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SocialMedia,RxPromo1on,&FDA
Results of a survey ofreaders & followers ofPharma Marketing News,Pharma Marketing Blog,and @pharmaguy
John MackPublisher, Pharma marketing News &Pharma Marketing Blog@pharmaguy on Twitter
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JohnMackhasBeenHere,DoneThis
Tes1fiedasPanelMemberduring1996FDA
HearingonInternet
Co‐FoundedInternetHealthcareCoali1on(1997)
Co‐AuthoredtheeHealthCodeofEthics(2000)
Bloggedaboutpharmaceu1calmarke1ngbest&
worstprac1cessince2005
Creatorof“PhRMAIntern”and“FDAIntern”—
strangebedfellowsormortalenemies?
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Publica1ons&SocialMediaAccounts
PharmaMarke1ngNews
− MonthlyelectronicnewsleZer
− 6,880opt‐insubscribers
− Eighthconsecu1veyearofpublica1on
− www.news.pharma‐mk1ng.com
PharmaMarke1ngBlog
– 20,000visitspermonth
– pharmamk1ng.blogspot.com/
PharmaGuyTwiZerAccount
– 4,750Followers
– TwiZer.com/pharmaguy
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SurveyOverview
Online—started20September2009
IncludesAll19ques1onsforwhichFDAseeksanswers
Talliesvotesonspecificanswers/solu1ons
Plus575comments
354Respondentsasof1November2009
126Blogreaders
101PMNsubscribers
64TwiZerfollowers
45Websitevisitors
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Part1
Accountability,Disclosure,Correc1ons
FulfillingRegulatoryRequirementswithRegardtoFair
BalanceandSubmissionforReview
Pos1ngCorrec1veInforma1on
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Accountability:BestPrac1ces
DISCLOSUREofinvolvementwithorinfluenceover3rd‐partysocialmediacontentshouldbeprominentlydisplayedalongsiderelevantcontentwhenpossible.
Halfofsurveyrespondentsagree*
EachcompanyshouldhaveaPublicSocialMediaPolicy(SMP)thatincludesano1ceofitstransparency/disclosureandotherpoliciesrela1ngtosocialmedia.[JustlikeeverypharmacompanyhasapublicprivacypolicythatappliestoallitsproductWebsites,eachpharmacompanyshouldhaveapublicSMPthatappliestoallitssocialmediaac1vi1es,whetherownedorsponsoredbythecompany.]
Abouttwo‐thirdsofsurveyrespondentsagree*
Companiesshouldmonitorsocialmediasitesforunauthorizeduseormodifica1onofitsapprovedcontentandmakeabestefforttoremoveorcorrectthecontent.ButtheyshouldonlybeREQUIREDtodosoonlyforsitesownedordirectlysponsoredbythem.
*Seeslide#7
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Disclosureof3rd‐PartyContentInvolvement
How should companies disclose their involvement or influence over discussions or material,particularly discussions or material on third-party sites?
Disclosureisnecessaryonlywhencontentispaidfor
Disclosureshouldbeprominentlydisplayedalongsiderelevantcontentwhenpossible
Disclosureanddisclaimersshouldbeincludedprominentlyonthecorporatewebsitenearanylinkstosocialmediaoutlets
EachcompanyshouldhaveapublicSMpolicythatincludesano1ceofitstransparencypolicies
Accountability
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InfluenceOver3rd‐PartyContent
What parameters or criteria should be applied to determine when third-party communicationsoccurring on the Internet and through social media technologies are subject to substantiveinfluence by companies that market products related to the communication or discussion?
Marketeroragentpaidforanadonthepagethatisdisplayedbasedonthecontentofthepage(eg,GoogleAdwordoncontentsites)
Marketeroragentpaidforthecontent(eg,paidbloggerorTweetertowriteaboutproduct)
Anycommunica1onbyanyonethatisemployedby,orisaconsultantof,themanufacturershouldbeheldaccountable
Accountability
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Independenceof3rd‐PartyContent
When should third-party discussions be treated as being performed by, or on behalf of, thecompanies that market the product, as opposed to being performed independent of theinfluence of the companies marketing the products?
sponsorsthediscussion(eg,providesaspecificgranttoindependent3rd‐partyhostsuchasapa1entadvocacygrouptosponsorthediscussion)
paidforthecontent(eg,paidpa1entsfortes1monialsorotherwiseprovidedcompensa1on)
paidfordisplayadstoberunonspecificdiscussionpages(eg,onlydiscussionsrelatedtotheproductadver1sed)
Whenmarketeroragent
Accountability
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SpecialMedia/AudienceConsidera1ons?
Are there different considerations that should be weighed depending on the specific social mediaplatform that is used or based on the intended audience? If so, what are these considerations?
Spacelimita1ons(eg,TwiZervs.YouTube)
Pa1entsvsHCPs
Marke1ngvsDiseaseawareness
UGCvsPharma‐generatedcontent
ChildrenvsAdults
Someconsidera1ons:
Accountability
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SMSitesSeenwithUnauthorizedContent
With regard to the potential for company communications to be altered by third parties, what is theexperience to date with respect to the unauthorized dissemination of modified product information(originally created by a company) by noncompany users of the Internet?
productinforma1ononYouTube
productinforma1onpagesinWikipedia
productTwiZeraccounts
ProductBlogs
communica1onsindiscussionboards
GoogleSidewikicommentsondrug.comsites
Unauthorized…
Accountability
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FairBalance:KeyLearnings
Mediaagnos1cregula1onsarenotpopularamongindustryexperts*.
