Ozmosis Capabilities for

Ozmosis, Inc.
1000 Potomac St., Suite 125
Washington, DC 20007
(202) 595-8005
https://www.ozmosis.com
http://twitter.com/ozmosis

Joel Selzer
Co-Founder & CEO
joel@ozmosis.com
http://twitter.com/jbselz

March 16, 2010

Divisions of Dockets Management (HFA-305)

U.S. Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Docket No. FDA-2009-N-0441; Promotion of FDA-Regulated Medical Products Using the Internet and Social
Media Tools

Topic: Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools

To: U.S. Food and Drug Administration

As an active facilitator of social media interactions among thousands of healthcare professionals (HCPs), Ozmosis
appreciates the opportunity to provide its insights and recommendations for the FDA’s consideration. Known as the
"Trusted Physician's Network," Ozmosis brings U.S. licensed and verified physicians together in a private, online
community to share clinical insights, consult on cases, and discuss treatment options with their peers.

Since Ozmosis has worked closely over the past year with pharmaceutical manufacturers to develop a new approach to
engaging physicians through its online, on demand, social platform, the FDA's request for comments comes at a
welcome time. On Ozmosis, physicians use their real identities and share their professional affiliations, resulting in a
more trusted and transparent exchange of clinical information. Since physicians always know with whom they are
communicating and sharing knowledge, the insights and discussions that take place on Ozmosis are highly valued and
trusted. As the FDA considers recommendations on the regulation of medical products using the Internet and social
media tools, we believe that any regulatory framework must ensure the same level of trust, transparency and
accountability our physcians already benefit from every day.

Background

Following its Nov. 12-13 open hearings, the FDA has received over 150 comments from drug manufacturers, health
systems, consultants, agencies, advocacy groups, and private individuals. This debate is timely, with widespread adoption
of web and social media tools skyrocketing among patients and provders alike. Since our experience is primarily focused
on facilitating online HCP engagement, our comments will focus exclusively on recommendations related to the
promotion of FDA regulated medical products to HCPs.

The world has changed dramatically since the FDA's last hearings on internet use. In 1999, less than 50% of physicians
used the internet for professional purposes. Today, Google reports that virtually all physicians (92%) use the internet
to gather medical information in a clinical setting.1 In fact, 89% of U.S. physicians now describe the web as
"essential to their professional practice,"2 and the groundswell of demand for social media resources among physicians
continues to grow. According to Manhattan Research, 71% of U.S. physicians are interested in or already use
physician social networks for peer-to-peer interactions.3

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HCPs on private, physician social networks such as Ozmosis, Medscape Physician Connect, and Sermo use these
services to ask and answer questions, consult on clinical cases, discuss product efficacy and safety, and collaborate during
times of public health needs. Peer-to-peer interaction on these sites leads to more effective knowledge sharing and
collaboration at the point of patient care. For example, members of Ozmosis have immediate access to licensed and
verified physicians from across the U.S. for collective advice, consultations and access to real-time clinical alerts.

As physicians accelerate their shift to an online, social media driven world, they are clearly spending less and less time
interacting with the drug reps physically in their offices. 23.6% of physicians now refuse to let a drug rep visit their
practice,4 while 84% of physicians search for product information through digital channels.5 This shift to digital is both
undeniable and permanent. Doctors across the country need better access to fast, reliable information on
pharmaceutical products and treatment options. Access to this information needs to be embedded into the physician's
clinical workflow and offer balanced information from both the manufacturer and the larger community of HCPs.

Physician & Pharmacuetical Manufacturer Interaction in a Social Media World

In response to this need and the opportunity to reach HCPs more cost effectively, pharmaceutical manufacturers have
launched a variety of HCP-focused social media programs over the past 24 months. In addition to utilizing tools to
observe and monitor conversations on sites such as Twitter, Facebook, YouTube, Sermo, and others, pharmacuetical
manufacturers have begun to engage physicians directly through social media channels. For example:

• Novartis currently hosts a private online community for Primary Care Physicians called the PCP Heartburn
Advisory Board. Within this private PCP community, Novartis has created a virtual extension of the traditional
advisory board model, enabling the company to engage its advisory members in scientific and branded
discussions.

• AstraZeneca and the American College of Gastroenterology have launched GI Circle, an exclusive online
community for ACG members designed to foster ongoing scientific discussion. Through GI Circle, ACG
offers its members a secure social network to foster communication and collaboration within the GI specialty.

