1Headquarters Office Peter H. Friedman4340 Stevens Creek Blvd. Suite 101 Chairman & CEOSan Jose, CA 95129 408-666-1125408-871-5200 friedman@liveworld.comTwitter: @peterfriedman

February 28, 2010To: Division of Dockets Management (HFA-305)

Food and Drug Administration5630 Fishers Lane / Room 1061Rockville, MD 20852

From: LiveWorld, Inc.Subject: LiveWorld Comments on

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

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

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LiveWorld Comments: Pages 1-4

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Appendix: 2008 White Paper “Healthcare Social Networks” By LiveWorld & Grey Healthcare Group

LiveWorld Comments to FDARegarding Internet and Social Media for promoting FDA-regulated products.

LiveWorld Background:

LiveWorld (www.liveworld.com, ticker: lvwd.pk) is a leading global socialnetwork marketing agency that develops, operates and moderates private label social network sites (brandcentral sites, Facebook pages, etc.) for Fortune 500 brands and their marketing agencies. We currentlyhave dozens of such clients and have implemented hundreds of multi-year social media programs. Our management team is among the most experienced in the field of social media, with over 26 years creatingand managing social media solutions for global brands. (14 at LiveWorld and 12 before that at AppleComputer). We have been dealing with social networks and healthcare subjects for the entire 26 years andhave multiple pharmaceutical companies as clients.Moderation of user content related to healthcare subjects in social networks is central to the currentdiscussion and the primary focus of our recommendations. Approximately 50% of LiveWorld’s businessis the moderation of social network and user content sites, including those built on our platforms, sites built by other agencies and on other networks such as Facebook. In the last 14 years we have deliveredover 1 Million hours of moderation, typically delivering 10,000-20,000/month. Our services are deployedin 70 country-language combinations. With this long experience we have considerable insight into thedynamics of social networking, the consumer experience, the desire and need for discourse on healthcare.

Healthcare and Social Networks

Please see in the attached, Appendix our 2008 white paper on Healthcare Social Networks that we co-authored with Grey Healthcare Group. This white paper goes into additional depth, surveys and statistics.

2Healthcare has been a major and intense usage pattern in social networks for the entire 26 years of our experience—from the early days of the services we created at Apple, to AOL, to the modern Internet.This phenomenon is due to consumer need for emotional support related to illness and treatment, whether a simple cold or a terminal illness. With the rise of social networks as the dominant media form in our society, their use related to healthcare has risen and will continue to rise. Ultimately these venues will bethe primary means by which consumers engage with each other on healthcare topics, and as such, the primary venue by which they will receive, absorb and pass on their healthcare experiences, content andopinions. Social networks are especially helpful in bringing patients or their supportive friends and familytogether across geographies and social strata—to hear about their experiences coping with an illness,treating an illness and adjusting their lifestyles accordingly. This behavior applies to the patient and alsothose close to them. People want to find others like themselves—“people like me.” In this case that means“people who are sick like me,” or “people who are supporting a loved one who is sick like my lovedone.” There usually are a great many others like them, whether the illness affects many or a lesser number of people. But these others may be located across the country. Or they may be down the block, but not publicly disclosing their circumstances. The large and changing nature of information in thehealthcare space is another driver. People seek information and will rely more on others like them,trusting other people more than any other source. As noted in our white paper, a vast number of peoplenow first seek information on the Internet, then bring that framework to a medical professional to focustheir actions. The healthcare provider segment can also benefit from social networking, sharinginformation and building relationships that make them more effective in serving patients. These venuescan also help healthcare professionals further their own professional development (expertise and career advancement), improving their effectiveness and productivity and overall job satisfaction.

Opportunity:

In this context there is a significant opportunity to serve the consumer public and healthcare professionals by enabling the pharmaceutical industry to get involved, creating and participating inonline communities to foster more dialogue, access to information, connections, relationships andemotional support. Online community venues will also better connect pharmaceutical companies toconsumers and healthcare professionals, resulting in greater customer engagement and feedback. This inturn will make the pharmaceutical companies more market aware and customer centric, increasing their effectiveness in serving those markets. Pharmaceutical companies can bring great resources to onlinecommunity venues: First is a deep commitment to their customers and the venues. Second is their information and knowledge (and by this we don’t just mean the raw content, but, as important, sensitivityand depth in the subject matter). Third, and most important, is their people. As in all markets the peopleat the companies have a deep commitment, knowledge base and ability to interact with others on thesubject. The role of dialogue and personal touch in helping consumers in their health care journeys cannot be overstated.

