Speaker Programs Risks and Rewards. Presented by: Alan G. Minsk Partner, Arnall Golden Gregory LLP and Alliance Legal Counsel

Transcription

1 Speaker Programs Risks and Rewards Presented by: Alan G. Minsk Partner, Arnall Golden Gregory LLP and Alliance Legal Counsel

2 What is a Speaker Program! Company-Sponsored Program! Typically, medical peer-to-peer to educate about a company s product and a particular healthcare professional s experience with the product! Should be educational in providing information about the product s benefits, risks, and FDA-approved uses 2

3 What is PotenCal a Speaker Risks Program! FDA requirements on product information dissemination e.g., on label, truthful, fair balance! False Claims Act no off-label promotion of a reimbursable product! Anti-kickback engage speaker for general medical expertise, reputation, knowledge, and experience in the therapeutic space! employ only an appropriate number of speakers and be consistent with business needs do not engage speaker as an inducement or reward for prescribing a particular medicine or course of treatment do not create speaker programs merely to keep speaker and attendees happy with money and personal benefits 3

4 What PotenCal is a Speaker Risks Program (cont d) inviting same audience members to hear same message and feeding them PhRMA and AdvaMed Codes reiterate these points! Competitive challenge! State prosecution! Non-compliance with industry standards e.g., sales rep attending meals with doctors outside office, venue not conducive to educational presentation! Product liability 4

5 Where What is Do a You Speaker Find Program Speakers! Company s personal experience or familiarity leader in therapeutic space, authors, faculty, clinical experts good reputation! Third-party vendors may help identify potential speakers 5

6 What VeLng is a Speakers Program! Company (primarily Compliance Department) should vet speaker proper qualifications expertise, experience, knowledge with therapeutic area not engaged to encourage future prescriptions licensed no disciplinary actions or issues typically, should not be engaged by both Medical and Commercial to speak, so to minimize appearance that company is merely creating opportunities to personally benefit the speaker, who is likely a prescriber! Company policies and procedures should describe criteria for selecting and vetting speakers 6

7 What Fair is a Market Speaker Value Program! Reasonable compensation for time to prepare and present, considering the value of the services performed no government-set amount, but due diligence and independent calculations maximize a fair compensation amount! Should have a company standard for FMV for consistency and uniformity! Any exceptions to normal FMV compensation should be evaluated by the company s Compliance Officer 7

8 What Fair is Market a Speaker Value Program (cont d)! Cap total amount of annual compensation to a particular doctor for all engagements to minimize unduly benefitting one specific prescriber or finding unlawful ways to benefit personally the prescriber/speaker! Compensation should be included in a consulting agreement! Remember Sunshine and state reporting laws sign-in for attendees/capture data don t merely say well, others do it this way 8

9 What is Monitoring a Speaker Program! Companies should monitor speaker programs to ensure the speaker is using company-approved materials, staying on-label and truthful message, and otherwise following FDA requirements relating to information dissemination! Speakers should not unilaterally change or modify materials 9

10 What Monitoring is a Speaker (cont d) Program! Monitor invitations to, and participation of, repeat attendees unless there is something new that an attendee doesn t know, inviting the same audience member to benefit from a free meal might be perceived as an inducement or thank you for prescribing a company s product! Compliance Officer or designee should conduct monitoring, not Commercial or Sales! either have Compliance attend programs (or, if necessary, delegate to third-party vendor but have vendor prepare an audit report) " but try to have a Compliance representative attend as often as possible 10

11 What is a Speaker Program RecommendaCons to Maximize Compliance! Vetting of speakers and programs for compliance! Consultant agreement (personal services agreement) to ensure FDA and healthcare requirements are met! Training on FDA promotional requirements! Have speakers use only company-approved materials, which have been reviewed by medical, regulatory, and legal! Audit and monitor to ensure the speaker is following regulatory and company rules 11