Social Media for Pharma Brand Managers

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    The emergence o social mediahas posed some di fcult problems

    or marketers, in some ways morecomplex than the emergence oInternet marketing channels in the1990s.

    Drugmakers, or their part,must address even more di fcultchallenges than other industries.Pharma managers ace pain ulconsequences i their socialmedia promotions dont meetFDA requirementsand ignoringadverse reaction reports on orumslike Facebook or Twitter could leadto big problems as well.

    Fortunately, the next severalmonths should do much to clearup con usion and help pharmasmove ahead with their socialmedia plans.

    By the end o this year,drugmakers should be in a betterposition to move ahead with socialmedia, as the FDA is due to issueguidelines or the industry during2010. While the issues will remaincomplex, such guidance shouldreduce the risk o mounting socialmedia campaigns.

    With that sa ety net in plabrand managers can tap intoexperiences o colleagues whave already taken the plungA ter all, while the industrymay not have a best-practicemanual to work rom yet, eaadopters in the pharma worldhave begun to igure out whsocial techniques (such as edcational orums, support groand branded social media apcations) can produce results.

    In the ollowing pages, weset out a guide to help prepareyou or the next wave in pharsocial media useincludinga look at the important legal,regulatory and strategic problyoull encounter. Since issues still in ux, we havent got ha

    and- ast answers to o er, buhope to give you plenty o o

    or thought.Thank you in advance or

    reading this eBook. We hope ihelps you move orward in yosocial media e orts! l

    Edit f Fie ceP m

    Thank ou To our sPonsor:

    Soc al Med a forPharMa Bra dMa a erS

    3Meeting

    ConsumersWhere they Live

    5Pharma Social

    Media MarketingBlunders

    8What Works:

    Pharmas SocialMedia Success

    Stories

    9The Future o

    Pharma Advertising:DTC Goes Social

    12FDA Social

    Media ProposalsPut Pharmas

    on Notice

    7Sermo: Engaging

    PhysiciansOn-Demand Through

    Social Media*Sponsored Content*

    14Adverse Reaction

    ReportingChallenging inSocial Media

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    very e ective. Forty percent orespondents that use web toolsengage with social media tools onhealth sites, the frms researchers

    ound; in act, almost 20 percento respondents do so every week.Getting involved in these discus-sions is more e ective than o eringsolely branded drug content.

    Another key issue is understand-ing what consumers are looking

    or when they stumble acrosspharmaceutical advertising on theweb. Epsilon ound that about 50percent o consumers are looking

    or disease-related in ormation, andabout 30 percent are looking tocheck out what symptoms mean.Meanwhile, just over 10 percent o

    consumers reported that they werescouting or drug in ormation. Still,46.7 percent o comScore respon-dents reported that social mediasites help them make better medi-cal decisions, a stat that pharmabrand marketers can leverage.

    Its clear that the main interest

    o consumers is the oundationalin ormationthey want to under-stand their condition, learn aboutthe symptoms and treatmentoptions and understand key terms,the Epsilon report ound. Address-ing those content interests shouldbe ront and center or pharmamarketers, researchers concluded.

    Then theres the question owhos actually using social mediachannels and visiting health sites.According to comScore, 78 percento people with an identifed con-dition visit health sites and use

    the sites tools. But 56 percent caregivers also visit such sitesPharma marketers should also sider how consumers at di estages o treatment and awaredi er. For example, sophisticpatients may go directly to bradrug sites, while newly diagnopatients or caregivers may visisocial sites or channels to comnicate and share experiences.

    Perhaps most importantly, itsimportant to consider what behaconsumers engage in when they

    Pharma brand managers spenda lot o time wondering how toreach consumers through socialmedia. This is a risky proposition,given that the FDA is still weighingwhat kind o social media market-ing it will permit. As a result, somepharma marketers have stayedaway rom social media entirely,and others have cut o many com-munity-building eatures, includingconsumer comment unctions.

    But pharma marketers dont need

    to sit on their hands when it comesto social media, or mount crippledcampaigns. One way to keep mak-ing progress, researchers say, isto spend time digging into whereconsumers are already getting theirdrug-related in ormation online,both inside and outside o socialmedia channels. Studies increas-ingly suggest that i pharmas meetconsumers where they live, socialmedia-wise, their campaigns willbe ar more e ective.

