1.Pharmas Social Media Trialsand TribulationsPresented 14 September 2012 at: 2nd Annual eMarketing CongressBarcelona, Spain 2012 Pharmaguy

2. Learn from Milestones & Mistakes Constant Effort and Frequent Mistakes are the Stepping Stones to GeniusElbert Hubbard, American writer I will focus on: Milestones the important firststhat paved the way for others. Theseare the trials. Mistakes I call them as I see them.These are the tribulations. 2012 Pharmaguy 3. 3Pharma Embraces Social Media Pharma and Healthcare Social Media Wiki* >70 Twitter Accounts (excluding personal employee accts) 65 Facebook Sites (may be less post Aug 15, 2011) 38 YouTube Sites 37 Brand-Sponsored Patient Communities 10 Blogs *Source: Dose of Digital Blog. As of May, 2011. 2012 Pharmaguy 4. 4 Pharmas Social Media Readiness 4 2012 Pharmaguy 5. 5First Pharma Discussion BoardApril 2006 GSKs QuestionEverything.com allowed consumers to ask questions and have an online conversation among themselves and with experts. GSK said the purpose of the site was to offer peer support and professional advice to dieters and to "dispel the many myths about dieting, exercise and fraudulent weight loss products. In June 2007, GSK launched AlliConnectthe first pharma product branded Blogto promote Alli, its newly approved over-the-counter weight loss pill. 2012 Pharmaguy 6. 6First Pharma Sponsored YouTube VideoOctober 2006 GSK (UK) sponsors My Dad has Restless Leg Syndrome YouTube video, which includes a message at the end stating that My dad is one of a Million people in the UK who suffer from RESTLESS LEG SYNDROME. May 2008: Johnson & Johnson launches the first pharma YouTube unbranded Channel. September 2008: FDA issues first pharma YouTube video warning letter to Shire Pharmaceuticals (Vyvanse). February 2009: AstraZeneca launches "My Asthma Story," the First Rx (Symbicort) branded YouTube channel. 2012 Pharmaguy 7. 7 Pfizer Collaborates with Sermo October 2007 Sermo and Pfizer sign a deal whereby Pfizer gains access to the online physician community via surveys and sponsored content. More importantly, Pfizer physicians can join Sermo and openly participate in online physician conversations as long as they identify themselves as employees of Pfizer. A Sermo press release characterized the deal as a "strategic collaboration designed to redefine the way physicians in the U.S. and the healthcare industry work together to improve patient care. Only 24% of physicians are using physician peer communities like Sermo, Medscape, DrConnect, PhysicianConnect, Ozmosis, etc. 2012 Pharmaguy 8. 8First Pharma Facebook PageJune 2008 McNeil Pediatricsa division of J&Jlaunches ADHD Moms. Now to be fair, this Facebook page, still isnt all that interactive, said Marc Monseau, a J&J spokesperson. Though visitors can download podcasts, articles and participate in instant polls, they cant post comments to the wall on the page. What they can do, though, is use their own Facebook pages to connect with other ADHD Moms fans. Its a baby step, to be sure, but I understand the team is looking at other steps they can take to make it easier for people to share their insights into caring for kids with ADHD. 2012 Pharmaguy 9. 9FDA Sends 14 Warning LettersApril 2, 2009 FDA sends 14 letters on a single day to major pharmaceutical companies concerning their Google and Yahoo Rx paid search ads. Letters were dated 29 March 2009, but made public on 2 April 2009. April 1, 2009: Pharmaguy posts fake press release announcing FDA guidance on pharmas use of social media. Previously (December 2006) Pharmaguy said FDA should be taking a closer look at drug promotion via the Internet. 2012 Pharmaguy 10. 10Roadside Casualty: One-Click Rule Jim Nail, CMO at TNS Media Intelligence/Cymfony, defined the rule this way: ...there is no official FDA one-click rule...there is a received precedent that if you have one click from your brand site to the PI or labeling information, that is acceptable. Or call it best practice. Or call it just common practice. FDAs 14 warning letters put an END to the one-click rule, received precedent, best practice, or common practice, said Pharmaguy. 16 November 2006: First instance of the "one-click rule" debated in an open forum. At an industry conference, a Google presenter encouraged the use of an Adword format that included the drug brand name and indication BUT not including the fair balance (major side effects) saying the side effects were just one-click away. Pharmaguy challenged the speaker and said such ads violate FDA regulations. 28 August 2008: First indication that the one-click rule is not recognized by FDA: FDA sends a notice of violation letter to Novartis Pharmaceuticals regarding Diovan Web banner ads that fail to mention side effects. 2012 Pharmaguy 11. 