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Presentation made by John Mack at November 12-13, 2009 FDA public hearing on regulating pharmaceutical promotion on Internet and social networks. Covers issue:Adverse Event Repor1ng
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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
johnmack@virsci.com
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SurveyOverview
Online—started20September2009
IncludesAll19ques1onsforwhichFDAseeksanswers
Talliesvotesonspecificanswers/solu1ons
Plus575comments
354Respondentsasof1November2009
126Blogreaders
101PMNsubscribers
64TwiUerfollowers
45Websitevisitors
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Part2
AdverseEventRepor1ng
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AdverseEvents:SummaryofFindings
Vastmajorityof“AdverseExperiences”reportedonsocialmediasitesdoNOTmeettherequirementsforAErepor1ng
Greatmajorityofrespondents(upto87%)agree*
Althoughtherearemonitoringtoolsavailable,theresourcesrequiredtomonitorallsocialmediasitesforadverseeventsarenotjus1fiable
Consequently,fewcompanieshavestandardopera1ngproceduresforprocessingadverseeventinforma1onfromsocialmediasites
However,pharmacompaniescanhelpconsumersreportadverseeventsdirectlytotheFDAusingsocialmediatoolssuchaswidgetsplacedondrug.comWebsites(seeslide#9).
*Seeslide#5
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SocialMediaAEChallenges
What challenges are presented in handling adverse event information from these sources?
Theamountofinforma1onfromthesesourcesispoten1allytoovasttobeprocessedeconomically(lackofresources)Findingadverseeventinforma1onfromthesesourcesislikefindinganeedleinahaystack(toodaun1ng)
Theinforma1onisusuallyincompleteanddoesnotmeettherequirementsforsubmigngameaningfulAER(notac1onable)
Therearemanypoten1alissuesthatwon'tfullybeknownun1ltheprac1ceofmonitoringsocialmediaforAEsismoreprevalent(unknownissues)
Adverse Event Reporting
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SocialMediaAEUncertain1es
What uncertainties are there regarding what should be reported from these sources to meet FDAadverse event reporting obligations?
Uncertaintyregardingthetrueiden1tyofthereporter(anonymoussource)
Uncertaintyregardingthetrueiden1tyofthepa1ent(nopa1entnamed)
Uncertaintyregardingtheiden1tyofthedrug(eg,reporterrefersto"sleeppill"ratherthanbrandnameofdrug)
Uncertaintyregardingtheseriousnessoftheeventreported
Adverse Event Reporting
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MonitoringAEsonSocialMediaSites
How are entities with postmarketing reporting responsibilities and other stakeholders using theInternet and social media tools with regard to monitoring adverse event information about theirproducts?
Useofautomatedkeywordsearchesofselectedsocialmediasitesbyspecializedagenciesand/orprofessionals
IntermiUentsearchesofselectedsocialmediasitesperformedbycompanypersonneloragents
IntermiUentsearchesofSEARCHENGINESperformedbycompanypersonneloragents
Rou1neandautomatedkeywordsearchesofTWITTER(eg,performedbySocialOomphorotherservices)
Useofsocialmediamonitoringtoolsthatdonotincludekeywords
Adverse Event Reporting
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ProcessingSocialMediaAEInforma1on
How is adverse event information from these sources being received, reviewed, and processed?
Specialgroupwithinthecompanyisresponsibleforreceiving,reviewing,andprocessingAEs
ReceivingandprocessingAEsisoutsourcedtoaspecializedagency;reviewishandledin‐housetodeterminewhichAEsneedtobereportedasrequiredbylaw
WehavenoSOP(StandardOpera1ngProcedure)forreceiving,reviewing,andprocessingAEsfromthesesources
Adverse Event Reporting
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AERepor1ngSafeHarborWidget“One‐Click”AccesstoFDAand/orPharmacoAERepor=ngSystem
Pharmaceu1calcompaniesthatpostapprovedwidgetsontheirdrug.comWebsitesshouldbeallowedtomonitor3rd‐partysocialmediasiteswithouttheneedtoreportanypoten1aladverseeventstheymaycomeacross.
OnSaleOutsideorOnline
Hoping for HelpfulGuidelines, but NotExpecting Any
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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)
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