    Pharma marketers shouldntbe seduced by the bright, shiny

    object o running a social mediacampaign when theres so muchthat they can do with social mediabehind the scenes, argues AaronGerrick, senior director o theStrategic & Analytic ConsultingGroup with marketing services frmEpsilon. With the right tools and

    expertise, the social web becomesa rich source o consumer insight.

    To date, critics argue, drugmakershave been ar more prone to trans-

    er their existing sales pitch to, say,Facebook or YouTube rather than

    fnd out how to fnd and connect

    with their audience. But i they fndout which sources consumers trust,and what types o drug in orma-tion they share, this gives pharmamarketers a signifcant leg up.

    One data point worth consideringis that consumers fnd high-proflemedical Web properties like

    WebMD, YahooHealth and Google-Health to be credible, accordingto research by marketing servicesfrm Epsilon. Whats more, visitors

    spend an average o 91 percentmore time on health content sitesthan they do on branded pharmasites, according to a recent studyby digital marketing research frmcomScore. The most popular socialmedia sites used or fnding healthin ormation are Facebook and Wiki-pedia, comScore researchers ound.

    While websites are still pivotalchannels, social media channelsare becoming an important part othe mix, with 53 percent o Inter-net users reporting that theyveused social media tools to discuss

    health topics. Thirty-one percent othose respondents are looking orprescribed or available medication,comScore ound.

    Not surprisingly, Epsilonsresearch ound that pharma cam-paigns that reach out through thesesites social media tools can be

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    Measuring social Media roi

    It can be slippery to measure ROI when youre working in a new medi-um. (Remember when it seemed almost impossible to measure returns

    or Internet campaigns?) But according to researcher Kevin Kruse (@

    kevinkruse), theres a well-defned set o steps that provides reasonableROI numbers or your social media campaign. These include: Bear in mind that while social media use may be ree, creating cam-

    paigns isnt. To estimate social media expenses, pharmas shouldlook at actors such as sta time to be invested, agency ees, videoproduction and editing or YouTube campaigns, and the budget ormaking the videos sponsored content.

    Create a list o click-throughs that oster the goals o your marketinge ort. For example, pharma marketers might track click-throughs

    rom social media content to their branded sites, disease-relatedsites theyve sponsored, ree trials, doctor discussion guides orordering brochures.

    Establish which benefts youd like to realize as a result o your cam-paign. For drugmakers, Kruse suggests new p atient prescriptionstarts and increased reflls o existing scrips.

    Leverage your social media presence by driving patients intocustomer relationship management programs, and measure theresults. For example, Kruse notes, i patients in CRM programs stayon a drug our months longer than those who arent in the program,that could be a $ 4,000 gain in revenue. In that case, pharmas couldassign a $4,000 value to patients who sign up a ter clicking on asocial media link.

    on w y t k p m kingp g ss, s s s y,is t sp n tim iggingint w nsum s

    y g tting t i ug-t in m ti n n in ,

    b t insi n utsi s i m i nn s.

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    tainly did not mean to o endmoms through our advertising,said Kathy Widmer, vice presidento marketing. As a mom o threegirls, I understand many o thecomments made and agree thatwe know whats best or our kidsand or ourselves.

    While the statement was a goodidea, most critics suggested thatJ&J did too little, too late. For onething, in simply apologizing andmoving on, the pharma blew an

    important opportunity to engage ina conversation with its customers,according to Advertising Age s TomMartin. Perhaps more importantly,i J&J had tested the social mediawaters and taken the pulse o realmoms, it might never have had thisproblem in the frst place.

    Yaz brand gets trashedbY Youtube videos

    In theory, the brand managersbehind Bayer contraceptive YAZwere working rom the rightplaybook. With pharma market-ers being encouraged to pushtheir content onto social mediasites, a YouTube channel couldbe a great idea.

    Un ortunately, being one o thefrst pharmas to create a YouTubechannel didnt work out the waythat the company had hoped.Instead, Bayer lost control o itsmessage, which is just about anymarketers nightmare.

    As Pharma Marketing Blog editorJohn Mack notes, the YAZ BirthControl Channel looks fne whenviewed in its original orm. But iusers click on view comments,related videos and more, the

    trouble begins. T heyre presentedwith the generic YouTube ormat,which includes a sliding right-handpanel o video links presented by

    the site. Those links are chosenbe relevant to the video users awatching at that moment.