The“One‐ClickRule”isdesiredbytheindustry*.However,mostorenittakestwoclickstoreachtheapprovedlabeling(PI).SincethePIisvirtuallyunreadable,thereneedstobeabeZerwaytoprovidethefairbalanceregardlessofthenumberofclicks!
Therearesomeideasfordealingwithspacelimita1onsimposedbycertainsocialmediaapps**.
UseofhashtagsinTweets,forexample.
*Seeslide#13,**Seeslide#14
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HowtoReferenceRiskInforma1on
How should product information be presented using various social media tools to ensure that theuser has access to a balanced presentation of both risks and benefits of medical products?
NomaZerthemedia,allproductadsshouldincludemajorriskinforma1onalongwithbenefits(mediaagnos1c)
Whenitisnotpossibletoincludemajorriskinforma1onduetospacelimita1ons,itissufficienttoincludealinktotheproductWebsitewhereconsumerscanthenfindallthenecessaryriskinforma1oninthepackageinsert(2‐clickrule)
Whenitisnotpossibletoincludemajorriskinforma1onduetospacelimita1ons,itissufficienttoincludealinkdirectlytothepackageinsert(1‐clickrule)
Regulatory Requirements
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AreThereSolu1onsforSpaceLimita1ons?
Are there proposed solutions that may help address regulatory concerns when using social mediatools associated with space limitations or tools that allow for real-time communications topresent product information?
“A1‐clicklinktothePIortheAE'sinthePIismorethansufficient,wearenotanannystate!Givepeopletherightinforma1onandletthemprocessit.”
“productscanbeassignedhashtagsbyFDA,foraTwiZerexample(eg#Chillax),andberequiredtousethathashtaginallTwiZercommunica1onsrelatedtothatproduct,sothatFDAcaneasilyreviewthepublictweets.NotsurehowtheDMswouldbemonitored.SimilarrulesforotherspecificSMsites”
Regulatory Requirements
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DoesPresenta1onFormatImpactHealth?
Are there data to support conclusions about whether different types or formats of presentationshave a positive or negative impact on the public health?
“Arerextensiveresearchaboutsocialmedia,Ihavenotcomeacrossanydatatoconfirmtheimpactofsocialmediaonpublichealth”
“Wordofmouth(ie,communi1es)haveimpactoverpublicpercep1on,comparedtoclearlylabeledadver1sements”
“26%ofpurchasedecisionsbeingmadethroughsocialmedia(Comscore)”
“Thepowerofsocialmediahasbeenshowntoinfluenceposi1velifestylebehaviormodifica1onaroundsmokingcessa1on”
Regulatory Requirements
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RegulatoryRequirements:KeyLearnings
Someinnova1veideasforfulfillingregulatoryrequirementstosubmitsocialmediapromo1onalmaterialstoFDAweresuggested*,including:
RegistersiteswithFDAforagencytomonitor
Submit“template”(designand/orsamplecontent)ofsocialmediasitetoFDAforpre‐approval/approval
Buttherewasnoconsensusopinionaboutsa1sfyingregula1onsregardingsubmissionofsocialmediapromo1onalmaterials.
Toostringentregula1onswillpreventcompaniesfromcarryingontwo‐waysocialmediaconversa1onswithconsumersandHCPs.Suchconversa1onscanhaveabeneficialimpactonpublichealth,especiallywhenclarifyingorcorrec1ngmisinforma1on.
*Seeslide#17
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HowtoSubmitSMContentforFDAApproval
How should companies address the potential volume of information shared on various socialmedia sites with regard to real-time information that is continuously posted and regulatoryrequirements to submit promotional materials to FDA as applicable?
FDAShouldAuditSocialMediasitesonregularbasis‐‐eg,yearly(requiresmandatoryregistra1onofsiteswithFDA)
Drugcompanyshouldsubmitonlycontentthatitisresponsiblefor(ie,createddirectlyorpaida3rdpartytocreate)assoonasthatcontentisposted(nosubmissionofnon‐companycontent)
Drugcompanyshouldsubmitonlycontentthatthatitcreates(ie,createddirectlyorpaida3rdpartytocreate)uponfirstuseofsocialmediasite,thenperiodic‐‐eg,monthly‐‐submissionsarerward(nosubmissionofnon‐companycontent)
SubmitSocialMediaSite'template'(designand/orsamplecontent)toFDAforpre‐approval/approval.
Regulatory Requirements
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ParametersforCorrec1ngMisinforma1on
Are there any parameters or criteria that could be used to determine the appropriateness ofcorrecting misinformation and/or scope of information a company can provide when trying tocorrect misinformation on a Web site outside a company's control?
ONLYmisinforma1onofrealandimminentdangertothepublichealth(tobedeterminedbycompany)shouldbecorrected
ALLoff‐labelclaims—evenifsupportedbypeer‐reviewedmedicalliterature—shouldbecorrected)
Onlyoff‐labelclaimsNOTsubstan1atedbypeer‐reviewedmedicalliteratureshouldbecorrected)
CompaniesshouldnotbeburdenedbyFDAregula1onsrequiringthemtomakecorrec1onsaboutANYproductmisinforma1onpublishedonthird‐partysites
Posting Corrective Information
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ContactInforma1on
John Mack
Follow me on Twitter:http://twitter.com/pharmaguy
Facebook page:http://www.facebook.com/pharmaguy
www.news.pharma-mkting.comwww.pharmamkting.blogspot.com
215-504-4164215-504-5739 (Fax)
