2 Disclaimer The views expressed in this presentation are the views of the facilitators and do not necessarily represent the views or policies of our employer.
5 Why do we have Speaker Compliance Guidelines and Training? Pharmaceutical companies are responsible for activities conducted by or on behalf of that Company Considerations when engaging Speakers/Consultants: Speakers are acting on behalf of your Company Speakers are held to the same regulatory standards as your Company employees Speakers should only use your Company approved slide deck and materials Speakers should have fully executed contract in place with your Company 5
7 FDA Monitoring The FDA monitors company controlled activities by the pharmaceutical industry, examples include: Including complaints from speaker program attendees regarding inappropriate activities FDA s Bad Ad Program The FDA has cited companies and speakers for violations made by their speakers Such letters are made public on the FDA website
8 The Compliance Environment Compliance policies are based on government laws, regulations, industry codes and company guidelines Non-compliance can result in: Industry Fines Corporate Integrity Agreements (CIA) Government exclusion from federal health care programs (Medicare and Medicaid)
10 Criteria, criteria, criteria What does the selection process look like within your company? Where do speaker recommendations originate? How has Open Payments impacted speaker availability? Expected qualifications well documented? National/Regional/Local designations? Minimum requirements for continued participation?
11 Example Selection Process Criteria National Faculty Criteria Tier 1 Tier 2 Tier 3 Primary Considerations: -Years since Post Graduate Completion Professional Organizations (medically related) Presentations (includes promo, grand rounds, CME, etc.) Publications (includes articles & abstracts) Research experiences/trials Yes Yes No Optional Considerations: -Academic Appointments Yes Yes No -Previous Speaker Bureau experience (any company) Yes Yes No Minimum # of Qualifications Met: Minimum Primary Criteria Met
13 Speaker training, what does it look like? Who in your company is responsible for designing, creating and executing Speaker Training? Is there a standardized process? How is it executed? Live, virtual, other? How are you addressing scenarios where speakers cannot attend training? How are they trained to handle: Unsolicited off-label questions? Questions regarding reimbursement? Reports of Adverse Events or Product Quality Complaints? How do you handle speaker requests to modify or add slides? Speaker provides an additional handout to the audience, not company approved
14 Purpose of Programs GOAL Provide Truthful, Balanced and Accurate information about our company products to Health Care Professionals and Patients Promotional speakers : Remain on-label Provide information that is truthful and not false/misleading Provide fair-balance with product risk/benefit Only use the slide deck approved and provided by the Company Not solicit off-label inquiries
15 What is Considered Off-Label? Information not consistent with the FDA-approved PI is considered off-label Although physicians may prescribe or use products for off-label uses, the FDA currently prohibits pharmaceutical companies, and consequently any employees or representatives engaged in selling or marketing the Company's products, to promote those unapproved, or off-label uses
16 Program Watch Outs Promotional Speakers : Proactively discuss off-label use of the product Broaden of product indication Present data out of context Minimize safety issues Omit material information Compare efficacy or safety claims without substantial evidence Overstate efficacy or safety
18 Employee Training Beyond the standard HCC training, does your company conduct additional training for employees regarding Speaker Programs? What resources or tools do you make available? Does on-the-job training come into play? If so, is it standardized?
20 Summary: Company Representatives Provide attendees with Package Insert or company approved materials with Package Insert Should not interject while speaker is presenting approved content or solicit speaker to discuss off-label information Address speaker should he or she solicit discussions on off-label information Complete the speaker evaluation Report any non-compliance to manager and Health Care Compliance Officer immediately.
22 Mitigating Risks What safeguards do you have established regarding compliant speaker programs? Observations what is your process? How are observations allocated? Risk based?? Who conducts observations? How are they trained? Process for scheduling? Heads up vs. show up? Third-Party Vendor what is the scope of their role in this process? Other ways to mitigate risk?
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