    In this case, the videos werelargely placed by law frms suiBayer, alongside o parodies oYAZ television commercials, Mnotes. Bayer turned o commwhen it realized its image wasbeing compromised, but it stillprevent viewers rom seeing thinappropriate videos.

    Mack concludes, My advicto pharma marketers: Unless yintend to promote a real discus

    sion or upload a series o videthat will enhance the value oYouTube channel, stay away YouTube! l

    While pharma social mediamarketing is just beginning tohit its stride, the issues it raiseshave been percolating beneaththe sur ace or quite some time.Below, take a look at someexamples o how unskilled use osocial media tools can come backto bite brand managers.

    J&J stunned bY MotrinMoMs backlash

    Back in September 2009, Johnson& Johnsons McNeil Consumer

    Healthcare brand began runningtelevision ads promoting OTC painreliever Motrin. The ad suggestedthat mothers who wear babiesin slings develop backaches and,moreover, that mothers wear babyslings to be ashionable and trendy.

    The response was immediateand angry. Not long a ter the adsaired, o ended mothers began

    venting their eelings on Twitter.The topic became so popular that itacquired its own hashtag, #Motrin-Moms. Meanwhile, an aggrievedcritic seized the @motrin identity on

    Twitter and used it to post com-ments critical o the ad.

    From that point, J&Js problemescalated into a crisis. In uentialmommy bloggers posted itemscritical o the ad, other momsposted videos critical o the spoton YouTube, and more than 1,300

    members o Facebook joined agroup boycotting Motrin.

    Eventually, a senior member oMcNeils executive team postedan apology or the ad. We cer-

    P m S iM i M k tingB un sBy A Z

    hold health-related conversa-tions on social media sites.According to comScore,51 percent o respondentssaid that in ormation oundon social media sites hadprompted them to speakwith their doctor about a par-ticular drug, and 62 percentplanned to speak with theirdoctor about a disease orcondition.

    Ultimately, even withextensive consumer data inhand, social media mar-keting is still in transition,and drugmakers will needto experiment and learn,observers argue. The keyis to simply jump in and getengaged in the social mediaconversation, suggestspharmaceutical industry

    blogger Steve Woodru .Measure what and whenyou can, Woodru says.But dont sit at the startingline when being involved insocial networking can bringabout so much potentialgood over time. l

    J ns n & J ns n t st t s i m iw t s n t k n t pu s m ms, it mig tn v v t is p b m in t st p .

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    by McNeil. However, it doesntpitch any orm o medications.

    Johnson & Johnson AcuvuesAcuminder application onFacebook o ers the ability toremind consumers o any littledetails that their li e involvesincluding, o course, reminders owhen to change contact lenses,buy new ones or schedule an eyeexam. With 567 ans, its only aminor success rom a Facebookstandpointsome retailers havehundreds o thousandsandseems to have gone non-

    unctional in the roughly 15months since it was created. Still,

    or a while it did a good job otying together real conversationswith promotions, Krall reports.

    GlaxoSmithKlines MyAlli o ersa community unction it callsallicircles. While the approachharkens back to computing dayso oldits a modern version oa basic threaded discussionitstill gets the job done, osteringsupportiveconversationsand in ormationsharing amongusers in a waywhich alsopromotes trust inthe product. Not

    surprisingly, thesite also o erslinks to its pageon Facebook, itsTwitter accountand YouTube,but these seemto be there to

    enhance, not substitute or, conversation-building.

    AstraZeneca maintains aYouTube channel o erupdates on charitable activitsuch as its support or BostoHope Lodge Center. It alsopresents a large number ovideos eaturing AZs CEOBrennan. As with many othepharmaceutical companies, has turned o the commen

    unction that accompanies tvideos. Much o the materiseems to involve o fcialstatements more typically aiat members o the media orWall Street.

    Many pharma marketing expepredict that as DTC ads migra

    online, and the FDA o ers mguidance or drugmakers on smedia marketing, pharmaceutcompanies will launch ar morobust social media o eringsuntil then, success stories mayhard to come by. l

    Given the regulatory issuespharma companies ace whenexperimenting with social media,its hardly surprising that manybrand managers decide to take apass. But that doesnt mean phar-ma has stayed away rom it entirely.