Challenge:

The challenge we’ve seen in this context is the understandable concern that anymisinformation about pharmaceutical products could cause serious medical consequences for consumers.This of course has lead to many of the regulations in the pharmaceutical industry. In social networkswhere most of the content and dialogue is coming from consumers, the natural industry response is toattempt to control consumer dialogue or avoid the venues completely for fear of legal liability. However,we believe this is the wrong response. The vast array of social networks means that consumers are goingto talk about whatever they want and can easily do so in many venues. Consumers will find each other and dialogue about healthcare in one form of social network or another, regardless of FDA regulations,actions or inactions by the pharmaceutical industry. If a venue is overly controlled, the consumers willsimply go elsewhere. If a company holds back from participating for fear of legal liability, then the publicloses the benefits that the company can bring to them. Time and again, we have seen our pharmaceuticalclients move toward social networking, only to cancel a project or try to overly control it out of fear for legal liability.

LiveWorld Recommendations

With these dynamics, opportunities and challenges in mind and based on our 26 years of experience,LiveWorld has put together the following recommendations for the FDA. These recommendations seek a balance between pro-actively managing the venues, rather than futile attempts to control them. We seek a balance that constructively enables the pharmaceutical companies to responsibly participate, providing amix of best practice guidelines and regulations that realistically recognize the true dynamics of socialnetworks and consumer behavior in them.

Recommendation 1:

Federal Communications Decency Act of 1996 (CDA) Safe Harbor

The FDA should confirm that the CDA (Federal Communications Decency Act of 1996) applies to pharmaceutical companies just as it does to all other web site operators in any industry. Including thatweb site operators have a safe harbor under which they are not liable for user content posted on their sitesnor any consequences thereof. Noting the CDA law includes specific process to follow and requirementsregarding follow-ups on notifications of trade market/copyright infringements. Also noting that this is afederal law and takes precedence over any conflicting state and local laws or regulations.

Recommendation 2:

Moderation Best Practices Guidelines

The FDA should required that pharmaceutical companies provide moderation of the social network sitesthey operate, but rather than regulate specifics, provide best practice guidelines. The moderation can be provided by the company itself or by 3rd party vendors that the company has approved. The specifics of the moderation (including types of moderation, pre-screening or post-screening, volume of moderationand time coverage, and how all of that applies to different types of content) are to be determined in thereasonable judgment of the company. We specifically do not recommend that companies be required to pre-screen all user content before displaying it on their sites. Consumers in most markets are nowaccustomed to their content appearing on a site immediately and being post-screened. If companies areregulated to a pre-screen only environment, the resulting lag time (many minutes, even hours) for contentto appear will cause their online communities to have weak dynamics, and consumers will head to other venues such as Yahoo or Facebook. There are pharmaceutical companies today that provide disease stateonline communities with a post-screen model. A pre-screen-only regulation would actually force thesecompanies to take a step backward.There may be circumstances where pre-screening user content for all or parts of an online community site,or at different stages of the site will be appropriate. But this will vary by site, content type and over time.For example a typical practice today in family oriented sites in the US is to post-screen text content fromusers, but pre-screen photo and video content. Other sites post-screen all content. Depending on contenttype and volume, some sites moderate 24 hours/day; others, 6 hours/day—checking the site every 4 hours.Any number of variations can be appropriate for any particular site, and even these will change over timeas an online community evolves. We believe the judgment about when to pre-screen vs. post screenshould be situation specific and as such left to the pharmaceutical company involved.Provision of moderation should not affect the safe harbor aspects of the CDA. That is, even withmoderation, the web site operator is not liable for user content posted to its site or consequence thereof (as prescribed by the CDA).

Recommendation 3:

Adverse Events Escalation

in a pharmaceutical operated online community orsocial network site.

Studies such as the one by Nielson Online suggest that very little user content in these sites meets the four elements required for reporting an adverse event. This is also our experience in healthcare online