© 2011 Pharmaguy

A Social Media Strategy

John Mack/Pharmaguy

Publisher, Pharma marketing News & Pharma Marketing Blog

@pharmaguy on Twitter

pharmaguy@virsci.com

Presented at

6th Annual Pharma Marketing & Branding Excellence

25 January 2011 Milano, Italy

Deal with (LACK) of Regulations, Develop Best Practices

Osso Whaaaat?

Mack's Osso Bucco recipe!

© 2011 Pharmaguy

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Topics

An overview of regulatory issues

Overcoming insufficient guidance from FDA

Social media best practices (examples)

Internal & external social media policies

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Issues

AccountabilityFulfilling Regulatory RequirementsPosting Corrective InformationLinksAdverse Event Reporting

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FDA’s Guidance Sausage-Making Process

Publish Intent in Federal Register.

Although NOT Required, Hold a Public Hearing.

Have a Public Comment Period.

Review Comments Submitted to Docket.

Issue DRAFT Guidance.

Collect & Review Comments on DRAFT Guidance.

Revise DRAFT Guidance Based on Comments, If

Necessary and Issue FINAL Guidance.

STILL WAITING!

There might be a market for this shirt after all!

There might be a market for this shirt after all!

© 2011 Pharmaguy

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While FDA Ponders the Issues, Pharma Dives Into Social Media

Pharma and Healthcare Social Media Wiki*55 Twitter Accounts (excluding personal

accts) 45 Facebook Sites 35 YouTube Sites31 Brand-Sponsored Patient Communities19 Blogs

*Source: Dose of Digital Blog. As of May, 2010.

Updated in September 2010. Too many to keep track of. Many, however, do not qualify as

pharma sites or social media sites.

Updated in September 2010. Too many to keep track of. Many, however, do not qualify as

pharma sites or social media sites.

Got SM Swimmies?Got SM Swimmies?

© 2011 Pharmaguy

Accountability

For what online communications are manufacturers, packers, or distributors accountable? In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?

When marketer or agent sponsors the discussion (eg, provides a specific grant to independent 3rd-party host such as a patient advocacy group to sponsor the discussion)

When marketer or agent paid for the content (eg, paid patients for testimonials or otherwise provided compensation)

When marketer or agent paid for display ads to be run on specific discussion pages (eg, only discussions related to the product advertised)

3rd-Party Independence

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© 2011 Pharmaguy

Pharma Parses Accountability

Earned MediaNo control of content, therefore not accountable

Paid Advertising & Shared Social MediaAccountable for initial message, but not if content

modified independent of company at later date

Owned MediaControl of content & distribution means company is

accountable all the time

This schema was presented by Abbott in its

comments submitted to the docket. Lilly divides communications into

Advertising, Content, and Discussion. Johnson & Johnson points out that user-generated content

“does not constitute labeling or advertising.”

This schema was presented by Abbott in its

comments submitted to the docket. Lilly divides communications into

Advertising, Content, and Discussion. Johnson & Johnson points out that user-generated content

“does not constitute labeling or advertising.”

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© 2011 Pharmaguy

Parameters for Correcting Misinformation

Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?

ONLY misinformation of real and imminent danger to the public health (to be determined by company) should be corrected

ALL off-label claims—even if supported by peer-reviewed medical literature—should be corrected)

Only off-label claims NOT substantiated by peer-reviewed medical literature should be corrected

Companies should not be burdened by FDA regulations requiring them to make corrections about ANY product misinformation published on 3rd-party sites

Posting Corrective Information

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© 2011 Pharmaguy

Accountability: Best Practices

DISCLOSURE 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.

PhRMA suggested that manufacturers would welcome correcting

misinformation about their products posted to 3rd-party sites such as Wikipedia IF these corrections were NOT

subject to FDA regulation.

PhRMA suggested that manufacturers would welcome correcting

misinformation about their products posted to 3rd-party sites such as Wikipedia IF these corrections were NOT

subject to FDA regulation.

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Social Media AE Challenges

What challenges are presented in handling adverse event information from these sources?

The amount of information from these sources is potentially too vast to be processed economically (lack of resources)

Finding adverse event information from these sources is like finding a needle in a haystack (too daunting)

The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable)

There are many potential issues that won't fully be known until the practice of monitoring social media for AEs is more prevalent (unknown issues)

Adverse Event Reporting

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AE Reporting: Industry Comments Regarding Privacy Issues

PhRMA raised privacy issue: FDA should not force manufacturers to seek personal health information from patients or reporters in a public forum

Lilly also cited privacy issues and said “National and international privacy laws …may preclude sponsors from attempting to obtain follow-up information… any attempts to request personal information create significant mistrust in any company or other entity attempting to obtain that information”

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AE Reporting: Industry Comments

Novartis suggested that FDA redefine “identifiable reporter” as “privately contactable” (e-mail address w/o name, phone number is

not suitable)

AstraZeneca suggested e-mail address or Facebook contact alone is suitable

J&J proposed that the technology of the Internet be used to assist in routing potential adverse events to the FDA

Abbott suggested FDA make available a user-friendly system through which web users can report events directly to FDA as was suggested by speakers at the public hearing

© 2011 Pharmaguy

This is what happens when you don’t implement a policy for handling user-generated content.