    The ollowing case studies wereselected by Jay Krall o Cision,a public relations shop based inChicago. Some are airly dated,but as Krall notes, the pickings areslim, since many drugmakers put

    a reeze on social media marketingonce the FDA began to ocus onthe issue.

    Having said that, there are stillsome good ideas being tested.Here are Kralls top choices orpharma social media campaigns:

    McNeil Pediatrics choseFacebook or its ADHD Moms site, which osters both medicaland social discussion amongparticipants. The page o erseducational in ormation, advice,guided community discussion, a

    non-employee Mom-bassadortasked with writing up herexperiences as a caregiver, andpodcasts. When checked inmid-2010 the page had morethan 11,000 ans.The site, whichseems to be active, states in a

    ew locations that its sponsored

    W t W ks:P m s S iM i Su ssSt i sBy A Z

    the serMo coMMunitY:

    As the largest online community orphysicians, Sermo has become avaluable resource or MDs to shareadvice and educate each other. Todate, more than 115,000 physicianshave joined Sermo to discuss awide range o issues ranging romclinical cases to advice about drugsand practice management. Sermois only or physicians and everymember must be verifed and cre-dentialed be ore they can join.

    Unlike a standard discussionboard, Sermo conversationshappen in the orm o a post andare not edited or moderated.

    Each post includes an insight orquestion, a poll, and a commentsection. This allows physiciansto gather both qualitative andquantitative eedback romcolleagues both within andoutside their specialty. Thismodel has driven nearly 50,000posts, 1 million comments and3.5 million votes. It also allows

    or crowdsourcing aboutthe most talked about drugs,disease states, and therapies even new innovations.

    the business Model:how does it work?

    Sermos social media plat ormallows Li e Sciences Companies(pharma, med device, biotech)to interact directly with its physi-cian community. Becau se theresalready an active group o MDs

    collaborating online, Sermo canprovide ast, candid exchanges notpossible through other channels.Engagements that used to takemonths can now happen in as littleas a ew days.

    Sermos business model iso ten described as a two-sided marketplace. On oneside, physicians bene it byteaching and learning rom eachother in a private, peer-to-peersetting. On the other side, Li eSciences Companies bene it byengaging physicians in the Sermocommunity or market research,awareness, and promotion.

    engaging PhYsicians:Proven social Mediainteractions

    Market research

    Because physicians on Sermoare already collaborating online,Sermo can provide ast, quality,and cost-e ective interactionswith any group o physicians. Youcan target physicians by demo-graphic criteria or match themagainst a target list. Perhaps thebiggest di erentiator or Sermo

    is that its physicians are alreadysharing honest and candid eed-back with each other and theybring that same thought ulness totheir interactions with clients.

    Sermos market researchincludes both quantitative andqualitative services. Clients

    can survey physicians, conductonline ocus groups, sparkdiscussions, and monitororganic physician dialog acrossthe entire community.

    awareness & ProMotion

    Sermo does not o er traditionaladvertising. Instead, it allows oreducational exchanges with practic-ing MDs about topics o interestsuch as clinical trial data, new stud-ies, products, or events.

    In order to achieve the bestpossible outcome, Sermoworks with every client topinpoint key messages andcreate a productive dialog.This can be done in the ormo a Sermo Survey or SermoPanel, which allow clients

    to in orm their message(s)be ore launching a campaign.

    A ter determining the rightmessage set, Sermo works withits clients to create awarenessabout the topic through varietyo promotional channels,including email, special highlightareas within its community,sponsorships, and pagesdedicated to a therapeutic area,topic, or drug (sponsorships/ pages coming soon!)

    To learn more about engagingphysicians on Sermo visit

    www.sermo.com/client.

    S m : eng ging P ysi i nson-d m n T ug S i M iBy Sh k

    sPonsored content

    http://www.facebook.com/apps/application.php?id=27415190831http://www.myalli.com/http://www.youtube.com/user/azvideochannelhttp://www.facebook.com/ADHDMoms?v=wallhttp://www.sermo.com/clienthttp://www.sermo.com/clienthttp://www.facebook.com/ADHDMoms?v=wallhttp://www.youtube.com/user/azvideochannelhttp://www.myalli.com/http://www.facebook.com/apps/application.php?id=27415190831
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    Fie ce P m : W y ep m i g ci l medi t

    ll, give t e eg l t y ii v lved?

