Welcome To The Pharma Compliance Webinar - Ehcca

Welcome to the Pharma Compliance WebinarMedical Affairs Compliance ‐Lessons Learned and Best PracticesJune 7, 2016 2016 GHC LIFE SCIENCES1

Featured PresentersDisclaimer: Speakers’ remarks are their personal opinions, and should not beconsidered to represent the position of their current or former employers.June 7, 2016 2016 GHC LIFE SCIENCES2

Agenda1:00 pm Welcome, Introduction and Overview of Legal Framework and LandscapeBrian Bohnenkamp1:20 pm Strategic Planning and the Interface between Medical Affairs and MarketingBrian Conner1:40 pm Customer‐Facing Medical Affairs Roles: Medical Affairs Interactions withHCPs and Managed Markets AccountsKevin Ryan2:00 pm Medical Affairs: Operations and MeasurementKevin Espinoza2:20 pm Q&A2:30 pm Webinar AdjournmentJune 7, 2016 2016 GHC LIFE SCIENCES3

Who’s on the Line?A few polling questions Note: Individual responses will be protected for anonymity. Only aggregate data will be reported andmade available after the webinar concludes. Benchmarking is conducted solely to provide industrybenchmarks regarding compliance program issues. There is no purpose to agree among companies onany specific compliance policy or procedure. Companies should decide on their own how to develop andimplement their compliance programs.June 7, 2016 2016 GHC LIFE SCIENCES4

POLL 1: What’s your role?June 7, 2016 2016 GHC LIFE SCIENCES5

POLL 2: How big is your company in terms ofannual revenue (roughly)?June 7, 2016 2016 GHC LIFE SCIENCES6

POLL 3: Does your company have a distinctMedical Affairs Department?June 7, 2016 2016 GHC LIFE SCIENCES7

POLL 4: How many FTEs work in US Medical Affairsfunction? (even if not a distinct Medical Affairs dept)June 7, 2016 2016 GHC LIFE SCIENCES8

Overview of Legal Framework andLandscapeBrian BohnenkampJune 7, 2016 2016 GHC LIFE SCIENCES9

Medical Affairs is Not Special “FDA holds the medical affairs department to thesame standards as it does sales reps. It’simportant to keep from blurring the linesbetween promotion and responses to unsolicitedrequests.” “Just because you have a person with a differenthat in a different booth, if they are promoting adrug [providing off‐label information is still]against the law.”June 7, 2016 2016 GHC LIFE SCIENCESTom Abrams,Director of FDA'sOffice of Prescription DrugPromotion (OPDP)10

Overview of Legal FrameworkNo statutory or regulatory requirement to have a Medical Affairsdepartment or functionAs a general matter, the same laws and regulations apply to MedicalAffairs personnel that apply to Sales and Marketing personnel. Thisincludes, but is not limited to: The Food, Drug, and Cosmetic Act The Anti‐Kickback StatuteA primary purpose of Medical Affairs should be to help ensure that non‐promotional interactions remain appropriately non‐promotional andare not tainted by Sales and Marketing considerations or influence Company organizational structure, processes, and incentives also should bedesigned and administered to avoid inappropriate influence or theappearance of inappropriate influenceJune 7, 2016 2016 GHC LIFE SCIENCES11

Promotionvs.Scientific ExchangeNo official FDA definitionNo official FDA definitionGenerally, would include express or impliedwritten or oral statements distributed to or madeto customers and/or patients by a company or itsrepresentatives with the intent to proactivelycommunicate attributes (e.g., safety,effectiveness, indication, etc.) of company‐promoted products and their useTypically understood to refer to the dissemination anddiscussion of scientific research / medical findings, withoutmaking promotional claims about a productExamples: Sales aids, brochures, notes, email messages,blog postings, social media, website materials,videos, etc. Proactive statements made during in‐person,phone, or email discussions with HCPsExamples of practices commonly understood to be scientificexchange: Responding to unsolicited requests for off‐labelinformation in accordance with FDA draft guidance Distributing scientific and medical publications on off‐label uses in accordance with FDA draft guidance Providing financial support for independent medicaleducation programs Appropriate scientific discussions at legitimatescientific or medical conferences Scientific advisory meetings/focus groups, inappropriate circumstances and with limitations Appropriate communications intended for recruitmentof clinical investigators and study subjectsJune 7, 2016 2016 GHC LIFE SCIENCES12

First Amendment CasesUnited States v. Caronia (2d Cir. 2012) Construes misbranding provisions not to criminalize truthful, non‐misleadingspeech about off‐label uses to avoid First Amendment violationPacira v. FDA (S.D.N.Y.) (dec. action, settled in 2015) Settlement with FDA permits company to market product for specific proceduresnot limited to those studied in the product’s pivotal trialsAmarin v. FDA (dec. action, settled 2016) Settlement with FDA provides that Amarin may engage in “truthful and non‐misleading speech promoting the off‐label use of [the product] . . ., and underCaronia, such speech may not form the basis of a prosecution for misbranding”United States v. Vascular Solutions, Inc. (W.D. Tex.) (acquittals in 2016) Jury instructions stated: “It is also not a crime for a device company or itsrepresentatives to give doctors wholly truthful and non‐misleading informationabout the unapproved use of a device. If you find that VSI's promotional speechto doctors was solely truthful and not misleading, then you must find theDefendants not guilty of the misbranding offense.”June 7, 2016 2016 GHC LIFE SCIENCES13

POLL 5: In response to the court decisions regarding the FirstAmendment, what changes in compliance rules is yourcompany considering:June 7, 2016 2016 GHC LIFE SCIENCES14

POLL 6: What status applies to your company:June 7, 2016 2016 GHC LIFE SCIENCES15

