearly display complete safety and product information
Both Google and Yahoo! presented concepts presently being tested that afford companies and marketers
access to expanded link capabilities intended to accommodate the special needs of black box warning
products and products with special REMs requirements.

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 Question 3:
What parameters should apply to the posting of corrective information on websites
controlled by third parties?

Presentations and discussion around the posting of corrective information appeared to be an area in which
the water is most murky.

While all parties agreed it is impossible and unreasonable to expect any company to police the entire
Internet, Jeffery Francer from PhRMA proposed the best guidance we can reasonable follow now:
• Monitor your own sites and those for which you have control (without control, your ability to post
corrective information is impossible)
• Per FDAs policy ICH E2D, companies are not (and should not be) responsible for monitoring ADRs on
external sites
• In the event a company becomes aware of information that could pose a serious or life-threatening
health concern, it should put forth its best effort to try and correct such misinformation

The question remains, however. If a company inserts corrective information (or sponsors the insertion
of corrective information) into a 3rd party website, to what degree must it monitor that website and for
how long?

While there is no clear answer to this question, WebMD offered interesting food for thought.

Web 2.0 (when done correctly) offers an effective method by which we can inform consumers of accurate
information, enabling them to take control of their health – or at least play a more active role in it – and
enhance the dialogue with their doctors.

“Credible information improves doctor-to-patient interaction and improves health

outcomes…75% of doctors recommend websites to their patients as they leave the office."

–Wayne Gattinella, CEO of WebMD

Wayne Gattinella, CEO of WebMD, offered two suggestions that health-oriented social communities could
employ that have the potential for consumers to play a role in policing the internet.

• Add a "Report Abuse" button or link wherever possible

- This would allow consumers to monitor their own social spaces and report someone demonstrating
irresponsible behavior. The person and post would then be reported to the company (and the FDA)
so that follow-up corrections can be made.

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 • Prominently display a link to the FDA's MedWatch site
- This link would enable consumers to properly report adverse events through the FDA’s own online tool.
All parties would get better results and alleviate the burden of trying to evaluate and determine what
is and is not a reportable event.

Question 4:
When is the use of links appropriate? 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.

A wealth of data was shared by Manhattan Research, ComScore and others demonstrating that virtually all
US consumers and all US healthcare professionals are online and that social media is connecting people
‘where’ and ‘when’ they are. However, little to no data was presented around research designed to
understand whether or not users find certain approaches to be misleading.

One thing is clear. Digital and social media are here to stay. And there are ways we can facilitate link
strategies and foster access to user generated content (UGC) in responsible ways.

1. Establish clear UGC terms of use, linking/posting policies, and enforce the use of mandatory
check boxes
- Clear site-specific guidelines will educate users about what they can and cannot do on the website
- Prominently display language that UGC and posts are for branded indication only and off-label
comments and links will be removed
- Utilize site alert links so users can report misuse of the site and also properly report AEs
through FDA’s MedWatch program

2. Advise users when they are leaving your site

- When linking to external content that is not contained within the main website domain, companies
should always advise consumers that they are now leaving the original site and that the company is
not responsible for the content or opinions of the destination site.

While many presentations focused on the use of an “FDA universal symbol” designating a site or link as ‘safe’,
the reality is this puts too much of an additional burden on the already overtaxed FDA staff and opens the
door for misuse of the symbol by opportunistic unregulated companies.

To put things quite simply, links are the Internet. They are what allow people to explore and go from one place
to another. We need to be good stewards and traffic cops and make sure the road signs are clear. Let
consumers know where all of the exit and on ramps are, and we need to do our best to educate them about
what they’ll find when they reach their destinations.

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 Question 5:
Questions specific to Internet adverse event reporting and safety.

We all recognize that policing the Internet and ‘sleuthing’ social media profiles is an unreasonable and
impossible task. Even if we were able to do it, the real question becomes, would it be beneficial?

During a cursory review of the data presented at the hearings, several figures indicated that less than
3% of patients feel they were harmed by information found on the Internet. That’s lower than most actual
side effects experienced by patients taking real medications.

Arnold Friede, from Arnold Friede & Associates, cited one Facebook example where 400 comments
were placed on a Facebook wall. Of those comments, only 1 contained information that warranted
further investigation. And that single comment did not meet the 4 criteria required to constitute a
reportable adverse event.

The reality is the vast majority of social discussions occurring online do not meet the 4 criteria required by
the FDA to constitute a reportable adverse event.

The larger issue appears to center around health literacy (a consumer’s ability to understand the health
information they are reading and make sound decisions about their healthcare and treatment based on
that information).

Jim Walker from Cadient Group shared a few interesting data points that support the need for improved
online health literacy:
• It is estimated that 30 million Americans are health-illiterate
• Understanding the average ISI requires a college education
• Understanding the average PI requires post-graduate education
What’s really needed is a holistic approach where the identification and reporting of AEs is simplified,
and health literacy is improved.

Several ideas surfaced that might help the FDA in crafting guidelines to provide better online safety:

• Replace MedWatch with a 2-way reporting widget

- Presently MedWatch is a 1-way communication stream. Enabling a bi-directional communication
widget would allow companies and the FDA to follow up on reported events and collect additional
information to complete the 4 criteria.

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• Establish product-specific hashtags the FDA can assign to branded products
- Much like a social security number, a hashtag is unique. Assigning hashtags and enforcing their use
in microblog communications (like Twitter) would allow the FDA and companies to automate the
surveillance of online discussions around their brands.
• Radically simplify the consumer versions of the ISI and PI
- Creating consumer-friendly versions of important safety and product information will help improve health
literacy. It will help consumers perform easier self-assessments so they can better determine if they
think they are experiencing an adverse event and if they should seek additional medical attention and
speak with their doctor (or report the event to the company and the FDA).

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