social media, rx promotion, & fda, part1

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

johnmack@virsci.com

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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

8

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

10

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

15

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

johnmack@virsci.com

215-504-4164215-504-5739 (Fax)