Enforcement ExamplesU.S. enforcement authorities are sensitive to Medical Affairs departments engaging inimproper Sales or Marketing activities and/or being inappropriately influenced by Salesand Marketing considerationsSettlements involving Medical Affairs activities have included allegations of, among otherthings Promoting MSLs based on ability to sellFunding CME on off‐label uses and creating and controlling contentTraining MSLs to prompt off‐label questionsPaying HCPs to speak on off‐label usesDeveloping KOLs to support and promote off‐label usesUsing advisory boards to promote off‐label usesUsing IIS grants to promote off‐label usesGhostwriting articles on off‐label usesMSLs accompanying sales reps on in‐office visits and providing presentations on off‐label usesCreating teams of Reimbursement, Sales, and Medical personnel to track off‐labelpromotion and use and to target HCPs for visits by MSLs Preparing and publishing a misleading journal article that misreported clinical trial results Publicizing and circulating positive study results and failing to discuss negative study resultsJune 7, 2016 2016 GHC LIFE SCIENCES16

CIA RequirementsMany recent CIAs require manufacturers to implement at least some ofthe following measures: Creation of policies/procedures to control provision of off‐label information byMedical Affairs personnel Creation of policies/procedures to require sales reps to refer requests foroff‐label information to Medical Affairs Development and maintenance of inquiries databases to track and monitorHCP requests for off‐label information and company responses Policies/procedures related to the manner and circumstances under whichMedical Affairs personnel participate in meetings or events with HCPs (eitheralone or with sales reps or account executives) and the role of the MedicalAffairs personnel at such meetings or events Representations that Sales and Marketing departments have no involvement inmedical education grants or charitable contribution requests, and that all suchgrants requests will be processed in accordance with standardized criteriadeveloped by Medical Affairs Requirements to develop annual publication plans and establish a publicationmonitoring programJune 7, 2016 2016 GHC LIFE SCIENCES17

Strategic Planning and the Interfacebetween Medical Affairs and MarketingBrian ConnerJune 7, 2016 2016 GHC LIFE SCIENCES18

Commercial and Medical AffairsAlignmentWhat is the appropriate firewall between Medical Affairs andCommercial?The changing healthcare environment has encouraged the formation ofindependent Medical Affairs departmentsThere is not a rigid set of requirements that dictate how a Medical Affairsdepartment should look or operateAs a result, the industry has developed a wide variety of models, allseeking to address intensified public and regulatory scrutinyTypical models:1. Prohibit all communication between medical affairs and commercial2. Allow open communication between medical affairs and commercial3. Establish guardrails and protocols to allow compliant communicationbetween medical affairs and commercialJune 7, 2016 2016 GHC LIFE SCIENCES19

Commercial and Medical Affairs AlignmentDisease analysis andindication sequencing Initial commercialopportunity assessmentand revenue target Initial access environmentassessment Long range forecast Market positioning strategyand messagingCompetitive monitoring andresponse Access planning (payerneeds, by country)Marketing strategyevolution New indications,formulations, publications Pre/peri LOE planning Franchise/portfolio planning Product concept/TPPtesting HEOR requirements Field resourcing (sales,clinical, scientific support)Medical Affairs Functions (Examples) MedicalEducation Scientific CommunicationsInvestigatorManagement/IIS MSLManagement SurveillanceKOL Engagement andRelations Publications Trial Design and Demonstration Clinical Context/Expertise June 7, 2016 2016 GHC LIFE SCIENCES20

Commercial and Medical Affairs AlignmentKeyKey LifeLife SciencesSciences TrendsTrendsMedicalMedical AffairsAffairs ImperativesImperatives MoreMore aggressiveaggressive andand sophisticatedsophisticatedaccessaccess managementmanagement OutcomesOutcomes metricsmetrics beingbeing usedused moremorebroadlybroadly (indications,(indications, payers)payers) ProviderProvider integrationintegration andand ITIT investmentinvestmentasas enablerenabler ofof HECON--andHECON--and newnew payerpayeraudienceaudience EmergenceEmergence ofof newnew decision-makersdecision-makers(e.g.(e.g. hospitalhospital admin,admin, hospitalists,hospitalists,patients/patients/ advocacy,advocacy, etc.)etc.) IncreasinglyIncreasingly patientpatient centriccentric (and(andlongitudinal)longitudinal) approachapproach toto carecare deliverydelivery IncreasingIncreasing biopharmabiopharma andand medtechmedtechreliancereliance onon emergingemerging marketsmarketsJune 7, 2016 AddressAddress shiftshift inin definitiondefinition ofof valuevalue andandassociatedassociated informationinformation requirementsrequirements EngageEngage newnew stakeholdersstakeholders andand tailortailorcontentcontent ofof communicationcommunication accordinglyaccordingly EmbraceEmbrace “patient“patient journey”journey” approachapproach UnderstandUnderstand andand harnessharness new,new, digitaldigitalmediamedia channelschannels wherewhere appropriateappropriate BuildBuild expertiseexpertise andand structurestructureorganizationorganization inin aa wayway thatthat addressesaddressesneedsneeds (region(region specific)specific) execute execute inin anan increasinglyincreasingly rigorousrigorousandand transparenttransparent regulatoryregulatoryenvironmentenvironment 2016 GHC LIFE SCIENCES21

POLL 7: Does the current Strategy for yourCommercial activity align with the MedicalAffairs Dept?June 7, 2016 2016 GHC LIFE SCIENCES22

POLL 8: Does Medical Affairs provide input intoCommercial strategic planning?June 7, 2016 2016 GHC LIFE SCIENCES23

POLL 9: Does Compliance have a role in thestrategic planning process?June 7, 2016 2016 GHC LIFE SCIENCES24