11 UCB Embraces Adverse Events on Sponsored Discussion BoardJune 16, 2009 Goal: Generate patient-reported outcomes that mayhelp UCB better understand how patients live withepilepsy and help advance epilepsy care. Provides disease tracking tools Deployed a system for reporting adverse events toFDAUCB has an ethical and legal responsibility to report adverse events associatedwith 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 allowus to assess and process potential adverse events, report them to the FDA, andcapture them in the UCB safety database. -- Peter Verdru, MD, UCBs VicePresident of Clinical Research 2012 Pharmaguy 12. 12First Pharma Rx Branded Tweet!June 18, 2009I called this tweetSleazy Twitter SpamChallenge (US): Howto fit benefits and fairbalance in 140 characters or less? Were Still Friends!Challenge (Globally):How to make itmeaningful forpatients 2012 Pharmaguy 13. 13FDA Announces Public Hearing September 21, 2009 This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.April 2, 2009: Pharmaguy issuesfirst public call for FDA publichearing on social media. Weshould make sure that when itcomes time for the FDA toactually create a guidancedocument on social media thatit does it with input from ALLstakeholders. 2012 Pharmaguy 14. 14 FDA Hosts Public Hearing November 12-13, 2009 Accountability Fulfilling Regulatory Requirements Posting Corrective Information Links Adverse Event Reporting 2012 Pharmaguy 15. 15 FDAs 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,more or less 2012 Pharmaguy 16. 16 FDA Off-Label Guidance & Social Media December 27, 2011 Section VI addresses responding to unsolicitedrequests on public forums such as the Internet and"emerging electronic media Cites cases on YouTube, blogs, and Twitter:Pharma should respond to unsolicited requests viaprivate channels FDA recommends that sales and marketingpersonnel have no input on the content ofresponses to unsolicited questions orrequests for off-label information 2012 Pharmaguy 17. 17Congress Gives FDA 2 Years to IssueSocial Media GuidanceJuly 2012 "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act" (aka PDUFA) Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.All Bark, No Bite? 2012 Pharmaguy 18. 18 Traffic Congestion Slows Down FDA26 February 2010: Pfizer contends that FDAs proposed social media guidanceraises First Amendment concerns. Guidance, said Pfizer, is too vague andengenders extensive litigation.15 June 2010: FDA says it plans to issue multiple guidance documents onInternet promotion. Sounds like they bit off more than they can chew.28 April 2010: A series of proposed studies by the FDA designed to test differentways of presenting prescription drug risk and benefit information on branded drugWeb sites may further delay issuance of social media guidelines by FDA.21 May 2011: FDA Involvement in criminal investigation of Google may furtherdelay social media guidelines. Pharmaguy speculates that there is evidence thatthe delay may be due to the ongoing legal case against Google and onlinepharmacies by the Department of Justice. 1 June 2011: FDA drops Social Media from its 2011 Guidance Agenda, but agenda hints that responding to unsolicited statements/requests on pharma social media sites may first guidance to be issued in 2011. 5 July 2011: Pharma Citizen Petition Filed. Asks for binding regulations not guidelines for responding to unsolicited requests for off-label information. FDA must respond to this before issuing guidance as planned. 2012 Pharmaguy 19. 19 Roche Publicly Discloses Social Media Principles August 16, 2010 A significant, albeit, small step in the direction of corporate transparency, normally so difficult toachieve 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 mediapolicies. Why is the industry so reticent? -- Len Starnes, Bayer 2012 Pharmaguy 20. 20Pfizers SM Guard Rails andSecret SM PlaybookDecember 2010 Pfizer talks about a SM Playbook, but wont let us see it. "The playbook and social media policy are constantly evolving, said Ray Kerins, Pfizers Vice President of Worldwide Communications. We thought we had it finished last December, and then we realized we didnt and we went back to update it. So, its constantly moving. While I dont want to say its proprietary, I also dont want to make too big of a deal about it because we call it common sense." Based on a U.S. Air Force Chart. Guides Pfizer Canada in responding to remarks on social media networks which areeither the property of, sponsored by or have a relation ofsome kind to Pfizer Canada. 2012 Pharmaguy 21. 21 Sanofi-Aventis & Patient Collide on Facebook March 15, 2010 The pharmaceutical industrys worst fear was realized when a disgruntled patient posted multiple adverse event messages and photos on the wall of a Sanofi-Aventis Facebook page (VOICES). The page did not have comments turned off and did not include any terms of use. "A precedent has been set by this experience, said Pharmaguy, which does not bode well for the future of pharma social media. 2012 Pharmaguy 22. 22 Janssens Open Road Youtube Policy June 9, 2010"Heres a hint forpharma. Nothing will go viral if you dont allow Likes or comments. Guaranteed. -- Jon RichmanComments are reviewed before posting - in line withthe commenting policy on the site. The vast majority of comments have been posted, Kindregards, Gary -- Gary Monk, Product Manager. 