    DJE: Obviously, the regulations inplace never have considered socialmedia as a type o communicationthat would ever exist.

    I think the knee-jerk reactionis that i pharma companies andbrands dont participate, others willparticipate on their behal . The con-versation is happening regardless.Consumers in general are partici-

    pating in a conversation whetherits specifc to a disease state ortreatment in general. I think its theresponsibility o the pharmas toparticipate in the conversation.

    Also, when pharma companiesare looking to put their fnger onthe pulse o whats going on outthere, theres no better ormatthan social media to reach peoplesu ering rom diseases or healthconditions. You cant go the busstop and talk to another momwhose child su ers rom MS.Those people dont exist in thelocalized circle o in uence, so itsvery hard to share some o thechallenges involved. Social mediaallows or some very strong bondsto occur, and o ten they go o ineas bonds mature.

    Another reason why pharma com-panies are going this way is becausethey see the potential in what wecall enlightened moderation. Youcan empower patients, caregiversand physicians with the plat ormsthat they need to have real, mean-ing ul dialogue and sharing.

    Fie ce P m : W t ci lmedi tec iq e ve y

    ee t t ve p ve t becce f l f p m b d

    m ge ?

    DJE: Sites that I think haveprovided value include (Facebook-based) ADHD Moms , which waslaunched with the intent to providereal in ormation to moms whosechildren have the disorder. This has

    created a community o parentswho really do share in ormation.

    The trend is that patients aregoing to the Internet or third-partyendorsements in circles o in u-

    ence that they trust. I you cancreate a community o like-mindedindividuals acing the same health-care challenges, you are inherentlygoing to create a bond among

    them that will have a trickle-de ect to that pharmaceuticalcompany and brand associatedwith that support mechanism.dont necessarily have to pitch

    particular drug; alhave to do is emppeople to talk amothemselves as a seto them because yreally care.

    The pharmaceucompanies that pebelieve actually cathe ones that will success ul. And s

    medias not the be all and end but it is a wonder ully e ectto give people the impression you actually care. Consumers

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    m is s s t n iti ns.

    T futu P m a v tising: dTc s S i

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    Many non pro it disease advo-cacy groups which are primarilyor substantially unded by indus-try have expanded the scope andrange o material and interactivemedia tools they have on the Web.This is o great concern to us.We have reached the conclusionthat FDA should consider regulat-ing portions o the content o theWeb sites o groups that get a

    substantial portion or majority otheir unding rom drug or devicecompanies.

    steve Fi dl y, se i he ltP licy a ly t, C me u i

    To date, Lilly has avoided signi icant interactionwith healthcare pro essionals and patients about ourproducts in social media orumslargely because oa lack o clarity in understanding FDAs expectationsas to how we could participate and comply withFDA requirements.

    We did recently launch a blog on Medscape, writ-ten by our U.S. medical team, to share in ormationwith physicians. Participants are allowed to post com-ments, either about our blog post or about each otherscomments. Thats the essence o social media, a ter

    allthe ability to share in ormation, experiences andopinions with others in the community. We are pre-screening all comments, however, and declining to postany that mention a product.

    Eli Lilly d C mp y

    M Vi ws n

    P mS iM iUs

    Should [pharmas] actively avoid participationeven to the degree omonitoringlest they uncover an adverse experience? Shouldnt companiesembrace social media so that adverse experiences can be ound with greateralacrity? Shouldnt companies be rewarded or such behavior? I regulatedindustry wants the FDA to be both regulator and colleague, then its not a leapo aith to imagine that the FDA would like industry to be proactive in its search

    or new ways to sur ace adverse events.I know o one large pharmaceutical company whose policy is not to moni-

    tor social media sites because they dont want to unearth adverse events. Isthis responsible? Is it even supportable? I this company received a call rom areporter and was asked i they purposely avoid social media so as not to fnd

    adverse experiences, would the truth set them ree? Legally they may be incompliance, but it wouldnt look good on Page One or sound very good in ronto a congressional subcommittee. In compliance and in the best interest othe public health must not be mutually exclusive propositions.