• Boehringer Ingelheim announced the results of the RE-LY Trial to physicians and the broader world via
Twitter. The results of the study were presented for the first time at the European Society of Cardiology (ESC)
Congress and Boehringer Ingelheim live-tweeted from the RE-LY press briefing and presentation in Barcelona.

• Pfizer runs a service called AskRx within an online physician community that allows a doctor to
instantaneously submit a medical inquiry to Pfizer’s medical information department. Pfizer provides a
scientific response within 24 hours, and then the doctor can share the full exchange with the broader physician
community.

From monitoring physician conversations for product insights to hosting virtual communities to drive scientific
discussions, pharmaceutical manufacturers continue to seek new ways to interact with and learn from HCPs
online. Through these physician-centric social media efforts, manufacturers have gained new insights regarding their
products and directly answered clinical questions posed by physicians in a more timely and meaningful way. While no
conclusive studies have been published that measure outcomes to date, anecdotal evidence shows that such interactions
are improving the delivery of patient care. Despite the early success yielded by manufacturer participation in and
sponsorship of physician social networks, many manufacturers hesitate to enter this space due to the uncertain
regulatory landscape. This missed opportunity is a detriment to patients, providers and manufacturers alike, and we
strongly encourage the FDA to provide clear guidance to avoid further delay.

Analysis of PhRMA's FDA Comments

In recent months, many organizations (including Ozmosis) have publicly called on pharmaceutical manufacturers to
expand their HCP social media programs ahead of regulatory guidance from the FDA. This call to action is not an
attempt to circumvent the regulatory process. To the contrary, it is intended to drive both manufacturers and the FDA
to accelerate their mutual efforts to define a clear regulatory framework by demonstrating the efficacy of new social
media initiatives.

Seeking to expand and support the existing social media efforts of manufacturers, PhRMA and its members recently
submitted a dozen individual comments to the FDA, citing examples and recommendations for the FDA to consider.
These comments yield valuable insight into how these firms plan to embrace new, innovative programs for physician

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outreach while mitigating concerns around Off Label Discussions and the monitoring and reporting of Adverse Events.

Pharmaceutical manufacturers can redefine their relationships with HCPs by participating in the conversations
that are already taking place around their products and services. A properly designed and regulated social media
program can be integrated directly into the HCP's clinical workflow, providing the information they need to make more
informed medical decisions at the point of care.

When reviewing comments from PhRMA, Abbott Labs, AstraZeneca, Bayer, Eli Lilly, Genentech, Johnson & Johnson
Merck, Novartis, Pfizer, Sanofi-Aventis, and Sepracor, a high level of consensus emerges on some key issues. This
consensus is summarized in the table below, along with Ozmosis' view on an appropriate regulatory framework for HCP
engagement:

Pharmaceutical Manufacturer's Supporting Ozmosis' Position for HCP

Issue
Consensus Viewpoint Organizations* Engagement
PhRMA, Abbott
Companies should be held accountable
Companies should only be accountable for Labs, AstraZeneca,
according to the "3 C's Rule" for pharma
content they created and that remains Bayer, Eli Lilly,
Accountability for marketing offered by Rohit Bhargava of
within their span of control. Sponsoring Genentech, Johnson
online content Oglivy: if a piece of content was created,
independently-created content should not & Johnson, Novartis,
collaborated on, or compensated for by a
imply accountability. Pfizer, Sanofi-
marketer, then they are accountable for it.
Aventis, Sepracor
PhRMA, Abbott Trust and transparency are essential. Any
Labs, AstraZeneca, party who is acting on behalf of the
Disclosing Companies and their agents should disclose
Bayer, Eli Lilly, manufacturer, whether employed,
corporate identity their identities in all communications
Genentech, Novartis, compensated, or otherwise influenced, must
or affiliation online.
Sanofi-Aventis, clearly disclose their identity and affiliations
Sepracor in all online activities.
Companies should have no obligation to
PhRMA, Abbott
provide corrective information on third-
Labs, AstraZeneca, Companies should be required and
party websites; however, if they wish to do
Bayer, Eli Lilly, encouraged to provide corrective
Posting corrective so on an ad-hoc basis, they should have the
Genentech, Johnson information anywhere they are accountable
information option (provided the message is clearly
& Johnson, Novartis, for online content according to the 3 C's
disclosed as coming from an official
Pfizer, Sanofi- rule (as described above).
company representative and balances safety
Aventis, Sepracor
and efficacy information).
Companies that weigh in largely believe To participate effectively in a social media
they should be able to participate in real- context, companies and their representatives
time discussions without FDA pre-approval need the flexibility to post and respond as
AstraZeneca, Bayer,
FDA approving of statements, especially non-branded rapidly as an ongoing conversation requires.
Sanofi-Aventis,
real-time content statements that do not need approval in Companies should therefore be able to
Sepracor
other media. Sepracor dissents and suggests participate in real-time discussions without
FDA approval the first time a stock FDA pre-approval of statements, especially
response is used. in HCP-specific programs.
On any site where the company is
accountable for content they should
expressly prohibit off-label comments
within the Terms of Use. Furthermore,
Companies tended to avoid this issue. they should reinforce this restriction by
Those who commented (see right) Bayer, Novartis, prominently displaying guidelines and
Flagging off-label
regarded off-label comments as something Sanofi-Aventis, reminders of this policy in any content area
conversation
to be managed via Terms of Use, flagging, Sepracor where users may post comments.
and deletion.
Companies should also encourage self-
reporting of off label discussions among
HCPs by encouraging users to flag
inappropriate comments.
Companies should only be required to PhRMA, Abbott Eli Lilly conducted a 10-week monitoring
monitor their own sites; many expressed Labs, AstraZeneca, pilot for adverse effect on the web. Despite
Monitoring for concern that monitoring the web for Bayer, Eli Lilly, yielding 521 initial hits (which mentioned
adverse event cases adverse event reports will prove counter- Johnson & Johnson, the drug by name), only four cases met the
productive by diluting signals and chasing Merck, Novartis, bar for severity and each was a duplicate
incomplete information. Sepracor event reported through other channels.