S-A’s VOICES: A Reason to Fear Comments

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© 2011 Pharmaguy

sanofi-aventis U.S. Diabetes

S-A recently launched a “Diabetes Co-Star” FB page

featuring movie actor and diabetic Paul Sorvino. While

comments are allowed, so far only comments from S-A have

been published.

S-A recently launched a “Diabetes Co-Star” FB page

featuring movie actor and diabetic Paul Sorvino. While

comments are allowed, so far only comments from S-A have

been published.

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“Since we operate in a heavily regulated industry, we… must preview all messages.”

“While some messages may not be posted, we are listening and encourage you to continue sharing.”

The page has only 522 people who “Like” it, whereas there are dozens of other diabetes

FB pages like by thousands of people!

The page has only 522 people who “Like” it, whereas there are dozens of other diabetes

FB pages like by thousands of people!

© 2011 Pharmaguy

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

Psoriasis 360: Comments Allowed!

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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.

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.

© 2011 Pharmaguy

“moderation is about engagement, leading and responding to the community not censorship Negative comments r V valuable”

“If you want to receive the benefits of SM engagement it has to be real, community moderate themselves in the end”

“if a brand, company, person is that worried about comments in SM there is probably a deeper issue under the surface”

Thoughts on Social Media Comment Moderation

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Alex Butler, Digital Strategy and Social Media Manager at Janssen & recipient of first ever Pharmaguy Social Media Pioneer Award, says:

Comments made by @Alex__Butler during #hcsmeu chat on 21 Jan 2011.Comments made by @Alex__Butler during #hcsmeu chat on 21 Jan 2011.

Pharmaguy Social Media Pioneer Lapel Pin

© 2011 Pharmaguy

Janssen-Cilag on Youtube: Allowing Comments & Likes

“Comments are reviewed before posting - in line with the commenting policy on

the site. The vast majority of comments have been

posted, Kind regards, Gary” -- Gary Monk, Product

Manager.

“Comments are reviewed before posting - in line with the commenting policy on

the site. The vast majority of comments have been

posted, Kind regards, Gary” -- Gary Monk, Product

Manager.

"Here's a hint for pharma. Nothing will go viral if you

don't allow 'Likes' or comments. Guaranteed.” --

Jon Richman

"Here's a hint for pharma. Nothing will go viral if you

don't allow 'Likes' or comments. Guaranteed.” --

Jon Richman

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© 2011 Pharmaguy

UCB-Sponsored PLM Epilepsy Community

“UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.” -- Peter Verdru, MD, UCB’s Vice President of Clinical Research

Goal: Generate patient-reported outcomes that may help

UCB better understand how patients live with epilepsy and

help advance epilepsy care.

Provides disease tracking tools

Deployed a system for reporting adverse events to FDA

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Roche 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

“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

© 2011 Pharmaguy

Pfizer Canada’s SM “Guard Rails” Chart

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Base on a U.S. Air Force Chart. Guides

Pfizer Canada in responding to remarks

on social media networks which are

either the property of, sponsored by or have a relation of some kind to

Pfizer Canada.

Base on a U.S. Air Force Chart. Guides

Pfizer Canada in responding to remarks

on social media networks which are

either the property of, sponsored by or have a relation of some kind to

Pfizer Canada.

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Thoughts on an Outward-Facing SM Policy

A promise to visitors of SM sites you own or sponsor about how YOU will behave, not how you expect THEM to behave

Think of it as serving a similar purpose as your privacy policy

Includes:

Your comment moderation policy; this requires more details than what we’ve seen so far

Rules for participation by your employees (reflects the internal policy that your employees are trained on)

Rules for participation by agents of your company (should be same as apply to your employees; trained on also)

Other “rules of engagement”; e.g., correction of misinformation

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Resources

www.FDAsm.com

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!

Overcoming Space Limitations in Social Media; http://bit.ly/fdasmSpace. Use code ‘FDA397’ to get it FREE!

Accountability for Pharma Content on Social Media Sites; http://bit.ly/fdasmAcct. Use code ‘FDA497’ to get it FREE!

Solving the Social Media Adverse Event Reporting Problem; http://bit.ly/fdasmAE. Use code ‘AE495’ to get it FREE!

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Contact Me

John Mack/Pharmaguy

Publisher, Pharma marketing News & Pharma Marketing Blog

@pharmaguy on Twitter

pharmaguy@virsci.com