    Pete J. Pitt , P e ide t, Ce te f Medici e i t e P blic I te e t

    http://m.facebook.com/ADHDMomshttp://m.facebook.com/ADHDMoms
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    see right through the sales pitch,but theyll embrace the communityaspect i you support it in an hon-est and e ective way.

    Fie ce P m : W t p mci l medi t tegie ve

    bee le cce f l?

    DJE: One o the things to keepin mind is that the most e ectivecomponent o social media on,say, Facebook is the Wall post.Its an immediate opportunity tohave conversations on particularsubject matters.

    The problem is that under FDAguidelines the need to reportadverse events creates such alevel o risk that most pharma-ceutical companies shut o that

    unctionality.

    But in my opinion, that robs theaudience o the entire reason thatthey want to participate in the com-munity. Its kind o like throwinga party and putting duct tape oneveryones mouth. No ones goingto go to that party.

    The reality is, nobody wants to riend Lipitor, but people will joina community that provides in or-mation and support so that peoplewith high cholesterol and who have

    amily with high choles-terol will socialize.

    Besides, tech-nology is nowavailablethroughsemantic fltrationas well as buildingapplications withinFacebookto allow orthe dialogue to happenbut also weed out and agconversations that might be risky.

    One o the things pharmaceuti-cal companies orget is that i youprovide real value exchange, con-sumers will agree to terms andconditions that are o ten ar morerestrictive than what the commonconsumer would agree to. I youback up those terms and condi-tions with technology that monitorsposts, you can provide an environ-ment which allows people to havehealthy and compliant communica-

    tion without creatingan enormous amounto risk.

    And the upsidepotential is huge.With just some intel-ligent tweaks to theconsumer model, youcan leverage socialmedia so that youcreate a groundswell

    o patient support and insightthat goes a long way in develop-ing a relationship. The consumeris going to know who was therewhen they needed them.

    On the other hand, not havingguidelines is a big mistake. Be oremoving in any direction at all, youneed to have in your corporateDNA the willingness to changethe way you talk to your consum-ers. Because the way people are

    communicating witheach other is chang-

    ing, and i you dontadopt your guide-lines correctly andempower youremployees to do

    the right thing, yourun the risk o some

    un ortunate situations.

    Fie ce P m : Fi lly, w i t -diti l DTC dve ti i g g i gt be ffected by ci l medi ?Will it c ge?

    DJE: DTC advertising is goingto change with regulation to thepoint where its almost undoable.Nobodys going to pay or threeminutes to o er the necessary airbalance that will be required. Andwho wants to pay or fve ads in amagazine when one is brand-relat-

    ed and the rest is only in ormationthat goes behind it?

    One o the big things thats goingto happen in the next 12 to 24months, i not sooner, is that digitalwill be driving DTC. As [a speakerat a con erence] said, the onlyplace that real DTC belongs is onthe Internet. Instead o it just beingbranded messaging to in orm peo-ple about a brand and what diseaseit treats, its going to be more alongthe lines o in orming and educat-ing people to a whole suite o otherthings related to that drug.

    My suggestion would be themost success ul strategies or DTCwill be the ones that are drivenby digital, not where digital is anadjunct. Because the place wherepatients will be truly educated is notgoing to be a TV commercial or aprint ad, its going to be the web. l

    Last November, the FDA let thepublicand more notably, drug-makersknow that it planned toissue regulations on how pharmascould use social media. While thenew regs should hit the street bythe end o this year, thats still along time or pharma marketerswho are struggling to make theircampaigns meet existing o ineguidelines.

    The agency is starting prettymuch rom ground zero in itse orts. O fcials concede thattheres no regulation specifcallyaddressing Internet promotionseparately rom other types o pro-motion. Whats more, no regulationprohibits the use o certain typeso media to promote drugs andmedical devices.

    The question or the FDA is

    whether existing rules can bestretched to cover regulation osocial media, and i not, whatlations would best extend exisdrug and device standards to thnew tools.

    Perhaps the most basic issuthe FDA aces is determiningwhich online communications

    rom manu acturers, packersdistributors should be regulatthe frst place.

