© 2011 Pharmaguy

Pharmaguy (aka John Mack)

Publisher, Pharma marketing News & Pharma Marketing Blog

@pharmaguy on Twitter

pharmaguy@pharmaguy.com

A workshop at

Doctors 2.0 & You22 June 2011 Paris, France

Building “Fair Social Media Practice Principles”

Essentials of a Social Media Policy

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Internal vs. External

Internal polices define how management expects

employees to act on company-owned and 3rd-party social

media sites (eg, Facebook, Twitter, etc.).

External policies are promises by management about

how their employees will engage with users of company-

owned or sponsored social media sites.

Privacy

Terms of Use (legal document explaining acceptable and

unacceptable uses of site by visitors)

NEW! Fair Social Media Principles

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“A significant, albeit, small step in the direction of corporate transparency, normally so difficult to achieve within the pharma industry but so essential if it is to regain the trust that will be crucial

for its long-term survival…[yet] so few pharmas have publicly revealed their social media policies. Why is the industry so reticent?” -- Len Starnes, Bayer

August 16, 2010

Roche’s Social Media Principles (Internal Policy)

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Fair Information Practice Principles

Principle Data

Notice/Awareness Give notice of data handling practices

Choice/Consent Give choice about how data is used

Access/Participation Ability to view personal data & correct

Integrity/Security Ensure data is protected against unauthorized access

Enforcement/Redress Mechanisms in place to enforce principles

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Fair Social Media Practice Principles

Precedent: Fair Information Practice Principles

Principle Data Discussions

Notice/Awareness Give notice of data handling practices

Give notice of discussion hosting practices

Choice/Consent Give choice about how data is used

Give choice about how discussions are used

Access/Participation Ability to view personal data & correct

Ability to view personal discussions & correct

Integrity/Security Ensure data is protected against unauthorized access

Ensure discussions are protected against unauthorized access (?)

Enforcement/Redress Mechanisms in place to enforce principles

Mechanisms in place to enforce principles

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FDA Hosts Public HearingNovember 12-13, 2009

AccountabilityFulfilling Regulatory RequirementsPosting Corrective InformationLinksAdverse Event Reporting

FDA Hosts Public Hearing

© 2011 Pharmaguy

“If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.

“Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine.”

Prescription Medicines Code of Practice Authority (PMCPA)

publishes "informal guidance” regarding Twitter

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While FDA Fiddles, ABPI Acts April 1, 2011

While FDA Fiddles, ABPI Acts

© 2011 Pharmaguy

“The company’s involvement in the social media site must be transparent to the users.” Even when just “listening in,” the company "should declare its presence by registering on the site using the company name.”

Regarding the identity of the reporter of an AE, PEN says an e-mail address would be considered acceptable and even a screen name would be acceptable IF the screen name allowed for contact to be made. PEN recommends companies implement “a formal site registration process” that can be utilized to obtain information enabling regulated companies to “identify and contact users in order to validate and follow-up on safety information.” During registration, users should give consent for the company to follow-up with a user should they report AEs, says ABPI. “It should also be made clear that personal information may be processed on internal company databases and sent to regulators.”

The ABPI Pharmacovigilance Expert Network (PEN) publishes

social media guidance for Adverse Event Reporting

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June 13, 2011

While FDA Fiddles, ABPI Acts (cont’d)

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Survey Overview

Online — started 20 September 2009

Includes All 19 questions for which FDA seeks answers

Tallies votes on specific answers/solutions

Plus 575 comments

354 Respondents as of 1 November 2009

126 Blog readers

101 PMN subscribers

64 Twitter followers

45 Web site visitors

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Accountability: Best PracticesDISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible. Half of survey respondents agree*

Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.]About two-thirds of survey respondents agree*

Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should only be REQUIRED to do so only for sites owned or directly sponsored by them.

* See next slide

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Disclosure of 3rd-Party Content Involvement

How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?

Disclosure is necessary only when content is paid forDisclosure should be prominently displayed alongside relevant content when possibleDisclosure and disclaimers should be included prominently on the corporate website near any links to social media outletsEach company should have a public SM policy that includes a notice of its transparency policies

Accountability

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Type of Moderation

Some comments from survey respondents: “Depends on how fast the review process is…” “Screen only for vulgar language, nothing else…” “Screening can lead to censorship…” “Must pre-screen to prevent misinformation…” “Post-screening encourages conversation…” “Site owner should be able to remove

misinformation…”

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Consequences of No Moderation

A = The company's brand will suffer because of illegal, inappropriate, inaccurate, or misleading comments no matter what corrections are posted.