2012 Pharmaguy 23. 23 Janssens Open Road Facebook Policy October 7, 2010Publishes all commentsbefore reviewing, butreserves right to deletecomments if offensive ormention ANY product. 2012 Pharmaguy 24. 24 First Pharmaguy Social Media Pioneer Award October 19, 2010Alex Butler, Digital Strategy andSocial Media Manager at Janssen &recipient of first ever PharmaguySocial Media Pioneer Award, says: 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 2012 Pharmaguy 25. 25 First Live Pharma Twitter ChatFebruary 16, 2011 AstraZeneca hosts a one-hour chat on Twitter to raise awareness about helping patients save money through prescription savings programs. Pharmaguy said, "This is quite gutsy of AZ considering that anyone can join the chat simply by posting a message containing the #rxsave hashtag. And anyone can post messages about AZ drugs and mention side effects too even though AZ might say that it will not respond to questions about specific drugs. 2012 Pharmaguy 26. 26 First Hack of a Pharma Facebook Page July 20, 2011 Pfizers US corporate FB page broken into by Script Kiddies. Shut down for several hours over weekend. Admin password guessed by hackers after finding a LinkedIn page of an outside PR agency person who was responsible for creating or overseeing the pages development 2012 Pharmaguy 27. 27First Hack of a Pharma Facebook Page July 20, 2011 Pfizer promises to share lessons with other pharma companies. Some lessons might include: Make sure your passwords are strong & protected Hire competent outside agencies (PR vs Interactive?) Have competent in-house FTEs oversee SM agencies monitor SM sites 24/7 2012 Pharmaguy 28. 28 Pharma Phases Out Facebook Pages August 15, 2011 New Facebook Policy: Pharma is no longer be able to shut off comments to pages Among First to go: ADHD Moms (FIFO) Then Janssens Psoriasis 360 page (April 2012)Are some pharmacos using this an excuse toshut down pages that have not been effective? 2012 Pharmaguy 29. 29 Pharma Social Media Flash Mob August 19, 2011 GSK (UK) Facebook page experiences first-ever flash mob an organized grassroots comment attack SEROXAT SUFFERERS Blog posted these instructions: 1. Sign up to the GlaxoSmithKline Facebook page. [Do this by clicking the Like button.] 2. Open comments under the "Glaxo "Builds Bonnie Babies" advertising hoarding opposite Kings Cross Station, London in 1921, UK" thread. 3. Ask them a question about one of their products. 4. Sit back and watch consumer queries get deleted. 2012 Pharmaguy 30. 30 BIs Famously Unpronounceable YouTube Video September 20, 2011 2012 Pharmaguy 31. 31Pfizers Chapstick Slapstick FB FiascoOctober 27, 2011 A social media death spiral says AdWeek Negative comments deleted without explanation People complain about comments being deleted Eventually (maybe too late!), Pfizer apologizes but tempers the apology by saying it only deletes repetitive & spam-like comments 2012 Pharmaguy 32. 32Pharma Employee Tweet Problem December 13, 2011 The Prescription Medicines Code of Practice Authority (PMCPA) ruled Allergan breached the Code on several counts after an employee accidentally tweeted publicly about Botox Employee violated Allergans "Global Social Media Policy that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity." Should pharmacos make their SM policies public to be more transparent & accountable? 2012 Pharmaguy 33. 33 Novo Nordisk & Bayer on April, 2012 2012 Pharmaguy 34. 34 Pharma Wikipedians June 13, 2012 Bertalan Mesk, MD, founder and managing director of Webicina.com, called for pharma companies to appoint a spokeperson in Wikipedia who would perform all edits on behalf of the company. Raises a number of questions 2012 Pharmaguy 35. 35 Should Pharma Edit Drug Articles on Wikipedia: Survey Results 35 2012 Pharmaguy 36. 36 Engaging Consumers via Social Media36 2012 Pharmaguy 37. 37Pfizers Get Old Community June 18, 2012 Registered visitors are encouraged to "Share your thoughts and experiences about getting old." Can post links, videos, photos, or stories Posts reviewed within 48 hours Most posts are from patient advocacy partners (eg., Alzheimers Association) 2012 Pharmaguy 38. 38 BI Launches Syrum Facebook Game September 2012 Touted as a very unique offering from a highly regulated industry, Syrum is a Facebook game develop-ed by Boehringer Ingelheim (BI) over a period of two years. The objective of the game is to educate people about drug development. BI is offering rewards and prizes for people to give feedback. I have seen a lot of very dumb moves butthis may be the king of stupid ways tospend your money, said Rich Meyer, blogger at World of DTC Marketing. 2012 Pharmaguy 39. Resources Social Media Pharma Marketing Readiness Self-Assessment -- http://tinyurl.com/caghnm 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! 2012 Pharmaguy 40. Contact Me 2012 Pharmaguy