    For one thing, the agency istrying to fgure out how muchcontrol such entities should ex

    over their own content. O fciaare also trying to sort out whetdrug- and devicemakers shouldscreen and respond to commenby the public, and i so, underwhat circumstances. Not onlythat, the agency is mulling howmuch companies involved withmanu acturers o pharma proshould control content, and evedisclose their involvement.

    Where do drugmakers stand this issue? According to Johnso& Johnson, pharmas should beheld responsible or content thpost on their own site or third-psites, according to J&J presenteElizabeth Forminard and Philo

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    For years, pharmas have beenstruggling to use promotionaladvertising on the web e ectively,as the medium is ar more elasticthan traditional product packag-ing or even television advertising.While most have managed toadapt, a ew have received FDAwarnings over content that theagency perceived as lacking risk-beneft balance.

    The game has gotten morecomplex with the emergence osocial media. Not only do pharmashave to meet FDA promotionalguidelines, they also have to fgure

    out how to deal with adverse eventreports. Whats more, the problemis likely to grow more complex associal media networks emerge,merge and add new eatures.

    At the moment, drugmakersstill arent sure how to cope withadverse events reported on theweb, much less on Facebook,within tweets, in articles targetedby social bookmarking sites, orcontent on blogs.

    The FDAs current position isthat pharmaceutical companiesshould simply ollow existing guide-lines or other media when they goonline. However, that leaves ques-tions unanswered, said Areta L.Kupchyk, a DC-based partner in theli e science health industry group olaw frm ReedSmith.

    Lets say theres a websitetalking about the use o a specifc

    product, and party X says thatsomeone was killed by that prod-uct, Kupchyk said. The questionis whether pharmas should monitor[all comments to screen or thistype]. And i theyre not monitor-ing comments, do they need torespond to them at all? Do theyneed to have a disclaimer on apage o ering consumers a phonenumber to call i theyve experi-enced adverse events?

    Then theres the question o

    whether pharmas have an a frmtive obligation to mine the web social media or adverse reactireports. The FDA is mulling ovissue, but hasnt reached a concsion. Not surprisingly, drugmakaddressing a recent FDA meetinon social media promotion empcally denied that they should berequired to do such research.

    With the stakes so high, shopharmas avoid social media unthe FDA o ers ironclad guidon the adverse event issue? Nonecessarily, as long as they do care ully, argues Kalah Auchian associate with the D.C. o flaw frm Foley Hoag LLP.

    Id advise any company to tuo the comment eature o inactive websites, but I dont think

    pharmas should be a raid to usesocial media, i they use it in a that complies with the law, shesaid. Just be smart about it. Useyour intuition, and i somethinglike its wrong, check it out.

    McArthur, who spoke at theNovember hearing. A drug-maker should also discloseany material connectionbetween itsel and a con-tent provider, they said.

    On the other hand, com-ments by the public areanother matter entirely.Generally, user-generatedcontent should not be con-sidered promotional labelingor advertising, the J&Jreps argued.

    Another concern orthe FDA is how to makesure pharmas provide air,balanced and accuratein ormation in new mediachannels (such as Twitter)that dont allow or deepermessages. While websites

    may o er plenty o spaceto present complete drugin ormation, a Facebook anpage may not.

    Yet another question the agencyis examining is the use o links inpharma social media marketing.While drugmakers are not allowedto promote drugs or unapprovedpurposes, the Internet and social

    media seem to be providing themwith a loophole. At present, somepharmas provide links rom brand-ed sites to other in ormation sitesthat may contain in ormation on o -

    label uses o those drugs.Some observers consider the

    FDAs battery o questions to bethorough, but some critics stillthink the agency hasnt coveredall o its bases. Theres more

    than meets the eye here, saidJe Chester, executive director othe Center or Digital Democracy.Pharmas have presented socialmedia as mom and apple pie, but

    there will be serious consequencesi FDA allows them to use the ullarray o social media.

    Whats more, the FDA hasbypassed an issue Chester seesas critical. Drugmakers never talkabout the social media monitoringthey may be deploying, he notes.I think pharmas thought theycould pull the wool over the Com-missions eyes.

    Chester, who expects to meetwith top FDA o fcials soon, willurge them to ocus more onconsumer data collection throughsocial media. The agency didntget into privacy concerns thistime, Chester said. I think it ailedto do due diligence. l

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    a v s r ti n r p tingc nging in S i M iBy A Z

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pcfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pcf