B = Users will suffer because of exposure to illegal, inappropriate, inaccurate, or misleading comments no matter what corrections are posted.

C = The company can always counteract any illegal, inappropriate, inaccurate, or misleading comments with its own truthful statements.

D = The community of users, apart from the company itself, will self-correct any illegal, inappropriate, inaccurate, or misleading comments.

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Consequences of No Moderation

“There must be a proactive, consistent effort to manage site rogues, but the essence of a social site is open interaction, engagement and connection.”

“My experience with healthcare social media tells me that there is less negative/inappropriate discussion than many companies fear they will see.”

“I think that once the ‘genie is out of the bottle’ you can't put it back in. So even if a company provides correcting information to a post, it will be seen as them being self serving. Also, it is very difficult to post correcting information against a determined poster, or group of posters, who can inundate the board with ‘negative’ posts.”

Comments from survey respondents

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Benefits/Drawbacks of Pre-Screening

A = Prevents misinformation (including off-label drug information) from being published and then possibly propagated throughout the Internet.

B = Keeps the site from being overrun by spam or other malicious posts.

C = Requires too many resources (ie, FTEs) or nearly impossible to do in a timely fashion considering the 24/7 nature of online discussions.

D = The delay -- even a short delay -- before posts appear will inhibit the use of the site and make it virtually useless.

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Benefits/Drawbacks of Pre-Screening

“Due to the sensitivity of the information being posted, precautions need to be taken. Resources need allocated regardless of cost, and a delays in postings are necessary.”

“I feel pre screening is not consistent with the meaning behind social networking.”

“There is only a small expectation among consumers that their comments are posted immediately in most cases. This is especially true if you make it clear to people that they won't be posted immediately and explain what types of comments are appropriate.”

“The bigger issue is the sense that screening will be used to mask issues or avoid competitive mentions, etc.”

Comments from survey respondents

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Post-Screening Best Practices

A = Review all new posts in a timely fashion (eg, within 48 hours).

B = Before deleting posts, publish a response indicating that the post violates the terms and will be deleted.

C = When posts are deleted, perform a "soft delete," which shows that a post was deleted and why it was deleted.

D = Do a "hard delete" (remove completely with no remaining record that the post existed).

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Post-Screening Best Practices

“The why and what for arguments of deleting the post will be informative to readers.”

“By doing a soft delete, you're informing that posts are being deleted and users will be suspicious. In fact, it might even discourage them from using the site.”

“Soft-delete vs. hard-delete needs a clear decision tree/policy within the company. Hard-delete should be used only in cases where comments are very incorrect, very misleading, illegal or very damaging. Otherwise, soft-delete is the more transparent approach.”

Comments from survey respondents

© 2011 Pharmaguy

Publishes all comments before reviewing, but reserves right to delete comments if offensive or mention ANY product.

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While many pharma companies attempt to shy away from allowing

comments on their Facebook & Youtube pages or participating in

online patient communities due to AE reporting challenges, a few are

undeterred and seem to have figured it out. EU-based companies like

Janssen UK and UCB lead the way.

October 7, 2010

A Pharma FaceBook Page That Allows Unscreened Comments

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Essential Elements of Disclosure

A = A comment moderation policy that explains how discussions are reviewed before or after publication.

B = Disclose how "misinformation" is defined and what the policy is for correcting such information.

C = Disclose rules for participation in discussions by site owner employees.

D = Disclose rules for participation by third-party sponsors, clients or their agents.

E = Disclose how site moderators are trained regarding policies.

F = Disclose the qualifications for discussion moderators, if there are moderators.

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Essential Elements of Disclosure

Disclose the purpose or goal of using social media for the company.

Disclose if social media "listening/mining” function is in place.

Real employees, with real names, of the Pharma company should engage in the discussion, not ghost writers or third party contractors.

Other suggestions from survey respondents

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Resources

FDA's Regulation of Drug & Device Promotion via the Internet & Social Media -- a detailed summary of PMN survey results & comments as submitted to the FDA; http://bit.ly/fdasmSurvey; use code ‘2F28AD’ to get it FREE!

ABPI Pharmacovigilance Expert Network’s social media guidance for adverse

event reporting; http://bit.ly/PenGuide

Moderation Best Practices for Pharma Social Networks; http://bit.ly/PMN9403; use code ‘SMOD368’ to get it FREE!

Rules for Pharma Engagement in Patient & Physician Social Networks; http://bit.ly/EngageRules

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Contact Me

Pharmaguy (aka John Mack)

Publisher, Pharma marketing News & Pharma Marketing Blog

@pharmaguy on Twitter

pharmaguy@pharmaguy.com