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 These results strongly suggest that
pharmaceutical company fears about an
explosion of reportable adverse events are
unfounded and companies should be
required to monitor content areas they are
accountable for.

Companies should be allowed to partner

Companies are concerned about finding
cases that meet the four stated criteria for
Adverse Effects and some ask for revisions
Reporting adverse
on what constitutes an Identifiable
event cases
Reporter, given the anonymous nature of
much of the web. Most recommend
following their existing SOPs for reporting.
with third-party monitoring services and
leverage social media monitoring tools like
Radian6 and others to minimize concerns
over increased workload.
While companies fret over the difficulty of
monitoring the web for AE reports,
ultimately social media provides a valuable
new channel to identify such incidents. The
PhRMA, Abbott FDA, however, should provide guidance on
Labs, AstraZeneca, how many attempts to contact the reporter
Bayer, Eli Lilly, constitute "due diligence."
Johnson & Johnson,
Merck, Sepracor All company-owned or sponsored sites
should adopt a "Report AE" button, making
it easy for the reporter to provide the
necessary information in an efficient and
uniform manner.

*Companies not listed as supporting organizations do not necessarily oppose these positions; their comments did not include a position on the particular issue

Conclusion

Pharmaceutical manufacturers and the industry representatives who work closely with them clearly want broad latitude
to communicate with patients and HCPs online. As our comments illustrate, the social web is a medium both
constituencies widely use to obtain medical information. That said, we believe manufacturers should be given wider
latitude in their online interactions with trained medical professionals. HCPs know how to propely research and
assess product information (including dosage, efficacy, and safety data) and should not be unduly hindered in their ability
to engage online.

One proposal following this theme would create a Fair Balance Certification System for HCPs. This certification would
allow HCPs to acknowledge they understand the fair balance information for an individual drug or class of drugs. By
accessing the certification system, manufacturers and their representatives would then know which providers could
receive product information and materials in a more streamlined and easy to digest fashion. (HCPs would only be
required to update their certification once a year or upon a change in label)

Whether the FDA adopts this recommendation or similar measures, manufacturers who elect to interact with HCPs
online and through social media efforts should recognize they have certain responsibilities: to prominently disclose their
identities, to accept accountability for content produced within the span of their control, to provide a balanced account
in every message (even if doing so by linking to a page with more complete information), and to monitor the web
properties they maintain for off-label comments and adverse event reports.

If the FDA adopts these standards and manufacturers adhere to them, the net effect on the availability of online
medical information and the conversations that surround them will be positive. As the internet becomes more open,
social, and delivers real-time services, manufacturers and physicians must have the leeway to participate in the online
conversations taking shape around medical products. This can be achieved while following the same core principles that
govern their behavior in other mediums.

1 Google/Think Health http://www.youtube.com/watch?v=Jd0WF9nP4LA

2 Manhattan Research – Taking the Pulse v.9 2009
3 Manhattan Research – Taking the Pulse v.9 2009
4 http://www.ama-assn.org/amednews/2009/03/23/prl10323.htm
5 Manhattan Research – Taking the Pulse v.9 2009